MyHealth@Eu Laboratory Report
9.1.1 - trial-use 150

This page is part of the MyHealth@Eu Laboratory Report (v9.1.1: Wave 9) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: ObservationResultsLaboratoryMyHealthEu - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the Observation-resultslab-lab-myhealtheu resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Observation
Definition

This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations


Measurements and simple assertions made about a patient, device or other subject.

ShortLaboratory result for a simple test or for a panel/studyMeasurements and simple assertions
Comments

Represents either a lab simple observation or the group of observations produced by a laboratory study.


Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

Control0..*
Is Modifierfalse
Impose ProfileThis profile also requires that the instance also conform this additional profile:
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
obs-value-1: The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously. (value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.extension:bodyStructure
Slice NamebodyStructure
Definition

R5: Observation.bodyStructure (new:Reference(BodyStructure))

ShortR5: Observed body structure (new)
Comments

Element Observation.bodyStructure has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.bodyStructure has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Only used if not implicit in code found in Observation.code or bodySite is used. In many systems, this may be represented as a related observation instead of an inline component.

Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(R5: Observed body structure (new)) (Extension Type: Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4, BodyStructure))
Is Modifierfalse
Summaryfalse
Requirements

EHDSObservation.anatomicLocation

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Observation.extension:triggeredBy
Slice NametriggeredBy
Definition

R5: Observation.triggeredBy (new:BackboneElement)

ShortR5: Triggering observation(s) (new)
Comments

Element Observation.triggeredBy has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(R5: Triggering observation(s) (new)) (Complex Extension)
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Observation.extension:triggeredBy.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control20..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 10. Observation.extension:triggeredBy.extension:observation
    Slice Nameobservation
    Definition

    An Extension

    ShortExtensionAdditional content defined by implementations
    Control10..1*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    12. Observation.extension:triggeredBy.extension:observation.extension
    Definition

    An Extension


    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortExtensionAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..0*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 14. Observation.extension:triggeredBy.extension:observation.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed Valueobservation
      16. Observation.extension:triggeredBy.extension:observation.value[x]
      Definition

      Reference to the triggering observation.


      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      ShortTriggering observationValue of extension
      Control10..1
      TypeReference(Observation: Medical Test Result (Core)), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summaryfalse
      Requirements

      EHDSObservation.triggeredBy[x]

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. Observation.extension:triggeredBy.extension:type
      Slice Nametype
      Definition

      R5: Observation.triggeredBy.type (new:code)

      ShortR5: reflex | repeat | re-run (new)Additional content defined by implementations
      Comments

      Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control10..1*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Requirements

      Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      20. Observation.extension:triggeredBy.extension:type.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed Valuetype
      22. Observation.extension:triggeredBy.extension:type.value[x]
      Definition

      The type of trigger. Reflex | Repeat | Re-run.


      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      Shortreflex | repeat | re-runValue of extension
      Control10..1
      BindingThe codes SHALL be taken from For codes, see R5ObservationTriggeredbytypeForR4 (0.1.0)
      (required to http://hl7.org/fhir/uv/xver/ValueSet/R5-observation-triggeredbytype-for-R4|0.1.0)

      The type of TriggeredBy Observation.

      Typecode, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. Observation.extension:triggeredBy.extension:reason
      Slice Namereason
      Definition

      R5: Observation.triggeredBy.reason (new:string)

      ShortR5: Reason that the observation was triggered (new)Additional content defined by implementations
      Comments

      Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..1*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Requirements

      Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      26. Observation.extension:triggeredBy.extension:reason.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed Valuereason
      28. Observation.extension:triggeredBy.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
      30. Observation.extension:triggeredBy.value[x]
      Definition

      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      ShortValue of extension
      Control0..01
      TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. Observation.extension:value-r5
      Slice Namevalue-r5
      Definition

      When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.value[x] element using the cross-version extension.

      Shortonly for Diagrams or Pictures
      Comments

      Element Observation.value[x] is mapped to FHIR R4 element Observation.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.value[x] do not cover the following types: Attachment, Reference. The target context Observation.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.

      • An observation may have:
        1. a single value here
        2. both a value and a set of related or component values
        3. only a set of related or component values.
      • If a value is present, the datatype for this element should be determined by the code.
      • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
      • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
      • For additional guidance, see the Notes section below.
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      34. Observation.extension:value-r5.extension
      Definition

      An Extension


      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortExtensionAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 36. Observation.extension:value-r5.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
        38. Observation.extension:supportingInfo
        Slice NamesupportingInfo
        Definition

        Other resources from the patient record that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension should not be used if more specific inline elements or extensions are available. For example, use Observation.hasMember instead of supportingInformation for representing the members of an Observation panel.

        ShortOther information that may be relevant to this event.
        Control0..*
        TypeExtension(Supporting info) (Extension Type: Reference(Resource))
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        40. Observation.extension:labTestKit
        Slice NamelabTestKit
        Definition

        The laboratory test kit used for this test.

        ShortLaboratory Test Kit
        Control0..*
        TypeExtension(Device Laboratory Test Kit) (Extension Type: Reference(Device))
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        42. Observation.extension:certifiedRefMaterialCodeable
        Slice NamecertifiedRefMaterialCodeable
        Definition

        This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using a CodeableConcept. This extension should be used when the unit is UCUM [IU].

        ShortCertified Reference Material: CodeableConcept
        Control0..*
        TypeExtension(Certified Reference Material: CodeableConcept) (Extension Type: CodeableConcept)
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        44. Observation.extension:certifiedRefMaterialIdentifer
        Slice NamecertifiedRefMaterialIdentifer
        Definition

        This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using an Identifier. This extension should be used when the unit is UCUM [IU].

        ShortCertified Reference Material: Identifier
        Control0..*
        TypeExtension(Certified Reference Material: Identifier) (Extension Type: Identifier)
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        46. Observation.extension:accredited
        Slice Nameaccredited
        Definition

        Indicates that this laboratory test was/is accredited.

        ShortAccredited test
        Control0..1
        TypeExtension(Laboratory Accredited) (Extension Type: boolean)
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        48. Observation.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
        Summaryfalse
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        50. Observation.basedOn
        Definition

        A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

        ShortFulfills plan, proposal or order
        Control0..*
        TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
        Is Modifierfalse
        Obligations
          ObligationsActor
          SHOULD:handleMyHealth@EU Handler
          Summarytrue
          Requirements

          EHDSObservation.order


          Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

          Alternate NamesFulfills
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. Observation.status
          Definition

          The status of the result value.

          Shortregistered | preliminary | final | amended +
          Comments

          This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

          Control1..1
          BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
          (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

          Codes providing the status of an observation.

          Typecode
          Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          EHDSObservation.header.status


          Need to track the status of individual results. Some results are finalized before the whole report is finalized.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. Observation.category
          Definition

          A code that classifies the general type of observation being made.

          ShortClassification of type of observation
          Comments

          In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

          Control10..*
          BindingUnless not suitable, these codes SHALL be taken from The codes SHOULD be taken from eHDSI Observation categoryhttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
          (extensible to http://terminology.ehdsi.eu/ValueSet/eHDSIObservationCategory)
          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • pattern @ $this
          • 56. Observation.category:laboratory
            Slice Namelaboratory
            Definition

            A code that classifies the general type of observation being made.

            ShortClassification of type of observation
            Comments

            In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

            Control10..1*
            BindingUnless not suitable, these codes SHALL be taken from The codes SHOULD be taken from eHDSI Observation categoryhttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
            (extensible to http://terminology.ehdsi.eu/ValueSet/eHDSIObservationCategory)
            TypeCodeableConcept
            Is Modifierfalse
            Summaryfalse
            Requirements

            Used for filtering what observations are retrieved and displayed.

            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                "code" : "laboratory"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. Observation.category:studyType
            Slice NamestudyType
            Definition

            A code that classifies the general type of observation being made.

            ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)Classification of type of observation
            Comments

            In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

            Control0..*
            BindingThe codes SHALL be taken from The codes SHOULD be taken from Laboratory Study Typeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
            (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
            TypeCodeableConcept
            Is Modifierfalse
            Summaryfalse
            Requirements

            Used for filtering what observations are retrieved and displayed.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. Observation.category:specialty
            Slice Namespecialty
            Definition

            A code that classifies the general type of observation being made.

            ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)Classification of type of observation
            Comments

            In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

            Control0..*
            BindingThe codes SHALL be taken from The codes SHOULD be taken from Laboratory Specialtyhttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
            (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
            TypeCodeableConcept
            Is Modifierfalse
            Summaryfalse
            Requirements

            Used for filtering what observations are retrieved and displayed.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            62. Observation.code
            Definition

            Describes what was observed. Sometimes this is called the observation "name".

            ShortType of observation (code / type)
            Comments

            All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

            Control1..1
            BindingThe codes SHALL be taken from For example codes, see eHDSI Laboratory Codes With Exceptionshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
            (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabCodeWithExceptions)
            TypeCodeableConcept
            Is Modifierfalse
            Obligations
              ObligationsActor
              SHALL:handleMyHealth@EU Handler
              Summarytrue
              Requirements

              EHDSObservation.code


              Knowing what kind of observation is being made is essential to understanding the observation.

              Alternate NamesName
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              64. Observation.subject
              Definition

              The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

              ShortWho and/or what the observation is about
              Comments

              One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

              Control10..1
              TypeReference(Patient (Core), Patient, Group, Device, Location)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.header.subject


              Observations have no value if you don't know who or what they're about.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              66. Observation.focus
              Definition

              The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

              ShortWhat the observation is about, when it is not about the subject of record
              Comments

              Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

              Control0..*
              TypeReference(Patient (Core), RelatedPerson: Animal, Location (Core), Resource)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.directSubject[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. Observation.effective[x]
              Definition

              The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

              ShortClinically relevant time/time-period for observation
              Comments

              At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

              Control10..1
              TypeChoice of: dateTime, Period, Timing, instant
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Obligations
                ObligationsActor
                SHALL:handleMyHealth@EU Handler
                Summarytrue
                Requirements

                EHDSObservation.observationDate[x]


                Knowing when an observation was deemed true is important to its relevance as well as determining trends.

                Alternate NamesOccurrence
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. Observation.performer
                Definition

                Who was responsible for asserting the observed value as "true".

                ShortWho is responsible for the observation
                Control10..*
                TypeReference(Practitioner (Core), PractitionerRole (Core), Organization (Core), Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                Is Modifierfalse
                Obligations
                  ObligationsActor
                  SHOULD:handleMyHealth@EU Handler
                  Summarytrue
                  Requirements

                  EHDSObservation.header.performer


                  May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  72. Observation.performer.extension:performerFunction
                  Slice NameperformerFunction
                  Definition

                  Distinguishes the type of involvement of the performer in the event. For example, 'author', 'verifier' or 'responsible party'.

                  ShortType of performance
                  Control0..1
                  TypeExtension(Performer function) (Extension Type: CodeableConcept)
                  Is Modifierfalse
                  Summaryfalse
                  Requirements

                  EHDSObservation.performer.function

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  74. Observation.value[x]
                  Definition

                  The information determined as a result of making the observation, if the information has a simple value.

                  ShortLaboratory result valueActual result
                  Comments

                  An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                  Control0..1
                  This element is affected by the following invariants: obs-7
                  TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  EHDSObservation.result.value[x]


                  An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 76. Observation.value[x]:valueCodeableConcept
                    Slice NamevalueCodeableConcept
                    Definition

                    The information determined as a result of making the observation, if the information has a simple value.

                    ShortActual result
                    Comments

                    An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                    Control0..1
                    This element is affected by the following invariants: obs-7
                    BindingThe codes SHALL be taken from For codes, see eHDSI Results Coded Value Laboratory With Exceptions
                    (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIResultsCodedValueLaboratory)
                    TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    EHDSObservation.result.value[x]


                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    78. Observation.value[x]:valueRange
                    Slice NamevalueRange
                    Definition

                    The information determined as a result of making the observation, if the information has a simple value.

                    ShortActual result
                    Comments

                    An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                    Control0..1
                    This element is affected by the following invariants: obs-7
                    TypeRange(Range (Eu Lab)), dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, CodeableConcept
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    EHDSObservation.result.value[x]


                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    80. Observation.value[x]:valueQuantity
                    Slice NamevalueQuantity
                    Definition

                    The information determined as a result of making the observation, if the information has a simple value.

                    ShortActual result
                    Comments

                    An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                    Control0..1
                    This element is affected by the following invariants: obs-7
                    TypeQuantity(Quantity (MyHealth@EU)), dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    82. Observation.value[x]:valueQuantity.extension:uncertainty
                    Slice Nameuncertainty
                    Definition

                    The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                    ShortStandard Deviation (same units as the quantity)
                    Comments

                    standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                    Control0..1
                    TypeExtension(Uncertainty) (Extension Type: decimal)
                    Is Modifierfalse
                    Summaryfalse
                    Requirements

                    EHDSObservation.result.uncertainty

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    84. Observation.value[x]:valueQuantity.comparator
                    Definition

                    How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                    Short< | <= | >= | > - how to understand the value
                    Control0..1
                    BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
                    (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                    How the Quantity should be understood and represented.

                    Typecode
                    Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

                    Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                    Meaning if MissingIf there is no comparator, then there is no modification of the value
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    86. Observation.value[x]:valueRatio
                    Slice NamevalueRatio
                    Definition

                    The information determined as a result of making the observation, if the information has a simple value.

                    ShortActual result
                    Comments

                    An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                    Control0..1
                    This element is affected by the following invariants: obs-7
                    TypeRatio(Ratio (MyHealth@EU)), dateTime, boolean, string, SampledData, Quantity, Period, integer, time, Range, CodeableConcept
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    EHDSObservation.result.value[x]


                    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    88. Observation.method
                    Definition

                    Indicates the mechanism used to perform the observation.

                    ShortHow it was done
                    Comments

                    Only used if not implicit in code for Observation.code.

                    Control0..1
                    BindingThe codes SHALL be taken from For example codes, see eHDSI Laboratory Technique With Exceptionshttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
                    (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabTechniqueWithExceptions)
                    TypeCodeableConcept
                    Is Modifierfalse
                    Summaryfalse
                    Requirements

                    EHDSObservation.method


                    In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    90. Observation.specimen
                    Definition

                    The specimen that was used when this observation was made.

                    ShortSpecimen used for the observationSpecimen used for this observation
                    Comments

                    Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

                    Control0..1
                    TypeReference(Specimen: Laboratory, Specimen)
                    Is Modifierfalse
                    Obligations
                      ObligationsActor
                      SHOULD:handleMyHealth@EU Handler
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      92. Observation.device
                      Definition

                      The device used to generate the observation data.

                      Short(Measurement) Device
                      Comments

                      Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

                      Control0..1
                      TypeReference(Device: Measuring, Device, DeviceMetric)
                      Is Modifierfalse
                      Summaryfalse
                      Requirements

                      Device information for laboratory observations

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      94. Observation.hasMember
                      Definition

                      This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

                      ShortRelated resource that belongs to the Observation group
                      Comments

                      When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.


                      When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

                      Control0..*
                      TypeReference(ObservationResults: Laboratory, Observation, QuestionnaireResponse, MolecularSequence)
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      EHDSObservation.hasMember[x]

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      96. Observation.component
                      Definition

                      Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                      ShortLaboratory resultComponent results
                      Comments

                      For a discussion on the ways Observations can be assembled in groups together see Notes below.

                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      EHDSObservation.component


                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      98. Observation.component.extension:value-r5
                      Slice Namevalue-r5
                      Definition

                      When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.value[x] element using the cross-version extension.

                      Shortonly for Diagrams or Pictures
                      Comments

                      Element Observation.value[x] is mapped to FHIR R4 element Observation.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.value[x] do not cover the following types: Attachment, Reference. The target context Observation.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.

                      • An observation may have:
                        1. a single value here
                        2. both a value and a set of related or component values
                        3. only a set of related or component values.
                      • If a value is present, the datatype for this element should be determined by the code.
                      • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                      • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                      • For additional guidance, see the Notes section below.
                      Control0..1
                      This element is affected by the following invariants: ele-1
                      TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      100. Observation.component.extension:value-r5.extension
                      Definition

                      An Extension


                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      ShortExtensionAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..0*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on Observation.component.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 102. Observation.component.extension:value-r5.url
                        Definition

                        Source of the definition for the extension code - a logical name or a URL.

                        Shortidentifies the meaning of the extension
                        Comments

                        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                        Control1..1
                        Typeuri
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
                        104. Observation.component.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        106. Observation.component.code
                        Definition

                        Describes what was observed. Sometimes this is called the observation "code".

                        ShortType of component observation (code / type)
                        Comments

                        All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                        Control1..1
                        BindingThe codes SHALL be taken from For example codes, see eHDSI Laboratory Codes With Exceptionshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
                        (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabCodeWithExceptions)
                        TypeCodeableConcept
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        EHDSObservation.component.code


                        Knowing what kind of observation is being made is essential to understanding the observation.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        108. Observation.component.value[x]
                        Definition

                        The information determined as a result of making the observation, if the information has a simple value.

                        ShortActual component result
                        Comments

                        Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                        Control0..1
                        TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        EHDSObservation.component.result.value[x]


                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                        • type @ $this
                        • 110. Observation.component.value[x]:valueCodeableConcept
                          Slice NamevalueCodeableConcept
                          Definition

                          The information determined as a result of making the observation, if the information has a simple value.

                          ShortActual component result
                          Comments

                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                          Control0..1
                          BindingThe codes SHALL be taken from For codes, see eHDSI Results Coded Value Laboratory With Exceptions
                          (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIResultsCodedValueLaboratory)
                          TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          EHDSObservation.component.result.value[x]


                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          112. Observation.component.value[x]:valueQuantity
                          Slice NamevalueQuantity
                          Definition

                          The information determined as a result of making the observation, if the information has a simple value.

                          ShortActual component result
                          Comments

                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                          Control0..1
                          TypeQuantity(Quantity (MyHealth@EU)), dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          114. Observation.component.value[x]:valueQuantity.extension:uncertainty
                          Slice Nameuncertainty
                          Definition

                          The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                          ShortStandard Deviation (same units as the quantity)
                          Comments

                          standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                          Control0..1
                          TypeExtension(Uncertainty) (Extension Type: decimal)
                          Is Modifierfalse
                          Summaryfalse
                          Requirements

                          EHDSObservation.component.result.uncertainty

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          116. Observation.component.value[x]:valueQuantity.comparator
                          Definition

                          How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                          Short< | <= | >= | > - how to understand the value
                          Control0..1
                          BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
                          (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                          How the Quantity should be understood and represented.

                          Typecode
                          Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                          Meaning if MissingIf there is no comparator, then there is no modification of the value
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          118. Observation.component.value[x]:valueRatio
                          Slice NamevalueRatio
                          Definition

                          The information determined as a result of making the observation, if the information has a simple value.

                          ShortActual component result
                          Comments

                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                          Control0..1
                          TypeRatio(Ratio (MyHealth@EU)), dateTime, boolean, string, SampledData, Quantity, Period, integer, time, Range, CodeableConcept
                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          EHDSObservation.component.result.value[x]


                          An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                          Guidance on how to interpret the contents of this table can be foundhere

                          0. Observation
                          Definition

                          This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations

                          ShortLaboratory result for a simple test or for a panel/study
                          Comments

                          Represents either a lab simple observation or the group of observations produced by a laboratory study.

                          Impose ProfileThis profile also requires that the instance also conform this additional profile:
                          2. Observation.extension:supportingInfo
                          Slice NamesupportingInfo
                          Control0..*
                          TypeExtension(Supporting info) (Extension Type: Reference(Resource))
                          4. Observation.extension:labTestKit
                          Slice NamelabTestKit
                          Definition

                          The laboratory test kit used for this test.

                          ShortLaboratory Test Kit
                          Control0..*
                          TypeExtension(Device Laboratory Test Kit) (Extension Type: Reference(Device))
                          6. Observation.extension:certifiedRefMaterialCodeable
                          Slice NamecertifiedRefMaterialCodeable
                          Control0..*
                          TypeExtension(Certified Reference Material: CodeableConcept) (Extension Type: CodeableConcept)
                          8. Observation.extension:certifiedRefMaterialIdentifer
                          Slice NamecertifiedRefMaterialIdentifer
                          Control0..*
                          TypeExtension(Certified Reference Material: Identifier) (Extension Type: Identifier)
                          10. Observation.extension:accredited
                          Slice Nameaccredited
                          Definition

                          Indicates that this laboratory test was/is accredited.

                          ShortAccredited test
                          Control0..1
                          TypeExtension(Laboratory Accredited) (Extension Type: boolean)
                          12. Observation.basedOn
                          Obligations
                            ObligationsActor
                            SHOULD:handleMyHealth@EU Handler
                            14. Observation.category
                            SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • pattern @ $this
                            • 16. Observation.category:laboratory
                              Slice Namelaboratory
                              Control1..1
                              Pattern Value{
                                "coding" : [{
                                  "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                  "code" : "laboratory"
                                }]
                              }
                              18. Observation.category:studyType
                              Slice NamestudyType
                              ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
                              Control0..*
                              BindingThe codes SHALL be taken from Laboratory Study Types
                              (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
                              20. Observation.category:specialty
                              Slice Namespecialty
                              ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
                              Control0..*
                              BindingThe codes SHALL be taken from Laboratory Specialty
                              (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
                              22. Observation.code
                              BindingThe codes SHALL be taken from eHDSI Laboratory Codes With Exceptions
                              (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabCodeWithExceptions)
                              Obligations
                                ObligationsActor
                                SHALL:handleMyHealth@EU Handler
                                24. Observation.focus
                                TypeReference(Patient (Core), RelatedPerson: Animal, Location (Core))
                                26. Observation.effective[x]
                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                Obligations
                                  ObligationsActor
                                  SHALL:handleMyHealth@EU Handler
                                  28. Observation.performer
                                  Control1..?
                                  Obligations
                                    ObligationsActor
                                    SHOULD:handleMyHealth@EU Handler
                                    30. Observation.value[x]
                                    ShortLaboratory result value
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    32. Observation.value[x]:valueCodeableConcept
                                    Slice NamevalueCodeableConcept
                                    BindingThe codes SHALL be taken from eHDSI Results Coded Value Laboratory With Exceptions
                                    (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIResultsCodedValueLaboratory)
                                    TypeCodeableConcept
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    34. Observation.value[x]:valueRange
                                    Slice NamevalueRange
                                    Control0..1
                                    TypeRange(Range (Eu Lab))
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    36. Observation.method
                                    BindingThe codes SHALL be taken from eHDSI Laboratory Technique With Exceptions
                                    (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabTechniqueWithExceptions)
                                    38. Observation.specimen
                                    TypeReference(Specimen: Laboratory)
                                    Obligations
                                      ObligationsActor
                                      SHOULD:handleMyHealth@EU Handler
                                      40. Observation.device
                                      TypeReference(Device: Measuring)
                                      42. Observation.hasMember
                                      TypeReference(ObservationResults: Laboratory)
                                      44. Observation.component
                                      ShortLaboratory result
                                      46. Observation.component.code
                                      BindingThe codes SHALL be taken from eHDSI Laboratory Codes With Exceptions
                                      (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabCodeWithExceptions)
                                      48. Observation.component.value[x]:valueCodeableConcept
                                      Slice NamevalueCodeableConcept
                                      BindingThe codes SHALL be taken from eHDSI Results Coded Value Laboratory With Exceptions
                                      (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIResultsCodedValueLaboratory)
                                      TypeCodeableConcept
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]

                                      Guidance on how to interpret the contents of this table can be foundhere

                                      0. Observation
                                      Definition

                                      This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations

                                      ShortLaboratory result for a simple test or for a panel/study
                                      Comments

                                      Represents either a lab simple observation or the group of observations produced by a laboratory study.

                                      Control0..*
                                      Is Modifierfalse
                                      Impose ProfileThis profile also requires that the instance also conform this additional profile:
                                      Summaryfalse
                                      Alternate NamesVital Signs, Measurement, Results, Tests
                                      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                                      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                                      dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                                      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                                      dom-6: A resource should have narrative for robust management (text.`div`.exists())
                                      obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
                                      obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
                                      obs-value-1: The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously. (value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty())
                                      2. Observation.id
                                      Definition

                                      The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                                      ShortLogical id of this artifact
                                      Comments

                                      The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                                      Control0..1
                                      Typeid
                                      Is Modifierfalse
                                      Summarytrue
                                      4. Observation.meta
                                      Definition

                                      The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                                      ShortMetadata about the resource
                                      Control0..1
                                      TypeMeta
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      6. Observation.implicitRules
                                      Definition

                                      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                                      ShortA set of rules under which this content was created
                                      Comments

                                      Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

                                      Control0..1
                                      Typeuri
                                      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      8. Observation.language
                                      Definition

                                      The base language in which the resource is written.

                                      ShortLanguage of the observation
                                      Comments

                                      Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                                      Control0..1
                                      BindingThe codes SHALL be taken from eHDSI Language
                                      (required to http://terminology.ehdsi.eu/ValueSet/eHDSILanguage)
                                      Typecode
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summaryfalse
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      10. Observation.text
                                      Definition

                                      A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                                      ShortText summary of the resource, for human interpretation
                                      Comments

                                      Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                                      Control0..1
                                      TypeNarrative
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesnarrative, html, xhtml, display
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      12. Observation.contained
                                      Definition

                                      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

                                      ShortContained, inline Resources
                                      Comments

                                      This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

                                      Control0..*
                                      TypeResource
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesinline resources, anonymous resources, contained resources
                                      14. Observation.extension
                                      Definition

                                      An Extension

                                      ShortExtension
                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 16. Observation.extension:bodyStructure
                                        Slice NamebodyStructure
                                        Definition

                                        R5: Observation.bodyStructure (new:Reference(BodyStructure))

                                        ShortR5: Observed body structure (new)
                                        Comments

                                        Element Observation.bodyStructure has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.bodyStructure has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Only used if not implicit in code found in Observation.code or bodySite is used. In many systems, this may be represented as a related observation instead of an inline component.

                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        TypeExtension(R5: Observed body structure (new)) (Extension Type: Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4, BodyStructure))
                                        Is Modifierfalse
                                        Summaryfalse
                                        Requirements

                                        EHDSObservation.anatomicLocation

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        18. Observation.extension:triggeredBy
                                        Slice NametriggeredBy
                                        Definition

                                        R5: Observation.triggeredBy (new:BackboneElement)

                                        ShortR5: Triggering observation(s) (new)
                                        Comments

                                        Element Observation.triggeredBy has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                                        Control0..*
                                        This element is affected by the following invariants: ele-1
                                        TypeExtension(R5: Triggering observation(s) (new)) (Complex Extension)
                                        Is Modifierfalse
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        20. Observation.extension:triggeredBy.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        Typestring
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        22. Observation.extension:triggeredBy.extension
                                        Definition

                                        An Extension

                                        ShortExtension
                                        Control2..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 24. Observation.extension:triggeredBy.extension:observation
                                          Slice Nameobservation
                                          Definition

                                          An Extension

                                          ShortExtension
                                          Control1..1
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          26. Observation.extension:triggeredBy.extension:observation.id
                                          Definition

                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          28. Observation.extension:triggeredBy.extension:observation.extension
                                          Definition

                                          An Extension

                                          ShortExtension
                                          Control0..0
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 30. Observation.extension:triggeredBy.extension:observation.url
                                            Definition

                                            Source of the definition for the extension code - a logical name or a URL.

                                            Shortidentifies the meaning of the extension
                                            Comments

                                            The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                            Control1..1
                                            Typeuri
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            Fixed Valueobservation
                                            32. Observation.extension:triggeredBy.extension:observation.value[x]
                                            Definition

                                            Reference to the triggering observation.

                                            ShortTriggering observation
                                            Control1..1
                                            TypeReference(Observation: Medical Test Result (Core))
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Summaryfalse
                                            Requirements

                                            EHDSObservation.triggeredBy[x]

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            34. Observation.extension:triggeredBy.extension:type
                                            Slice Nametype
                                            Definition

                                            R5: Observation.triggeredBy.type (new:code)

                                            ShortR5: reflex | repeat | re-run (new)
                                            Comments

                                            Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                                            Control1..1
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Requirements

                                            Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            36. Observation.extension:triggeredBy.extension:type.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            38. Observation.extension:triggeredBy.extension:type.extension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 40. Observation.extension:triggeredBy.extension:type.url
                                              Definition

                                              Source of the definition for the extension code - a logical name or a URL.

                                              Shortidentifies the meaning of the extension
                                              Comments

                                              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                              Control1..1
                                              Typeuri
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              Fixed Valuetype
                                              42. Observation.extension:triggeredBy.extension:type.value[x]
                                              Definition

                                              The type of trigger. Reflex | Repeat | Re-run.

                                              Shortreflex | repeat | re-run
                                              Control1..1
                                              BindingThe codes SHALL be taken from R5ObservationTriggeredbytypeForR4 (0.1.0)
                                              (required to http://hl7.org/fhir/uv/xver/ValueSet/R5-observation-triggeredbytype-for-R4|0.1.0)

                                              The type of TriggeredBy Observation.

                                              Typecode
                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              44. Observation.extension:triggeredBy.extension:reason
                                              Slice Namereason
                                              Definition

                                              R5: Observation.triggeredBy.reason (new:string)

                                              ShortR5: Reason that the observation was triggered (new)
                                              Comments

                                              Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                                              Control0..1
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              46. Observation.extension:triggeredBy.extension:reason.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              Typestring
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              48. Observation.extension:triggeredBy.extension:reason.extension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                              • value @ url
                                              • 50. Observation.extension:triggeredBy.extension:reason.url
                                                Definition

                                                Source of the definition for the extension code - a logical name or a URL.

                                                Shortidentifies the meaning of the extension
                                                Comments

                                                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                                Control1..1
                                                Typeuri
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                Fixed Valuereason
                                                52. Observation.extension:triggeredBy.extension:reason.value[x]
                                                Definition

                                                Provides the reason why this observation was performed as a result of the observation(s) referenced.

                                                ShortReason that the observation was triggered
                                                Control0..1
                                                Typestring
                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                54. Observation.extension:triggeredBy.url
                                                Definition

                                                Source of the definition for the extension code - a logical name or a URL.

                                                Shortidentifies the meaning of the extension
                                                Comments

                                                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                                Control1..1
                                                Typeuri
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
                                                56. Observation.extension:triggeredBy.value[x]
                                                Definition

                                                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                                ShortValue of extension
                                                Control0..0
                                                TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                58. Observation.extension:value-r5
                                                Slice Namevalue-r5
                                                Definition

                                                When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.value[x] element using the cross-version extension.

                                                Shortonly for Diagrams or Pictures
                                                Comments

                                                Element Observation.value[x] is mapped to FHIR R4 element Observation.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.value[x] do not cover the following types: Attachment, Reference. The target context Observation.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.

                                                • An observation may have:
                                                  1. a single value here
                                                  2. both a value and a set of related or component values
                                                  3. only a set of related or component values.
                                                • If a value is present, the datatype for this element should be determined by the code.
                                                • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                                                • For additional guidance, see the Notes section below.
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
                                                Is Modifierfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                60. Observation.extension:value-r5.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                Typestring
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                62. Observation.extension:value-r5.extension
                                                Definition

                                                An Extension

                                                ShortExtension
                                                Control0..0
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                • value @ url
                                                • 64. Observation.extension:value-r5.url
                                                  Definition

                                                  Source of the definition for the extension code - a logical name or a URL.

                                                  Shortidentifies the meaning of the extension
                                                  Comments

                                                  The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                                  Control1..1
                                                  Typeuri
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
                                                  66. Observation.extension:value-r5.value[x]
                                                  Definition

                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                  ShortActual result
                                                  Comments
                                                  • An observation may have:
                                                    1. a single value here
                                                    2. both a value and a set of related or component values
                                                    3. only a set of related or component values.
                                                  • If a value is present, the datatype for this element should be determined by the code.
                                                  • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                  • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                  • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                                                  • For additional guidance, see the Notes section below.
                                                  Control0..1
                                                  TypeAttachment
                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  68. Observation.extension:supportingInfo
                                                  Slice NamesupportingInfo
                                                  Definition

                                                  Other resources from the patient record that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension should not be used if more specific inline elements or extensions are available. For example, use Observation.hasMember instead of supportingInformation for representing the members of an Observation panel.

                                                  ShortOther information that may be relevant to this event.
                                                  Control0..*
                                                  TypeExtension(Supporting info) (Extension Type: Reference(Resource))
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  70. Observation.extension:labTestKit
                                                  Slice NamelabTestKit
                                                  Definition

                                                  The laboratory test kit used for this test.

                                                  ShortLaboratory Test Kit
                                                  Control0..*
                                                  TypeExtension(Device Laboratory Test Kit) (Extension Type: Reference(Device))
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  72. Observation.extension:certifiedRefMaterialCodeable
                                                  Slice NamecertifiedRefMaterialCodeable
                                                  Definition

                                                  This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using a CodeableConcept. This extension should be used when the unit is UCUM [IU].

                                                  ShortCertified Reference Material: CodeableConcept
                                                  Control0..*
                                                  TypeExtension(Certified Reference Material: CodeableConcept) (Extension Type: CodeableConcept)
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  74. Observation.extension:certifiedRefMaterialIdentifer
                                                  Slice NamecertifiedRefMaterialIdentifer
                                                  Definition

                                                  This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using an Identifier. This extension should be used when the unit is UCUM [IU].

                                                  ShortCertified Reference Material: Identifier
                                                  Control0..*
                                                  TypeExtension(Certified Reference Material: Identifier) (Extension Type: Identifier)
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  76. Observation.extension:accredited
                                                  Slice Nameaccredited
                                                  Definition

                                                  Indicates that this laboratory test was/is accredited.

                                                  ShortAccredited test
                                                  Control0..1
                                                  TypeExtension(Laboratory Accredited) (Extension Type: boolean)
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  78. Observation.modifierExtension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                  ShortExtensions that cannot be ignored
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                                                  Summaryfalse
                                                  Requirements

                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  80. Observation.identifier
                                                  Definition

                                                  A unique identifier assigned to this observation.

                                                  ShortBusiness Identifier for observation
                                                  NoteThis is a business identifier, not a resource identifier (see discussion)
                                                  Control0..*
                                                  TypeIdentifier
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Requirements

                                                  EHDSObservation.header.identifier

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  82. Observation.basedOn
                                                  Definition

                                                  A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

                                                  ShortFulfills plan, proposal or order
                                                  Control0..*
                                                  TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                                                  Is Modifierfalse
                                                  Obligations
                                                    ObligationsActor
                                                    SHOULD:handleMyHealth@EU Handler
                                                    Summarytrue
                                                    Requirements

                                                    EHDSObservation.order

                                                    Alternate NamesFulfills
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    84. Observation.partOf
                                                    Definition

                                                    A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

                                                    ShortPart of referenced event
                                                    Comments

                                                    To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

                                                    Control0..*
                                                    TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                                                    Is Modifierfalse
                                                    Summarytrue
                                                    Alternate NamesContainer
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    86. Observation.status
                                                    Definition

                                                    The status of the result value.

                                                    Shortregistered | preliminary | final | amended +
                                                    Comments

                                                    This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

                                                    Control1..1
                                                    BindingThe codes SHALL be taken from ObservationStatus
                                                    (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

                                                    Codes providing the status of an observation.

                                                    Typecode
                                                    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    EHDSObservation.header.status

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    88. Observation.category
                                                    Definition

                                                    A code that classifies the general type of observation being made.

                                                    ShortClassification of type of observation
                                                    Comments

                                                    In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                                    Control1..*
                                                    BindingUnless not suitable, these codes SHALL be taken from eHDSI Observation category
                                                    (extensible to http://terminology.ehdsi.eu/ValueSet/eHDSIObservationCategory)
                                                    TypeCodeableConcept
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Requirements

                                                    Used for filtering what observations are retrieved and displayed.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                    • pattern @ $this
                                                    • 90. Observation.category:laboratory
                                                      Slice Namelaboratory
                                                      Definition

                                                      A code that classifies the general type of observation being made.

                                                      ShortClassification of type of observation
                                                      Comments

                                                      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                                      Control1..1
                                                      BindingUnless not suitable, these codes SHALL be taken from eHDSI Observation category
                                                      (extensible to http://terminology.ehdsi.eu/ValueSet/eHDSIObservationCategory)
                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Requirements

                                                      Used for filtering what observations are retrieved and displayed.

                                                      Pattern Value{
                                                        "coding" : [{
                                                          "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                                          "code" : "laboratory"
                                                        }]
                                                      }
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      92. Observation.category:studyType
                                                      Slice NamestudyType
                                                      Definition

                                                      A code that classifies the general type of observation being made.

                                                      ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
                                                      Comments

                                                      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                                      Control0..*
                                                      BindingThe codes SHALL be taken from Laboratory Study Types
                                                      (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Requirements

                                                      Used for filtering what observations are retrieved and displayed.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      94. Observation.category:specialty
                                                      Slice Namespecialty
                                                      Definition

                                                      A code that classifies the general type of observation being made.

                                                      ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
                                                      Comments

                                                      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                                      Control0..*
                                                      BindingThe codes SHALL be taken from Laboratory Specialty
                                                      (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Requirements

                                                      Used for filtering what observations are retrieved and displayed.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      96. Observation.code
                                                      Definition

                                                      Describes what was observed. Sometimes this is called the observation "name".

                                                      ShortType of observation (code / type)
                                                      Comments

                                                      All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                      Control1..1
                                                      BindingThe codes SHALL be taken from eHDSI Laboratory Codes With Exceptions
                                                      (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabCodeWithExceptions)
                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Obligations
                                                        ObligationsActor
                                                        SHALL:handleMyHealth@EU Handler
                                                        Summarytrue
                                                        Requirements

                                                        EHDSObservation.code

                                                        Alternate NamesName
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        98. Observation.subject
                                                        Definition

                                                        The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

                                                        ShortWho and/or what the observation is about
                                                        Comments

                                                        One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

                                                        Control1..1
                                                        TypeReference(Patient (Core))
                                                        Is Modifierfalse
                                                        Summarytrue
                                                        Requirements

                                                        EHDSObservation.header.subject

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        100. Observation.focus
                                                        Definition

                                                        The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

                                                        ShortWhat the observation is about, when it is not about the subject of record
                                                        Comments

                                                        Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

                                                        Control0..*
                                                        TypeReference(Patient (Core), RelatedPerson: Animal, Location (Core))
                                                        Is Modifierfalse
                                                        Summarytrue
                                                        Requirements

                                                        EHDSObservation.directSubject[x]

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        102. Observation.encounter
                                                        Definition

                                                        The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

                                                        ShortHealthcare event during which this observation is made
                                                        Comments

                                                        This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

                                                        Control0..1
                                                        TypeReference(Encounter)
                                                        Is Modifierfalse
                                                        Summarytrue
                                                        Requirements

                                                        For some observations it may be important to know the link between an observation and a particular encounter.

                                                        Alternate NamesContext
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        104. Observation.effective[x]
                                                        Definition

                                                        The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                                                        ShortClinically relevant time/time-period for observation
                                                        Comments

                                                        At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

                                                        Control1..1
                                                        TypeChoice of: dateTime, Period
                                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Obligations
                                                          ObligationsActor
                                                          SHALL:handleMyHealth@EU Handler
                                                          Summarytrue
                                                          Requirements

                                                          EHDSObservation.observationDate[x]

                                                          Alternate NamesOccurrence
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          106. Observation.issued
                                                          Definition

                                                          The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

                                                          ShortDate/Time this version was made available
                                                          Comments

                                                          For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

                                                          Control0..1
                                                          Typeinstant
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          EHDSObservation.header.authorship.datetime

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          108. Observation.performer
                                                          Definition

                                                          Who was responsible for asserting the observed value as "true".

                                                          ShortWho is responsible for the observation
                                                          Control1..*
                                                          TypeReference(Practitioner (Core), PractitionerRole (Core), Organization (Core))
                                                          Is Modifierfalse
                                                          Obligations
                                                            ObligationsActor
                                                            SHOULD:handleMyHealth@EU Handler
                                                            Summarytrue
                                                            Requirements

                                                            EHDSObservation.header.performer

                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            110. Observation.performer.id
                                                            Definition

                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                            ShortUnique id for inter-element referencing
                                                            Control0..1
                                                            Typestring
                                                            Is Modifierfalse
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Summaryfalse
                                                            112. Observation.performer.extension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                            ShortAdditional content defined by implementations
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Alternate Namesextensions, user content
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            SlicingThis element introduces a set of slices on Observation.performer.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                            • value @ url
                                                            • 114. Observation.performer.extension:performerFunction
                                                              Slice NameperformerFunction
                                                              Definition

                                                              Distinguishes the type of involvement of the performer in the event. For example, 'author', 'verifier' or 'responsible party'.

                                                              ShortType of performance
                                                              Control0..1
                                                              TypeExtension(Performer function) (Extension Type: CodeableConcept)
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Requirements

                                                              EHDSObservation.performer.function

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              116. Observation.performer.reference
                                                              Definition

                                                              A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                                                              ShortLiteral reference, Relative, internal or absolute URL
                                                              Comments

                                                              Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                                                              Control0..1
                                                              This element is affected by the following invariants: ref-1
                                                              Typestring
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Summarytrue
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              118. Observation.performer.type
                                                              Definition

                                                              The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                                                              The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                                                              ShortType the reference refers to (e.g. "Patient")
                                                              Comments

                                                              This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                                                              Control0..1
                                                              BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                                              (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

                                                              Aa resource (or, for logical models, the URI of the logical model).

                                                              Typeuri
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Summarytrue
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              120. Observation.performer.identifier
                                                              Definition

                                                              An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                                                              ShortLogical reference, when literal reference is not known
                                                              Comments

                                                              When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                                                              When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                                                              Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                                                              Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                                                              NoteThis is a business identifier, not a resource identifier (see discussion)
                                                              Control0..1
                                                              TypeIdentifier
                                                              Is Modifierfalse
                                                              Summarytrue
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              122. Observation.performer.display
                                                              Definition

                                                              Plain text narrative that identifies the resource in addition to the resource reference.

                                                              ShortText alternative for the resource
                                                              Comments

                                                              This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                                                              Control0..1
                                                              Typestring
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Summarytrue
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              124. Observation.value[x]
                                                              Definition

                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                              ShortLaboratory result value
                                                              Comments

                                                              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                              Control0..1
                                                              This element is affected by the following invariants: obs-7
                                                              TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Summarytrue
                                                              Requirements

                                                              EHDSObservation.result.value[x]

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                              • type @ $this
                                                              • 126. Observation.value[x]:valueCodeableConcept
                                                                Slice NamevalueCodeableConcept
                                                                Definition

                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                ShortActual result
                                                                Comments

                                                                An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                Control0..1
                                                                This element is affected by the following invariants: obs-7
                                                                BindingThe codes SHALL be taken from eHDSI Results Coded Value Laboratory With Exceptions
                                                                (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIResultsCodedValueLaboratory)
                                                                TypeCodeableConcept
                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                Is Modifierfalse
                                                                Summarytrue
                                                                Requirements

                                                                EHDSObservation.result.value[x]

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                128. Observation.value[x]:valueRange
                                                                Slice NamevalueRange
                                                                Definition

                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                ShortActual result
                                                                Comments

                                                                An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                Control0..1
                                                                This element is affected by the following invariants: obs-7
                                                                TypeRange(Range (Eu Lab))
                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                Is Modifierfalse
                                                                Summarytrue
                                                                Requirements

                                                                EHDSObservation.result.value[x]

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                130. Observation.value[x]:valueQuantity
                                                                Slice NamevalueQuantity
                                                                Definition

                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                ShortActual result
                                                                Comments

                                                                An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                Control0..1
                                                                This element is affected by the following invariants: obs-7
                                                                TypeQuantity(Quantity (MyHealth@EU))
                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                Is Modifierfalse
                                                                Summarytrue
                                                                Requirements

                                                                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                132. Observation.value[x]:valueQuantity.id
                                                                Definition

                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                ShortUnique id for inter-element referencing
                                                                Control0..1
                                                                Typestring
                                                                Is Modifierfalse
                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                Summaryfalse
                                                                134. Observation.value[x]:valueQuantity.extension
                                                                Definition

                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                ShortAdditional content defined by implementations
                                                                Comments

                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                Control0..*
                                                                TypeExtension
                                                                Is Modifierfalse
                                                                Summaryfalse
                                                                Alternate Namesextensions, user content
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                SlicingThis element introduces a set of slices on Observation.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                • value @ url
                                                                • 136. Observation.value[x]:valueQuantity.extension:uncertainty
                                                                  Slice Nameuncertainty
                                                                  Definition

                                                                  The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                                                                  ShortStandard Deviation (same units as the quantity)
                                                                  Comments

                                                                  standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                                                                  Control0..1
                                                                  TypeExtension(Uncertainty) (Extension Type: decimal)
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Requirements

                                                                  EHDSObservation.result.uncertainty

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  138. Observation.value[x]:valueQuantity.value
                                                                  Definition

                                                                  The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                                                  ShortNumerical value (with implicit precision)
                                                                  Comments

                                                                  The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                                                  Control0..1
                                                                  Typedecimal
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Summarytrue
                                                                  Requirements

                                                                  Precision is handled implicitly in almost all cases of measurement.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  140. Observation.value[x]:valueQuantity.comparator
                                                                  Definition

                                                                  How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                                                  Short< | <= | >= | > - how to understand the value
                                                                  Control0..1
                                                                  BindingThe codes SHALL be taken from QuantityComparator
                                                                  (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                                                  How the Quantity should be understood and represented.

                                                                  Typecode
                                                                  Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Summarytrue
                                                                  Requirements

                                                                  Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                                                  Meaning if MissingIf there is no comparator, then there is no modification of the value
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  142. Observation.value[x]:valueQuantity.unit
                                                                  Definition

                                                                  A human-readable form of the unit.

                                                                  ShortUnit representation
                                                                  Control0..1
                                                                  Typestring
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Summarytrue
                                                                  Requirements

                                                                  There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  144. Observation.value[x]:valueQuantity.system
                                                                  Definition

                                                                  The identification of the system that provides the coded form of the unit.

                                                                  ShortSystem that defines coded unit form
                                                                  Control0..1
                                                                  This element is affected by the following invariants: qty-3
                                                                  Typeuri
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Summarytrue
                                                                  Requirements

                                                                  Need to know the system that defines the coded form of the unit.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  146. Observation.value[x]:valueQuantity.code
                                                                  Definition

                                                                  A computer processable form of the unit in some unit representation system.

                                                                  ShortCoded form of the unit
                                                                  Comments

                                                                  The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                                                                  Control0..1
                                                                  Typecode
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Summarytrue
                                                                  Requirements

                                                                  Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  148. Observation.value[x]:valueRatio
                                                                  Slice NamevalueRatio
                                                                  Definition

                                                                  The information determined as a result of making the observation, if the information has a simple value.

                                                                  ShortActual result
                                                                  Comments

                                                                  An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                  Control0..1
                                                                  This element is affected by the following invariants: obs-7
                                                                  TypeRatio(Ratio (MyHealth@EU))
                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                  Is Modifierfalse
                                                                  Summarytrue
                                                                  Requirements

                                                                  EHDSObservation.result.value[x]

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  150. Observation.dataAbsentReason
                                                                  Definition

                                                                  Provides a reason why the expected value in the element Observation.value[x] is missing.

                                                                  ShortWhy the result is missing
                                                                  Comments

                                                                  Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

                                                                  The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

                                                                  Control0..1
                                                                  This element is affected by the following invariants: obs-6
                                                                  BindingUnless not suitable, these codes SHALL be taken from eHDSI Data Absent Reason
                                                                  (extensible to http://terminology.ehdsi.eu/ValueSet/eHDSIDataAbsentReason)
                                                                  TypeCodeableConcept
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Requirements

                                                                  EHDSObservation.dataAbsentReason

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  152. Observation.interpretation
                                                                  Definition

                                                                  A categorical assessment of an observation value. For example, high, low, normal.

                                                                  ShortHigh, low, normal, etc.
                                                                  Comments

                                                                  Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                  Control0..*
                                                                  BindingThe codes SHALL be taken from eHDSI Observation Interpretation With Exceptions
                                                                  (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIObservationInterpretationWithExceptions)
                                                                  TypeCodeableConcept
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Requirements

                                                                  EHDSObservation.interpretation

                                                                  Alternate NamesAbnormal Flag
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  154. Observation.note
                                                                  Definition

                                                                  Comments about the observation or the results.

                                                                  ShortComments about the observation
                                                                  Comments

                                                                  May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

                                                                  Control0..*
                                                                  TypeAnnotation
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Requirements

                                                                  EHDSObservation.resultDescription

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  156. Observation.bodySite
                                                                  Definition

                                                                  Indicates the site on the subject's body where the observation was made (i.e. the target site).

                                                                  ShortObserved body part
                                                                  Comments

                                                                  Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

                                                                  If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

                                                                  Control0..1
                                                                  BindingThe codes SHALL be taken from eHDSI Body Site With Exceptions
                                                                  (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIBodySiteWithExceptions)
                                                                  TypeCodeableConcept
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Requirements

                                                                  EHDSObservation.anatomicLocation

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  158. Observation.bodySite.id
                                                                  Definition

                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                  ShortUnique id for inter-element referencing
                                                                  Control0..1
                                                                  Typestring
                                                                  Is Modifierfalse
                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                  Summaryfalse
                                                                  160. Observation.bodySite.extension
                                                                  Definition

                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                  ShortAdditional content defined by implementations
                                                                  Comments

                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                  Control0..*
                                                                  TypeExtension
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Alternate Namesextensions, user content
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  SlicingThis element introduces a set of slices on Observation.bodySite.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                  • value @ url
                                                                  • 162. Observation.bodySite.extension:bodySite
                                                                    Slice NamebodySite
                                                                    Definition

                                                                    Record details about the anatomical location of a specimen or body part. This resource may be used when a coded concept does not provide the necessary detail needed for the use case.

                                                                    ShortTarget anatomic location or structure
                                                                    Control0..1
                                                                    TypeExtension(BodyStructure Reference) (Extension Type: Reference(BodyStructure))
                                                                    Is Modifierfalse
                                                                    Summaryfalse
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    164. Observation.bodySite.extension:bodySite.id
                                                                    Definition

                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                    ShortUnique id for inter-element referencing
                                                                    Control0..1
                                                                    This element is affected by the following invariants: ele-1
                                                                    Typeid
                                                                    Is Modifierfalse
                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                    Summaryfalse
                                                                    166. Observation.bodySite.extension:bodySite.extension
                                                                    Definition

                                                                    An Extension

                                                                    ShortExtension
                                                                    Control0..0
                                                                    TypeExtension
                                                                    Is Modifierfalse
                                                                    Summaryfalse
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    SlicingThis element introduces a set of slices on Observation.bodySite.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                    • value @ url
                                                                    • 168. Observation.bodySite.extension:bodySite.url
                                                                      Definition

                                                                      Source of the definition for the extension code - a logical name or a URL.

                                                                      Shortidentifies the meaning of the extension
                                                                      Comments

                                                                      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                                                      Control1..1
                                                                      Typeuri
                                                                      Is Modifierfalse
                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                      Summaryfalse
                                                                      Fixed Valuehttp://hl7.org/fhir/StructureDefinition/bodySite
                                                                      170. Observation.bodySite.extension:bodySite.value[x]
                                                                      Definition

                                                                      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                                                      ShortValue of extension
                                                                      Control1..1
                                                                      This element is affected by the following invariants: ext-1
                                                                      TypeReference(BodyStructure (Core))
                                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                      Is Modifierfalse
                                                                      Summaryfalse
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      172. Observation.bodySite.coding
                                                                      Definition

                                                                      A reference to a code defined by a terminology system.

                                                                      ShortCode defined by a terminology system
                                                                      Comments

                                                                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                                      Control0..*
                                                                      TypeCoding
                                                                      Is Modifierfalse
                                                                      Summarytrue
                                                                      Requirements

                                                                      Allows for alternative encodings within a code system, and translations to other code systems.

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      174. Observation.bodySite.text
                                                                      Definition

                                                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                                      ShortPlain text representation of the concept
                                                                      Comments

                                                                      Very often the text is the same as a displayName of one of the codings.

                                                                      Control0..1
                                                                      Typestring
                                                                      Is Modifierfalse
                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                      Summarytrue
                                                                      Requirements

                                                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      176. Observation.method
                                                                      Definition

                                                                      Indicates the mechanism used to perform the observation.

                                                                      ShortHow it was done
                                                                      Comments

                                                                      Only used if not implicit in code for Observation.code.

                                                                      Control0..1
                                                                      BindingThe codes SHALL be taken from eHDSI Laboratory Technique With Exceptions
                                                                      (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabTechniqueWithExceptions)
                                                                      TypeCodeableConcept
                                                                      Is Modifierfalse
                                                                      Summaryfalse
                                                                      Requirements

                                                                      EHDSObservation.method

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      178. Observation.specimen
                                                                      Definition

                                                                      The specimen that was used when this observation was made.

                                                                      ShortSpecimen used for the observation
                                                                      Comments

                                                                      Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

                                                                      Control0..1
                                                                      TypeReference(Specimen: Laboratory)
                                                                      Is Modifierfalse
                                                                      Obligations
                                                                        ObligationsActor
                                                                        SHOULD:handleMyHealth@EU Handler
                                                                        Summaryfalse
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        180. Observation.device
                                                                        Definition

                                                                        The device used to generate the observation data.

                                                                        Short(Measurement) Device
                                                                        Comments

                                                                        Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

                                                                        Control0..1
                                                                        TypeReference(Device: Measuring)
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Requirements

                                                                        Device information for laboratory observations

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        182. Observation.referenceRange
                                                                        Definition

                                                                        Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

                                                                        ShortProvides guide for interpretation
                                                                        Comments

                                                                        Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                        Control0..*
                                                                        TypeBackboneElement
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Requirements

                                                                        EHDSObservation.referenceRange

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                                                                        184. Observation.referenceRange.id
                                                                        Definition

                                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                        ShortUnique id for inter-element referencing
                                                                        Control0..1
                                                                        Typestring
                                                                        Is Modifierfalse
                                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                                        Summaryfalse
                                                                        186. Observation.referenceRange.extension
                                                                        Definition

                                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                        ShortAdditional content defined by implementations
                                                                        Comments

                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                        Control0..*
                                                                        TypeExtension
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Alternate Namesextensions, user content
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                        188. Observation.referenceRange.modifierExtension
                                                                        Definition

                                                                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                                        Comments

                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                        Control0..*
                                                                        TypeExtension
                                                                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                        Summarytrue
                                                                        Requirements

                                                                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                        Alternate Namesextensions, user content, modifiers
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                        190. Observation.referenceRange.low
                                                                        Definition

                                                                        The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

                                                                        ShortLow Range, if relevant
                                                                        Control0..1
                                                                        This element is affected by the following invariants: obs-3
                                                                        TypeQuantity(SimpleQuantity)
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        192. Observation.referenceRange.high
                                                                        Definition

                                                                        The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

                                                                        ShortHigh Range, if relevant
                                                                        Control0..1
                                                                        This element is affected by the following invariants: obs-3
                                                                        TypeQuantity(SimpleQuantity)
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        194. Observation.referenceRange.type
                                                                        Definition

                                                                        Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                                                                        ShortReference range qualifier
                                                                        Comments

                                                                        This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                                                                        Control0..1
                                                                        BindingThe codes SHALL be taken from eHDSI Reference Range Meaning With Exceptions
                                                                        (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIReferenceRangeMeaningWithExceptions)
                                                                        TypeCodeableConcept
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Requirements

                                                                        Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        196. Observation.referenceRange.appliesTo
                                                                        Definition

                                                                        Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                                                                        ShortReference range population
                                                                        Comments

                                                                        This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                                                                        Control0..*
                                                                        BindingThe codes SHALL be taken from eHDSI Reference Range Applies To With Exceptions
                                                                        (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions)
                                                                        TypeCodeableConcept
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Requirements

                                                                        Need to be able to identify the target population for proper interpretation.

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        198. Observation.referenceRange.age
                                                                        Definition

                                                                        The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

                                                                        ShortApplicable age range, if relevant
                                                                        Control0..1
                                                                        TypeRange
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Requirements

                                                                        Some analytes vary greatly over age.

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        200. Observation.referenceRange.text
                                                                        Definition

                                                                        Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

                                                                        ShortText based reference range in an observation
                                                                        Control0..1
                                                                        Typestring
                                                                        Is Modifierfalse
                                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                        Summaryfalse
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        202. Observation.hasMember
                                                                        Definition

                                                                        This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

                                                                        ShortRelated resource that belongs to the Observation group
                                                                        Comments

                                                                        When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

                                                                        Control0..*
                                                                        TypeReference(ObservationResults: Laboratory)
                                                                        Is Modifierfalse
                                                                        Summarytrue
                                                                        Requirements

                                                                        EHDSObservation.hasMember[x]

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        204. Observation.derivedFrom
                                                                        Definition

                                                                        The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                                                                        ShortRelated measurements the observation is made from
                                                                        Comments

                                                                        All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

                                                                        Control0..*
                                                                        TypeReference(Observation: Medical Test Result (Core), ImagingStudy)
                                                                        Is Modifierfalse
                                                                        Summarytrue
                                                                        Requirements

                                                                        EHDSObservation.derivedFrom[x]

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        206. Observation.component
                                                                        Definition

                                                                        Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                                                        ShortLaboratory result
                                                                        Comments

                                                                        For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                                                        Control0..*
                                                                        TypeBackboneElement
                                                                        Is Modifierfalse
                                                                        Summarytrue
                                                                        Requirements

                                                                        EHDSObservation.component

                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        208. Observation.component.id
                                                                        Definition

                                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                        ShortUnique id for inter-element referencing
                                                                        Control0..1
                                                                        Typestring
                                                                        Is Modifierfalse
                                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                                        Summaryfalse
                                                                        210. Observation.component.extension
                                                                        Definition

                                                                        An Extension

                                                                        ShortExtension
                                                                        Control0..*
                                                                        TypeExtension
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                        SlicingThis element introduces a set of slices on Observation.component.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                        • value @ url
                                                                        • 212. Observation.component.extension:value-r5
                                                                          Slice Namevalue-r5
                                                                          Definition

                                                                          When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.value[x] element using the cross-version extension.

                                                                          Shortonly for Diagrams or Pictures
                                                                          Comments

                                                                          Element Observation.value[x] is mapped to FHIR R4 element Observation.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.value[x] do not cover the following types: Attachment, Reference. The target context Observation.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.

                                                                          • An observation may have:
                                                                            1. a single value here
                                                                            2. both a value and a set of related or component values
                                                                            3. only a set of related or component values.
                                                                          • If a value is present, the datatype for this element should be determined by the code.
                                                                          • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                                          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                                          • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                                                                          • For additional guidance, see the Notes section below.
                                                                          Control0..1
                                                                          This element is affected by the following invariants: ele-1
                                                                          TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
                                                                          Is Modifierfalse
                                                                          Summaryfalse
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                          214. Observation.component.extension:value-r5.id
                                                                          Definition

                                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                          ShortUnique id for inter-element referencing
                                                                          Control0..1
                                                                          Typestring
                                                                          Is Modifierfalse
                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                          Summaryfalse
                                                                          216. Observation.component.extension:value-r5.extension
                                                                          Definition

                                                                          An Extension

                                                                          ShortExtension
                                                                          Control0..0
                                                                          TypeExtension
                                                                          Is Modifierfalse
                                                                          Summaryfalse
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                          SlicingThis element introduces a set of slices on Observation.component.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                          • value @ url
                                                                          • 218. Observation.component.extension:value-r5.url
                                                                            Definition

                                                                            Source of the definition for the extension code - a logical name or a URL.

                                                                            Shortidentifies the meaning of the extension
                                                                            Comments

                                                                            The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                                                            Control1..1
                                                                            Typeuri
                                                                            Is Modifierfalse
                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                            Summaryfalse
                                                                            Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
                                                                            220. Observation.component.extension:value-r5.value[x]
                                                                            Definition

                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                            ShortActual result
                                                                            Comments
                                                                            • An observation may have:
                                                                              1. a single value here
                                                                              2. both a value and a set of related or component values
                                                                              3. only a set of related or component values.
                                                                            • If a value is present, the datatype for this element should be determined by the code.
                                                                            • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                                            • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                                            • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
                                                                            • For additional guidance, see the Notes section below.
                                                                            Control0..1
                                                                            TypeAttachment
                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                            Is Modifierfalse
                                                                            Summaryfalse
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            222. Observation.component.modifierExtension
                                                                            Definition

                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                            Comments

                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                            Control0..*
                                                                            TypeExtension
                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                            Summarytrue
                                                                            Requirements

                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                            Alternate Namesextensions, user content, modifiers
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                            224. Observation.component.code
                                                                            Definition

                                                                            Describes what was observed. Sometimes this is called the observation "code".

                                                                            ShortType of component observation (code / type)
                                                                            Comments

                                                                            All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                                                            Control1..1
                                                                            BindingThe codes SHALL be taken from eHDSI Laboratory Codes With Exceptions
                                                                            (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSILabCodeWithExceptions)
                                                                            TypeCodeableConcept
                                                                            Is Modifierfalse
                                                                            Summarytrue
                                                                            Requirements

                                                                            EHDSObservation.component.code

                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            226. Observation.component.value[x]
                                                                            Definition

                                                                            The information determined as a result of making the observation, if the information has a simple value.

                                                                            ShortActual component result
                                                                            Comments

                                                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                            Control0..1
                                                                            TypeCodeableConcept
                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                            Is Modifierfalse
                                                                            Summarytrue
                                                                            Requirements

                                                                            EHDSObservation.component.result.value[x]

                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                                            • type @ $this
                                                                            • 228. Observation.component.value[x]:valueCodeableConcept
                                                                              Slice NamevalueCodeableConcept
                                                                              Definition

                                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                                              ShortActual component result
                                                                              Comments

                                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                              Control0..1
                                                                              BindingThe codes SHALL be taken from eHDSI Results Coded Value Laboratory With Exceptions
                                                                              (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIResultsCodedValueLaboratory)
                                                                              TypeCodeableConcept
                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                              Is Modifierfalse
                                                                              Summarytrue
                                                                              Requirements

                                                                              EHDSObservation.component.result.value[x]

                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                              230. Observation.component.value[x]:valueQuantity
                                                                              Slice NamevalueQuantity
                                                                              Definition

                                                                              The information determined as a result of making the observation, if the information has a simple value.

                                                                              ShortActual component result
                                                                              Comments

                                                                              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                              Control0..1
                                                                              TypeQuantity(Quantity (MyHealth@EU))
                                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                              Is Modifierfalse
                                                                              Summarytrue
                                                                              Requirements

                                                                              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                              232. Observation.component.value[x]:valueQuantity.id
                                                                              Definition

                                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                              ShortUnique id for inter-element referencing
                                                                              Control0..1
                                                                              Typestring
                                                                              Is Modifierfalse
                                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                                              Summaryfalse
                                                                              234. Observation.component.value[x]:valueQuantity.extension
                                                                              Definition

                                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                              ShortAdditional content defined by implementations
                                                                              Comments

                                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                              Control0..*
                                                                              TypeExtension
                                                                              Is Modifierfalse
                                                                              Summaryfalse
                                                                              Alternate Namesextensions, user content
                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                              SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                              • value @ url
                                                                              • 236. Observation.component.value[x]:valueQuantity.extension:uncertainty
                                                                                Slice Nameuncertainty
                                                                                Definition

                                                                                The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                                                                                ShortStandard Deviation (same units as the quantity)
                                                                                Comments

                                                                                standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                                                                                Control0..1
                                                                                TypeExtension(Uncertainty) (Extension Type: decimal)
                                                                                Is Modifierfalse
                                                                                Summaryfalse
                                                                                Requirements

                                                                                EHDSObservation.component.result.uncertainty

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                238. Observation.component.value[x]:valueQuantity.value
                                                                                Definition

                                                                                The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                                                                ShortNumerical value (with implicit precision)
                                                                                Comments

                                                                                The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                                                                Control0..1
                                                                                Typedecimal
                                                                                Is Modifierfalse
                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                Summarytrue
                                                                                Requirements

                                                                                Precision is handled implicitly in almost all cases of measurement.

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                240. Observation.component.value[x]:valueQuantity.comparator
                                                                                Definition

                                                                                How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                                                                Short< | <= | >= | > - how to understand the value
                                                                                Control0..1
                                                                                BindingThe codes SHALL be taken from QuantityComparator
                                                                                (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                                                                How the Quantity should be understood and represented.

                                                                                Typecode
                                                                                Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                Summarytrue
                                                                                Requirements

                                                                                Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                                                                Meaning if MissingIf there is no comparator, then there is no modification of the value
                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                242. Observation.component.value[x]:valueQuantity.unit
                                                                                Definition

                                                                                A human-readable form of the unit.

                                                                                ShortUnit representation
                                                                                Control0..1
                                                                                Typestring
                                                                                Is Modifierfalse
                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                Summarytrue
                                                                                Requirements

                                                                                There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                244. Observation.component.value[x]:valueQuantity.system
                                                                                Definition

                                                                                The identification of the system that provides the coded form of the unit.

                                                                                ShortSystem that defines coded unit form
                                                                                Control0..1
                                                                                This element is affected by the following invariants: qty-3
                                                                                Typeuri
                                                                                Is Modifierfalse
                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                Summarytrue
                                                                                Requirements

                                                                                Need to know the system that defines the coded form of the unit.

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                246. Observation.component.value[x]:valueQuantity.code
                                                                                Definition

                                                                                A computer processable form of the unit in some unit representation system.

                                                                                ShortCoded form of the unit
                                                                                Comments

                                                                                The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                                                                                Control0..1
                                                                                Typecode
                                                                                Is Modifierfalse
                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                Summarytrue
                                                                                Requirements

                                                                                Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                248. Observation.component.value[x]:valueRatio
                                                                                Slice NamevalueRatio
                                                                                Definition

                                                                                The information determined as a result of making the observation, if the information has a simple value.

                                                                                ShortActual component result
                                                                                Comments

                                                                                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                                                                Control0..1
                                                                                TypeRatio(Ratio (MyHealth@EU))
                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                Is Modifierfalse
                                                                                Summarytrue
                                                                                Requirements

                                                                                EHDSObservation.component.result.value[x]

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                250. Observation.component.dataAbsentReason
                                                                                Definition

                                                                                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                                                                ShortWhy the component result is missing
                                                                                Comments

                                                                                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                                                                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                                                                Control0..1
                                                                                This element is affected by the following invariants: obs-6
                                                                                BindingUnless not suitable, these codes SHALL be taken from eHDSI Data Absent Reason
                                                                                (extensible to http://terminology.ehdsi.eu/ValueSet/eHDSIDataAbsentReason)
                                                                                TypeCodeableConcept
                                                                                Is Modifierfalse
                                                                                Summaryfalse
                                                                                Requirements

                                                                                EHDSObservation.component.dataAbsentReason

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                252. Observation.component.interpretation
                                                                                Definition

                                                                                A categorical assessment of an observation value. For example, high, low, normal.

                                                                                ShortHigh, low, normal, etc.
                                                                                Comments

                                                                                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                                                                Control0..*
                                                                                BindingThe codes SHALL be taken from eHDSI Observation Interpretation With Exceptions
                                                                                (required to http://fhir.ehdsi.eu/core/ValueSet/eHDSIObservationInterpretationWithExceptions)
                                                                                TypeCodeableConcept
                                                                                Is Modifierfalse
                                                                                Summaryfalse
                                                                                Requirements

                                                                                EHDSObservation.component.interpretation

                                                                                Alternate NamesAbnormal Flag
                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                254. Observation.component.referenceRange
                                                                                Definition

                                                                                Guidance on how to interpret the value by comparison to a normal or recommended range.

                                                                                ShortProvides guide for interpretation of component result
                                                                                Comments

                                                                                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                                                                Control0..*
                                                                                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                                                                Is Modifierfalse
                                                                                Summaryfalse
                                                                                Requirements

                                                                                EHDSObservation.component.referenceRange

                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))