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

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Official URL: http://fhir.ehdsi.eu/laboratory/ImplementationGuide/myhealth.eu.fhir.laboratory Version: 0.0.1
Draft as of 2024-04-18 Computable Name: MyHealthEuLaboratoryIg

Obligations have been added to this version of the guide only as Informative material to collect feedback about their usage.

For more details about obligations please refer to the Obligations page

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 Requirements 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 choiches

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

Package hl7.fhir.uv.extensions.r4#1.0.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sun, Mar 26, 2023 08:46+1100+11:00)

Package hl7.fhir.uv.ips#1.1.0

International Patient Summary (IPS) FHIR Implementation Guide (built Tue, Oct 24, 2023 13:36+0000+00:00)

Package hl7.fhir.eu.extensions#0.1.0

This guide lists the extensions speciifed for the European REALM. (built Mon, Feb 19, 2024 08:53+0100+01:00)

Package hl7.fhir.eu.laboratory#0.1.0

This guide describes how the Laboratory Report can be represented in the European REALM. (built Tue, Feb 20, 2024 12:27+0100+01:00)

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.