MyHealth@Eu Laboratory Report
9.1.1-ci-build - trial-use 150

MyHealth@Eu Laboratory Report - Local Development build (v9.1.1-ci-build) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Official URL: http://fhir.ehdsi.eu/laboratory/ImplementationGuide/myhealth.eu.fhir.laboratory Version: 9.1.1-ci-build
Draft as of 2026-04-09 Computable Name: MyHealthEuLaboratoryIg

Scope

Specify a set of rules to be applied to HL7 FHIR to define how to represent a Laboratory Report for the European cross-borders exchange, coherently with the European eHN Guidelines (see the European eHealth - Key documents ).

This Implementation Guide applies to laboratory reports within the core fields of in-vitro diagnostics (e.g. clinical biochemistry, haematology, microbiology, …), while leaving out some specialised laboratory domains like histopathology or medical genetics.

This guide is derived for the HL7 Europe Laboratory Report HL7 FHIR IG fulfilling the MyHealth@EU Functional Requirements (see the MyHealth@EU Laboratory Models Overview page)

MyHealth@EU

The Use Case originates from the Change Proposal produced by the X-eHealth project/MyHealth@EU New Use Case Workgroup, and the details are available in the corresponding Change Proposal: CP-eHealthDSI-073: Implement the new service Laboratory Result Report (corresponding to the Wave 8 of MyHealth@EU).

The corresponding eHN Guidelines: eHN Laboratory Result Guidelines (release 1) are available here

Design choices

The solution adopted by this guide - and detailed in the HL7 EU Laboratory Report Design choices page - balances the business requirement of Laboratory Report as legally signable document (i.e. as a HL7 FHIR document), with the expectation to get Lab Report by searching per DiagnosticReport. All this, taking into account the R5 DiagnosticReport design pattern where the DiagnosticReport - Composition relationship is directed from the DiagnosticReport to the Composition resource.

This is done by supporting both perspectives (see figure below) requiring the document bundle ( BundleLabReportMyHealthEu ) to always include a DiagnosticReport ( DiagnosticReportLabMyHealthEu ) and enabling the pre-adoption of the R5 rules for the inclusion of entries in the Document Bundle.

Laboratory report design approach

Figure 1 - Overview of the report design approach

The following diagrams provide a browseable overview of the profiles specified by this guide (not all the relationships have been reported).

The first highlights the most relevant relationships starting from the DiagnosticReport ( DiagnosticReportLabMyHealthEu ) resource (REST Perspective).

The second the profiles included in the document bundle ( BundleLabReportMyHealthEu ) (Document Perspective).

Dependencies

IGPackageFHIRComment
.. MyHealth@Eu Laboratory Reportmyhealth.eu.fhir.laboratory#9.1.1-ci-buildR4
... HL7 Terminology (THO)hl7.terminology.r4#7.1.0R4Automatically added as a dependency - all IGs depend on HL7 Terminology
.... FHIR Extensions Packhl7.fhir.uv.extensions.r4#5.2.0R4
... International Patient Summary Implementation Guidehl7.fhir.uv.ips#2.0.0R4
.... HL7 Terminology (THO)hl7.terminology.r4#6.5.0R4
.... International Patient Accesshl7.fhir.uv.ipa#1.1.0R4
..... HL7 Terminology (THO)hl7.terminology.r4#6.2.0R4
..... SMART App Launchhl7.fhir.uv.smart-app-launch#2.0.0R4
... HL7 Europe Laboratory Reporthl7.fhir.eu.laboratory#2.0.0-alphaR4
.... HL7 Terminology (THO)hl7.terminology.r4#7.0.1R4
.... FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5hl7.fhir.uv.xver-r5.r4#0.0.1-snapshot-2R4
.... HL7 Europe Extensionshl7.fhir.eu.extensions.r4#1.2.0R4
.... HL7 Europe Base and Core FHIR IGhl7.fhir.eu.base#2.0.0-gammaR4
..... Medication Prescription and Dispense (MPD)ihe.pharm.mpd.r4#1.0.0-comment-2R4
...... HL7 Terminology (THO)hl7.terminology.r4#6.3.0R4
... MyHealth@Eu Coremyhealth.eu.fhir.core#devR4
.... HL7 Europe Base and Core FHIR IGhl7.fhir.eu.base#2.0.0-ballotR4
.... EHDS Logical Information Modelsxtehr.eu.ehds.models#0.3.0R5
..... HL7 Terminology (THO)hl7.terminology.r5#7.0.1R5
... FHIR Tooling Extensions IGhl7.fhir.uv.tools.r4#1.1.2R4for example references

Package hl7.fhir.uv.extensions.r4#5.2.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.ipa#1.1.0

This IG describes how an application acting on behalf of a patient can access information about the patient from an clinical records system using a FHIR based API. The clinical records system may be supporting a clinical care provider (e.g. a hospital, or a general practitioner), or a health data exchange, including a national health record system. (built Wed, Mar 19, 2025 14:34+0000+00:00)

Package hl7.fhir.uv.xver-r5.r4#0.0.1-snapshot-2

The cross-version extensions available in FHIR R4 from FHIR R5 (built Sat, Sep 13, 2025 16:55-0400-04:00)

Package hl7.fhir.eu.extensions.r4#1.2.0

This guide lists the extensions specified for the European REALM. (built Fri, Dec 19, 2025 11:52+0100+01:00)

Package ihe.pharm.mpd.r4#1.0.0-comment-2

ImplementationGuide for IHE Pharmacy Medication Prescription and Dispense (MPD) profile (built Tue, May 27, 2025 16:32+0200+02:00)

Package hl7.fhir.eu.base#2.0.0-gamma

This guide collects base and core profiles to be used in the European context. It also includes common artifacts, such as the profiles describing the European Health Insurance Card. (built Wed, Feb 25, 2026 10:00+0100+01:00)

Package hl7.fhir.eu.laboratory#2.0.0-alpha

This guide describes how the Laboratory Report can be represented in the European REALM. (built Wed, Feb 25, 2026 15:28+0100+01:00)

Package myhealth.eu.fhir.mvc-package#9.1.0

MyHealthEu Master Value Sets Catalog (built Fri, Feb 13, 2026 16:03+0000+00:00)

Package hl7.fhir.eu.base#2.0.0-ballot

This guide collects base and core profiles to be used in the European context. It also includes common artifacts, such as the profiles describing the European Health Insurance Card. (built Fri, Dec 19, 2025 18:28+0100+01:00)

Package xtehr.eu.ehds.models#0.3.0

EHDS Logical Information Models (built Fri, Feb 6, 2026 19:33+0100+01:00)

Package myhealth.eu.fhir.core#dev

This guide describes how the Core can be represented for the purpose of the MyHealthEu. (built Wed, Apr 1, 2026 13:24+0000+00:00)

Package hl7.fhir.uv.tools.r4#1.1.2

This IG defines the extensions that the tools use internally. Some of these extensions are content that are being evaluated for elevation into the main spec, and others are tooling concerns (built Tue, Mar 24, 2026 11:13+1100+11:00)

Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (myhealth.eu.fhir.laboratory.r4) and R4B (myhealth.eu.fhir.laboratory.r4b) are available.

Global Profiles

There are no Global profiles defined

IP statements

This publication includes IP covered under the following statements.