HL7 Europe Imaging Report R5, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/imaging-r5/ and changes regularly. See the Directory of published versions

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Acknowledgment
The development of this Implementation Guide version has been supported by the Xt-EHR Joint Action. Xt-EHR provided expertise, alignment with European health policy priorities, and validation of specifications to enable consistency with EHDS requirements.

Scope

This implementation guide specifies imaging study report data in the European context, as defined in eHN Imaging Studies and Reports and refined by Xt-EHR Imaging Logical Model, as a FHIR model. It defines:

• The structure and contents of a FHIR imaging study report.
• Mapping between this IG and the Xt-EHR logical models for imaging reports, as functional requirements.
• Example implementations of the defined models for Imaging Study Reports.
• Relation of this specification with the existing ecosystem, including IHE MADO, IHE RAD, and EHDS API specifications.

This specification has been designed to be compatible with EU Health Data API.

Relationship and scope boundaries

This guide is part of the broader European EHDS-aligned interoperability landscape and focuses on the imaging report model and related access patterns. It is designed to be complementary to other EHDS family guides and to remain interoperable with established IHE workflows.

In particular, this guide aligns with IHE-MADO / Imaging Manifest and related IHE document exchange infrastructure. The separation between report and manifest is intentional:

• The report communicates the clinician-authored interpretation and supporting clinical content.
• The manifest communicates imaging-study inventory and retrieval context for DICOM access.

This split preserves clinical traceability while avoiding coupling report content to potentially changing image-location endpoints. Historically, report workflows (RIS/EHR-centric) and image-storage workflows (PACS-centric) evolved in different technical stacks, and this guide keeps that separation explicit while keeping both artifacts linkable.

For operational workflows, both directions are expected:

• starting from a report, discover the related manifest;
• starting from a manifest, discover the related report(s).

In both directions, ImagingStudy identifiers such as StudyInstanceUID and order-level identifiers such as accession-number are key matching anchors.

Purpose

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

The development of this implementation guide is promoted by HL7 Europe, but realized in collaboration with several other European and national organizations and projects. The aspiration of this guide is to be used as basis for European National Guides, the European EHRxF ,and - consequently - by MyHealth@EU for the EU cross-border services.

How to read this guide

This guide is organized to support both functional and technical readers.

Start here:

1. Read the Home page for scope, purpose, and baseline dependencies.
2. Read Background and context to understand high-level context and relations of this IG with EHDS, Xt-EHR, HL7 Europe, and IHE.
3. Open Use Cases to understand clinical and workflow context represented in this IG.
4. Review System actors for roles and responsibilities.
5. Continue with Imaging Report and Data formats to understand the model and exchange options.
6. Use Patterns and Guidelines and Design considerations for implementation rules and rationale.
7. Use Examples and Artifacts for conformance and testing.

Functional and technical paths

If you are a policy or functional stakeholder, focus on:

• Background and context
• Use Cases
• Xt-EHR mapping
• System actors
• Imaging Report

If you are an implementer, architect, or validator, focus on:

• Data formats
• EU Health Data API for Imaging Reports
• Patterns and Guidelines
• Artifacts
• Obligations

FHIR versions

This implementation guide is published and maintained in both FHIR R4 and R5 versions.

• Conceptual content is aligned across versions.
• Some technical details differ because of FHIR version-specific constraints.
• Always verify examples and artifacts in the version you are implementing.

Practical reading tips

• Use the top menu to navigate by topic.
• Use the Table of Contents for a full page index.
• Check Changes to understand updates between releases.
• Check Dependencies and References for external constraints and standards.
• Suggestions and contributions are welcome and done through Jira.