Estudios de imagen médica e informes en FHIR
Estudios de imagen médica e informes es una categoría prioritaria del Espacio Europeo de Datos de Salud (artículo 14(1), letra (d) del Reglamento (UE) 2025/327). Se aplica desde el 26 de marzo de 2031. HL7 Europe la cubre con imaging 1.0.0-ballot, imaging-manifest 1.0.0-ballot.
- Reglamento
- Regulation (EU) 2025/327, Article 14(1)(d), Annex I
- Se aplica desde
- 26 de marzo de 2031
- Guías HL7 Europe
- hl7.fhir.eu.imaging 1.0.0-ballot, en ballothl7.fhir.eu.imaging-manifest 1.0.0-ballot, en ballot
- Modelos lógicos Xt-EHR
- EHDSImagingReportEHDSImagingStudy
- Tipo de documento
LOINC 85430-7Diagnostic imaging reportLOINC 18748-4Diagnostic imaging study- Validador
- Abrir el validador de perfiles EHDS
Qué dice el Reglamento
El anexo I del Reglamento describe las características principales de esta categoría. El texto es el original en inglés.
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.
Perfiles FHIR 38
Perfiles definidos por las guías anteriores. La columna de reglas cuenta los elementos en los que el perfil va más allá de FHIR base (obligatorios, prohibidos o limitados), que el validador comprueba; de los slices solo se comprueban los obligatorios que un valor fijo o el tipo de recurso permiten identificar.
| Perfil | Recurso | Guía HL7 Europe | Reglas comprobadas | Slices comprobados / definidos |
|---|---|---|---|---|
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 |
Estructura del documento
Los perfiles de documento de esta categoría: las secciones que puede llevar una Composition y las entradas que puede contener un Bundle, tal como los perfiles las establecen. Los nombres son nombres de slice; el código de sección es el código LOINC que fija el perfil.
Bundle: Imaging Report: entradas del Bundle 11
| Entrada | Card. | Recurso FHIR | Perfil |
|---|---|---|---|
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: entradas del Bundle 3
| Entrada | Card. | Recurso FHIR | Perfil |
|---|---|---|---|
DiagnosticReportEuImagingMinimalMetadata | 1..1 | DiagnosticReport | DiagnosticReportEuImagingMinimalMetadata |
Patient | 0..1 | Patient | PatientEuCore |
ImagingStudy | 0..1 | ImagingStudy | ImagingStudyEuImaging |
MADO EU FHIR Imaging Study Manifest Bundle: entradas del Bundle 8
| Entrada | Card. | Recurso FHIR | Perfil |
|---|---|---|---|
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: secciones 10
| Sección | Card. | Código de sección | Descripción |
|---|---|---|---|
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 |
Bindings de terminología 7
Value sets a los que los perfiles de esta categoría enlazan elementos con un binding required o extensible. Un binding required solo admite códigos del value set; uno extensible los espera salvo que ninguno encaje. Los value sets que definen los paquetes de HL7 Europe se listan con sus códigos en la referencia de value sets.
Los perfiles también declaran 8 bindings preferred y 1 example.
| Value set | Binding | Usado por | Códigos |
|---|---|---|---|
diagnostic-service-sections http://hl7.org/fhir/ValueSet/diagnostic-service-sections | required | CompositionEuImaging category:diagnostic-serviceDiagnosticReportEuImaging category:diagnostic-serviceDiagnosticReportEuImagingMinimalMetadata category:diagnostic-service | definido fuera de los paquetes de HL7 Europe |
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] | definido fuera de los paquetes de HL7 Europe |
ValueSet: Imaging Device Type http://hl7.eu/fhir/imaging/ValueSet/DeviceEuImagingType | extensible | DeviceEuImaging type | definido por reglas |
ValueSet: Anatomical Region http://hl7.eu/fhir/imaging/ValueSet/im-anatomical-region-valueset | extensible | DocumentReferenceImagingReport extension:bodysite.extension:concept.value[x] | 10 códigos |
ValueSet: Imaging Study Performer Type Value Set http://hl7.eu/fhir/imaging/ValueSet/im-imaging-study-performer-type | extensible | ImagingStudyEuImaging series.performer.function | 1 códigos, definido por reglas |
ValueSet: Imaging Procedure Type http://hl7.eu/fhir/imaging/ValueSet/im-procedure-type | extensible | ProcedureEuImaging code | definido por reglas |
age-units http://hl7.org/fhir/ValueSet/age-units | extensible | ObservationGestationalAgeEuImaging value[x] | definido fuera de los paquetes de HL7 Europe |
Extensiones 15
Extensiones de HL7 Europe que llevan los perfiles de esta categoría, con el elemento que contiene cada una.
| Extensión | Contexto | Valor | Usada en |
|---|---|---|---|
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 |
Modelo lógico EHDSImagingReport 56
Elementos del modelo lógico Xt-EHR con su cardinalidad y obligaciones. Las obligaciones indican a productores y consumidores de los datos qué DEBE o DEBERÍA hacer un sistema con cada elemento.
Obligaciones por actor
Cuántos elementos de EHDSImagingReport llevan cada obligación para cada actor.
| Obligación | Actor | Elementos |
|---|---|---|
SHALL:able-to-populate | productor | 32 |
SHALL:process | consumidor | 6 |
SHOULD:able-to-populate | productor | 19 |
SHOULD:process | consumidor | 30 |
Elementos 56
| Elemento | Card. | Obligaciones | Descripción |
|---|---|---|---|
header | 1..1 | SHALL:able-to-populate productorSHALL:process consumidor | Imaging report header |
subject | 1..1 | SHALL:able-to-populate productorSHALL:process consumidor | Patient/subject information |
identifier | 1..* | SHALL:able-to-populate productorSHALL:process consumidor | Unique identifier of the document |
author[x] | 1..* | SHALL:able-to-populate productorSHOULD:process consumidor | The author of the report. |
date | 1..1 | SHALL:able-to-populate productorSHALL:process consumidor | Date of finalising/issuing the document |
status | 1..1 | SHALL:able-to-populate productorSHALL:process consumidor | 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 productor | Language in which the resource is written. Language is expressed by the IETF language tag. |
documentType | 1..1 | SHALL:able-to-populate productor | Type of document (e.g. 18748-4 Diagnostic imaging study) |
documentTitle | 1..1 | SHALL:able-to-populate productor | 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 productor | 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 productor | Document attestation details |
attester[x] | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Attester who validated the document |
datetime | 1..1 | SHALL:able-to-populate productor | Date and time of the approval of the document by Attester |
legalAuthentication | 0..* | SHALL:able-to-populate productor | Document legal authentication details |
legalAuthenticator[x] | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | The person or organisation taking responsibility for the content of the document. |
datetime | 1..1 | SHALL:able-to-populate productor | Date and time when the document was authorised |
eventType | 0..* | SHOULD:able-to-populate productorSHOULD:process consumidor | 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 consumidor | Additional details about where the content was created (e.g. clinical specialty) |
custodian | 0..1 | SHOULD:able-to-populate productorSHOULD:process consumidor | Organisation that is in charge of maintaining the document/report. |
accessionNumber | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | 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 productor | 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 productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | Imaging report structured body |
orderInformation | 0..* | SHOULD:able-to-populate productorSHOULD:process consumidor | Order Information (Imaging Result Report could respond to multiple orders). |
orderId | 1..* | SHALL:able-to-populate productorSHALL:process consumidor | 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 productorSHOULD:process consumidor | An explanation or justification for why this service is being requested. |
clinicalQuestion | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Specification of clinical question (goal of the investigation) to be answered by the imaging investigation. |
supportingInformation | 0..1 | SHOULD:able-to-populate productorSHOULD:process consumidor | 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 productor | Clinical findings and other observations (e.g., height and weights of the patient). |
condition | 0..* | SHOULD:able-to-populate productor | Conditions that may influence the service or result interpretation. |
priorMedicationAdministration | 0..* | SHOULD:able-to-populate productor | Medication administered before ordering the service specifically for this procedure. |
device | 0..* | SHOULD:able-to-populate productor | 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 productor | Pregnancy status when the imaging examination was performed (e.g., pregnant, not pregnant, unknown). |
sexForClinicalUse | 0..1 | SHOULD:able-to-populate productor | 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 productorSHOULD:process consumidor | 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 productor | Information on total exposure to ionising radiation. This information is required by regulations in several EU countries. |
examinationReport | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Examination report content. |
modality | 1..* | SHALL:able-to-populate productorSHOULD:process consumidor | Imaging modality (or modalities) used during imaging investigation (DICOM CID029). |
bodySite | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | All body parts investigated |
imagingProcedures | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | Imaging procedure performed during imaging study. |
medicationAdministration | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | Information about medications administered (contrast, sedation, stress agents, etc) during the procedure. |
adverseReaction | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | Adverse reactions manifested during imaging investigation. |
results[x] | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | Imaging report result data (report could consist of multiple observations) |
conclusion | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | A concise and clinically contextualised summary including interpretation/impression of the diagnostic report. |
impression | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Narrative description of the clinical conclusion (impression). |
conditionOrFinding[x] | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | Condition or finding from imaging investigation. |
recommendation | 0..1 | SHOULD:able-to-populate productorSHOULD:process consumidor | Recommendation section for additional imaging tests or other actions |
description | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Narrative description of the recommended activities including additional test, medication etc. |
carePlan | 0..* | SHOULD:able-to-populate productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | Documentation (reference) of a prior Imaging Report to which the current images were compared. |
dicomStudyMetadata | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | Report attachments |
Mapeo de EHDSImagingReport a FHIR 93
Cómo aterriza cada elemento lógico en FHIR, según lo publicado en la guía de HL7 Europe.
| Elemento | Relación | Recurso FHIR | Elemento FHIR | Notas |
|---|---|---|---|---|
header | N/A | |||
subject | equivalente | CompositionEuImaging | subject | |
subject | equivalente | DiagnosticReportEuImaging | subject | |
identifier | equivalente | CompositionEuImaging | identifier | |
identifier | equivalente | DiagnosticReportEuImaging | identifier | |
author[ EHDSHealthProfessional ] | equivalente | CompositionEuImaging | author[author] | |
author[ EHDSHealthProfessional ] | equivalente | CompositionEuImaging | author[organization] | |
author[ EHDSOrganisation ] | equivalente | DiagnosticReportEuImaging | performer[organization] | |
author[ EHDSDevice ] | equivalente | DiagnosticReportEuImaging | resultsInterpreter[author] | |
date | equivalente | CompositionEuImaging | date | |
date | equivalente | DiagnosticReportEuImaging | issued | |
status | equivalente | CompositionEuImaging | status | |
status | equivalente | DiagnosticReportEuImaging | status | |
source | N/A | |||
language | equivalente | CompositionEuImaging | language | |
language | equivalente | DiagnosticReportEuImaging | language | |
documentType | equivalente | CompositionEuImaging | category[diagnostic-service] | |
documentTitle | equivalente | CompositionEuImaging | title | |
period | equivalente | CompositionEuImaging | event.period | |
period | equivalente | DiagnosticReportEuImaging | effectivePeriod | |
version | equivalente | CompositionEuImaging | extension[version] | |
version | equivalente | DiagnosticReportEuImaging | extension[artifactVersion] | |
attestation | CompositionEuImaging | attester[resultValidator] | ||
attester[ EHDSHealthProfessional ] | equivalente | CompositionEuImaging | attester[resultValidator].party | |
attester[ EHDSDevice ] | equivalente | CompositionEuImaging | attester[resultValidator].party | |
datetime | equivalente | CompositionEuImaging | attester[resultValidator].time | |
legalAuthentication | CompositionEuImaging | attester[legalAuthenticator] | ||
legalAuthenticator[ EHDSHealthProfessional ] | equivalente | CompositionEuImaging | attester[legalAuthenticator].party | |
legalAuthenticator[ EHDSOrganisation ] | equivalente | CompositionEuImaging | attester[legalAuthenticator].party | |
datetime | equivalente | CompositionEuImaging | attester[legalAuthenticator].time | |
eventType | más amplio que el destino | CompositionEuImaging | category[diagnostic-service] | |
eventType | más amplio que el destino | ProcedureEuImaging | code | |
eventType | más amplio que el destino | ImagingStudyEuImaging | series.modality | |
eventType | más amplio que el destino | ImagingStudyEuImaging | modality | |
serviceSpecialty | equivalente | DiagnosticReportEuImaging | category[diagnostic-service] | |
custodian | equivalente | CompositionEuImaging | custodian | |
presentedForm | equivalente | DiagnosticReportEuImaging | presentedForm | |
presentedForm | equivalente | CompositionEuImaging | text | For all the resources that don't have a .presentedForm element, the .text is the default element to map this requirement. |
accessionNumber | equivalente | ServiceRequestOrderEuImaging | identifier[accessionNumber] | |
intendedRecipient[ EHDSPatient ] | equivalente | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSRelatedPerson ] | equivalente | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSHealthProfessional ] | equivalente | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSOrganisation ] | equivalente | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSDevice ] | equivalente | CompositionEuImaging | extension[informationRecipient] | |
body | N/A | |||
orderInformation | equivalente | CompositionEuImaging | section[order] | |
orderId | equivalente | CompositionEuImaging | extension[basedOn] | |
orderId | equivalente | DiagnosticReportEuImaging | basedOn[ServiceRequestOrderEuImagingaccession] | |
orderDateAndTime | equivalente | ServiceRequestOrderEuImaging | authoredOn | |
orderPlacer[ EHDSHealthProfessional ] | equivalente | ServiceRequestOrderEuImaging | requester | |
orderReason[CodeableConcept] | equivalente | ServiceRequestOrderEuImaging | extension[reason].extension[concept].valueCodeableConcept | |
orderReason[ EHDSCondition ] | ||||
orderReason[ EHDSObservation ] | ||||
orderReason[string] | ||||
clinicalQuestion | más estrecho que el destino | ServiceRequestOrderEuImaging | extension[reason].extension[concept].valueCodeableConcept | Order reason and clinical question map to the same element by design choice |
supportingInformation | N/A | |||
observation | más estrecho que el destino | CompositionEuImaging | section[history].entry | |
condition | más estrecho que el destino | CompositionEuImaging | section[history].entry | |
priorMedicationAdministration | más estrecho que el destino | CompositionEuImaging | section[history].entry | |
device | más estrecho que el destino | CompositionEuImaging | section[history].entry | |
pregnancyStatus | más estrecho que el destino | CompositionEuImaging | section[history].entry | |
sexForClinicalUse | equivalente | |||
specimen | equivalente | ImagingStudyEuImaging | series.specimen | |
exposureInformation | equivalente | DiagnosticReportEuImaging | extension[radiationDose] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
exposureInformation | equivalente | CompositionEuImaging | section[procedure].extension[radiationDose] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
exposureInformation | equivalente | ObservationRadiationDoseEuImaging | value[x] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
examinationReport | N/A | |||
modality | equivalente | ImagingStudyEuImaging | series.modality | |
bodySite | equivalente | ImagingStudyEuImaging | series.bodySite | |
imagingProcedures | equivalente | CompositionEuImaging | section[procedure].entry[procedure] | |
imagingProcedures | equivalente | DiagnosticReportEuImaging | extension[procedure] | |
medicationAdministration | equivalente | EuMedicationAdministration | partOf | |
adverseReaction | equivalente | AdverseEventEuImaging | ||
adverseReaction | equivalente | CompositionEuImaging | section[procedure].entry[adverse-event] | |
results[ EHDSObservation ] | equivalente | CompositionEuImaging | section[findings].entry[finding] | |
results[string] | equivalente | CompositionEuImaging | section[findings].extension[note] | |
results[string] | equivalente | DiagnosticReportEuImaging | extension[note] | |
conclusion | N/A | |||
impression | equivalente | CompositionEuImaging | section[impression].extension[note] | |
impression | equivalente | DiagnosticReportEuImaging | extension[note] | |
conditionOrFinding[ EHDSCondition ] | equivalente | CompositionEuImaging | section[impression].entry[impression] | |
conditionOrFinding[ EHDSCondition ] | equivalente | DiagnosticReportEuImaging | extension[impression] | |
conditionOrFinding[ EHDSObservation ] | equivalente | CompositionEuImaging | section[impression].entry[finding] | |
conditionOrFinding[ EHDSObservation ] | equivalente | DiagnosticReportEuImaging | .extension[impression] | |
recommendation | equivalente | CompositionEuImaging | section[recommendation] | |
recommendation | equivalente | DiagnosticReportEuImaging | extension[recommendation] | |
description | equivalente | EuCarePlan | description | |
carePlan | equivalente | CompositionEuImaging | section[recommendation].entry[suggestion] | |
comparisonStudy | equivalente | CompositionEuImaging | section[comparison].entry[comparedstudy] | |
comparisonStudy | equivalente | DiagnosticReportEuImaging | extension[comparison] | |
dicomStudyMetadata | equivalente | ImagingStudyEuImaging | ||
attachments | equivalente | DiagnosticReportEuImaging | media | |
attachments | equivalente | ObservationFindingEuImaging | derivedFrom |
Modelo lógico EHDSImagingStudy 39
Elementos del modelo lógico Xt-EHR con su cardinalidad y obligaciones. Las obligaciones indican a productores y consumidores de los datos qué DEBE o DEBERÍA hacer un sistema con cada elemento.
Obligaciones por actor
Cuántos elementos de EHDSImagingStudy llevan cada obligación para cada actor.
| Obligación | Actor | Elementos |
|---|---|---|
SHALL:able-to-populate | productor | 29 |
SHALL:process | consumidor | 2 |
SHOULD:able-to-populate | productor | 8 |
SHOULD:process | consumidor | 27 |
Elementos 39
| Elemento | Card. | Obligaciones | Descripción |
|---|---|---|---|
header | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Basic metadata for this information |
subject | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Patient/subject information |
identifier | 1..* | SHALL:able-to-populate productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | Author(s) responsible for the provided information. |
date | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Date and optionally time of authoring/issuing |
status | 1..1 | SHALL:able-to-populate productor | 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 productor | Language in which the resource is written. Language is expressed by the IETF language tag. |
modality | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | All of the distinct values for series' modalities |
bodySite | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | All of the distinct values for series' examined body parts. |
encounter | 0..1 | SHOULD:able-to-populate productorSHOULD:process consumidor | Reference to the encounter with which this imaging study is associated |
started | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Date and time the study started. |
basedOn | 0..* | SHOULD:able-to-populate productorSHOULD:process consumidor | References to the diagnostic requests that resulted in this imaging study being performed. |
numberOfSeries | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | The imaging manager description of the study. Institution-generated description or classification of the study (component) performed. |
studyCustodian | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Organisation name, address, contact information. |
studyEndpoint | 0..* | SHALL:able-to-populate productorSHALL:process consumidor | 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 productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | DICOM Series Instance UID for the series |
number | 0..1 | SHOULD:able-to-populate productorSHOULD:process consumidor | Numeric identifier of this series |
seriesModality | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Acquisition modality - the modality used for this series |
description | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | A short human readable summary of the series |
numberOfInstances | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | Number of series related instances |
seriesEndpoint | 0..* | SHALL:able-to-populate productorSHALL:process consumidor | 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 productorSHOULD:process consumidor | Body part (with laterality) examined |
specimen | 0..* | Specimen imaged | |
started | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | When the series started |
instancesInTheSeries | 0..* | SHALL:able-to-populate productorSHOULD:process consumidor | 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 productorSHOULD:process consumidor | Instance title that is the description of the instance. |
instanceUid | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | DICOM SOP Instance UID |
sopClass | 1..1 | SHALL:able-to-populate productorSHOULD:process consumidor | SOP class - DICOM class type |
instanceNumber | 0..1 | SHALL:able-to-populate productorSHOULD:process consumidor | The number of this instance in the series |
numberOfFrames | 0..1 | SHOULD:able-to-populate productor | The number of frames in a multiframe instance |
keyImage | 0..* | SHOULD:able-to-populate productor | 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 productor | Reason for flagging the image as significant |
reason | 0..1 | SHOULD:able-to-populate productor | Textual reason for flagging the image as significant |
seriesUID | 1..* | SHALL:able-to-populate productor | Series instance UID for the series that contains the instances flagged as significant |
instanceUID | 1..* | SHALL:able-to-populate productor | SOP Instance UID for the instances flagged as significant by the Key Image Note object (DICOM KOS) that flags this image |
Mapeo de EHDSImagingStudy a FHIR 41
Cómo aterriza cada elemento lógico en FHIR, según lo publicado en la guía de HL7 Europe.
| Elemento | Relación | Recurso FHIR | Elemento FHIR | Notas |
|---|---|---|---|---|
header | N/A | |||
subject | equivalente | ImagingStudyEuImaging | subject | |
identifier | equivalente | ImagingStudyEuImaging | identifier[studyInstanceUid] | |
author[ EHDSHealthProfessional ] | equivalente | ImagingStudyEuImaging | series.performer[performer] | |
author[ EHDSOrganisation ] | ImagingStudyEuImaging | series.performer[organization] | ||
author[ EHDSDevice ] | equivalente | ImagingStudyEuImaging | series.performer[device] | |
date | equivalente | 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 | equivalente | ImagingStudyEuImaging | status | |
source | ||||
language | equivalente | ImagingStudyEuImaging | language | |
modality | equivalente | ImagingStudyEuImaging | series.modality | |
bodySite | equivalente | ImagingStudyEuImaging | series.bodySite | |
encounter | equivalente | ImagingStudyEuImaging | encounter | |
started | equivalente | ImagingStudyEuImaging | started | |
basedOn | equivalente | ImagingStudyEuImaging | basedOn | |
numberOfSeries | equivalente | ImagingStudyEuImaging | numberOfSeries | |
numberOfInstances | equivalente | ImagingStudyEuImaging | numberOfInstances | |
description | equivalente | ImagingStudyEuImaging | description | |
studyCustodian | equivalente | ImagingStudyEuImaging | series.performer[custodian] | |
studyEndpoint | equivalente | ImagingStudyEuImaging | endpoint | |
series | equivalente | ImagingStudyEuImaging | series | |
seriesUid | equivalente | ImagingStudyEuImaging | series.uid | |
number | equivalente | ImagingStudyEuImaging | series.number | |
seriesModality | equivalente | ImagingStudyEuImaging | series.modality | |
description | equivalente | ImagingStudyEuImaging | series.description | |
numberOfInstances | equivalente | ImagingStudyEuImaging | series.numberOfInstances | |
seriesEndpoint | equivalente | ImagingStudyEuImaging | series.endpoint | |
bodySite | equivalente | ImagingStudyEuImaging | series.bodySite | |
specimen | equivalente | ImagingStudyEuImaging | series.specimen | |
started | equivalente | ImagingStudyEuImaging | series.started | |
instancesInTheSeries | equivalente | ImagingStudyEuImaging | series.instance | |
instanceTitle | equivalente | ImagingStudyEuImaging | series.instance.extension[instance-description] | |
instanceUid | equivalente | ImagingStudyEuImaging | series.instance.uid | |
sopClass | equivalente | ImagingStudyEuImaging | series.instance.sopClass | |
instanceNumber | equivalente | ImagingStudyEuImaging | series.instance.number | |
numberOfFrames | equivalente | ImagingStudyEuImaging | series.instance.extension[number-of-frames] | |
keyImage | ||||
flag | ||||
reason | ||||
seriesUID | ||||
instanceUID |
Documentos CDA (eHDSI)
La misma categoría se transporta en CDA con estas plantillas de documento eHDSI. Su estructura, sus conjuntos de valores y un validador de documentos CDA están en la guía CDA.
Fuentes
Reglamento (UE) 2025/327, Diario Oficial de la Unión Europea; guías de implementación FHIR de HL7 Europe; modelos lógicos Xt-EHR (xtehr.eu.ehds.models). Las guías en ballot aún pueden cambiar. Esta guía es informativa: no es asesoramiento jurídico ni una certificación de conformidad.