Badania obrazowe i ich opisy w FHIR
Badania obrazowe i ich opisy to priorytetowa kategoria Europejskiej Przestrzeni Danych dotyczących Zdrowia (art. 14 ust. 1 lit. (d) rozporządzenia (UE) 2025/327). Stosuje się ją od 26 marca 2031. HL7 Europe obejmuje ją przewodnikami: imaging 1.0.0-ballot, imaging-manifest 1.0.0-ballot.
- Rozporządzenie
- Regulation (EU) 2025/327, Article 14(1)(d), Annex I
- Stosuje się od
- 26 marca 2031
- Przewodniki HL7 Europe
- hl7.fhir.eu.imaging 1.0.0-ballot, w ballociehl7.fhir.eu.imaging-manifest 1.0.0-ballot, w ballocie
- Modele logiczne Xt-EHR
- EHDSImagingReportEHDSImagingStudy
- Typ dokumentu
LOINC 85430-7Diagnostic imaging reportLOINC 18748-4Diagnostic imaging study- Walidator
- Otwórz walidator profili EHDS
Co mówi rozporządzenie
Załącznik I do rozporządzenia opisuje główne cechy tej kategorii. Tekst jest angielskim oryginałem.
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.
Profile FHIR 38
Profile zdefiniowane przez powyższe przewodniki. Kolumna reguł liczy elementy, w których profil wykracza poza bazowy FHIR (wymagane, zakazane lub ograniczone) i które sprawdza walidator; spośród slice’ów sprawdzane są tylko wymagane, które odróżnia stała wartość lub typ zasobu.
| Profil | Zasób | Przewodnik HL7 Europe | Sprawdzane reguły | Slice’y sprawdzane / zdefiniowane |
|---|---|---|---|---|
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 |
Struktura dokumentu
Profile dokumentów tej kategorii: sekcje, które może zawierać Composition, i wpisy, które może zawierać Bundle, tak jak określają je profile. Nazwy to nazwy slice’ów; kod sekcji to kod LOINC ustalony przez profil.
Bundle: Imaging Report: wpisy Bundle 11
| Wpis | Licz. | Zasób FHIR | Profil |
|---|---|---|---|
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: wpisy Bundle 3
| Wpis | Licz. | Zasób FHIR | Profil |
|---|---|---|---|
DiagnosticReportEuImagingMinimalMetadata | 1..1 | DiagnosticReport | DiagnosticReportEuImagingMinimalMetadata |
Patient | 0..1 | Patient | PatientEuCore |
ImagingStudy | 0..1 | ImagingStudy | ImagingStudyEuImaging |
MADO EU FHIR Imaging Study Manifest Bundle: wpisy Bundle 8
| Wpis | Licz. | Zasób FHIR | Profil |
|---|---|---|---|
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: sekcje 10
| Sekcja | Licz. | Kod sekcji | Opis |
|---|---|---|---|
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 |
Powiązania terminologiczne 7
Value sets, z którymi profile tej kategorii wiążą elementy powiązaniem required lub extensible. Powiązanie required dopuszcza tylko kody z value set; extensible oczekuje ich, chyba że żaden nie pasuje. Value sets definiowane w pakietach HL7 Europe są wypisane z kodami w wykazie value sets.
Profile określają też powiązania: preferred – 8, example – 1.
| Value set | Powiązanie | Używany przez | Kody |
|---|---|---|---|
diagnostic-service-sections http://hl7.org/fhir/ValueSet/diagnostic-service-sections | required | CompositionEuImaging category:diagnostic-serviceDiagnosticReportEuImaging category:diagnostic-serviceDiagnosticReportEuImagingMinimalMetadata category:diagnostic-service | zdefiniowany poza pakietami 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] | zdefiniowany poza pakietami HL7 Europe |
ValueSet: Imaging Device Type http://hl7.eu/fhir/imaging/ValueSet/DeviceEuImagingType | extensible | DeviceEuImaging type | zdefiniowany regułami |
ValueSet: Anatomical Region http://hl7.eu/fhir/imaging/ValueSet/im-anatomical-region-valueset | extensible | DocumentReferenceImagingReport extension:bodysite.extension:concept.value[x] | kody: 10 |
ValueSet: Imaging Study Performer Type Value Set http://hl7.eu/fhir/imaging/ValueSet/im-imaging-study-performer-type | extensible | ImagingStudyEuImaging series.performer.function | kody: 1, zdefiniowany regułami |
ValueSet: Imaging Procedure Type http://hl7.eu/fhir/imaging/ValueSet/im-procedure-type | extensible | ProcedureEuImaging code | zdefiniowany regułami |
age-units http://hl7.org/fhir/ValueSet/age-units | extensible | ObservationGestationalAgeEuImaging value[x] | zdefiniowany poza pakietami HL7 Europe |
Rozszerzenia 15
Rozszerzenia HL7 Europe, które zawierają profile tej kategorii, z elementem, który je przechowuje.
| Rozszerzenie | Kontekst | Wartość | Użyte w |
|---|---|---|---|
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 |
Model logiczny EHDSImagingReport 56
Elementy modelu logicznego Xt-EHR z licznością i obowiązkami. Obowiązki mówią producentom i odbiorcom danych, co system MUSI lub POWINIEN robić z każdym elementem.
Obowiązki według uczestnika
Ile elementów EHDSImagingReport niesie dany obowiązek dla danego uczestnika.
| Obowiązek | Uczestnik | Elementy |
|---|---|---|
SHALL:able-to-populate | producent | 32 |
SHALL:process | odbiorca | 6 |
SHOULD:able-to-populate | producent | 19 |
SHOULD:process | odbiorca | 30 |
Elementy 56
| Element | Licz. | Obowiązki | Opis |
|---|---|---|---|
header | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | Imaging report header |
subject | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | Patient/subject information |
identifier | 1..* | SHALL:able-to-populate producentSHALL:process odbiorca | Unique identifier of the document |
author[x] | 1..* | SHALL:able-to-populate producentSHOULD:process odbiorca | The author of the report. |
date | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | Date of finalising/issuing the document |
status | 1..1 | SHALL:able-to-populate producentSHALL:process odbiorca | 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 producent | Language in which the resource is written. Language is expressed by the IETF language tag. |
documentType | 1..1 | SHALL:able-to-populate producent | Type of document (e.g. 18748-4 Diagnostic imaging study) |
documentTitle | 1..1 | SHALL:able-to-populate producent | 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 producent | 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 producent | Document attestation details |
attester[x] | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Attester who validated the document |
datetime | 1..1 | SHALL:able-to-populate producent | Date and time of the approval of the document by Attester |
legalAuthentication | 0..* | SHALL:able-to-populate producent | Document legal authentication details |
legalAuthenticator[x] | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | The person or organisation taking responsibility for the content of the document. |
datetime | 1..1 | SHALL:able-to-populate producent | Date and time when the document was authorised |
eventType | 0..* | SHOULD:able-to-populate producentSHOULD:process odbiorca | 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 odbiorca | Additional details about where the content was created (e.g. clinical specialty) |
custodian | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | Organisation that is in charge of maintaining the document/report. |
accessionNumber | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | 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 producent | 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 producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | Imaging report structured body |
orderInformation | 0..* | SHOULD:able-to-populate producentSHOULD:process odbiorca | Order Information (Imaging Result Report could respond to multiple orders). |
orderId | 1..* | SHALL:able-to-populate producentSHALL:process odbiorca | 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 producentSHOULD:process odbiorca | An explanation or justification for why this service is being requested. |
clinicalQuestion | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Specification of clinical question (goal of the investigation) to be answered by the imaging investigation. |
supportingInformation | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | 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 producent | Clinical findings and other observations (e.g., height and weights of the patient). |
condition | 0..* | SHOULD:able-to-populate producent | Conditions that may influence the service or result interpretation. |
priorMedicationAdministration | 0..* | SHOULD:able-to-populate producent | Medication administered before ordering the service specifically for this procedure. |
device | 0..* | SHOULD:able-to-populate producent | 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 producent | Pregnancy status when the imaging examination was performed (e.g., pregnant, not pregnant, unknown). |
sexForClinicalUse | 0..1 | SHOULD:able-to-populate producent | 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 producentSHOULD:process odbiorca | 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 producent | Information on total exposure to ionising radiation. This information is required by regulations in several EU countries. |
examinationReport | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Examination report content. |
modality | 1..* | SHALL:able-to-populate producentSHOULD:process odbiorca | Imaging modality (or modalities) used during imaging investigation (DICOM CID029). |
bodySite | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | All body parts investigated |
imagingProcedures | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | Imaging procedure performed during imaging study. |
medicationAdministration | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | Information about medications administered (contrast, sedation, stress agents, etc) during the procedure. |
adverseReaction | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | Adverse reactions manifested during imaging investigation. |
results[x] | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | Imaging report result data (report could consist of multiple observations) |
conclusion | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | A concise and clinically contextualised summary including interpretation/impression of the diagnostic report. |
impression | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Narrative description of the clinical conclusion (impression). |
conditionOrFinding[x] | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | Condition or finding from imaging investigation. |
recommendation | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | Recommendation section for additional imaging tests or other actions |
description | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Narrative description of the recommended activities including additional test, medication etc. |
carePlan | 0..* | SHOULD:able-to-populate producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | Documentation (reference) of a prior Imaging Report to which the current images were compared. |
dicomStudyMetadata | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | Report attachments |
Odwzorowanie EHDSImagingReport na FHIR 93
Jak każdy element logiczny trafia do FHIR, według przewodnika HL7 Europe.
| Element | Relacja | Zasób FHIR | Element FHIR | Uwagi |
|---|---|---|---|---|
header | N/A | |||
subject | równoważny | CompositionEuImaging | subject | |
subject | równoważny | DiagnosticReportEuImaging | subject | |
identifier | równoważny | CompositionEuImaging | identifier | |
identifier | równoważny | DiagnosticReportEuImaging | identifier | |
author[ EHDSHealthProfessional ] | równoważny | CompositionEuImaging | author[author] | |
author[ EHDSHealthProfessional ] | równoważny | CompositionEuImaging | author[organization] | |
author[ EHDSOrganisation ] | równoważny | DiagnosticReportEuImaging | performer[organization] | |
author[ EHDSDevice ] | równoważny | DiagnosticReportEuImaging | resultsInterpreter[author] | |
date | równoważny | CompositionEuImaging | date | |
date | równoważny | DiagnosticReportEuImaging | issued | |
status | równoważny | CompositionEuImaging | status | |
status | równoważny | DiagnosticReportEuImaging | status | |
source | N/A | |||
language | równoważny | CompositionEuImaging | language | |
language | równoważny | DiagnosticReportEuImaging | language | |
documentType | równoważny | CompositionEuImaging | category[diagnostic-service] | |
documentTitle | równoważny | CompositionEuImaging | title | |
period | równoważny | CompositionEuImaging | event.period | |
period | równoważny | DiagnosticReportEuImaging | effectivePeriod | |
version | równoważny | CompositionEuImaging | extension[version] | |
version | równoważny | DiagnosticReportEuImaging | extension[artifactVersion] | |
attestation | CompositionEuImaging | attester[resultValidator] | ||
attester[ EHDSHealthProfessional ] | równoważny | CompositionEuImaging | attester[resultValidator].party | |
attester[ EHDSDevice ] | równoważny | CompositionEuImaging | attester[resultValidator].party | |
datetime | równoważny | CompositionEuImaging | attester[resultValidator].time | |
legalAuthentication | CompositionEuImaging | attester[legalAuthenticator] | ||
legalAuthenticator[ EHDSHealthProfessional ] | równoważny | CompositionEuImaging | attester[legalAuthenticator].party | |
legalAuthenticator[ EHDSOrganisation ] | równoważny | CompositionEuImaging | attester[legalAuthenticator].party | |
datetime | równoważny | CompositionEuImaging | attester[legalAuthenticator].time | |
eventType | szerszy niż cel | CompositionEuImaging | category[diagnostic-service] | |
eventType | szerszy niż cel | ProcedureEuImaging | code | |
eventType | szerszy niż cel | ImagingStudyEuImaging | series.modality | |
eventType | szerszy niż cel | ImagingStudyEuImaging | modality | |
serviceSpecialty | równoważny | DiagnosticReportEuImaging | category[diagnostic-service] | |
custodian | równoważny | CompositionEuImaging | custodian | |
presentedForm | równoważny | DiagnosticReportEuImaging | presentedForm | |
presentedForm | równoważny | CompositionEuImaging | text | For all the resources that don't have a .presentedForm element, the .text is the default element to map this requirement. |
accessionNumber | równoważny | ServiceRequestOrderEuImaging | identifier[accessionNumber] | |
intendedRecipient[ EHDSPatient ] | równoważny | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSRelatedPerson ] | równoważny | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSHealthProfessional ] | równoważny | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSOrganisation ] | równoważny | CompositionEuImaging | extension[informationRecipient] | |
intendedRecipient[ EHDSDevice ] | równoważny | CompositionEuImaging | extension[informationRecipient] | |
body | N/A | |||
orderInformation | równoważny | CompositionEuImaging | section[order] | |
orderId | równoważny | CompositionEuImaging | extension[basedOn] | |
orderId | równoważny | DiagnosticReportEuImaging | basedOn[ServiceRequestOrderEuImagingaccession] | |
orderDateAndTime | równoważny | ServiceRequestOrderEuImaging | authoredOn | |
orderPlacer[ EHDSHealthProfessional ] | równoważny | ServiceRequestOrderEuImaging | requester | |
orderReason[CodeableConcept] | równoważny | ServiceRequestOrderEuImaging | extension[reason].extension[concept].valueCodeableConcept | |
orderReason[ EHDSCondition ] | ||||
orderReason[ EHDSObservation ] | ||||
orderReason[string] | ||||
clinicalQuestion | węższy niż cel | ServiceRequestOrderEuImaging | extension[reason].extension[concept].valueCodeableConcept | Order reason and clinical question map to the same element by design choice |
supportingInformation | N/A | |||
observation | węższy niż cel | CompositionEuImaging | section[history].entry | |
condition | węższy niż cel | CompositionEuImaging | section[history].entry | |
priorMedicationAdministration | węższy niż cel | CompositionEuImaging | section[history].entry | |
device | węższy niż cel | CompositionEuImaging | section[history].entry | |
pregnancyStatus | węższy niż cel | CompositionEuImaging | section[history].entry | |
sexForClinicalUse | równoważny | |||
specimen | równoważny | ImagingStudyEuImaging | series.specimen | |
exposureInformation | równoważny | DiagnosticReportEuImaging | extension[radiationDose] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
exposureInformation | równoważny | CompositionEuImaging | section[procedure].extension[radiationDose] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
exposureInformation | równoważny | ObservationRadiationDoseEuImaging | value[x] | Comments in this issue https://github.com/Xt-EHR/xt-ehr-common/issues/365 |
examinationReport | N/A | |||
modality | równoważny | ImagingStudyEuImaging | series.modality | |
bodySite | równoważny | ImagingStudyEuImaging | series.bodySite | |
imagingProcedures | równoważny | CompositionEuImaging | section[procedure].entry[procedure] | |
imagingProcedures | równoważny | DiagnosticReportEuImaging | extension[procedure] | |
medicationAdministration | równoważny | EuMedicationAdministration | partOf | |
adverseReaction | równoważny | AdverseEventEuImaging | ||
adverseReaction | równoważny | CompositionEuImaging | section[procedure].entry[adverse-event] | |
results[ EHDSObservation ] | równoważny | CompositionEuImaging | section[findings].entry[finding] | |
results[string] | równoważny | CompositionEuImaging | section[findings].extension[note] | |
results[string] | równoważny | DiagnosticReportEuImaging | extension[note] | |
conclusion | N/A | |||
impression | równoważny | CompositionEuImaging | section[impression].extension[note] | |
impression | równoważny | DiagnosticReportEuImaging | extension[note] | |
conditionOrFinding[ EHDSCondition ] | równoważny | CompositionEuImaging | section[impression].entry[impression] | |
conditionOrFinding[ EHDSCondition ] | równoważny | DiagnosticReportEuImaging | extension[impression] | |
conditionOrFinding[ EHDSObservation ] | równoważny | CompositionEuImaging | section[impression].entry[finding] | |
conditionOrFinding[ EHDSObservation ] | równoważny | DiagnosticReportEuImaging | .extension[impression] | |
recommendation | równoważny | CompositionEuImaging | section[recommendation] | |
recommendation | równoważny | DiagnosticReportEuImaging | extension[recommendation] | |
description | równoważny | EuCarePlan | description | |
carePlan | równoważny | CompositionEuImaging | section[recommendation].entry[suggestion] | |
comparisonStudy | równoważny | CompositionEuImaging | section[comparison].entry[comparedstudy] | |
comparisonStudy | równoważny | DiagnosticReportEuImaging | extension[comparison] | |
dicomStudyMetadata | równoważny | ImagingStudyEuImaging | ||
attachments | równoważny | DiagnosticReportEuImaging | media | |
attachments | równoważny | ObservationFindingEuImaging | derivedFrom |
Model logiczny EHDSImagingStudy 39
Elementy modelu logicznego Xt-EHR z licznością i obowiązkami. Obowiązki mówią producentom i odbiorcom danych, co system MUSI lub POWINIEN robić z każdym elementem.
Obowiązki według uczestnika
Ile elementów EHDSImagingStudy niesie dany obowiązek dla danego uczestnika.
| Obowiązek | Uczestnik | Elementy |
|---|---|---|
SHALL:able-to-populate | producent | 29 |
SHALL:process | odbiorca | 2 |
SHOULD:able-to-populate | producent | 8 |
SHOULD:process | odbiorca | 27 |
Elementy 39
| Element | Licz. | Obowiązki | Opis |
|---|---|---|---|
header | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Basic metadata for this information |
subject | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Patient/subject information |
identifier | 1..* | SHALL:able-to-populate producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | Author(s) responsible for the provided information. |
date | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Date and optionally time of authoring/issuing |
status | 1..1 | SHALL:able-to-populate producent | 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 producent | Language in which the resource is written. Language is expressed by the IETF language tag. |
modality | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | All of the distinct values for series' modalities |
bodySite | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | All of the distinct values for series' examined body parts. |
encounter | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | Reference to the encounter with which this imaging study is associated |
started | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Date and time the study started. |
basedOn | 0..* | SHOULD:able-to-populate producentSHOULD:process odbiorca | References to the diagnostic requests that resulted in this imaging study being performed. |
numberOfSeries | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | The imaging manager description of the study. Institution-generated description or classification of the study (component) performed. |
studyCustodian | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Organisation name, address, contact information. |
studyEndpoint | 0..* | SHALL:able-to-populate producentSHALL:process odbiorca | 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 producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | DICOM Series Instance UID for the series |
number | 0..1 | SHOULD:able-to-populate producentSHOULD:process odbiorca | Numeric identifier of this series |
seriesModality | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Acquisition modality - the modality used for this series |
description | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | A short human readable summary of the series |
numberOfInstances | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | Number of series related instances |
seriesEndpoint | 0..* | SHALL:able-to-populate producentSHALL:process odbiorca | 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 producentSHOULD:process odbiorca | Body part (with laterality) examined |
specimen | 0..* | Specimen imaged | |
started | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | When the series started |
instancesInTheSeries | 0..* | SHALL:able-to-populate producentSHOULD:process odbiorca | 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 producentSHOULD:process odbiorca | Instance title that is the description of the instance. |
instanceUid | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | DICOM SOP Instance UID |
sopClass | 1..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | SOP class - DICOM class type |
instanceNumber | 0..1 | SHALL:able-to-populate producentSHOULD:process odbiorca | The number of this instance in the series |
numberOfFrames | 0..1 | SHOULD:able-to-populate producent | The number of frames in a multiframe instance |
keyImage | 0..* | SHOULD:able-to-populate producent | 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 producent | Reason for flagging the image as significant |
reason | 0..1 | SHOULD:able-to-populate producent | Textual reason for flagging the image as significant |
seriesUID | 1..* | SHALL:able-to-populate producent | Series instance UID for the series that contains the instances flagged as significant |
instanceUID | 1..* | SHALL:able-to-populate producent | SOP Instance UID for the instances flagged as significant by the Key Image Note object (DICOM KOS) that flags this image |
Odwzorowanie EHDSImagingStudy na FHIR 41
Jak każdy element logiczny trafia do FHIR, według przewodnika HL7 Europe.
| Element | Relacja | Zasób FHIR | Element FHIR | Uwagi |
|---|---|---|---|---|
header | N/A | |||
subject | równoważny | ImagingStudyEuImaging | subject | |
identifier | równoważny | ImagingStudyEuImaging | identifier[studyInstanceUid] | |
author[ EHDSHealthProfessional ] | równoważny | ImagingStudyEuImaging | series.performer[performer] | |
author[ EHDSOrganisation ] | ImagingStudyEuImaging | series.performer[organization] | ||
author[ EHDSDevice ] | równoważny | ImagingStudyEuImaging | series.performer[device] | |
date | równoważny | 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 | równoważny | ImagingStudyEuImaging | status | |
source | ||||
language | równoważny | ImagingStudyEuImaging | language | |
modality | równoważny | ImagingStudyEuImaging | series.modality | |
bodySite | równoważny | ImagingStudyEuImaging | series.bodySite | |
encounter | równoważny | ImagingStudyEuImaging | encounter | |
started | równoważny | ImagingStudyEuImaging | started | |
basedOn | równoważny | ImagingStudyEuImaging | basedOn | |
numberOfSeries | równoważny | ImagingStudyEuImaging | numberOfSeries | |
numberOfInstances | równoważny | ImagingStudyEuImaging | numberOfInstances | |
description | równoważny | ImagingStudyEuImaging | description | |
studyCustodian | równoważny | ImagingStudyEuImaging | series.performer[custodian] | |
studyEndpoint | równoważny | ImagingStudyEuImaging | endpoint | |
series | równoważny | ImagingStudyEuImaging | series | |
seriesUid | równoważny | ImagingStudyEuImaging | series.uid | |
number | równoważny | ImagingStudyEuImaging | series.number | |
seriesModality | równoważny | ImagingStudyEuImaging | series.modality | |
description | równoważny | ImagingStudyEuImaging | series.description | |
numberOfInstances | równoważny | ImagingStudyEuImaging | series.numberOfInstances | |
seriesEndpoint | równoważny | ImagingStudyEuImaging | series.endpoint | |
bodySite | równoważny | ImagingStudyEuImaging | series.bodySite | |
specimen | równoważny | ImagingStudyEuImaging | series.specimen | |
started | równoważny | ImagingStudyEuImaging | series.started | |
instancesInTheSeries | równoważny | ImagingStudyEuImaging | series.instance | |
instanceTitle | równoważny | ImagingStudyEuImaging | series.instance.extension[instance-description] | |
instanceUid | równoważny | ImagingStudyEuImaging | series.instance.uid | |
sopClass | równoważny | ImagingStudyEuImaging | series.instance.sopClass | |
instanceNumber | równoważny | ImagingStudyEuImaging | series.instance.number | |
numberOfFrames | równoważny | ImagingStudyEuImaging | series.instance.extension[number-of-frames] | |
keyImage | ||||
flag | ||||
reason | ||||
seriesUID | ||||
instanceUID |
Dokumenty CDA (eHDSI)
Tę samą kategorię niosą w CDA te szablony dokumentów eHDSI. Ich struktura, zbiory wartości i walidator dokumentów CDA są w przewodniku CDA.
Źródła
Rozporządzenie (UE) 2025/327, Dziennik Urzędowy Unii Europejskiej; przewodniki wdrożeniowe FHIR HL7 Europe; modele logiczne Xt-EHR (xtehr.eu.ehds.models). Przewodniki w ballocie mogą się jeszcze zmienić. Ten przewodnik ma charakter informacyjny: nie jest poradą prawną ani certyfikacją zgodności.