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

Functional Requirements

This page summarizes the functional requirements addressed by this implementation guide. The guide constrains and extends IHE-MADO with EU-specific requirements and content so that the manifest can be used consistently in the European interoperability context.

EU-specific requirements

This implementation guide is intended to:

• Align with the EU Health Data API;
• Support the Xt-EHR requirements for ImagingStudy and related EHDS imaging concepts;
• Provide a mapping between the Xt-EHR logical model and the FHIR artifacts in this guide;
• Stay compatible with EU-core profiles where EU-core requirements apply;
• Mandate the presence of the anatomical-region extension on MADO EU Imaging Study and make the anatomical region value set a required binding.

Delta relative to IHE MADO

Compared with IHE-MADO, this implementation guide introduces the following EU-specific delta:

• It adds traceability from the FHIR artifacts to Xt-EHR logical model elements (see Xt-EHR Medical Images) and related actor obligations.
• It refines IHE-MADO resources to EU-specific profiles, including compatibility with EU-core where applicable.
• It publishes explicit Xt-EHR mapping content for the EHDS logical model to FHIR and DICOM representations used in this guide.
• It strengthens anatomical region requirements by making the extension mandatory on the EU ImagingStudy profile and binding it to a required value set.

Requirements realized in this guide

The current implementation realizes these requirements in the following way:

• The guide declares alignment with the European health-data interoperability context and references the EU Health Data API as the external framework this specification is intended to fit into.
• The XtEHR Mapping page documents how Xt-EHR logical model elements are mapped to the FHIR profiles and DICOM data carried by this guide.
• The MADO EU Imaging Study profile adds EHDS/Xt-EHR traceability and obligations on key elements such as subject, modality, body site, series metadata, and endpoints.
• The EU MADO Patient profile declares compliance with the EU-core patient profile, providing EU-core compatibility for patient data carried in the manifest.
• The MADO EU Imaging Study profile requires extension[anatomical-region] 1..* and binds its value to ValueSetAnatomicalRegion with required strength.

Summary

In short, this implementation guide is not a generic restatement of IHE-MADO. It is the EU-specific realization of MADO for the imaging-manifest use case, with added alignment to the EU Health Data API, support for Xt-EHR ImagingStudy requirements, explicit Xt-EHR-to-FHIR mapping, EU-core compatibility, and stricter anatomical-region semantics.