This page is part of the HL7 Europe Imaging Study Report (v0.1.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. 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://hl7.eu/fhir/imaging-r5/ImplementationGuide/hl7.fhir.eu.imaging-r5				Version: 0.1.0-ballot
Draft as of 2025-05-14				Computable Name: HL7EuImagingStudyReport
Copyright/Legal: Used by permission of HL7 Europe, all rights reserved Creative Commons License

Scope

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

• The structure and contents of a FHIR imaging studies and reports.
• Different options for publishing and searching for such studies and reports.
• Discovery of available mechanisms to access the imaging data.

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.

Current approaches within Europe use different approaches to information exchange:

• Document based exchange, the document is represented as a FHIR Document Bundle.
• REST API based access to documents, a Composition and DiagnosticReport for each document including instances of the referred resources
• REST API based access to resources, as the previous but the (important) resources are harmonized, meaning that all documents point to the same Patient, Organization and other resources.

The specification is being designed in such a way that it can be used in all of these deployment scenarios.

Purpose

The goal of this Implementation Guide is to define an European standard for the Imaging Study 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.

References

This specification defines the representation of the data sets required by Guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU Medical imaging studies and reports, release 1.1".

Besides the requirements defined in the eHN Imaging Studies and Reports guidelines, it also uses input from other related activities:

• Related activities in other Standard Development Organizations (SDO):

  • IHE-RAD
  • HL7 FHIR Imaging Integration

• Related specifications:

  • IHE-IDR, draft version as discussed on Jan 19 2025
    • IHE-RAD is working on a machine readable specification for diagnostic reports of (common) radiology procedures. The draft results of this activity have been taken along in the definition of this IG.
  • HL7 EU Base
    • Base and code profiles for European specifications.
  • HL7 Europe Extensions
    • This specification defines a set of extensions by HL7 Europe for the EU realm.
  • HL7 EU Laboratory Reports
    • This specification defines 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).
  • HL7 EU Hospital Discharge Reports
    • This specification defines an European standard for the Hospital Discharge Report to facilitate the harmonization among the national initiatives and prepare the ground for the European EHR eXchange Format (E-EHRxF)."
  • Argonaut Imaging

Dependencies

Package hl7.fhir.uv.extensions.r5#5.2.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.extensions#5.2.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

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#0.1.1-ballot This guide lists the extensions speciifed for the European REALM. (built Tue, Apr 22, 2025 11:47+0200+02:00)

Package hl7.fhir.eu.extensions.r5#0.1.1-ballot This guide lists the extensions speciifed for the European REALM. (built Wed, Apr 30, 2025 14:07+0200+02:00)

Package hl7.fhir.eu.base-r5#0.1.0-ballot This guide collects base and core profiles to be used in the European context. It also includes common artifacts, such as the profiles describing the European Health Insurance Card. (built Tue, May 6, 2025 08:06+0200+02:00)

Cross Version Analysis

Global Profiles

There are no Global profiles defined

IP statements

This publication includes IP covered under the following statements.

• The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
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  • Unified Code for Units of Measure (UCUM): ImDoseLengthUnits, ImEffectiveDoseUnits, ImGestationalAgeObservation, ImGraySquareUnits and ImRadiationDoseObservation
• 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.
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  • DICOM Controlled Terminology Definitions: ImKeyImageDocumentReference, ImRadiationDoseObservation and Report_ImRadiationDoseObservation
• 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.
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  • LOINC: ImComposition, ImDiagnosticReport... Show 11 more, ImKeyImageDocumentReference, ImManifestIheMhdDocumentReference, ImOrder, ImRadiationDoseObservation, ImReportIheMhdDocumentReference, ImSectionEmptyReason, Manifest_ImManifestDocumentReference, Report_ImComposition, Report_ImDiagnosticReport, Report_ImRadiationDoseObservation and Report_ImReportDocumentReference
• 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.
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  • SNOMED Clinical Terms® (SNOMED CT®): ConditionEu, CrossVersionMediaView... Show 14 more, CrossVersionMediaViewExtension, ImGestationalAgeObservation, ImImagingDevice, ImImagingDeviceType, ImOrder, ImProcedure, ImProcedureType, Manifest_ImOrder, Manifest_ImProcedure, PeriodsOfLifeExtension, PeriodsOfLifeValueSet, Report_ImGestationalAgeObservation, Report_ImOrder and Report_ImProcedure
• 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
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  • Endpoint Connection Type: ImWadoEndpoint and Manifest_ImWadoEndpoint
  • List Empty Reasons: ImComposition and ImSectionEmptyReason
  • identifierType: ImAccessionNumberIdentifier
  • ActCode: EncounterEu
  • ActPriority: EncounterEu
  • ParticipationType: EncounterEu, ImImagingStudy... Show 4 more, ImImagingStudyPerformerTypeVS, Manifest_ImImagingStudy, Report_EuEncounter and Report_ImImagingStudy
• Used by permission of HL7 Europe, all rights reserved Creative Commons License
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  • HL7 EU Document Types: ImComposition, ImDiagnosticReport... Show 6 more, ImImagingManifestTypesEuVS, ImImagingReportTypesEuVS, ImManifestIheMhdDocumentReference, ImReportIheMhdDocumentReference, Report_ImComposition and Report_ImDiagnosticReport
  • Diagnostic Report Support Info Code System: DiagnosticReportSupportingInfoVCodes, ImDiagnosticReport and Report_ImDiagnosticReport
  • CodeSystem for terminology used in Endpoint resources in the EU Imaging IG.: ImImageIidViewerEndpoint and Manifest_ImImageIidViewerEndpoint
  • Missing DICOM Terminology: ImFinding, ImKeyImageDocumentReference... Show 5 more, ImRadiationDoseObservation, ImSopInstanceUidIdentifier, ImStudyInstanceUidIdentifier, Report_ImFinding and Report_ImRadiationDoseObservation

Authors and Contributors

Please refer to the Authors and Contributors page.