Medical imaging studies and reports in FHIR
Medical imaging studies and reports is a priority category of the European Health Data Space (Article 14(1) point (d) of Regulation (EU) 2025/327). It applies from March 26, 2031. HL7 Europe covers it with imaging 1.0.0-ballot, imaging-manifest 1.0.0-ballot.
- Regulation
- Regulation (EU) 2025/327, Article 14(1)(d), Annex I
- Applies from
- March 26, 2031
- HL7 Europe guides
- hl7.fhir.eu.imaging 1.0.0-ballot, ballothl7.fhir.eu.imaging-manifest 1.0.0-ballot, ballot
- Xt-EHR logical models
- EHDSImagingReportEHDSImagingStudy
- Document type
LOINC 85430-7Diagnostic imaging reportLOINC 18748-4Diagnostic imaging study- Validator
- Open the EHDS profile validator
What the Regulation says
Annex I of the Regulation describes the main characteristics of this category. The text is the English original.
Medical imaging studies and related imaging reportsElectronic health data related to the use of or produced by technologies that are used to view the human body in order to prevent, diagnose, monitor or treat medical conditions.
FHIR profiles 38
Profiles defined by the guides above. The rules column counts the elements where the profile goes beyond base FHIR (required, forbidden or limited), which the validator checks; of the slices, only the required ones that a fixed value or the resource type identifies are checked.
| Profile | Resource | HL7 Europe guide | Rules checked | Slices checked / defined |
|---|---|---|---|---|
AdverseEvent: Imaging Adverse Event http://hl7.eu/fhir/imaging/StructureDefinition/AdverseEventEuImaging | AdverseEvent | imaging | 0 | 0 / 2 |
Basic-ImagingSelection: General http://hl7.eu/fhir/imaging/StructureDefinition/ImagingSelectionEuImaging | Basic | imaging | 1 | 0 / 1 |
Key images represented as an ImagingSelection for R4 http://hl7.eu/fhir/imaging/StructureDefinition/ImagingSelectionKeyImageEuImaging | Basic | imaging | 1 | 0 / 3 |
Basic-ImagingSelection: DICOM SR Instance http://hl7.eu/fhir/imaging/StructureDefinition/SrInstanceImagingSelectionEuImaging | Basic | imaging | 2 | 1 / 31 |
Bundle: Imaging Report http://hl7.eu/fhir/imaging/StructureDefinition/BundleReportEuImaging | Bundle | imaging | 10 | 4 / 11 |
Bundle: Imaging Report Minimal Metadata http://hl7.eu/fhir/imaging/StructureDefinition/BundleReportMinimalMetadataEuImaging | Bundle | imaging | 9 | 0 / 3 |
MADO EU FHIR Imaging Study Manifest Bundle http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoBundle | Bundle | imaging-manifest | 9 | 4 / 8 |
EuCarePlan: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/care-plan-obligation-eu-imaging | CarePlan | imaging | 0 | 0 / 0 |
Composition: Imaging Report http://hl7.eu/fhir/imaging/StructureDefinition/CompositionEuImaging | Composition | imaging | 5 | 6 / 51 |
Composition: Imaging Report: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/composition-obligation-eu-imaging | Composition | imaging | 5 | 6 / 51 |
EU MADO Composition http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoComposition | Composition | imaging-manifest | 6 | 0 / 3 |
Device: Imaging Device http://hl7.eu/fhir/imaging/StructureDefinition/DeviceEuImaging | Device | imaging | 2 | 1 / 1 |
EU MADO Creator http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoCreator | Device | imaging-manifest | 2 | 0 / 0 |
DiagnosticReport: Imaging Report http://hl7.eu/fhir/imaging/StructureDefinition/DiagnosticReportEuImaging | DiagnosticReport | imaging | 4 | 3 / 20 |
DiagnosticReport: Imaging Report Minimal Metadata http://hl7.eu/fhir/imaging/StructureDefinition/DiagnosticReportEuImagingMinimalMetadata | DiagnosticReport | imaging | 3 | 2 / 21 |
DiagnosticReport: Imaging Report: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/diagnostic-report-obligation-eu-imaging | DiagnosticReport | imaging | 4 | 3 / 21 |
EEHRxF MHD DocumentReference Profile for Imaging Reports http://hl7.eu/fhir/imaging/StructureDefinition/DocumentReferenceImagingReport | DocumentReference | imaging | 16 | 2 / 10 |
DocumentReference: Key Image http://hl7.eu/fhir/imaging/StructureDefinition/DocumentReferenceKeyImageEuImaging | DocumentReference | imaging | 3 | 0 / 12 |
EU MADO MHD DocumentReference Profile for DICOM KOS Imaging Manifests http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoDicomKosDocumentReference | DocumentReference | imaging-manifest | 20 | 1 / 8 |
EU MADO MHD DocumentReference Profile for FHIR Imaging Study Manifest http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoFhirDocumentReference | DocumentReference | imaging-manifest | 22 | 2 / 11 |
EU MADO WADO Endpoint http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoWadoEndpoint | Endpoint | imaging-manifest | 1 | 0 / 4 |
EU MADO Web Viewer Endpoint http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoWebViewerEndpoint | Endpoint | imaging-manifest | 1 | 1 / 3 |
MADO EU Imaging Study http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoImagingStudy | ImagingStudy | imaging-manifest | 7 | 1 / 7 |
ImagingStudy: General http://hl7.eu/fhir/imaging/StructureDefinition/ImagingStudyEuImaging | ImagingStudy | imaging | 1 | 0 / 9 |
ImagingStudy: General: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/imaging-study-obligation-eu-imaging | ImagingStudy | imaging | 1 | 0 / 9 |
MedicationAdministration: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/medication-administration-obligation-eu-imaging | MedicationAdministration | imaging | 0 | 0 / 0 |
Observation: Imaging Finding http://hl7.eu/fhir/imaging/StructureDefinition/ObservationFindingEuImaging | Observation | imaging | 0 | 0 / 2 |
Observation: Imaging Finding: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/observation-finding-obligation-eu-imaging | Observation | imaging | 0 | 0 / 2 |
Observation: Gestational Age http://hl7.eu/fhir/imaging/StructureDefinition/ObservationGestationalAgeEuImaging | Observation | imaging | 1 | 0 / 0 |
Observation: Radiation Dose http://hl7.eu/fhir/imaging/StructureDefinition/ObservationRadiationDoseEuImaging | Observation | imaging | 4 | 1 / 4 |
ObservationRadiationDoseEuImaging: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/observation-radiation-dose-obligation-eu-imaging | Observation | imaging | 4 | 1 / 4 |
EU MADO Creator Organization http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoCreatorOrganization | Organization | imaging-manifest | 1 | 0 / 0 |
EU MADO Patient http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoPatient | Patient | imaging-manifest | 2 | 0 / 0 |
Procedure: Imaging Acquisition http://hl7.eu/fhir/imaging/StructureDefinition/ProcedureEuImaging | Procedure | imaging | 2 | 0 / 4 |
ProcedureEuImaging: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/procedure-obligation-eu-imaging | Procedure | imaging | 2 | 0 / 4 |
EU MADO Requested Procedure http://hl7.eu/fhir/imaging-manifest/StructureDefinition/EuMadoRequestedProcedure | ServiceRequest | imaging-manifest | 1 | 1 / 5 |
ServiceRequest: Imaging Order http://hl7.eu/fhir/imaging/StructureDefinition/ServiceRequestOrderEuImaging | ServiceRequest | imaging | 1 | 1 / 8 |
ServiceRequest: Imaging Order: Obligations http://hl7.eu/fhir/imaging/StructureDefinition/service-request-order-obligation-eu-imaging | ServiceRequest | imaging | 1 | 1 / 8 |
Document structure
The document profiles of this category: the sections a Composition can carry and the entries a Bundle can hold, as the profiles state them. Names are slice names; the section code is the LOINC code the profile fixes.
Bundle: Imaging Report: Bundle entries 11
| Entry | Card. | FHIR resource | Profile |
|---|---|---|---|
CompositionEuImaging | 1..1 | Composition | CompositionEuImaging |
DiagnosticReportEuImaging | 1..1 | DiagnosticReport | DiagnosticReportEuImaging |
Patient | 1..1 | Patient | PatientEuCore |
ImagingStudy | 1..* | ImagingStudy | ImagingStudyEuImaging |
requested-procedure | 0..* | ServiceRequest | ServiceRequestOrderEuImaging |
performed-procedure | 0..* | Procedure | ProcedureEuImaging |
findings | 0..* | Observation | ObservationFindingEuImaging |
key-images | 0..* | Basic | ImagingSelectionKeyImageEuImaging |
practitioner | 0..* | Practitioner | PractitionerEu |
organization | 0..* | Organization | OrganizationEuCore |
binary | 0..* | Binary |
Bundle: Imaging Report Minimal Metadata: Bundle entries 3
| Entry | Card. | FHIR resource | Profile |
|---|---|---|---|
DiagnosticReportEuImagingMinimalMetadata | 1..1 | DiagnosticReport | DiagnosticReportEuImagingMinimalMetadata |
Patient | 0..1 | Patient | PatientEuCore |
ImagingStudy | 0..1 | ImagingStudy | ImagingStudyEuImaging |
MADO EU FHIR Imaging Study Manifest Bundle: Bundle entries 8
| Entry | Card. | FHIR resource | Profile |
|---|---|---|---|
composition | 1..1 | Composition | EuMadoComposition |
imaging-study | 1..1 | ImagingStudy | EuMadoImagingStudy |
patient | 0..1 | Patient | EuMadoPatient |
wado-endpoint | 1..* | Endpoint | MadoWadoEndpoint |
web-endpoint | 0..* | Endpoint | EuMadoWebViewerEndpoint |
creator-device | 1..1 | Device | MadoCreator |
creator-organization | 0..1 | Organization | MadoCreatorOrganization |
requested-procedure | 0..* | ServiceRequest | EuMadoRequestedProcedure |
Composition: Imaging Report: sections 10
| Section | Card. | Section code | Description |
|---|---|---|---|
imagingstudy | 1..1 | LOINC 18726-0 | Imaging Study |
order | 1..1 | LOINC 55115-0 | Order |
history | 1..1 | LOINC 11329-0 | History |
procedure | 1..1 | LOINC 55111-9 | Procedure |
comparison | 0..1 | LOINC 18834-2 | History |
findings | 0..1 | LOINC 59776-5 | Findings |
impression | 0..1 | LOINC 19005-8 | Impressions |
recommendation | 0..1 | LOINC 18783-1 | Recommendations |
communication | 0..1 | LOINC 73568-8 | Communications |
report | 0..1 | LOINC LP173421-1 | Report - all content in one section |
Terminology bindings 7
Value sets that the profiles of this category bind elements to with a required or extensible binding. A required binding only allows codes of the value set; an extensible one expects them unless none fits. Value sets that the HL7 Europe packages define are listed with their codes in the value set reference.
The profiles also state 8 preferred and 1 example bindings.
| Value set | Binding | Used by | Codes |
|---|---|---|---|
diagnostic-service-sections http://hl7.org/fhir/ValueSet/diagnostic-service-sections | required | CompositionEuImaging category:diagnostic-serviceDiagnosticReportEuImaging category:diagnostic-serviceDiagnosticReportEuImagingMinimalMetadata category:diagnostic-service | defined outside the HL7 Europe packages |
ValueSetAnatomicalRegion https://profiles.ihe.net/RAD/MADO/ValueSet/ValueSetAnatomicalRegion | required | EuMadoDicomKosDocumentReference extension:bodysite.value[x]EuMadoFhirDocumentReference extension:bodysite.value[x]EuMadoImagingStudy extension:anatomical-region.value[x] | defined outside the HL7 Europe packages |
ValueSet: Imaging Device Type http://hl7.eu/fhir/imaging/ValueSet/DeviceEuImagingType | extensible | DeviceEuImaging type | defined by rules |
ValueSet: Anatomical Region http://hl7.eu/fhir/imaging/ValueSet/im-anatomical-region-valueset | extensible | DocumentReferenceImagingReport extension:bodysite.extension:concept.value[x] | 10 codes |
ValueSet: Imaging Study Performer Type Value Set http://hl7.eu/fhir/imaging/ValueSet/im-imaging-study-performer-type | extensible | ImagingStudyEuImaging series.performer.function | 1 codes, defined by rules |
ValueSet: Imaging Procedure Type http://hl7.eu/fhir/imaging/ValueSet/im-procedure-type | extensible | ProcedureEuImaging code | defined by rules |
age-units http://hl7.org/fhir/ValueSet/age-units | extensible | ObservationGestationalAgeEuImaging value[x] | defined outside the HL7 Europe packages |
Extensions 15
HL7 Europe extensions that the profiles of this category carry, with the element that holds each one.
| Extension | Context | Value | Used in |
|---|---|---|---|
Extension: Anatomical Region http://hl7.eu/fhir/imaging/StructureDefinition/AnatomicalRegionExtension | DiagnosticReportImagingStudy | CodeableConcept | DiagnosticReportEuImaging extension:anatomical-region 0..*DiagnosticReportEuImagingMinimalMetadata extension:anatomical-region 0..*ImagingStudyEuImaging extension:anatomical-region 0..* |
Extension: Device Attester http://hl7.eu/fhir/imaging/StructureDefinition/DeviceAttesterExt | Composition.attester.party | Reference | CompositionEuImaging attester:resultValidator.party.extension:deviceAttester 0..1 |
Document DiagnosticReport Reference http://hl7.eu/fhir/extensions/StructureDefinition/composition-diagnosticReportReference | Composition | Reference | CompositionEuImaging extension:diagnosticreport-reference 0..1 |
Extension: HL7IDR Communication http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRCommunication | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:communication 0..*DiagnosticReportEuImagingMinimalMetadata extension:communication 0..* |
Extension: HL7IDR DiagnosticReport Comparison Study http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRComparisonStudy | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:comparison 0..*DiagnosticReportEuImagingMinimalMetadata extension:comparison 0..* |
Extension: HL7IDR KeyImage Finding http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRFinding | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:finding 0..*DiagnosticReportEuImagingMinimalMetadata extension:finding 0..* |
Extension: HL7IDR Imaging Procedure http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRImagingProcedure | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:procedure 0..*DiagnosticReportEuImagingMinimalMetadata extension:procedure 0..* |
Extension: HL7IDR Impression http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRImpression | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:impression 0..*DiagnosticReportEuImagingMinimalMetadata extension:impression 0..* |
Extension: HL7IDR Patient History http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRPatientHistory | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:patientHistory 0..*DiagnosticReportEuImagingMinimalMetadata extension:patientHistory 0..* |
Extension: HL7IDR Recommendation http://hl7.eu/fhir/imaging/StructureDefinition/HL7IDRRecommendation | DiagnosticReport | Reference | DiagnosticReportEuImaging extension:recommendation 0..*DiagnosticReportEuImagingMinimalMetadata extension:recommendation 0..* |
Extension: Instance Description http://hl7.eu/fhir/imaging/StructureDefinition/ImagingStudyEuImagingInstanceDescription | ImagingStudy.series.instance | string | ImagingStudyEuImaging series.instance.extension:instance-description 0..1 |
Extension: DocumentReference content profile http://hl7.eu/fhir/imaging/StructureDefinition/im-documentreference-content-profile | DocumentReference.content | canonical | DocumentReferenceImagingReport content.extension:profile 1..* |
Composition: Information recipient http://hl7.eu/fhir/StructureDefinition/information-recipient | Composition | Reference | CompositionEuImaging extension:informationRecipient 0..*DiagnosticReportEuImaging extension:informationRecipient 0..* |
Extension: Number of Frames http://hl7.eu/fhir/imaging/StructureDefinition/NumberOfFrames | ImagingStudy.series.instance | integer | ImagingStudyEuImaging series.instance.extension:number-of-frames 0..1 |
Extension: Radiation Dose http://hl7.eu/fhir/imaging/StructureDefinition/RadiationDose | Composition.sectionDiagnosticReport | string | CompositionEuImaging section:procedure.extension:radiationDose 0..1DiagnosticReportEuImaging extension:radiationDose 0..1DiagnosticReportEuImagingMinimalMetadata extension:radiationDose 0..1 |
Logical model EHDSImagingReport 56
Elements of the Xt-EHR logical model with their cardinality and obligations. Obligations tell producers and consumers of the data what a system SHALL or SHOULD do with each element.
Obligations by actor
How many elements of EHDSImagingReport carry each obligation for each actor.
| Obligation | Actor | Elements |
|---|---|---|
SHALL:able-to-populate | producer | 32 |
SHALL:process | consumer | 6 |
SHOULD:able-to-populate | producer | 19 |
SHOULD:process | consumer | 30 |
Elements 56
| Element | Card. | Obligations | Description |
|---|---|---|---|
header | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | Imaging report header |
subject | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | Patient/subject information |
identifier | 1..* | SHALL:able-to-populate producerSHALL:process consumer | Unique identifier of the document |
author[x] | 1..* | SHALL:able-to-populate producerSHOULD:process consumer | The author of the report. |
date | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | Date of finalising/issuing the document |
status | 1..1 | SHALL:able-to-populate producerSHALL:process consumer | Status of the report |
source | 0..0 | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information. | |
language | 0..1 | SHALL:able-to-populate producer | Language in which the resource is written. Language is expressed by the IETF language tag. |
documentType | 1..1 | SHALL:able-to-populate producer | Type of document (e.g. 18748-4 Diagnostic imaging study) |
documentTitle | 1..1 | SHALL:able-to-populate producer | Human readable document title that can be displayed in search results, etc. This can be documentType's display name, or it can be assembled from multiple elements. Examples: 'Laboratory Result Report', 'Patient Summary of Jane Green 10.12.2024' |
period | 0..1 | SHOULD:able-to-populate producer | Time of service that is being documented |
version | 0..1 | Business version of the document. The exact algorithm for versioning is decided by the producer/custodian | |
attestation | 0..* | SHALL:able-to-populate producer | Document attestation details |
attester[x] | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Attester who validated the document |
datetime | 1..1 | SHALL:able-to-populate producer | Date and time of the approval of the document by Attester |
legalAuthentication | 0..* | SHALL:able-to-populate producer | Document legal authentication details |
legalAuthenticator[x] | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | The person or organisation taking responsibility for the content of the document. |
datetime | 1..1 | SHALL:able-to-populate producer | Date and time when the document was authorised |
eventType | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | Categorisation of the event covered by the document (e.g. imaging study types, body regions, modality, etc.). Selection of such tags or labels depends on the use case and agreement between data sharing parties. This meta-data element serves primarily for searching and filtering purposes. |
serviceSpecialty | 0..* | SHOULD:process consumer | Additional details about where the content was created (e.g. clinical specialty) |
custodian | 0..1 | SHOULD:able-to-populate producerSHOULD:process consumer | Organisation that is in charge of maintaining the document/report. |
accessionNumber | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Accession number - an identifier, managed by the RIS at the local level, which usually uniquely identifies an imaging procedure request, and links it to imaging study(ies) and related imaging report(s). |
intendedRecipient[x] | 0..* | SHOULD:able-to-populate producer | Information recipient (intended recipient or recipients of the report, additional recipients might be identified by the ordering party, e.g. GP, other specialist), if applicable |
presentedForm | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document |
body | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Imaging report structured body |
orderInformation | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | Order Information (Imaging Result Report could respond to multiple orders). |
orderId | 1..* | SHALL:able-to-populate producerSHALL:process consumer | Identifier(s) of the imaging service order. |
orderDateAndTime | 0..1 | Date and time of the order placement. | |
orderPlacer[x] | 0..1 | The person/organisation "authorised" to place the order. Order placer could be either a health professional, health professional organisation or the patient himself. | |
orderReason[x] | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | An explanation or justification for why this service is being requested. |
clinicalQuestion | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Specification of clinical question (goal of the investigation) to be answered by the imaging investigation. |
supportingInformation | 0..1 | SHOULD:able-to-populate producerSHOULD:process consumer | Additional clinical information about the patient or specimen that may affect service delivery or interpretation (additional types of information may be allowed in implementations). |
observation | 0..* | SHOULD:able-to-populate producer | Clinical findings and other observations (e.g., height and weights of the patient). |
condition | 0..* | SHOULD:able-to-populate producer | Conditions that may influence the service or result interpretation. |
priorMedicationAdministration | 0..* | SHOULD:able-to-populate producer | Medication administered before ordering the service specifically for this procedure. |
device | 0..* | SHOULD:able-to-populate producer | List of implants or devices that affect the course of the examination or its interpretation (e.g. metal implants). |
pregnancyStatus | 0..1 | SHOULD:able-to-populate producer | Pregnancy status when the imaging examination was performed (e.g., pregnant, not pregnant, unknown). |
sexForClinicalUse | 0..1 | SHOULD:able-to-populate producer | Sex parameter for clinical use - provides guidance on how a recipient should apply settings or reference ranges that are derived from observable information such as an organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, etc. This property is intended for use in clinical decision making, and indicates that treatment or diagnostic tests should consider best practices associated with the relevant reference population. |
specimen | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | Specimen information. Note: A specimen (not attached to a body) can be used for diagnostic, forensic and medical research purposes. |
exposureInformation | 0..1 | SHOULD:able-to-populate producer | Information on total exposure to ionising radiation. This information is required by regulations in several EU countries. |
examinationReport | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Examination report content. |
modality | 1..* | SHALL:able-to-populate producerSHOULD:process consumer | Imaging modality (or modalities) used during imaging investigation (DICOM CID029). |
bodySite | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | All body parts investigated |
imagingProcedures | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Imaging procedure performed during imaging study. |
medicationAdministration | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Information about medications administered (contrast, sedation, stress agents, etc) during the procedure. |
adverseReaction | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Adverse reactions manifested during imaging investigation. |
results[x] | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Imaging report result data (report could consist of multiple observations) |
conclusion | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | A concise and clinically contextualised summary including interpretation/impression of the diagnostic report. |
impression | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Narrative description of the clinical conclusion (impression). |
conditionOrFinding[x] | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Condition or finding from imaging investigation. |
recommendation | 0..1 | SHOULD:able-to-populate producerSHOULD:process consumer | Recommendation section for additional imaging tests or other actions |
description | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Narrative description of the recommended activities including additional test, medication etc. |
carePlan | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | A complex and structured information about recommended goals, activities and objectives in the form of one or more formal care plan. |
comparisonStudy | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Documentation (reference) of a prior Imaging Report to which the current images were compared. |
dicomStudyMetadata | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Metadata of the DICOM study. A study comprises a set of series, each of which includes a set of Service-Object Pair Instances (SOP Instances - images or other data) acquired or produced in a common context. A series is of only one modality (e.g. X-ray, CT, MR, ultrasound), but a study may have multiple series of different modalities. |
attachments | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | Report attachments |
Mapping of EHDSImagingReport to FHIR 93
How each logical element lands in FHIR, as published in the HL7 Europe guide.
| Element | Relation | FHIR resource | FHIR element | Notes |
|---|---|---|---|---|
header | N/A | |||
subject | equivalent | CompositionEuImaging | subject | |
subject | equivalent | DiagnosticReportEuImaging | subject | |
identifier | equivalent | CompositionEuImaging | identifier | |
identifier | equivalent | DiagnosticReportEuImaging | identifier | |
author[ EHDSHealthProfessional ] | equivalent | CompositionEuImaging | author[author] | |
author[ EHDSHealthProfessional ] | equivalent | CompositionEuImaging | author[organization] | |
author[ EHDSOrganisation ] | equivalent | DiagnosticReportEuImaging | performer[organization] | |
author[ EHDSDevice ] | equivalent | DiagnosticReportEuImaging | resultsInterpreter[author] | |
date | equivalent | CompositionEuImaging | date | |
date | equivalent | DiagnosticReportEuImaging | issued | |
status | equivalent | CompositionEuImaging | status | |
status | equivalent | DiagnosticReportEuImaging | status | |
source | N/A | |||
language | equivalent | CompositionEuImaging | language | |
language | equivalent | DiagnosticReportEuImaging | language | |
documentType | equivalent | CompositionEuImaging | category[diagnostic-service] | |
documentTitle | equivalent | CompositionEuImaging | title | |
period | equivalent | CompositionEuImaging | event.period | |
period | equivalent | DiagnosticReportEuImaging | effectivePeriod | |
version | equivalent | CompositionEuImaging | extension[version] | |
version | equivalent | DiagnosticReportEuImaging | extension[artifactVersion] | |
attestation | CompositionEuImaging | attester[resultValidator] | ||
attester[ EHDSHealthProfessional ] | equivalent | CompositionEuImaging | attester[resultValidator].party | |
attester[ EHDSDevice ] | equivalent | CompositionEuImaging | attester[resultValidator].party | |
datetime | equivalent | CompositionEuImaging | attester[resultValidator].time | |
legalAuthentication | CompositionEuImaging | attester[legalAuthenticator] | ||
legalAuthenticator[ EHDSHealthProfessional ] | equivalent | CompositionEuImaging | attester[legalAuthenticator].party | |
legalAuthenticator[ EHDSOrganisation ] | equivalent | CompositionEuImaging | attester[legalAuthenticator].party | |
datetime | equivalent | CompositionEuImaging | attester[legalAuthenticator].time | |
eventType | broader than target | CompositionEuImaging | category[diagnostic-service] | |
eventType | broader than target | ProcedureEuImaging | code | |
eventType | broader than target | ImagingStudyEuImaging | series.modality | |
eventType | broader than target | ImagingStudyEuImaging | modality | |
serviceSpecialty | equivalent | DiagnosticReportEuImaging | category[diagnostic-service] | |
custodian | equivalent | CompositionEuImaging | custodian | |
presentedForm | equivalent | DiagnosticReportEuImaging | presentedForm | |
presentedForm | equivalent | CompositionEuImaging | text | For all the resources that don't have a .presentedForm element, the .text is the default element to map this requirement. |
accessionNumber | equivalent | ServiceRequestOrderEuImaging | identifier[accessionNumber] | |
intendedRecipient[ EHDSPatient ] | equivalent | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSRelatedPerson ] | equivalent | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSHealthProfessional ] | equivalent | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSOrganisation ] | equivalent | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSDevice ] | equivalent | CompositionEuImaging | extension[informationRecipient] | |
body | N/A | |||
orderInformation | equivalent | CompositionEuImaging | section[order] | |
orderId | equivalent | CompositionEuImaging | extension[basedOn] | |
orderId | equivalent | DiagnosticReportEuImaging | basedOn[ServiceRequestOrderEuImagingaccession] | |
orderDateAndTime | equivalent | ServiceRequestOrderEuImaging | authoredOn | |
orderPlacer[ EHDSHealthProfessional ] | equivalent | ServiceRequestOrderEuImaging | requester | |
orderReason[CodeableConcept] | equivalent | ServiceRequestOrderEuImaging | extension[reason].extension[concept].valueCodeableConcept | |
orderReason[ EHDSCondition ] | ||||
orderReason[ EHDSObservation ] | ||||
orderReason[string] | ||||
clinicalQuestion | narrower than target | ServiceRequestOrderEuImaging | extension[reason].extension[concept].valueCodeableConcept | Order reason and clinical question map to the same element by design choice |
supportingInformation | N/A | |||
observation | narrower than target | CompositionEuImaging | section[history].entry | |
condition | narrower than target | CompositionEuImaging | section[history].entry | |
priorMedicationAdministration | narrower than target | CompositionEuImaging | section[history].entry | |
device | narrower than target | CompositionEuImaging | section[history].entry | |
pregnancyStatus | narrower than target | CompositionEuImaging | section[history].entry | |
sexForClinicalUse | equivalent | |||
specimen | equivalent | ImagingStudyEuImaging | series.specimen | |
exposureInformation | equivalent | DiagnosticReportEuImaging | extension[radiationDose] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
exposureInformation | equivalent | CompositionEuImaging | section[procedure].extension[radiationDose] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
exposureInformation | equivalent | ObservationRadiationDoseEuImaging | value[x] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
examinationReport | N/A | |||
modality | equivalent | ImagingStudyEuImaging | series.modality | |
bodySite | equivalent | ImagingStudyEuImaging | series.bodySite | |
imagingProcedures | equivalent | CompositionEuImaging | section[procedure].entry[procedure] | |
imagingProcedures | equivalent | DiagnosticReportEuImaging | extension[procedure] | |
medicationAdministration | equivalent | EuMedicationAdministration | partOf | |
adverseReaction | equivalent | AdverseEventEuImaging | ||
adverseReaction | equivalent | CompositionEuImaging | section[procedure].entry[adverse-event] | |
results[ EHDSObservation ] | equivalent | CompositionEuImaging | section[findings].entry[finding] | |
results[string] | equivalent | CompositionEuImaging | section[findings].extension[note] | |
results[string] | equivalent | DiagnosticReportEuImaging | extension[note] | |
conclusion | N/A | |||
impression | equivalent | CompositionEuImaging | section[impression].extension[note] | |
impression | equivalent | DiagnosticReportEuImaging | extension[note] | |
conditionOrFinding[ EHDSCondition ] | equivalent | CompositionEuImaging | section[impression].entry[impression] | |
conditionOrFinding[ EHDSCondition ] | equivalent | DiagnosticReportEuImaging | extension[impression] | |
conditionOrFinding[ EHDSObservation ] | equivalent | CompositionEuImaging | section[impression].entry[finding] | |
conditionOrFinding[ EHDSObservation ] | equivalent | DiagnosticReportEuImaging | .extension[impression] | |
recommendation | equivalent | CompositionEuImaging | section[recommendation] | |
recommendation | equivalent | DiagnosticReportEuImaging | extension[recommendation] | |
description | equivalent | EuCarePlan | description | |
carePlan | equivalent | CompositionEuImaging | section[recommendation].entry[suggestion] | |
comparisonStudy | equivalent | CompositionEuImaging | section[comparison].entry[comparedstudy] | |
comparisonStudy | equivalent | DiagnosticReportEuImaging | extension[comparison] | |
dicomStudyMetadata | equivalent | ImagingStudyEuImaging | ||
attachments | equivalent | DiagnosticReportEuImaging | media | |
attachments | equivalent | ObservationFindingEuImaging | derivedFrom |
Logical model EHDSImagingStudy 39
Elements of the Xt-EHR logical model with their cardinality and obligations. Obligations tell producers and consumers of the data what a system SHALL or SHOULD do with each element.
Obligations by actor
How many elements of EHDSImagingStudy carry each obligation for each actor.
| Obligation | Actor | Elements |
|---|---|---|
SHALL:able-to-populate | producer | 29 |
SHALL:process | consumer | 2 |
SHOULD:able-to-populate | producer | 8 |
SHOULD:process | consumer | 27 |
Elements 39
| Element | Card. | Obligations | Description |
|---|---|---|---|
header | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Basic metadata for this information |
subject | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Patient/subject information |
identifier | 1..* | SHALL:able-to-populate producerSHOULD:process consumer | Identifiers for the imaging study such as DICOM Study Instance UID. If one or more series elements are present in the imaging study, then there shall be one DICOM Study UID identifier. |
author[x] | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Author(s) responsible for the provided information. |
date | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Date and optionally time of authoring/issuing |
status | 1..1 | SHALL:able-to-populate producer | Status of the resource or document |
source | 0..0 | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information. | |
language | 0..1 | SHOULD:able-to-populate producer | Language in which the resource is written. Language is expressed by the IETF language tag. |
modality | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | All of the distinct values for series' modalities |
bodySite | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | All of the distinct values for series' examined body parts. |
encounter | 0..1 | SHOULD:able-to-populate producerSHOULD:process consumer | Reference to the encounter with which this imaging study is associated |
started | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Date and time the study started. |
basedOn | 0..* | SHOULD:able-to-populate producerSHOULD:process consumer | References to the diagnostic requests that resulted in this imaging study being performed. |
numberOfSeries | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Number of series in the study. This value given may be larger than the number of series elements this Resource contains due to resource availability, security, or other factors. This element should be present if any series elements are present. |
numberOfInstances | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Number of service-object pair (SOP) instances in the study. This value given may be larger than the number of instance elements this resource contains due to resource availability, security, or other factors. This element should be present if any instance elements are present. |
description | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | The imaging manager description of the study. Institution-generated description or classification of the study (component) performed. |
studyCustodian | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Organisation name, address, contact information. |
studyEndpoint | 0..* | SHALL:able-to-populate producerSHALL:process consumer | Study endpoint describing the technical details of a location that can be connected to for the delivery/retrieval of information. Sufficient information is required to ensure that a connection can be made securely, and appropriate data transmitted as defined by the endpoint owner. These may be locally hosted services, regional services, or national service. |
series | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Series. Each study has one or more series of instances, but they may be absent when no series information needs to be conveyed |
seriesUid | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | DICOM Series Instance UID for the series |
number | 0..1 | SHOULD:able-to-populate producerSHOULD:process consumer | Numeric identifier of this series |
seriesModality | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | Acquisition modality - the modality used for this series |
description | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | A short human readable summary of the series |
numberOfInstances | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Number of series related instances |
seriesEndpoint | 0..* | SHALL:able-to-populate producerSHALL:process consumer | Series endpoint describing the technical details of a location that can be connected to for the delivery/retrieval of information. Sufficient information is required to ensure that a connection can be made securely, and appropriate data transmitted as defined by the endpoint owner. These may be locally hosted services, regional services, or national service. |
bodySite | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Body part (with laterality) examined |
specimen | 0..* | Specimen imaged | |
started | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | When the series started |
instancesInTheSeries | 0..* | SHALL:able-to-populate producerSHOULD:process consumer | Each series has one or more instances, but they may be absent when no instance information needs to be conveyed |
instanceTitle | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | Instance title that is the description of the instance. |
instanceUid | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | DICOM SOP Instance UID |
sopClass | 1..1 | SHALL:able-to-populate producerSHOULD:process consumer | SOP class - DICOM class type |
instanceNumber | 0..1 | SHALL:able-to-populate producerSHOULD:process consumer | The number of this instance in the series |
numberOfFrames | 0..1 | SHOULD:able-to-populate producer | The number of frames in a multiframe instance |
keyImage | 0..* | SHOULD:able-to-populate producer | List of key image flags with a reason why this image is selected as a key image, and reference to the Key Image Note that flags the image as significant within the Imaging Study Manifest |
flag | 1..1 | SHOULD:able-to-populate producer | Reason for flagging the image as significant |
reason | 0..1 | SHOULD:able-to-populate producer | Textual reason for flagging the image as significant |
seriesUID | 1..* | SHALL:able-to-populate producer | Series instance UID for the series that contains the instances flagged as significant |
instanceUID | 1..* | SHALL:able-to-populate producer | SOP Instance UID for the instances flagged as significant by the Key Image Note object (DICOM KOS) that flags this image |
Mapping of EHDSImagingStudy to FHIR 41
How each logical element lands in FHIR, as published in the HL7 Europe guide.
| Element | Relation | FHIR resource | FHIR element | Notes |
|---|---|---|---|---|
header | N/A | |||
subject | equivalent | ImagingStudyEuImaging | subject | |
identifier | equivalent | ImagingStudyEuImaging | identifier[studyInstanceUid] | |
author[ EHDSHealthProfessional ] | equivalent | ImagingStudyEuImaging | series.performer[performer] | |
author[ EHDSOrganisation ] | ImagingStudyEuImaging | series.performer[organization] | ||
author[ EHDSDevice ] | equivalent | ImagingStudyEuImaging | series.performer[device] | |
date | equivalent | ImagingStudyEuImaging | started | No core element to map the issuing of the Study. An extension might be needed to be defined as part of the Imaging-manifest IG |
status | equivalent | ImagingStudyEuImaging | status | |
source | ||||
language | equivalent | ImagingStudyEuImaging | language | |
modality | equivalent | ImagingStudyEuImaging | series.modality | |
bodySite | equivalent | ImagingStudyEuImaging | series.bodySite | |
encounter | equivalent | ImagingStudyEuImaging | encounter | |
started | equivalent | ImagingStudyEuImaging | started | |
basedOn | equivalent | ImagingStudyEuImaging | basedOn | |
numberOfSeries | equivalent | ImagingStudyEuImaging | numberOfSeries | |
numberOfInstances | equivalent | ImagingStudyEuImaging | numberOfInstances | |
description | equivalent | ImagingStudyEuImaging | description | |
studyCustodian | equivalent | ImagingStudyEuImaging | series.performer[custodian] | |
studyEndpoint | equivalent | ImagingStudyEuImaging | endpoint | |
series | equivalent | ImagingStudyEuImaging | series | |
seriesUid | equivalent | ImagingStudyEuImaging | series.uid | |
number | equivalent | ImagingStudyEuImaging | series.number | |
seriesModality | equivalent | ImagingStudyEuImaging | series.modality | |
description | equivalent | ImagingStudyEuImaging | series.description | |
numberOfInstances | equivalent | ImagingStudyEuImaging | series.numberOfInstances | |
seriesEndpoint | equivalent | ImagingStudyEuImaging | series.endpoint | |
bodySite | equivalent | ImagingStudyEuImaging | series.bodySite | |
specimen | equivalent | ImagingStudyEuImaging | series.specimen | |
started | equivalent | ImagingStudyEuImaging | series.started | |
instancesInTheSeries | equivalent | ImagingStudyEuImaging | series.instance | |
instanceTitle | equivalent | ImagingStudyEuImaging | series.instance.extension[instance-description] | |
instanceUid | equivalent | ImagingStudyEuImaging | series.instance.uid | |
sopClass | equivalent | ImagingStudyEuImaging | series.instance.sopClass | |
instanceNumber | equivalent | ImagingStudyEuImaging | series.instance.number | |
numberOfFrames | equivalent | ImagingStudyEuImaging | series.instance.extension[number-of-frames] | |
keyImage | ||||
flag | ||||
reason | ||||
seriesUID | ||||
instanceUID |
CDA documents (eHDSI)
The same category is carried in CDA by these eHDSI document templates. Their structure, value sets and a validator for CDA documents are in the CDA guide.
Sources
Regulation (EU) 2025/327, Official Journal of the European Union; HL7 Europe FHIR implementation guides; Xt-EHR logical models (xtehr.eu.ehds.models). Ballot guides may still change. This guide is informational: it is not legal advice and not a certification of conformity.