MyHealth@EU Laboratory Report - Local Development build (v9.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Change Log

This page lists the changes made in each version of this guide.

Version 9.2.0

Trial-use release for MyHealth@EU Wave 9.

Potentially breaking changes

The changes below may make instances that conform to version 9.1.1 non-conformant, or may affect systems that receive the reports. They are grouped by where the change comes from.

Changes made in this guide

• Animal patients are no longer supported. The PatientAnimal: Laboratory profile (patient-animal-myhealtheu-lab) and its example have been removed. ServiceRequestLabMyHealthEu.subject no longer allows an animal patient. This also follows HL7 Europe Laboratory Report 2.1.0 (see below).
• Specimen focus restricted. In SpecimenMyHealthEu, the focus extension now references only these profiles:
  • PatientMyHealthCore;
  • AnimalSpecimenMyHealthLab, for an animal specimen source; it was animal-specimen-eu-lab before;
  • the MyHealth@EU Core Location profile; it was any Location before;
  • Group, Device, Substance or BiologicallyDerivedProduct.

Changes inherited from HL7 Europe Laboratory Report 2.1.0

• Specimen body site reference moved. The extension that references a BodyStructure is no longer on Specimen.collection (Specimen.collection.extension:bodySite, http://hl7.org/fhir/StructureDefinition/bodySite). It is now on Specimen.collection.bodySite (Specimen.collection.bodySite.extension:bodySite, the R5 cross-version extension http://hl7.org/fhir/5.0/StructureDefinition/extension-Specimen.collection.bodySite). In SpecimenMyHealthEu, the reference must be a BodyStructureMyHealthCore.
• Specimen container device required. When Specimen.container is present, its device extension (extension-Specimen.container.device) is now required (1..1, was 0..1).
• Specimen type optional. Specimen.type is now 0..1 (was 1..1). Receiving systems must accept a specimen without a type.
• No animal patient as ServiceRequest subject. ServiceRequest.subject no longer allows an animal patient (Patient-animal-eu-lab).
• Component value extension URL changed. The R5 cross-version extension on Observation.component is now http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value (was …/extension-Observation.value). The same change is in MyHealth@EU Core 1.0.1.

Changes inherited from MyHealth@EU Core 1.0.1

• DiagnosticReport reference in the Composition. In CompositionLabReportMyHealthEu, the diagnosticReport extension must now reference a DiagnosticReport that conforms to the MyHealth@EU Core DiagnosticReport profile (was any DiagnosticReport). A report that uses DiagnosticReportLabMyHealthEu, which is based on that profile, is not affected.
• Component value extension URL changed in MedicalTestResultMyHealthCore, as in HL7 Europe Laboratory Report 2.1.0 (see above).

Dependencies

The EHDS logical models package is based on HL7 FHIR R5; see Known Issues.

Logical models

The logical models are not meant to be implemented or exchanged, so these changes do not affect instances.

• MyHealthEuLabReport:
  • the intended recipient is now header.intendedRecipient[x], as in the EHDS model;
  • body.orderInformation is no longer typed as MyHealthEuLabServiceRequest. It keeps the EHDS definition, with its own elements, which the previous type conflicted with.
• All logical models now have a maturity level (FMM 2) and the trial-use status.

Other profile changes

• ObservationResultsLaboratoryMyHealthEu: value[x] is no longer limited to Quantity, Range and Ratio; all the result types of the base resource are allowed (work item 5).
• SpecimenMyHealthEu: the collector can be a patient or a related person, through the collector extension on Specimen.collection.collector (inherited from HL7 Europe Laboratory Report 2.1.0).
• CompositionLabReportMyHealthEu: the attachment section now explains that the referenced Binary and DocumentReference resources are included in the document Bundle as additional entries.
• The animal specimen source profile is now titled RelatedPerson: Animal specimen source.
• All profiles now have a maturity level (FMM 2) and the trial-use status. Some short descriptions and definitions have been corrected.

Examples

• The Bundle example now follows a consistent timeline, and populates the mandatory and required elements: language, version and author of the Composition; order, specimen and issue time of the DiagnosticReport; order, specimen and performer of the Observation; identifier, subject and collection time of the Specimen; requester and order date of the ServiceRequest.
• Example titles and descriptions follow a single pattern.
• The Czech and Italian NamingSystems, which support the identifiers used in the examples, are now published as examples, not as conformance resources.

Pages

• New Known Issues page (FHIR version of the EHDS logical models, pattern discriminators), and this Change Log page.
• The obligation levels are described once, in the Introduction; the Laboratory Models Overview links to it.
• The mapping page (Mapping to Profiles) has been updated for the new logical models.
• The Introduction clarifies that consuming systems must display every element with an obligation that is present in the document.

Publication

• The guide is now published under the CC0-1.0 licence.
• The artifacts are organised in three groups: Logical Models, Document-related Profiles and Entry Profiles.