HL7 Europe Laboratory Report
0.1.0-ballot - ballot 150

This page is part of the HL7 Europe Laboratory Report (v0.1.0-ballot: STU 1 Ballot 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions


Official URL: http://hl7.eu/fhir/laboratory/ImplementationGuide/hl7.fhir.eu.laboratory Version: 0.1.0-ballot
Draft as of 2023-10-22 Computable Name: Hl7EuLaboratoryIg

Copyright/Legal: Used by permission of HL7 Europe, all rights reserved Creative Commons License

Notes for ballotters

Ballotters are invited to evaluate and provide their feedbacks of the following open issues:

  • Allow for more than one DiagnosticReport resource as Bundle.entry. See Bundle-eu-lab for more details
  • Allow Composition to have as section entry the DiagnosticReport resource. See Composition-eu-lab for more details
  • Adoption of obligations. See the Obligations page for more details

The laboratory domain

Clinical laboratory results play an important role in diagnosis, treatment, and follow-up of patients. The availability of high quality test results, and the capacity of sharing them, is therefore essential being often the basis for clinical decision making. For this reason the Laboratory has been selceted as one of the priority domains for the European EHR eXchange Format (E-EHRxF)


Define a set of common rules to be applied to HL7 FHIR to define how to represent a Laboratory Report in the European Context, coherently with the European eHN Guidelines (see the Eruopean eHealth - Key documents ).

This IG covers laboratory result reports within the core fields of in-vitro diagnostics, for example clinical biochemistry, haematology, immunohematology, microbiology, immunology, while leaving out some specialised laboratory domains requiring specialised reporting structure like histopathology or medical genetics.

This guide is not limited to test results performed by clinical laboratories on Human specimens (from human subject), but it considers also results on non-human materials or living subjects; or non-human specimens paired with a human subject. Derived guides may restrict the scope as needed (e.g. limiting the scope to well-identified human beings)


The goal of this Implementation Guide is to define an European standard for the Laboratory Report to facilitate the harmonization among the national initiatives and prepare the ground for the European EHR eXchange Format (E-EHRxF).

This project is promoted by HL7 Europe, but realized in collaboration with several other European and national organizations and project.

The aspiration of this guide is that of being used as basis for European National Guides, the Euroepan EHRxF and - consequently - by MyHealth@EU for the EU cross-border services.


The project background and the reasons for the design choiches (a FHIR document including the DiagnosticReport resource) are described in the Design choices page.


.. HL7 Europe Laboratory Reporthl7.fhir.eu.laboratory#0.1.0-ballotR4
... HL7 Terminology (THO)hl7.terminology.r4#5.3.0R4Automatically added as a dependency - all IGs depend on HL7 Terminology
... FHIR Extensions Packhl7.fhir.uv.extensions.r4#1.0.0R4Automatically added as a dependency - all IGs depend on the HL7 Extension Pack
... International Patient Summary Implementation Guidehl7.fhir.uv.ips#1.1.0R4
.... fhir.dicom#2022.4.20221006R4

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 Thu, Oct 5, 2023 02:41+0000+00:00)

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 (hl7.fhir.eu.laboratory.r4) and R4B (hl7.fhir.eu.laboratory.r4b) are available.

Global Profiles

There are no Global profiles defined

IP statements

This publication includes IP covered under the following statements.

Authors and Contributors

Please refer to the Authors and Contributors page.