0.1.0 - ci-build

EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EU AI Generated Observation

Official URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-observation Version: 0.1.0
Draft as of 2026-06-18 Computable Name: EU_AIObservation

An Observation profile representing a clinical output generated by an AI system, including AI-related transparency metadata and links to the relevant patient, encounter, and AI system.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:caseIndication S 1..1 CodeableConcept Case-Specific Indication
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication
Binding: EU AI Case-Specific Indication ValueSet (extensible)
.... extension:automatedDecision S 1..1 boolean Automated Decision-Making Flag
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag
... status ?!Σ 1..1 code Workflow state: preliminary (unseen) | final (checked) | entered-in-error (overridden)
Binding: ObservationStatus (required): Codes providing the status of an observation.
... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
... subject SΣ 1..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) Who and/or what the observation is about
... effective[x] SΣ 1..1 dateTime Time the AI generated this result
... value[x] ΣC 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment
.... valueReference Reference(MolecularSequence)
... Slices for interpretation 1..* CodeableConcept High, low, normal, etc
Slice: Unordered, Open by value:coding
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... interpretation:aiGeneratedFlag S 1..1 CodeableConcept Mandatory flag indicating AI origin
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... coding Σ 1..* Coding Code defined by a terminology system

Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ai-generated
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
... device S 1..1 Reference(EU AI System Device) Link to the AI Device that generated this result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required Observation Status 📍5.0.0 FHIR Std.
Observation.code Base example LOINC Codes 📍5.0.0 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.
Observation.interpretation:aiGeneratedFlag Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8 error Observation bodyStructure SHALL only be present if Observation.bodySite is not present bodySite.exists() implies bodyStructure.empty()

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:caseIndication S 1..1 CodeableConcept Case-Specific Indication
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication
Binding: EU AI Case-Specific Indication ValueSet (extensible)
.... extension:automatedDecision S 1..1 boolean Automated Decision-Making Flag
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag
... status 1..1 code Workflow state: preliminary (unseen) | final (checked) | entered-in-error (overridden)
... code S 1..1 CodeableConcept Type of observation (code / type)
... effective[x] S 1..1 dateTime Time the AI generated this result
... Slices for interpretation 1..* CodeableConcept High, low, normal, etc
Slice: Unordered, Open by value:coding
.... interpretation:aiGeneratedFlag S 1..1 CodeableConcept Mandatory flag indicating AI origin
..... coding 1..* Coding Code defined by a terminology system
Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ai-generated
... device S 1..1 Reference(EU AI System Device) Link to the AI Device that generated this result

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:caseIndication S 1..1 CodeableConcept Case-Specific Indication
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication
Binding: EU AI Case-Specific Indication ValueSet (extensible)
.... extension:automatedDecision S 1..1 boolean Automated Decision-Making Flag
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... instantiates[x] Σ 0..1 canonical(ObservationDefinition), Reference(ObservationDefinition) Instantiates FHIR ObservationDefinition
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... triggeredBy 0..* BackboneElement Triggering observation(s)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... observation Σ 1..1 Reference(Observation) Triggering observation
.... type Σ 1..1 code reflex | repeat | re-run
Binding: TriggeredBytype (required): The type of TriggeredBy Observation.
.... reason 0..1 string Reason that the observation was triggered
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy | GenomicStudy) Part of referenced event
... status ?!Σ 1..1 code Workflow state: preliminary (unseen) | final (checked) | entered-in-error (overridden)
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
... subject SΣ 1..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 1..1 dateTime Time the AI generated this result
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] ΣC 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment
.... valueReference Reference(MolecularSequence)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... Slices for interpretation 1..* CodeableConcept High, low, normal, etc
Slice: Unordered, Open by value:coding
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... interpretation:aiGeneratedFlag S 1..1 CodeableConcept Mandatory flag indicating AI origin
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..* Coding Code defined by a terminology system

Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ai-generated
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
... note 0..* Annotation Comments about the observation
... bodySite C 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
... bodyStructure C 0..1 Reference(BodyStructure) Observed body structure
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen C 0..1 Reference(Specimen | Group) Specimen used for this observation
Constraints: obs-9
... device S 1..1 Reference(EU AI System Device) Link to the AI Device that generated this result
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(5.0.0) Low Range, if relevant
.... high C 0..1 SimpleQuantity(5.0.0) High Range, if relevant
.... normalValue 0..1 CodeableConcept Normal value, if relevant
Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation.
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text C 0..1 markdown Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
... component ΣC 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... valueAttachment Attachment
..... valueReference Reference(MolecularSequence)
.... dataAbsentReason 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... interpretation 0..* CodeableConcept High, low, normal, etc
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.language Base required All Languages 📍5.0.0 FHIR Std.
Observation.triggeredBy.​type Base required triggered Bytype 📍5.0.0 FHIR Std.
Observation.status Base required Observation Status 📍5.0.0 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍5.0.0 FHIR Std.
Observation.code Base example LOINC Codes 📍5.0.0 FHIR Std.
Observation.dataAbsentReason Base extensible Data Absent Reason 📍5.0.0 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.
Observation.interpretation:aiGeneratedFlag Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍5.0.0 FHIR Std.
Observation.method Base example Observation Methods 📍5.0.0 FHIR Std.
Observation.referenceRange.​normalValue Base extensible Observation Reference Range Normal Value Codes 📍5.0.0 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍5.0.0 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍5.0.0 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍5.0.0 FHIR Std.
Observation.component.​dataAbsentReason Base extensible Data Absent Reason 📍5.0.0 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8 error Observation bodyStructure SHALL only be present if Observation.bodySite is not present bodySite.exists() implies bodyStructure.empty()
obs-9 error Observation.specimen If Observation.specimen is a reference to Group, the group can only have specimens (reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

This structure is derived from Observation

Summary

Mandatory: 8 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.interpretation

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:caseIndication S 1..1 CodeableConcept Case-Specific Indication
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication
Binding: EU AI Case-Specific Indication ValueSet (extensible)
.... extension:automatedDecision S 1..1 boolean Automated Decision-Making Flag
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag
... status ?!Σ 1..1 code Workflow state: preliminary (unseen) | final (checked) | entered-in-error (overridden)
Binding: ObservationStatus (required): Codes providing the status of an observation.
... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
... subject SΣ 1..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) Who and/or what the observation is about
... effective[x] SΣ 1..1 dateTime Time the AI generated this result
... value[x] ΣC 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment
.... valueReference Reference(MolecularSequence)
... Slices for interpretation 1..* CodeableConcept High, low, normal, etc
Slice: Unordered, Open by value:coding
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... interpretation:aiGeneratedFlag S 1..1 CodeableConcept Mandatory flag indicating AI origin
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... coding Σ 1..* Coding Code defined by a terminology system

Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ai-generated
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
... device S 1..1 Reference(EU AI System Device) Link to the AI Device that generated this result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required Observation Status 📍5.0.0 FHIR Std.
Observation.code Base example LOINC Codes 📍5.0.0 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.
Observation.interpretation:aiGeneratedFlag Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8 error Observation bodyStructure SHALL only be present if Observation.bodySite is not present bodySite.exists() implies bodyStructure.empty()

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:caseIndication S 1..1 CodeableConcept Case-Specific Indication
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication
Binding: EU AI Case-Specific Indication ValueSet (extensible)
.... extension:automatedDecision S 1..1 boolean Automated Decision-Making Flag
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag
... status 1..1 code Workflow state: preliminary (unseen) | final (checked) | entered-in-error (overridden)
... code S 1..1 CodeableConcept Type of observation (code / type)
... effective[x] S 1..1 dateTime Time the AI generated this result
... Slices for interpretation 1..* CodeableConcept High, low, normal, etc
Slice: Unordered, Open by value:coding
.... interpretation:aiGeneratedFlag S 1..1 CodeableConcept Mandatory flag indicating AI origin
..... coding 1..* Coding Code defined by a terminology system
Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ai-generated
... device S 1..1 Reference(EU AI System Device) Link to the AI Device that generated this result

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:caseIndication S 1..1 CodeableConcept Case-Specific Indication
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/case-specific-indication
Binding: EU AI Case-Specific Indication ValueSet (extensible)
.... extension:automatedDecision S 1..1 boolean Automated Decision-Making Flag
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/automated-decision-flag
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... instantiates[x] Σ 0..1 canonical(ObservationDefinition), Reference(ObservationDefinition) Instantiates FHIR ObservationDefinition
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... triggeredBy 0..* BackboneElement Triggering observation(s)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... observation Σ 1..1 Reference(Observation) Triggering observation
.... type Σ 1..1 code reflex | repeat | re-run
Binding: TriggeredBytype (required): The type of TriggeredBy Observation.
.... reason 0..1 string Reason that the observation was triggered
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy | GenomicStudy) Part of referenced event
... status ?!Σ 1..1 code Workflow state: preliminary (unseen) | final (checked) | entered-in-error (overridden)
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
... subject SΣ 1..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 1..1 dateTime Time the AI generated this result
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] ΣC 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment
.... valueReference Reference(MolecularSequence)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... Slices for interpretation 1..* CodeableConcept High, low, normal, etc
Slice: Unordered, Open by value:coding
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... interpretation:aiGeneratedFlag S 1..1 CodeableConcept Mandatory flag indicating AI origin
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..* Coding Code defined by a terminology system

Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ai-generated
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
... note 0..* Annotation Comments about the observation
... bodySite C 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
... bodyStructure C 0..1 Reference(BodyStructure) Observed body structure
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen C 0..1 Reference(Specimen | Group) Specimen used for this observation
Constraints: obs-9
... device S 1..1 Reference(EU AI System Device) Link to the AI Device that generated this result
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(5.0.0) Low Range, if relevant
.... high C 0..1 SimpleQuantity(5.0.0) High Range, if relevant
.... normalValue 0..1 CodeableConcept Normal value, if relevant
Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation.
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text C 0..1 markdown Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
... component ΣC 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... valueAttachment Attachment
..... valueReference Reference(MolecularSequence)
.... dataAbsentReason 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... interpretation 0..* CodeableConcept High, low, normal, etc
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.language Base required All Languages 📍5.0.0 FHIR Std.
Observation.triggeredBy.​type Base required triggered Bytype 📍5.0.0 FHIR Std.
Observation.status Base required Observation Status 📍5.0.0 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍5.0.0 FHIR Std.
Observation.code Base example LOINC Codes 📍5.0.0 FHIR Std.
Observation.dataAbsentReason Base extensible Data Absent Reason 📍5.0.0 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.
Observation.interpretation:aiGeneratedFlag Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍5.0.0 FHIR Std.
Observation.method Base example Observation Methods 📍5.0.0 FHIR Std.
Observation.referenceRange.​normalValue Base extensible Observation Reference Range Normal Value Codes 📍5.0.0 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍5.0.0 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍5.0.0 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍5.0.0 FHIR Std.
Observation.component.​dataAbsentReason Base extensible Data Absent Reason 📍5.0.0 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8 error Observation bodyStructure SHALL only be present if Observation.bodySite is not present bodySite.exists() implies bodyStructure.empty()
obs-9 error Observation.specimen If Observation.specimen is a reference to Group, the group can only have specimens (reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

This structure is derived from Observation

Summary

Mandatory: 8 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.interpretation

 

Other representations of profile: CSV, Excel, Schematron