This page is part of the EU Manifest-based Access to DICOM Objects (EU-MADO) (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Home

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 defines the European specific IHE-MADO specification following the definition in eHN Imaging Studies and Reports and refined by XtEHR Imaging Logical Model, as a DICOM and FHIR model. It defines:

• The structure and contents of imaging study manifests in two complementary representations: a FHIR Bundle manifest and a DICOM KOS (Key Object Selection) manifest.
• The MHD (Mobile access to Health Documents) envelopes used to package and exchange these manifests.
• 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 Manifests.
• The relation of this specification with the existing ecosystem, including IHE-MADO, IHE-RAD, and EU Health Data API specifications.

The specification is to be used in a variety of deployment models, which includes the EHDS use cases: exchange data within healthcare organizations, across nations/regions and cross border information exchange. In all of these use cases it is important that it is compatible with the existing ecosystem.

Summary of differences

• Update the MADO profiles to use the required EU profiles
• Mapping on the XtEHR model for ImagingStudy
• Requiring anatomical regions with values from the anatomical region valueset.

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 HL7 Europe Imaging Report. 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 AccessionNumber are key matching anchors.

Purpose

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

The development of this implementation guide is promoted by HL7 and IHE Europe under the flag of Euridice, 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.

Structure

This specification follows the IHE supplement structure, organised as follows:

1. The volume 1 is the profile overview in term of Actor/Transactions, the overall use case and associated scenarios. Volume 1 alsos state the required and optional transactions, as well as the required/optional grouping. The actors defined by this guide are the Content Creator/Document Source (Imaging Manifest), the Document Consumer (Imaging Manifest), and the Document Access Provider (Imaging Manifest), whose server behaviour is described in the MADO Document Responder CapabilityStatement.
2. Volume 2 Chapter on the WADO-RS Retrieve Transaction.
3. A volume 3 Chapter on the Manifest content that includes a section A on the DICOM KOS based Manifest, and one section B on the FHIR based Manifest. The section C (for information) would include the mapping of A to B and B from A

How to read this guide

The following pages provide the substantive content of this guide:

• Functional Requirements — the requirements this specification must satisfy.
• EHDS logical model mapping — mapping between this IG and the Xt-EHR logical models.
• Volume 1 — actors, transactions, use cases and scenarios.
• Volume 2 — the WADO-RS Retrieve transaction.
• Volume 3 — the manifest content, with:
  • FHIR Imaging Manifest — the FHIR Bundle representation.
  • DICOM KOS Manifest — the DICOM KOS representation.
  • Manifest Envelopes for IHE-MHD — the MHD packaging of the manifests.
  • FHIR / KOS Mappings — the mapping between the two representations.

The formal definitions — profiles, actors, the capability statement, terminology and examples — are listed on the Artifacts page.

FHIR specific Dependencies

IG	Package	FHIR	Comment
EU Imaging Manifest and Access (IHE-MADO additions)	hl7.fhir.eu.imaging-manifest#1.0.0-ballot	R4
EU Imaging Manifest and Access (IHE-MADO additions) / HL7 Terminology (THO)	hl7.terminology.r4#7.4.0	R4	Automatically added as a dependency - all IGs depend on HL7 Terminology
EU Imaging Manifest and Access (IHE-MADO additions) / FHIR Extensions Pack	hl7.fhir.uv.extensions.r4#5.3.0	R4	Automatically added as a dependency - all IGs depend on the HL7 Extension Pack
EU Imaging Manifest and Access (IHE-MADO additions) / FHIR Extensions Pack / HL7 Terminology (THO)	hl7.terminology.r4#7.1.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / FHIR Extensions Pack / HL7 Terminology (THO) / FHIR Extensions Pack	hl7.fhir.uv.extensions.r4#5.2.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO)	ihe.rad.mado#1.0.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / HL7 Terminology (THO)	hl7.terminology.r4#7.3.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / Mobile access to Health Documents (MHD)	ihe.iti.mhd#4.2.3	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / Mobile access to Health Documents (MHD) / HL7 Terminology (THO)	hl7.terminology.r4#6.5.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / Mobile access to Health Documents (MHD) / Basic Audit Log Patterns (BALP)	ihe.iti.balp#1.1.4	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / Extensions for Using Data Elements from FHIR R5 in FHIR R4	hl7.fhir.uv.xver-r5.r4#0.1.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / fhir.dicom	fhir.dicom#2025.3.20250714	R4
EU Imaging Manifest and Access (IHE-MADO additions) / Manifest-based Access to DICOM Objects (MADO) / IHE FormatCode Vocabulary	ihe.formatcode.fhir#1.5.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / HL7 Europe Base and Core FHIR IG	hl7.fhir.eu.base#2.0.1	R4
EU Imaging Manifest and Access (IHE-MADO additions) / HL7 Europe Base and Core FHIR IG / HL7 Europe Extensions	hl7.fhir.eu.extensions.r4#1.3.1	R4
EU Imaging Manifest and Access (IHE-MADO additions) / HL7 Europe Base and Core FHIR IG / Medication Prescription and Dispense (MPD)	ihe.pharm.mpd.r4#1.0.0-comment-2	R4
EU Imaging Manifest and Access (IHE-MADO additions) / HL7 Europe Base and Core FHIR IG / Medication Prescription and Dispense (MPD) / HL7 Terminology (THO)	hl7.terminology.r4#6.3.0	R4
EU Imaging Manifest and Access (IHE-MADO additions) / FHIR Tooling Extensions IG	hl7.fhir.uv.tools.r4#1.3.0	R4	for example references

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.imaging-manifest.r4) and R4B (hl7.fhir.eu.imaging-manifest.r4b) are available.

Global Profiles

There are no Global profiles defined

IP statements

This publication includes IP covered under the following statements.

• Some content from IHE® Copyright © 2015 IHE International, Inc .
  Show Usage
  • IHE Format Code set for use with Document Sharing: DocumentReference/docref-fhir-example
• These codes are excerpted from Digital Imaging and Communications in Medicine (DICOM) Standard, Part 16: Content Mapping Resource, Copyright © 2011 by the National Electrical Manufacturers Association.
  Show Usage
  • DICOM Controlled Terminology Definitions: Bundle/bundle-mado-example, DocumentReference/docref-fhir-example... Show 4 more, DocumentReference/docref-kos-example, EuMadoRequestedProcedure, ImagingStudy/study-mado-example and ServiceRequest/reqproc-mado-example
• This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
  Show Usage
  • LOINC: Bundle/bundle-mado-example, Composition/composition-mado-example... Show 5 more, DocumentReference/docref-fhir-example, DocumentReference/docref-kos-example, EuMadoComposition, EuMadoDicomKosDocumentReference and EuMadoFhirDocumentReference
• This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact https://www.snomed.org/get-snomed or info@snomed.org.
  Show Usage
  • SNOMED Clinical Terms® (SNOMED CT®): Bundle/bundle-mado-example, DocumentReference/docref-fhir-example... Show 5 more, DocumentReference/docref-kos-example, EuMadoDicomKosDocumentReference, EuMadoFhirDocumentReference, EuMadoImagingStudy and ImagingStudy/study-mado-example
• This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
  Show Usage
  • Endpoint Connection Type: Bundle/bundle-mado-example, Endpoint/endpoint-wado and Endpoint/endpoint-wado-no-address
  • Endpoint Payload Type: Bundle/bundle-mado-example, Endpoint/endpoint-wado, Endpoint/endpoint-wado-no-address and Endpoint/endpoint-webviewer
  • identifierType: Bundle/bundle-mado-example, DocumentReference/docref-fhir-example... Show 5 more, DocumentReference/docref-kos-example, EuMadoRequestedProcedure, ImagingStudy/study-mado-example, Patient/pat-mado-example and ServiceRequest/reqproc-mado-example

Authors and Contributors

This guide is the result of a multi stakeholders effort involving different experts from several European countries, industry, projects (e.g. XpanDH, XtEHR) and initiatives (e.g. MyHealth@EU).

The main contributors to this specification are: