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 Execution Audit Event

Official URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-machine-execution-audit-event Version: 0.1.0
Draft as of 2026-06-18 Computable Name: EU_AIAuditEvent

An AuditEvent profile documenting execution-related metadata of an AI-supported processing event to support retrospective reconstruction and auditability.

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
.. AuditEvent 0..* AuditEvent Record of an event
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:logIntegrity S 1..1 Signature Cryptographic signature of this log entry
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity
... code Σ 1..1 CodeableConcept Specific type of event
Binding: AuditEventSubType (example): Specific type of event.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... 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://terminology.hl7.org/CodeSystem/audit-event-type
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: rest
..... display 1..1 string Representation defined by the system
Fixed Value: RESTful Operation
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... action Σ 0..1 code Type of action performed during the event
Binding: AuditEventAction (required): DICOM Audit Event Action
Required Pattern: C
... Slices for occurred[x] 1..1 Period When the activity occurred
Slice: Unordered, Closed by type:$this
.... occurred[x]:occurredPeriod S 1..1 Period Exact execution period (Start/End)
... recorded SΣ 1..1 instant Time when the event was recorded
... agent SΣ 1..* BackboneElement Actor involved in the event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... who Σ 1..1 Reference(EU AI System Device) Identifier of who
.... requestor Σ 0..1 boolean Whether user is initiator
Required Pattern: false
... source SΣ 1..1 BackboneElement Audit Event Reporter
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... observer Σ 1..1 Reference(EU AI System Device) The identity of source detecting the event
... Slices for entity Σ 2..* BackboneElement Data or objects used
Slice: Unordered, Open by value:role
.... entity:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... entity:inputData SΣ 1..* BackboneElement Input Data Processed
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 4
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
.... entity:referenceDb Σ 0..* BackboneElement Identification of specific reference databases or versions (e.g., Clinical Guidelines)
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 17
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
.... entity:outputData SΣ 1..* BackboneElement The resulting AI-generated Observation
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... what Σ 0..1 Reference(EU AI Generated Observation) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 3
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AuditEvent.code Base example Audit Event Sub-Type 📍5.0.0 FHIR Std.
AuditEvent.action Base required Audit Event Action 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AuditEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AuditEvent 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 AuditEvent 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 AuditEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AuditEvent 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()

This structure is derived from AuditEvent

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AuditEvent 0..* AuditEvent Record of an event
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:logIntegrity S 1..1 Signature Cryptographic signature of this log entry
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity
... code 1..1 CodeableConcept Specific type of event
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/audit-event-type
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: rest
..... display 1..1 string Representation defined by the system
Fixed Value: RESTful Operation
... action 0..1 code Type of action performed during the event
Required Pattern: C
.... occurred[x]:occurredPeriod S 1..1 Period Exact execution period (Start/End)
... recorded S 1..1 instant Time when the event was recorded
... agent S 1..* BackboneElement Actor involved in the event
.... who 1..1 Reference(EU AI System Device) Identifier of who
.... requestor 0..1 boolean Whether user is initiator
Required Pattern: false
... source S 1..1 BackboneElement Audit Event Reporter
.... observer 1..1 Reference(EU AI System Device) The identity of source detecting the event
... Slices for entity 2..* BackboneElement Data or objects used
Slice: Unordered, Open by value:role
.... entity:inputData S 1..* BackboneElement Input Data Processed
..... role 1..1 CodeableConcept What role the entity played
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/object-role
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 4
.... entity:referenceDb 0..* BackboneElement Identification of specific reference databases or versions (e.g., Clinical Guidelines)
..... role 1..1 CodeableConcept What role the entity played
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/object-role
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 17
.... entity:outputData S 1..* BackboneElement The resulting AI-generated Observation
..... what 0..1 Reference(EU AI Generated Observation) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/object-role
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 3

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AuditEvent 0..* AuditEvent Record of an event
... 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
... 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 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:logIntegrity S 1..1 Signature Cryptographic signature of this log entry
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... category Σ 0..* CodeableConcept Type/identifier of event
Binding: AuditEventID (example): Type of event.
... code Σ 1..1 CodeableConcept Specific type of event
Binding: AuditEventSubType (example): Specific type of event.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... 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://terminology.hl7.org/CodeSystem/audit-event-type
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: rest
..... display 1..1 string Representation defined by the system
Fixed Value: RESTful Operation
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... action Σ 0..1 code Type of action performed during the event
Binding: AuditEventAction (required): DICOM Audit Event Action
Required Pattern: C
... severity Σ 0..1 code emergency | alert | critical | error | warning | notice | informational | debug
Binding: AuditEventSeverity (required): This is in the SysLog header, PRI. http://tools.ietf.org/html/rfc5424#appendix-A.3
... Slices for occurred[x] 1..1 Period When the activity occurred
Slice: Unordered, Closed by type:$this
.... occurred[x]:occurredPeriod S 1..1 Period Exact execution period (Start/End)
... recorded SΣ 1..1 instant Time when the event was recorded
... outcome Σ 0..1 BackboneElement Whether the event succeeded or failed
.... 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 Σ 1..1 Coding Whether the event succeeded or failed
Binding: AuditEventOutcome (preferred): DICOM Audit Event Outcome
.... detail Σ 0..* CodeableConcept Additional outcome detail
Binding: AuditEventOutcomeDetail (example): A code that provides details as the exact issue.
... authorization Σ 0..* CodeableConcept Authorization related to the event
Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
... basedOn 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task) Workflow authorization within which this event occurred
... patient 0..1 Reference(Patient) The patient is the subject of the data used/created/updated/deleted during the activity
... encounter 0..1 Reference(Encounter) Encounter within which this event occurred or which the event is tightly associated
... agent SΣ 1..* BackboneElement Actor involved in the event
.... 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
.... type 0..1 CodeableConcept How agent participated
Binding: ParticipationRoleType (preferred): The Participation type of the agent to the event.
.... role 0..* CodeableConcept Agent role in the event
Binding: SecurityRoleType (example): What security role enabled the agent to participate in the event.
.... who Σ 1..1 Reference(EU AI System Device) Identifier of who
.... requestor Σ 0..1 boolean Whether user is initiator
Required Pattern: false
.... location 0..1 Reference(Location) The agent location when the event occurred
.... policy 0..* uri Policy that authorized the agent participation in the event
.... network[x] 0..1 This agent network location for the activity
..... networkReference Reference(Endpoint)
..... networkUri uri
..... networkString string
.... authorization 0..* CodeableConcept Allowable authorization for this agent
Binding: PurposeOfUse (example): The reason the activity took place.
... source SΣ 1..1 BackboneElement Audit Event Reporter
.... 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
.... site 0..1 Reference(Location) Logical source location within the enterprise
.... observer Σ 1..1 Reference(EU AI System Device) The identity of source detecting the event
.... type 0..* CodeableConcept The type of source where event originated
Binding: AuditEventSourceType (preferred): Code specifying the type of system that detected and recorded the event. Use of these codes is not required but is encouraged to maintain translation with DICOM AuditMessage schema.
... Slices for entity Σ 2..* BackboneElement Data or objects used
Slice: Unordered, Open by value:role
.... entity:All Slices Content/Rules for all slices
..... 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
..... what Σ 0..1 Reference(Resource) Specific instance of resource
..... role 0..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent
.... entity:inputData SΣ 1..* BackboneElement Input Data Processed
..... 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
..... what Σ 0..1 Reference(Resource) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 4
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent
.... entity:referenceDb Σ 0..* BackboneElement Identification of specific reference databases or versions (e.g., Clinical Guidelines)
..... 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
..... what Σ 0..1 Reference(Resource) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 17
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent
.... entity:outputData SΣ 1..* BackboneElement The resulting AI-generated Observation
..... 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
..... what Σ 0..1 Reference(EU AI Generated Observation) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 3
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AuditEvent.language Base required All Languages 📍5.0.0 FHIR Std.
AuditEvent.category Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.code Base example Audit Event Sub-Type 📍5.0.0 FHIR Std.
AuditEvent.action Base required Audit Event Action 📍5.0.0 FHIR Std.
AuditEvent.severity Base required Audit Event Severity 📍5.0.0 FHIR Std.
AuditEvent.outcome.code Base preferred Audit Event Outcome 📍5.0.0 FHIR Std.
AuditEvent.outcome.detail Base example Audit Event Outcome Detail 📍5.0.0 FHIR Std.
AuditEvent.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
AuditEvent.agent.type Base preferred Participation Role Type 📍5.0.0 FHIR Std.
AuditEvent.agent.role Base example Security Role Type 📍5.0.0 FHIR Std.
AuditEvent.agent.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
AuditEvent.source.type Base preferred Audit Event Source Type 📍5.0.0 FHIR Std.
AuditEvent.entity.role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity.securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity.detail.​type Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​detail.type Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​detail.type Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​detail.type Base example Audit Event ID 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AuditEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AuditEvent 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 AuditEvent 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 AuditEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AuditEvent 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()

This structure is derived from AuditEvent

Summary

Mandatory: 8 elements(1 nested mandatory element)
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 AuditEvent.occurred[x]
  • The element 1 is sliced based on the value of AuditEvent.entity

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AuditEvent 0..* AuditEvent Record of an event
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:logIntegrity S 1..1 Signature Cryptographic signature of this log entry
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity
... code Σ 1..1 CodeableConcept Specific type of event
Binding: AuditEventSubType (example): Specific type of event.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... 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://terminology.hl7.org/CodeSystem/audit-event-type
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: rest
..... display 1..1 string Representation defined by the system
Fixed Value: RESTful Operation
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... action Σ 0..1 code Type of action performed during the event
Binding: AuditEventAction (required): DICOM Audit Event Action
Required Pattern: C
... Slices for occurred[x] 1..1 Period When the activity occurred
Slice: Unordered, Closed by type:$this
.... occurred[x]:occurredPeriod S 1..1 Period Exact execution period (Start/End)
... recorded SΣ 1..1 instant Time when the event was recorded
... agent SΣ 1..* BackboneElement Actor involved in the event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... who Σ 1..1 Reference(EU AI System Device) Identifier of who
.... requestor Σ 0..1 boolean Whether user is initiator
Required Pattern: false
... source SΣ 1..1 BackboneElement Audit Event Reporter
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... observer Σ 1..1 Reference(EU AI System Device) The identity of source detecting the event
... Slices for entity Σ 2..* BackboneElement Data or objects used
Slice: Unordered, Open by value:role
.... entity:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... entity:inputData SΣ 1..* BackboneElement Input Data Processed
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 4
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
.... entity:referenceDb Σ 0..* BackboneElement Identification of specific reference databases or versions (e.g., Clinical Guidelines)
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 17
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
.... entity:outputData SΣ 1..* BackboneElement The resulting AI-generated Observation
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... what Σ 0..1 Reference(EU AI Generated Observation) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 3
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AuditEvent.code Base example Audit Event Sub-Type 📍5.0.0 FHIR Std.
AuditEvent.action Base required Audit Event Action 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AuditEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AuditEvent 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 AuditEvent 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 AuditEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AuditEvent 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()

Differential View

This structure is derived from AuditEvent

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AuditEvent 0..* AuditEvent Record of an event
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:logIntegrity S 1..1 Signature Cryptographic signature of this log entry
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity
... code 1..1 CodeableConcept Specific type of event
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/audit-event-type
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: rest
..... display 1..1 string Representation defined by the system
Fixed Value: RESTful Operation
... action 0..1 code Type of action performed during the event
Required Pattern: C
.... occurred[x]:occurredPeriod S 1..1 Period Exact execution period (Start/End)
... recorded S 1..1 instant Time when the event was recorded
... agent S 1..* BackboneElement Actor involved in the event
.... who 1..1 Reference(EU AI System Device) Identifier of who
.... requestor 0..1 boolean Whether user is initiator
Required Pattern: false
... source S 1..1 BackboneElement Audit Event Reporter
.... observer 1..1 Reference(EU AI System Device) The identity of source detecting the event
... Slices for entity 2..* BackboneElement Data or objects used
Slice: Unordered, Open by value:role
.... entity:inputData S 1..* BackboneElement Input Data Processed
..... role 1..1 CodeableConcept What role the entity played
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/object-role
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 4
.... entity:referenceDb 0..* BackboneElement Identification of specific reference databases or versions (e.g., Clinical Guidelines)
..... role 1..1 CodeableConcept What role the entity played
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/object-role
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 17
.... entity:outputData S 1..* BackboneElement The resulting AI-generated Observation
..... what 0..1 Reference(EU AI Generated Observation) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/object-role
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 3

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AuditEvent 0..* AuditEvent Record of an event
... 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
... 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 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:logIntegrity S 1..1 Signature Cryptographic signature of this log entry
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-log-integrity
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... category Σ 0..* CodeableConcept Type/identifier of event
Binding: AuditEventID (example): Type of event.
... code Σ 1..1 CodeableConcept Specific type of event
Binding: AuditEventSubType (example): Specific type of event.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... 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://terminology.hl7.org/CodeSystem/audit-event-type
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: rest
..... display 1..1 string Representation defined by the system
Fixed Value: RESTful Operation
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... action Σ 0..1 code Type of action performed during the event
Binding: AuditEventAction (required): DICOM Audit Event Action
Required Pattern: C
... severity Σ 0..1 code emergency | alert | critical | error | warning | notice | informational | debug
Binding: AuditEventSeverity (required): This is in the SysLog header, PRI. http://tools.ietf.org/html/rfc5424#appendix-A.3
... Slices for occurred[x] 1..1 Period When the activity occurred
Slice: Unordered, Closed by type:$this
.... occurred[x]:occurredPeriod S 1..1 Period Exact execution period (Start/End)
... recorded SΣ 1..1 instant Time when the event was recorded
... outcome Σ 0..1 BackboneElement Whether the event succeeded or failed
.... 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 Σ 1..1 Coding Whether the event succeeded or failed
Binding: AuditEventOutcome (preferred): DICOM Audit Event Outcome
.... detail Σ 0..* CodeableConcept Additional outcome detail
Binding: AuditEventOutcomeDetail (example): A code that provides details as the exact issue.
... authorization Σ 0..* CodeableConcept Authorization related to the event
Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
... basedOn 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task) Workflow authorization within which this event occurred
... patient 0..1 Reference(Patient) The patient is the subject of the data used/created/updated/deleted during the activity
... encounter 0..1 Reference(Encounter) Encounter within which this event occurred or which the event is tightly associated
... agent SΣ 1..* BackboneElement Actor involved in the event
.... 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
.... type 0..1 CodeableConcept How agent participated
Binding: ParticipationRoleType (preferred): The Participation type of the agent to the event.
.... role 0..* CodeableConcept Agent role in the event
Binding: SecurityRoleType (example): What security role enabled the agent to participate in the event.
.... who Σ 1..1 Reference(EU AI System Device) Identifier of who
.... requestor Σ 0..1 boolean Whether user is initiator
Required Pattern: false
.... location 0..1 Reference(Location) The agent location when the event occurred
.... policy 0..* uri Policy that authorized the agent participation in the event
.... network[x] 0..1 This agent network location for the activity
..... networkReference Reference(Endpoint)
..... networkUri uri
..... networkString string
.... authorization 0..* CodeableConcept Allowable authorization for this agent
Binding: PurposeOfUse (example): The reason the activity took place.
... source SΣ 1..1 BackboneElement Audit Event Reporter
.... 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
.... site 0..1 Reference(Location) Logical source location within the enterprise
.... observer Σ 1..1 Reference(EU AI System Device) The identity of source detecting the event
.... type 0..* CodeableConcept The type of source where event originated
Binding: AuditEventSourceType (preferred): Code specifying the type of system that detected and recorded the event. Use of these codes is not required but is encouraged to maintain translation with DICOM AuditMessage schema.
... Slices for entity Σ 2..* BackboneElement Data or objects used
Slice: Unordered, Open by value:role
.... entity:All Slices Content/Rules for all slices
..... 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
..... what Σ 0..1 Reference(Resource) Specific instance of resource
..... role 0..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent
.... entity:inputData SΣ 1..* BackboneElement Input Data Processed
..... 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
..... what Σ 0..1 Reference(Resource) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 4
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent
.... entity:referenceDb Σ 0..* BackboneElement Identification of specific reference databases or versions (e.g., Clinical Guidelines)
..... 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
..... what Σ 0..1 Reference(Resource) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 17
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent
.... entity:outputData SΣ 1..* BackboneElement The resulting AI-generated Observation
..... 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
..... what Σ 0..1 Reference(EU AI Generated Observation) Specific instance of resource
..... role 1..1 CodeableConcept What role the entity played
Binding: AuditEventEntityRole (example): DICOM Audit Event Entity Role
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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://terminology.hl7.org/CodeSystem/object-role
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 3
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... securityLabel 0..* CodeableConcept Security labels on the entity
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
..... query Σ 0..1 base64Binary Query parameters
..... detail 0..* BackboneElement Additional Information about the entity
...... 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
...... type 1..1 CodeableConcept Name of the property
Binding: AuditEventID (example): Additional detail about an entity used in an event.
...... value[x] 1..1 Property value
....... valueQuantity Quantity
....... valueCodeableConcept CodeableConcept
....... valueString string
....... valueBoolean boolean
....... valueInteger integer
....... valueRange Range
....... valueRatio Ratio
....... valueTime time
....... valueDateTime dateTime
....... valuePeriod Period
....... valueBase64Binary base64Binary
..... agent 0..* See agent (AuditEvent) Entity is attributed to this agent

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AuditEvent.language Base required All Languages 📍5.0.0 FHIR Std.
AuditEvent.category Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.code Base example Audit Event Sub-Type 📍5.0.0 FHIR Std.
AuditEvent.action Base required Audit Event Action 📍5.0.0 FHIR Std.
AuditEvent.severity Base required Audit Event Severity 📍5.0.0 FHIR Std.
AuditEvent.outcome.code Base preferred Audit Event Outcome 📍5.0.0 FHIR Std.
AuditEvent.outcome.detail Base example Audit Event Outcome Detail 📍5.0.0 FHIR Std.
AuditEvent.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
AuditEvent.agent.type Base preferred Participation Role Type 📍5.0.0 FHIR Std.
AuditEvent.agent.role Base example Security Role Type 📍5.0.0 FHIR Std.
AuditEvent.agent.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
AuditEvent.source.type Base preferred Audit Event Source Type 📍5.0.0 FHIR Std.
AuditEvent.entity.role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity.securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity.detail.​type Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity:inputData.​detail.type Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity:referenceDb.​detail.type Base example Audit Event ID 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​role Base example Audit Event Entity Role 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
AuditEvent.entity:outputData.​detail.type Base example Audit Event ID 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AuditEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AuditEvent 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 AuditEvent 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 AuditEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AuditEvent 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()

This structure is derived from AuditEvent

Summary

Mandatory: 8 elements(1 nested mandatory element)
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 AuditEvent.occurred[x]
  • The element 1 is sliced based on the value of AuditEvent.entity

 

Other representations of profile: CSV, Excel, Schematron