Resultados de pruebas médicas en FHIR

Resultados de pruebas médicas es una categoría prioritaria del Espacio Europeo de Datos de Salud (artículo 14(1), letra (e) del Reglamento (UE) 2025/327). Se aplica desde el 26 de marzo de 2031. HL7 Europe la cubre con laboratory 2.1.0.

Reglamento: Regulation (EU) 2025/327, Article 14(1)(e), Annex I
Se aplica desde: 26 de marzo de 2031
Guías HL7 Europe: hl7.fhir.eu.laboratory 2.1.0, publicada
Modelos lógicos Xt-EHR: EHDSLaboratoryReport
Tipo de documento: LOINC 11502-2 Laboratory report
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 test results, including laboratory and other diagnostic results and related reports
Electronic health data representing results of studies performed in particular through in vitro diagnostics such as clinical biochemistry, haematology, transfusion medicine, microbiology, immunology and others, and including, where relevant, reports supporting the interpretation of the results.

Perfiles FHIR 11

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
Bundle: Laboratory Report`http://hl7.eu/fhir/laboratory/StructureDefinition/Bundle-eu-lab`	`Bundle`	laboratory	11	2 / 20
Composition: Laboratory Report`http://hl7.eu/fhir/laboratory/StructureDefinition/Composition-eu-lab`	`Composition`	laboratory	6	0 / 10
Device: Measuring`http://hl7.eu/fhir/laboratory/StructureDefinition/Device-measuring-eu-lab`	`Device`	laboratory	0	0 / 2
Device: Specimen`http://hl7.eu/fhir/laboratory/StructureDefinition/Device-specimen-eu-lab`	`Device`	laboratory	0	0 / 0
DiagnosticReport: Laboratory Report`http://hl7.eu/fhir/laboratory/StructureDefinition/DiagnosticReport-eu-lab`	`DiagnosticReport`	laboratory	8	2 / 10
Observation Results: laboratory`http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab`	`Observation`	laboratory	4	1 / 43
Patient: Animal`http://hl7.eu/fhir/laboratory/StructureDefinition/Patient-animal-eu-lab`	`Patient`	laboratory	3	1 / 5
RelatedPerson: AnimalSpecimen`http://hl7.eu/fhir/laboratory/StructureDefinition/animal-specimen-eu-lab`	`RelatedPerson`	laboratory	8	1 / 2
ServiceRequest: Laboratory Order`http://hl7.eu/fhir/laboratory/StructureDefinition/ServiceRequest-eu-lab`	`ServiceRequest`	laboratory	1	0 / 1
Specimen: Laboratory`http://hl7.eu/fhir/laboratory/StructureDefinition/Specimen-eu-lab`	`Specimen`	laboratory	2	1 / 4
Substance: Specimen Additive Substance`http://hl7.eu/fhir/laboratory/StructureDefinition/Substance-additive-eu-lab`	`Substance`	laboratory	0	0 / 0

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: Laboratory Report: entradas del Bundle 20

Entrada	Card.	Recurso FHIR	Perfil
`composition`	`1..1`	`Composition`	`CompositionLabReportEu`
`diagnosticReport`	`1..1`	`DiagnosticReport`	`DiagnosticReportLabEu`
`patient`	`0..*`	`Patient`
`observation`	`0..*`	`Observation`
`specimen`	`0..*`	`Specimen`	`SpecimenEu`
`serviceRequest`	`0..*`	`ServiceRequest`	`ServiceRequestLabEu`
`organization`	`0..*`	`Organization`
`practitioner`	`0..*`	`Practitioner`	`PractitionerEuCore`
`practitionerRole`	`0..*`	`PractitionerRole`	`PractitionerRoleEuCore`
`bodyStructure`	`0..*`	`BodyStructure`	`BodyStructureEuCore`
`encounter`	`0..*`	`Encounter`
`location`	`0..*`	`Location`	`LocationEuCore`
`provenance`	`0..*`	`Provenance`
`coverage`	`0..*`	`Coverage`
`device`	`0..*`	`Device`
`condition`	`0..*`	`Condition`	`ConditionEuCore`
`procedure`	`0..*`	`Procedure`	`ProcedureEuCore`
`medication`	`0..*`	`Medication`	`MedicationEuCore`
`medicationStatement`	`0..*`	`MedicationStatement`	`MedicationStatementEuCore`
`medicationAdministration`	`0..*`	`MedicationAdministration`

Composition: Laboratory Report: secciones 1

Sección	Card.	Código de sección	Descripción
`annotations`	`0..*`	`LOINC 48767-8`	Annotation comment

Bindings de terminología 2

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 13 bindings preferred y 2 example.

Value set	Binding	Usado por	Códigos
Laboratory Specialty`http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab`	`required`	CompositionLabReportEu `category:specialty`DiagnosticReportLabEu `category:specialty`ObservationResultsLaboratoryEu `category:specialty`	8 códigos
Laboratory Study Types`http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab`	`required`	CompositionLabReportEu `category:studyType`DiagnosticReportLabEu `category:studyType`ObservationResultsLaboratoryEu `category:studyType`	7 códigos

Extensiones 7

Extensiones de HL7 Europe que llevan los perfiles de esta categoría, con el elemento que contiene cada una.

Extensión	Contexto	Valor	Usada en
Device Laboratory Test Kit`http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit`	`Observation`	`Reference`	ObservationResultsLaboratoryEu `extension:labTestKit` 0..*
Document DiagnosticReport Reference`http://hl7.eu/fhir/extensions/StructureDefinition/composition-diagnosticReportReference`	`Composition`	`Reference`	CompositionLabReportEu `extension:diagnosticReport` 0..1
Composition: Information recipient`http://hl7.eu/fhir/StructureDefinition/information-recipient`	`Composition`	`Reference`	CompositionLabReportEu `extension:informationRecipient` 0..*
Many: Laboratory Accredited`http://hl7.eu/fhir/StructureDefinition/laboratory-accredited`	`ObservationServiceRequest`	`boolean`	ObservationResultsLaboratoryEu `extension:accredited` 0..1ServiceRequestLabEu `extension:accreditedLab` 0..1
Certified Reference Material: CodeableConcept`http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable`	`Observation`	`CodeableConcept`	ObservationResultsLaboratoryEu `extension:certifiedRefMaterialCodeable` 0..*
Certified Reference Material: Identifier`http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer`	`Observation`	`Identifier`	ObservationResultsLaboratoryEu `extension:certifiedRefMaterialIdentifer` 0..*
Specimen Focus`http://hl7.eu/fhir/laboratory/StructureDefinition/specimen-focus`	`Specimen`	`Reference`	SpecimenEu `extension:focus` 0..1

Modelo lógico EHDSLaboratoryReport 43

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 EHDSLaboratoryReport llevan cada obligación para cada actor.

Obligación	Actor	Elementos
`SHALL:able-to-populate`	productor	34
`SHALL:display`	consumidor	20
`SHALL:process`	consumidor	5
`SHOULD:able-to-populate`	productor	5
`SHOULD:display`	consumidor	6
`SHOULD:process`	consumidor	2

Elementos 43

Elemento	Card.	Obligaciones	Descripción
`header`	`1..1`	`SHALL:able-to-populate` productor Each producer of a laboratory report SHALL be able to provide basic information, such as type of the report, authorship, status of the report, title, etc. This information is crucial for safe identification of the report and for searchability of the report using standardized searching parameters.`SHALL:process` consumidor EHR systems that consume laboratory report SHALL process document header information.	Laboratory Report header
`subject`	`1..1`	`SHALL:able-to-populate` productor EHR systems SHALL provide information about the subject of care.`SHALL:display` consumidor EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.`SHALL:process` consumidor Information about the subject of care SHALL be processed by the EHR system in such a way that the identity of the subject of care cannot be confused.	Patient/subject information
`identifier`	`1..*`	`SHALL:able-to-populate` productor`SHOULD:display` consumidor`SHALL:process` consumidor	Unique identifier of the document
`author[x]`	`1..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Author(s) by whom the laboratory result report was authored.
`date`	`1..1`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Date of finalising/issuing the document
`status`	`1..1`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Status of the 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`	`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 at hand, e.g. 60591-5 Patient summary document.
`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`	`SHALL: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`SHALL:display` consumidor	Document attestation details
`attester[x]`	`1..1`	`SHALL:able-to-populate` productor`SHALL:display` 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` productor	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..*`	`SHALL:able-to-populate` productor	Categorisation of the event covered by the document (e.g. laboratory study types, imaging study types including 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..*`	`SHALL:able-to-populate` productor`SHOULD:display` consumidor	Additional details about where the content was created (e.g. clinical specialty)
`custodian`	`0..1`	`SHALL:able-to-populate` productor	Organisation that is in charge of maintaining the document/report.
`intendedRecipient[x]`	`0..*`		Intended recipient
`presentedForm`	`0..*`	`SHALL:able-to-populate` productor Each EHR system that is a producer of a laboratory report SHALL be able to provide the entire report as issued by the laboratory in a human readable format, e.g. PDF.`SHALL:process` consumidor EHR systems that consume laboratory report SHALL process the human readable version of the report.`SHALL:display` consumidor EHR systems that consume laboratory report SHALL render human readable version of the report to the endusers.	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` productor Each EHR system that is a producer of a laboratory report SHALL be able to provide structured information about the laboratory investigation, such as order information, supporting information, specimen details and result data.`SHALL:process` consumidor EHR systems that consume laboratory report SHALL process structured body information.	Laboratory Report structured body
`orderInformation`	`0..*`	`SHALL:able-to-populate` productor EHR systems SHALL be able to populate information about one or more order which this report is based on.`SHALL:display` consumidor Consumer EHR systems SHALL display key order information to ensure traceability between order and report.	Order Information (Laboratory Result Report could respond to multiple test orders)
`orderId`	`1..*`	`SHALL:able-to-populate` productor`SHOULD:process` consumidor Consumer systems SHOULD use this element to pair result report with laboratory order.	An identifier of the laboratory test order. Laboratory Result Report may respond to multiple orders.
`orderDateAndTime`	`0..1`		Date and time of the order placement.
`orderPlacer[x]`	`0..1`	`SHALL:able-to-populate` productor`SHOULD:display` consumidor	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..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	An explanation or justification for why this service is being requested in coded form.
`clinicalQuestion`	`0..1`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Specification of clinical question (goal of the investigation) to be answered by the laboratory investigation.
`supportingInformation`	`0..1`	`SHOULD:able-to-populate` productor`SHALL:display` consumidor	Additional clinical information about the patient or specimen that may influence the services or their interpretations. This information includes diagnosis, clinical findings and other observations. In laboratory ordering these are typically referred to as 'ask at order entry questions (AOEs).' This includes observations explicitly requested by the producer (filler) to provide context or supporting information needed to complete the order. For example, reporting the amount of inspired oxygen for blood gas measurements.
`observation`	`0..*`	`SHOULD:able-to-populate` productor`SHALL:display` consumidor	Clinical findings and other observations.
`condition`	`0..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Condition that may influence the service or result interpretation.
`medicationAdministration`	`0..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Medication administered before ordering the service.
`sexForClinicalUse`	`0..1`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	A Sex Parameter for Clinical Use is a parameter that 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
`vaccination`	`0..*`	`SHOULD:able-to-populate` productor`SHALL:display` consumidor	Vaccination history of the patient.
`otherSupportingInformation`	`0..*`	`SHOULD:able-to-populate` productor`SHOULD:display` consumidor	Any other type of relevant supporting information
`specimen`	`0..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Specimen information
`serviceRequest`	`0..*`	`SHALL:able-to-populate` productor`SHOULD:display` consumidor	Specification of requested service or services
`resultData`	`1..1`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Laboratory report result data
`commentsInterpretationAndRecommendations`	`0..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Narrative Comments, such as a textual interpretation or advice accompanying the result report, for example.
`laboratoryTestResults`	`0..*`	`SHALL:able-to-populate` productor`SHALL:display` consumidor	Observation details (report could consist of multiple observations)
`attachments`	`0..*`	`SHOULD:able-to-populate` productor Each EHR system that is a producer of a laboratory report SHOULD be able to provide attachments related to the report, such as documents, diagrams, images of the results, etc.`SHOULD:process` consumidor EHR systems that consume laboratory report SHOULD process attachments related to the report.`SHOULD:display` consumidor EHR systems that consume laboratory report SHOULD render attachments related to the report to the endusers.	Report attachments

Mapeo de EHDSLaboratoryReport a FHIR 47

Cómo aterriza cada elemento lógico en FHIR, según lo publicado en la guía de HL7 Europe. Mapeado a: BundleLabReportEu, CompositionLabReportEu, DiagnosticReportLabEu, ServiceRequestLabEu.

Elemento	Relación	Recurso FHIR	Elemento FHIR	Notas
`header`	relacionado con	`Composition`	`.`
`subject`	equivalente	`Composition`	`subject`	Also aligned with DiagnosticReport.subject.
`identifier`	equivalente	`Composition`	`identifier`
`identifier`	equivalente	`DiagnosticReport`	`identifier`
`identifier`	equivalente	`Bundle`	`identifier`
`author[x]`	equivalente	`Composition`	`author`
`date`	equivalente	`Composition`	`date`
`status`	equivalente	`DiagnosticReport`	`status`	Composition and DiagnosticReport status are expected to be aligned.
`language`	equivalente	`Composition`	`language`
`documentType`	equivalente	`Composition`	`type`
`documentType`	equivalente	`DiagnosticReport`	`code`
`documentTitle`	equivalente	`Composition`	`title`
`period`	relacionado con	`Composition`	`event.period`
`version`	relacionado con	`Composition`	`extension:version`
`attestation`	relacionado con	`Composition`	`attester`
`attester[x]`	equivalente	`Composition`	`attester.party`
`datetime`	equivalente	`Composition`	`attester.time`
`legalAuthentication`	relacionado con	`Composition`	`attester`
`legalAuthenticator[x]`	relacionado con	`Composition`	`attester.party`	May require attester mode constraints by implementation rules.
`datetime`	equivalente	`Composition`	`attester.time`
`eventType`	relacionado con	`Composition`	`category:studyType`	The model gives laboratory study types as an example. This guide carries them in the studyType slice, which DiagnosticReport.category has as well.
`serviceSpecialty`	relacionado con	`Composition`	`category:specialty`	The slice is bound to LabSpecialtyEuVs. DiagnosticReport.category has the same slice.
`custodian`	equivalente	`Composition`	`custodian`
`presentedForm`	equivalente	`DiagnosticReport`	`presentedForm`
`intendedRecipient[x]`	equivalente	`Composition`	`extension:informationRecipient`	Uses EU extension on Composition.
`body`	relacionado con	`Composition`	`section`
`orderInformation`	relacionado con	`ServiceRequest`	`.`	Each order is a ServiceRequestLabEu, which DiagnosticReport.basedOn references. The child elements map to elements of that ServiceRequest.
`orderId`	equivalente	`ServiceRequest`	`identifier`
`orderDateAndTime`	equivalente	`ServiceRequest`	`authoredOn`
`orderPlacer[x]`	equivalente	`ServiceRequest`	`requester`
`orderReason[x]`	equivalente	`ServiceRequest`	`reasonCode / reasonReference`	Mapping depends on coded, textual, or referenced reason source.
`clinicalQuestion`	relacionado con	`ServiceRequest`	`note`
`supportingInformation`	relacionado con	`ServiceRequest`	`supportingInfo`
`observation`	equivalente	`ServiceRequest`	`supportingInfo`
`condition`	equivalente	`ServiceRequest`	`supportingInfo`
`medicationAdministration`	equivalente	`ServiceRequest`	`supportingInfo`
`sexForClinicalUse`	relacionado con	`Patient`	`extension:sex-for-clinical-use`	PatientEuCore of HL7 Europe Base profiles this extension.
`vaccination`	equivalente	`ServiceRequest`	`supportingInfo`
`otherSupportingInformation`	equivalente	`ServiceRequest`	`supportingInfo`
`specimen`	equivalente	`DiagnosticReport`	`specimen`	Also represented as Bundle entries of type SpecimenEu.
`serviceRequest`	equivalente	`DiagnosticReport`	`basedOn`
`resultData`	relacionado con	`DiagnosticReport`	`result / conclusion / presentedForm`
`laboratoryTestResults`	equivalente	`DiagnosticReport`	`result`	Observation resources are included as Bundle entries.
`laboratoryTestResults`	equivalente	`Composition`	`section.entry`
`commentsInterpretationAndRecommendations`	relacionado con	`Composition`	`section:text`	Often represented in annotation/comment section.
`commentsInterpretationAndRecommendations`	relacionado con	`DiagnosticReport`	`conclusion / conclusionCode`	When implemented in the DiagnosticReport profile instance.
`attachments`	relacionado con	`DiagnosticReport`	`media.link.extension:link`	Each attachment is a DocumentReference, referenced through the alternate-reference extension on media.link. The rendered report itself maps from presentedForm.

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.

eHDSI OrCD Laboratory Result

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.