Medical test results in FHIR

Medical test results is a priority category of the European Health Data Space (Article 14(1) point (e) of Regulation (EU) 2025/327). It applies from March 26, 2031. HL7 Europe covers it with laboratory 2.1.0.

Regulation: Regulation (EU) 2025/327, Article 14(1)(e), Annex I
Applies from: March 26, 2031
HL7 Europe guides: hl7.fhir.eu.laboratory 2.1.0, published
Xt-EHR logical models: EHDSLaboratoryReport
Document type: LOINC 11502-2 Laboratory report
Validator: Open the EHDS profile validator

What the Regulation says

Annex I of the Regulation describes the main characteristics of this category. The text is the English original.

Medical 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.

FHIR profiles 11

Profiles defined by the guides above. The rules column counts the elements where the profile goes beyond base FHIR (required, forbidden or limited), which the validator checks; of the slices, only the required ones that a fixed value or the resource type identifies are checked.

Profile	Resource	HL7 Europe guide	Rules checked	Slices checked / defined
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

Document structure

The document profiles of this category: the sections a Composition can carry and the entries a Bundle can hold, as the profiles state them. Names are slice names; the section code is the LOINC code the profile fixes.

Bundle: Laboratory Report: Bundle entries 20

Entry	Card.	FHIR resource	Profile
`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: sections 1

Section	Card.	Section code	Description
`annotations`	`0..*`	`LOINC 48767-8`	Annotation comment

Terminology bindings 2

Value sets that the profiles of this category bind elements to with a required or extensible binding. A required binding only allows codes of the value set; an extensible one expects them unless none fits. Value sets that the HL7 Europe packages define are listed with their codes in the value set reference.

The profiles also state 13 preferred and 2 example bindings.

Value set	Binding	Used by	Codes
Laboratory Specialty`http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab`	`required`	CompositionLabReportEu `category:specialty`DiagnosticReportLabEu `category:specialty`ObservationResultsLaboratoryEu `category:specialty`	8 codes
Laboratory Study Types`http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab`	`required`	CompositionLabReportEu `category:studyType`DiagnosticReportLabEu `category:studyType`ObservationResultsLaboratoryEu `category:studyType`	7 codes

Extensions 7

HL7 Europe extensions that the profiles of this category carry, with the element that holds each one.

Extension	Context	Value	Used in
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

Logical model EHDSLaboratoryReport 43

Elements of the Xt-EHR logical model with their cardinality and obligations. Obligations tell producers and consumers of the data what a system SHALL or SHOULD do with each element.

Obligations by actor

How many elements of EHDSLaboratoryReport carry each obligation for each actor.

Obligation	Actor	Elements
`SHALL:able-to-populate`	producer	34
`SHALL:display`	consumer	20
`SHALL:process`	consumer	5
`SHOULD:able-to-populate`	producer	5
`SHOULD:display`	consumer	6
`SHOULD:process`	consumer	2

Elements 43

Element	Card.	Obligations	Description
`header`	`1..1`	`SHALL:able-to-populate` producer 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` consumer EHR systems that consume laboratory report SHALL process document header information.	Laboratory Report header
`subject`	`1..1`	`SHALL:able-to-populate` producer EHR systems SHALL provide information about the subject of care.`SHALL:display` consumer 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` consumer 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` producer`SHOULD:display` consumer`SHALL:process` consumer	Unique identifier of the document
`author[x]`	`1..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Author(s) by whom the laboratory result report was authored.
`date`	`1..1`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Date of finalising/issuing the document
`status`	`1..1`	`SHALL:able-to-populate` producer`SHALL:display` consumer	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` producer	Language in which the resource is written. Language is expressed by the IETF language tag.
`documentType`	`1..1`	`SHALL:able-to-populate` producer	Type of document at hand, e.g. 60591-5 Patient summary document.
`documentTitle`	`1..1`	`SHALL:able-to-populate` producer	Human readable document title that can be displayed in search results, etc. This can be documentType's display name, or it can be assembled from multiple elements. Examples: 'Laboratory Result Report', 'Patient Summary of Jane Green 10.12.2024'
`period`	`0..1`	`SHALL:able-to-populate` producer	Time of service that is being documented
`version`	`0..1`		Business version of the document. The exact algorithm for versioning is decided by the producer/custodian
`attestation`	`0..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Document attestation details
`attester[x]`	`1..1`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Attester who validated the document
`datetime`	`1..1`	`SHALL:able-to-populate` producer	Date and time of the approval of the document by Attester
`legalAuthentication`	`0..*`	`SHALL:able-to-populate` producer	Document legal authentication details
`legalAuthenticator[x]`	`1..1`	`SHALL:able-to-populate` producer	The person or organisation taking responsibility for the content of the document.
`datetime`	`1..1`	`SHALL:able-to-populate` producer	Date and time when the document was authorised
`eventType`	`0..*`	`SHALL:able-to-populate` producer	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` producer`SHOULD:display` consumer	Additional details about where the content was created (e.g. clinical specialty)
`custodian`	`0..1`	`SHALL:able-to-populate` producer	Organisation that is in charge of maintaining the document/report.
`intendedRecipient[x]`	`0..*`		Intended recipient
`presentedForm`	`0..*`	`SHALL:able-to-populate` producer 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` consumer EHR systems that consume laboratory report SHALL process the human readable version of the report.`SHALL:display` consumer 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` producer 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` consumer EHR systems that consume laboratory report SHALL process structured body information.	Laboratory Report structured body
`orderInformation`	`0..*`	`SHALL:able-to-populate` producer EHR systems SHALL be able to populate information about one or more order which this report is based on.`SHALL:display` consumer 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` producer`SHOULD:process` consumer 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` producer`SHOULD:display` consumer	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` producer`SHALL:display` consumer	An explanation or justification for why this service is being requested in coded form.
`clinicalQuestion`	`0..1`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Specification of clinical question (goal of the investigation) to be answered by the laboratory investigation.
`supportingInformation`	`0..1`	`SHOULD:able-to-populate` producer`SHALL:display` consumer	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` producer`SHALL:display` consumer	Clinical findings and other observations.
`condition`	`0..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Condition that may influence the service or result interpretation.
`medicationAdministration`	`0..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Medication administered before ordering the service.
`sexForClinicalUse`	`0..1`	`SHALL:able-to-populate` producer`SHALL:display` consumer	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` producer`SHALL:display` consumer	Vaccination history of the patient.
`otherSupportingInformation`	`0..*`	`SHOULD:able-to-populate` producer`SHOULD:display` consumer	Any other type of relevant supporting information
`specimen`	`0..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Specimen information
`serviceRequest`	`0..*`	`SHALL:able-to-populate` producer`SHOULD:display` consumer	Specification of requested service or services
`resultData`	`1..1`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Laboratory report result data
`commentsInterpretationAndRecommendations`	`0..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Narrative Comments, such as a textual interpretation or advice accompanying the result report, for example.
`laboratoryTestResults`	`0..*`	`SHALL:able-to-populate` producer`SHALL:display` consumer	Observation details (report could consist of multiple observations)
`attachments`	`0..*`	`SHOULD:able-to-populate` producer 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` consumer EHR systems that consume laboratory report SHOULD process attachments related to the report.`SHOULD:display` consumer EHR systems that consume laboratory report SHOULD render attachments related to the report to the endusers.	Report attachments

Mapping of EHDSLaboratoryReport to FHIR 47

How each logical element lands in FHIR, as published in the HL7 Europe guide. Mapped to: BundleLabReportEu, CompositionLabReportEu, DiagnosticReportLabEu, ServiceRequestLabEu.

Element	Relation	FHIR resource	FHIR element	Notes
`header`	related to	`Composition`	`.`
`subject`	equivalent	`Composition`	`subject`	Also aligned with DiagnosticReport.subject.
`identifier`	equivalent	`Composition`	`identifier`
`identifier`	equivalent	`DiagnosticReport`	`identifier`
`identifier`	equivalent	`Bundle`	`identifier`
`author[x]`	equivalent	`Composition`	`author`
`date`	equivalent	`Composition`	`date`
`status`	equivalent	`DiagnosticReport`	`status`	Composition and DiagnosticReport status are expected to be aligned.
`language`	equivalent	`Composition`	`language`
`documentType`	equivalent	`Composition`	`type`
`documentType`	equivalent	`DiagnosticReport`	`code`
`documentTitle`	equivalent	`Composition`	`title`
`period`	related to	`Composition`	`event.period`
`version`	related to	`Composition`	`extension:version`
`attestation`	related to	`Composition`	`attester`
`attester[x]`	equivalent	`Composition`	`attester.party`
`datetime`	equivalent	`Composition`	`attester.time`
`legalAuthentication`	related to	`Composition`	`attester`
`legalAuthenticator[x]`	related to	`Composition`	`attester.party`	May require attester mode constraints by implementation rules.
`datetime`	equivalent	`Composition`	`attester.time`
`eventType`	related to	`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`	related to	`Composition`	`category:specialty`	The slice is bound to LabSpecialtyEuVs. DiagnosticReport.category has the same slice.
`custodian`	equivalent	`Composition`	`custodian`
`presentedForm`	equivalent	`DiagnosticReport`	`presentedForm`
`intendedRecipient[x]`	equivalent	`Composition`	`extension:informationRecipient`	Uses EU extension on Composition.
`body`	related to	`Composition`	`section`
`orderInformation`	related to	`ServiceRequest`	`.`	Each order is a ServiceRequestLabEu, which DiagnosticReport.basedOn references. The child elements map to elements of that ServiceRequest.
`orderId`	equivalent	`ServiceRequest`	`identifier`
`orderDateAndTime`	equivalent	`ServiceRequest`	`authoredOn`
`orderPlacer[x]`	equivalent	`ServiceRequest`	`requester`
`orderReason[x]`	equivalent	`ServiceRequest`	`reasonCode / reasonReference`	Mapping depends on coded, textual, or referenced reason source.
`clinicalQuestion`	related to	`ServiceRequest`	`note`
`supportingInformation`	related to	`ServiceRequest`	`supportingInfo`
`observation`	equivalent	`ServiceRequest`	`supportingInfo`
`condition`	equivalent	`ServiceRequest`	`supportingInfo`
`medicationAdministration`	equivalent	`ServiceRequest`	`supportingInfo`
`sexForClinicalUse`	related to	`Patient`	`extension:sex-for-clinical-use`	PatientEuCore of HL7 Europe Base profiles this extension.
`vaccination`	equivalent	`ServiceRequest`	`supportingInfo`
`otherSupportingInformation`	equivalent	`ServiceRequest`	`supportingInfo`
`specimen`	equivalent	`DiagnosticReport`	`specimen`	Also represented as Bundle entries of type SpecimenEu.
`serviceRequest`	equivalent	`DiagnosticReport`	`basedOn`
`resultData`	related to	`DiagnosticReport`	`result / conclusion / presentedForm`
`laboratoryTestResults`	equivalent	`DiagnosticReport`	`result`	Observation resources are included as Bundle entries.
`laboratoryTestResults`	equivalent	`Composition`	`section.entry`
`commentsInterpretationAndRecommendations`	related to	`Composition`	`section:text`	Often represented in annotation/comment section.
`commentsInterpretationAndRecommendations`	related to	`DiagnosticReport`	`conclusion / conclusionCode`	When implemented in the DiagnosticReport profile instance.
`attachments`	related to	`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.

CDA documents (eHDSI)

The same category is carried in CDA by these eHDSI document templates. Their structure, value sets and a validator for CDA documents are in the CDA guide.

eHDSI OrCD Laboratory Result

Sources

Regulation (EU) 2025/327, Official Journal of the European Union; HL7 Europe FHIR implementation guides; Xt-EHR logical models (xtehr.eu.ehds.models). Ballot guides may still change. This guide is informational: it is not legal advice and not a certification of conformity.