MyHealth@Eu Laboratory Report
0.0.1 - qa-preview 150

This page is part of the MyHealth@Eu Laboratory Report (v0.0.1: QA Preview) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: Device: specimen subject

Official URL: http://fhir.ehdsi.eu/laboratory/StructureDefinition/Device-specimen-lab-myhealtheu Version: 0.0.1
Draft as of 2024-04-18 Computable Name: DeviceSpecimenMyHealthEu

This profile defines how to represent a device in HL7 FHIR, when used as specimen subject, for the purpose of this guide.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device Device
... identifier O 0..* Identifier Instance identifier
ObligationsActor
handle LabReportHandler
... udiCarrier O 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
ObligationsActor
handle LabReportHandler
... manufacturer O 0..1 string Name of device manufacturer
ObligationsActor
handle LabReportHandler
handle LabReportHandler
.... name O 1..1 string The name of the device
ObligationsActor
handle LabReportHandler
... type O 0..1 CodeableConcept The type of device
Binding: eHDSI Medical Device with exceptions (required)
ObligationsActor
handle LabReportHandler

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typerequiredEHDSIMedicalDeviceWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier O 0..* Identifier Instance identifier
ObligationsActor
handle LabReportHandler
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... manufacturer O 0..1 string Name of device manufacturer
ObligationsActor
handle LabReportHandler
handle LabReportHandler
... type O 0..1 CodeableConcept The type of device
Binding: eHDSI Medical Device with exceptions (required)
ObligationsActor
handle LabReportHandler

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.typerequiredEHDSIMedicalDeviceWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier O 0..* Identifier Instance identifier
ObligationsActor
handle LabReportHandler
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier OΣ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
ObligationsActor
handle LabReportHandler
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier 0..1 string The distinct identification string
... manufacturer O 0..1 string Name of device manufacturer
ObligationsActor
handle LabReportHandler
handle LabReportHandler
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
... deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name O 1..1 string The name of the device
ObligationsActor
handle LabReportHandler
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type O 0..1 CodeableConcept The type of device
Binding: eHDSI Medical Device with exceptions (required)
ObligationsActor
handle LabReportHandler
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1 Reference(Patient) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typerequiredEHDSIMedicalDeviceWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

Summary

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device Device
... identifier O 0..* Identifier Instance identifier
ObligationsActor
handle LabReportHandler
... udiCarrier O 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
ObligationsActor
handle LabReportHandler
... manufacturer O 0..1 string Name of device manufacturer
ObligationsActor
handle LabReportHandler
handle LabReportHandler
.... name O 1..1 string The name of the device
ObligationsActor
handle LabReportHandler
... type O 0..1 CodeableConcept The type of device
Binding: eHDSI Medical Device with exceptions (required)
ObligationsActor
handle LabReportHandler

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typerequiredEHDSIMedicalDeviceWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier O 0..* Identifier Instance identifier
ObligationsActor
handle LabReportHandler
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... manufacturer O 0..1 string Name of device manufacturer
ObligationsActor
handle LabReportHandler
handle LabReportHandler
... type O 0..1 CodeableConcept The type of device
Binding: eHDSI Medical Device with exceptions (required)
ObligationsActor
handle LabReportHandler

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.typerequiredEHDSIMedicalDeviceWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier O 0..* Identifier Instance identifier
ObligationsActor
handle LabReportHandler
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier OΣ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
ObligationsActor
handle LabReportHandler
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier 0..1 string The distinct identification string
... manufacturer O 0..1 string Name of device manufacturer
ObligationsActor
handle LabReportHandler
handle LabReportHandler
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
... deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name O 1..1 string The name of the device
ObligationsActor
handle LabReportHandler
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type O 0..1 CodeableConcept The type of device
Binding: eHDSI Medical Device with exceptions (required)
ObligationsActor
handle LabReportHandler
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1 Reference(Patient) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typerequiredEHDSIMedicalDeviceWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

Summary

 

Other representations of profile: CSV, Excel, Schematron