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_AIAuditEvent - Detailed Descriptions

Draft as of 2026-07-31

Definitions for the eu-ai-machine-execution-audit-event resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. AuditEvent
Definition

A record of an event relevant for purposes such as operations, privacy, security, maintenance, and performance analysis.

ShortRecord of an event
Comments

Based on IHE-ATNA.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AuditEvent.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AuditEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. AuditEvent.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on AuditEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. AuditEvent.extension:logIntegrity
    Slice NamelogIntegrity
    Definition

    Provides a digital signature and associated metadata to support verification of the integrity and origin of the AI execution audit record.

    ShortCryptographic signature of this log entry
    Control0..1
    TypeExtension(EU AI Log Integrity Signature) (Extension Type: Signature)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    10. AuditEvent.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Must Supportfalse
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    12. AuditEvent.code
    Definition

    Describes what happened. The most specific code for the event.

    ShortSpecific type of event
    Control1..1
    BindingFor example codes, see AuditEventSubTypehttp://hl7.org/fhir/ValueSet/audit-event-sub-type|5.0.0
    (example to http://hl7.org/fhir/ValueSet/audit-event-sub-type|5.0.0)

    Specific type of event.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    This field enables queries of messages by implementation-defined event categories.

    Alternate Namessubtype
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. AuditEvent.occurred[x]
    Definition

    The time or period during which the activity occurred.

    ShortWhen the activity occurred
    Comments

    The time or period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time.

    Control0..1
    TypePeriod, dateTime
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. AuditEvent.occurred[x].start
    Definition

    The start of the period. The boundary is inclusive.

    ShortStarting time with inclusive boundary
    Comments

    If the low element is missing, the meaning is that the low boundary is not known.

    Control10..1
    This element is affected by the following invariants: per-1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. AuditEvent.occurred[x].end
    Definition

    The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

    ShortEnd time with inclusive boundary, if not ongoing
    Comments

    The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

    Control10..1
    This element is affected by the following invariants: per-1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. AuditEvent.recorded
    Definition

    The time when the event was recorded.

    ShortTime when the event was recorded
    Comments

    In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic.

    Control1..1
    Typeinstant
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    This ties an event to a specific date and time. Security audits typically require a consistent time base (e.g. UTC), to eliminate time-zone issues arising from geographical distribution.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. AuditEvent.agent
    Definition

    An actor taking an active role in the event or activity that is logged.

    ShortActor involved in the event
    Comments

    Several agents may be associated (i.e. have some responsibility for an activity) with an event or activity.

    For example, an activity may be initiated by one user for other users or involve more than one user. However, only one user may be the initiator/requestor for the activity.

    When a network are used in an event being recorded, there should be distinct agent elements for the known actors using the network. The agent with a network detail would be the responsible agent for use of that network.

    Control1..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility.

    Alternate NamesActiveParticipant
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. AuditEvent.agent.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    26. AuditEvent.agent.who
    Definition

    Reference to who this agent is that was involved in the event.

    ShortAI system that performed the processing activityIdentifier of who
    Comments

    Where a User ID is available it will go into who.identifier. Where a name of the user (human readable) it will go into who.display.

    Control1..1
    TypeReference(EU AI System Device, Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    This field ties an audit event to a specific resource or identifier.

    Alternate NamesuserId
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. AuditEvent.source
    Definition

    The actor that is reporting the event.

    ShortAudit Event Reporter
    Comments

    Events are reported by the actor that detected them. This may be one of the participating actors, but may also be different. The actor may be a human such as a medical-records clerk disclosing data manually, that clerk would be the source for the record of disclosure.

    Control1..1
    TypeBackboneElement
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    The event is reported by one source.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. AuditEvent.source.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    32. AuditEvent.source.observer
    Definition

    Identifier of the source where the event was detected.

    ShortAI system that generated this audit recordThe identity of source detecting the event
    Control1..1
    TypeReference(EU AI System Device, Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    This field ties the event to a specific source system. It may be used to group events for analysis according to where the event was detected.

    Alternate NamesSourceId
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. AuditEvent.entity
    Definition

    Specific instances of data or objects that have been accessed.

    ShortData or objects used
    Comments

    Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

    Control10..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    The event may have other entities involved.

    Alternate NamesParticipantObject
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on AuditEvent.entity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ role
    • 36. AuditEvent.entity.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      38. AuditEvent.entity:referenceDb
      Slice NamereferenceDb
      Definition

      Specific instances of data or objects that have been accessed.

      ShortReference database or knowledge source used by the AI systemData or objects used
      Comments

      Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      The event may have other entities involved.

      Alternate NamesParticipantObject
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. AuditEvent.entity:referenceDb.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      42. AuditEvent.entity:referenceDb.what
      Definition

      Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

      ShortSpecific instance of resource
      Comments

      Use .what.display when all you have is a string (e.g. ParticipantObjectName).

      Control10..1
      TypeReference(Resource)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. AuditEvent.entity:referenceDb.role
      Definition

      Code representing the role the entity played in the event being audited.

      ShortWhat role the entity played
      Control10..1
      BindingFor example codes, see AuditEventEntityRolehttp://hl7.org/fhir/ValueSet/object-role|5.0.0
      (example to http://hl7.org/fhir/ValueSet/object-role|5.0.0)

      DICOM Audit Event Entity Role

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

      For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.

      Pattern Value{
        "coding" : [{
          "system" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-audit-entity-role",
          "code" : "reference-database"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. AuditEvent.entity:outputData
      Slice NameoutputData
      Definition

      Specific instances of data or objects that have been accessed.

      ShortA FHIR resource representing an output generated by the AI system during the audited executionData or objects used
      Comments

      Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

      Control10..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      The event may have other entities involved.

      Alternate NamesParticipantObject
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. AuditEvent.entity:outputData.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      50. AuditEvent.entity:outputData.what
      Definition

      Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

      ShortSpecific instance of resource
      Comments

      Use .what.display when all you have is a string (e.g. ParticipantObjectName).

      Control10..1
      TypeReference(Resource)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. AuditEvent.entity:outputData.role
      Definition

      Code representing the role the entity played in the event being audited.

      ShortWhat role the entity played
      Control10..1
      BindingFor example codes, see AuditEventEntityRolehttp://hl7.org/fhir/ValueSet/object-role|5.0.0
      (example to http://hl7.org/fhir/ValueSet/object-role|5.0.0)

      DICOM Audit Event Entity Role

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

      For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.

      Pattern Value{
        "coding" : [{
          "system" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-audit-entity-role",
          "code" : "ai-output"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

      Guidance on how to interpret the contents of this table can be foundhere

      0. AuditEvent
      2. AuditEvent.extension
      SlicingThis element introduces a set of slices on AuditEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 4. AuditEvent.extension:logIntegrity
        Slice NamelogIntegrity
        ShortCryptographic signature of this log entry
        Control0..1
        TypeExtension(EU AI Log Integrity Signature) (Extension Type: Signature)
        Must Supporttrue
        6. AuditEvent.occurred[x]
        TypePeriod, dateTime
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        8. AuditEvent.occurred[x].start
        Control1..?
        Must Supporttrue
        10. AuditEvent.occurred[x].end
        Control1..?
        Must Supporttrue
        12. AuditEvent.recorded
        Must Supporttrue
        14. AuditEvent.agent
        Must Supporttrue
        16. AuditEvent.agent.who
        ShortAI system that performed the processing activity
        TypeReference(EU AI System Device)
        18. AuditEvent.source
        Must Supporttrue
        20. AuditEvent.source.observer
        ShortAI system that generated this audit record
        TypeReference(EU AI System Device)
        22. AuditEvent.entity
        Control1..?
        SlicingThis element introduces a set of slices on AuditEvent.entity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ role
        • 24. AuditEvent.entity:referenceDb
          Slice NamereferenceDb
          ShortReference database or knowledge source used by the AI system
          Control0..*
          Must Supporttrue
          26. AuditEvent.entity:referenceDb.what
          Control1..?
          28. AuditEvent.entity:referenceDb.role
          Control1..?
          Pattern Value{
            "coding" : [{
              "system" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-audit-entity-role",
              "code" : "reference-database"
            }]
          }
          30. AuditEvent.entity:outputData
          Slice NameoutputData
          ShortA FHIR resource representing an output generated by the AI system during the audited execution
          Control1..*
          Must Supporttrue
          32. AuditEvent.entity:outputData.what
          Control1..?
          34. AuditEvent.entity:outputData.role
          Control1..?
          Pattern Value{
            "coding" : [{
              "system" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-audit-entity-role",
              "code" : "ai-output"
            }]
          }

          Guidance on how to interpret the contents of this table can be foundhere

          0. AuditEvent
          Definition

          A record of an event relevant for purposes such as operations, privacy, security, maintenance, and performance analysis.

          ShortRecord of an event
          Comments

          Based on IHE-ATNA.

          Control0..*
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          2. AuditEvent.id
          Definition

          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

          ShortLogical id of this artifact
          Comments

          Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

          Control0..1
          Typeid
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          4. AuditEvent.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. AuditEvent.implicitRules
          Definition

          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

          ShortA set of rules under which this content was created
          Comments

          Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

          Control0..1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          8. AuditEvent.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

          Control0..1
          BindingThe codes SHALL be taken from AllLanguages
          (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

          IETF language tag for a human language

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. AuditEvent.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

          Control0..1
          This element is affected by the following invariants: dom-6
          TypeNarrative
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. AuditEvent.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

          ShortContained, inline Resources
          Comments

          This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

          Control0..*
          This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
          TypeResource
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          14. AuditEvent.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          TypeExtension
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on AuditEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 16. AuditEvent.extension:logIntegrity
            Slice NamelogIntegrity
            Definition

            Provides a digital signature and associated metadata to support verification of the integrity and origin of the AI execution audit record.

            ShortCryptographic signature of this log entry
            Control0..1
            TypeExtension(EU AI Log Integrity Signature) (Extension Type: Signature)
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            18. AuditEvent.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
            Must Supportfalse
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            20. AuditEvent.category
            Definition

            Classification of the type of event.

            ShortType/identifier of event
            Control0..*
            BindingFor example codes, see AuditEventID
            (example to http://hl7.org/fhir/ValueSet/audit-event-type|5.0.0)

            Type of event.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Requirements

            Codes that classify the general type of event that happened.

            Alternate Namestype
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            22. AuditEvent.code
            Definition

            Describes what happened. The most specific code for the event.

            ShortSpecific type of event
            Control1..1
            BindingFor example codes, see AuditEventSubType
            (example to http://hl7.org/fhir/ValueSet/audit-event-sub-type|5.0.0)

            Specific type of event.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Requirements

            This field enables queries of messages by implementation-defined event categories.

            Alternate Namessubtype
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            24. AuditEvent.action
            Definition

            Indicator for type of action performed during the event that generated the audit.

            ShortType of action performed during the event
            Control0..1
            BindingThe codes SHALL be taken from AuditEventAction
            (required to http://hl7.org/fhir/ValueSet/audit-event-action|5.0.0)

            DICOM Audit Event Action

            Typecode
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Requirements

            This broadly indicates what kind of action was done on the AuditEvent.entity by the AuditEvent.agent.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. AuditEvent.severity
            Definition

            Indicates and enables segmentation of various severity including debugging from critical.

            Shortemergency | alert | critical | error | warning | notice | informational | debug
            Comments

            ATNA will map this to the SYSLOG PRI element.

            Control0..1
            BindingThe codes SHALL be taken from AuditEventSeverity
            (required to http://hl7.org/fhir/ValueSet/audit-event-severity|5.0.0)

            This is in the SysLog header, PRI. http://tools.ietf.org/html/rfc5424#appendix-A.3

            Typecode
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            28. AuditEvent.occurred[x]
            Definition

            The time or period during which the activity occurred.

            ShortWhen the activity occurred
            Comments

            The time or period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time.

            Control0..1
            TypePeriod
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            30. AuditEvent.occurred[x].id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            This element is affected by the following invariants: ele-1
            Typeid
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            32. AuditEvent.occurred[x].extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortAdditional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on AuditEvent.occurred[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 34. AuditEvent.occurred[x].start
              Definition

              The start of the period. The boundary is inclusive.

              ShortStarting time with inclusive boundary
              Comments

              If the low element is missing, the meaning is that the low boundary is not known.

              Control1..1
              This element is affected by the following invariants: per-1
              TypedateTime
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              36. AuditEvent.occurred[x].end
              Definition

              The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

              ShortEnd time with inclusive boundary, if not ongoing
              Comments

              The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

              Control1..1
              This element is affected by the following invariants: per-1
              TypedateTime
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              38. AuditEvent.recorded
              Definition

              The time when the event was recorded.

              ShortTime when the event was recorded
              Comments

              In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic.

              Control1..1
              Typeinstant
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              This ties an event to a specific date and time. Security audits typically require a consistent time base (e.g. UTC), to eliminate time-zone issues arising from geographical distribution.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              40. AuditEvent.outcome
              Definition

              Indicates whether the event succeeded or failed. A free text descripiton can be given in outcome.text.

              ShortWhether the event succeeded or failed
              Comments

              In some cases a "success" may be partial, for example, an incomplete or interrupted transfer of a radiological study. For the purpose of establishing accountability, these distinctions are not relevant.

              Control0..1
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

              when a code is given there must be one code from the given codeSystem, and may be other equivilant codes from other codeSystems (for example http response codes such as 2xx, 4xx, or 5xx).

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. AuditEvent.outcome.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              44. AuditEvent.outcome.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              46. AuditEvent.outcome.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              48. AuditEvent.outcome.code
              Definition

              Indicates whether the event succeeded or failed.

              ShortWhether the event succeeded or failed
              Comments

              In some cases a "success" may be partial, for example, an incomplete or interrupted transfer of a radiological study. For the purpose of establishing accountability, these distinctions are not relevant.

              Control1..1
              BindingThe codes SHOULD be taken from AuditEventOutcome
              (preferred to http://hl7.org/fhir/ValueSet/audit-event-outcome|5.0.0)

              DICOM Audit Event Outcome

              TypeCoding
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

              when a code is given there must be one code from the given codeSystem.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              50. AuditEvent.outcome.detail
              Definition

              Additional details about the error. This may be a text description of the error or a system code that identifies the error.

              ShortAdditional outcome detail
              Comments

              A human readable description of the error issue SHOULD be placed in details.text.

              Control0..*
              BindingFor example codes, see AuditEventOutcomeDetail
              (example to http://hl7.org/fhir/ValueSet/audit-event-outcome-detail|5.0.0)

              A code that provides details as the exact issue.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              52. AuditEvent.authorization
              Definition

              The authorization (e.g., PurposeOfUse) that was used during the event being recorded.

              ShortAuthorization related to the event
              Comments

              Use AuditEvent.agent.authorization when you know that it is specific to the agent, otherwise use AuditEvent.authorization. For example, during a machine-to-machine transfer it might not be obvious to the audit system who caused the event, but it does know why.

              Control0..*
              BindingFor example codes, see PurposeOfUse
              (example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

              The authorized purposeOfUse for the activity.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

              Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

              Alternate NamesPurposeOfEvent
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              54. AuditEvent.basedOn
              Definition

              Allows tracing of authorizatino for the events and tracking whether proposals/recommendations were acted upon.

              ShortWorkflow authorization within which this event occurred
              Control0..*
              TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest, Task)
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              56. AuditEvent.patient
              Definition

              The patient element is available to enable deterministic tracking of activities that involve the patient as the subject of the data used in an activity.

              ShortThe patient is the subject of the data used/created/updated/deleted during the activity
              Control0..1
              TypeReference(Patient)
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              When the .patient is populated it shall be accurate to the subject of the used data. The .patient shall not be populated when the used data used/created/updated/deleted (.entity) by the activity does not involve a subject. Note that when the patient is an agent, they will be recorded as an agent. When the Patient resource is Created, Updated, or Deleted it will be recorded as an entity.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              58. AuditEvent.encounter
              Definition

              This will typically be the encounter the event occurred, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission lab tests).

              ShortEncounter within which this event occurred or which the event is tightly associated
              Control0..1
              TypeReference(Encounter)
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              60. AuditEvent.agent
              Definition

              An actor taking an active role in the event or activity that is logged.

              ShortActor involved in the event
              Comments

              Several agents may be associated (i.e. have some responsibility for an activity) with an event or activity.

              For example, an activity may be initiated by one user for other users or involve more than one user. However, only one user may be the initiator/requestor for the activity.

              When a network are used in an event being recorded, there should be distinct agent elements for the known actors using the network. The agent with a network detail would be the responsible agent for use of that network.

              Control1..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Requirements

              An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility.

              Alternate NamesActiveParticipant
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              62. AuditEvent.agent.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              64. AuditEvent.agent.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              66. AuditEvent.agent.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              68. AuditEvent.agent.type
              Definition

              The Functional Role of the user when performing the event.

              ShortHow agent participated
              Comments

              For example: assembler, author, prescriber, signer, investigator, etc.

              Control0..1
              BindingThe codes SHOULD be taken from ParticipationRoleType
              (preferred to http://hl7.org/fhir/ValueSet/participation-role-type|5.0.0)

              The Participation type of the agent to the event.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              Functional roles reflect functional aspects of relationships between entities. Functional roles are bound to the realization/performance of acts, where actions might be concatenated to an activity or even to a process. This element will hold the functional role that the agent played in the activity that is the focus of this Provenance. Where an agent played multiple functional roles, they will be listed as multiple .agent elements representing each functional participation. See ISO 21298:2018 - Health Informatics - Functional and structural roles, and ISO 22600-2:2014 - Health Informatics - Privilege Management and Access Control - Part 2: formal models.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              70. AuditEvent.agent.role
              Definition

              The structural roles of the agent indicating the agent's competency. The security role enabling the agent with respect to the activity.

              ShortAgent role in the event
              Comments

              For example: Chief-of-Radiology, Nurse, Physician, Medical-Student, etc.

              Control0..*
              BindingFor example codes, see SecurityRoleType
              (example to http://hl7.org/fhir/ValueSet/security-role-type|5.0.0)

              What security role enabled the agent to participate in the event.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              Structural roles reflect the structural aspects of relationships between entities. Structural roles describe prerequisites, feasibilities, or competences for acts. Functional roles reflect functional aspects of relationships between entities. Functional roles are bound to the realization/performance of acts, where actions might be concatenated to an activity or even to a process. See ISO 21298:2018 - Health Informatics - Functional and structural roles, and ISO 22600-2:2014 - Health Informatics - Privilege Management and Access Control - Part 2: formal models..

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              72. AuditEvent.agent.who
              Definition

              Reference to who this agent is that was involved in the event.

              ShortAI system that performed the processing activity
              Comments

              Where a User ID is available it will go into who.identifier. Where a name of the user (human readable) it will go into who.display.

              Control1..1
              TypeReference(EU AI System Device)
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

              This field ties an audit event to a specific resource or identifier.

              Alternate NamesuserId
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              74. AuditEvent.agent.requestor
              Definition

              Indicator that the user is or is not the requestor, or initiator, for the event being audited.

              ShortWhether user is initiator
              Comments

              There can only be one initiator. If the initiator is not clear, then do not choose any one agent as the initiator.

              Control0..1
              Typeboolean
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summarytrue
              Requirements

              This value is used to distinguish between requestor-users and recipient-users. For example, one person may initiate a report-output to be sent to another user.

              Meaning if Missingfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              76. AuditEvent.agent.location
              Definition

              Where the agent location is known, the agent location when the event occurred.

              ShortThe agent location when the event occurred
              Control0..1
              TypeReference(Location)
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              78. AuditEvent.agent.policy
              Definition

              Where the policy(ies) are known that authorized the agent participation in the event. Typically, a single activity may have multiple applicable policies, such as patient consent, guarantor funding, etc. The policy would also indicate the security token used.

              ShortPolicy that authorized the agent participation in the event
              Comments

              For example: Where an OAuth token authorizes, the unique identifier from the OAuth token is placed into the policy element Where a policy engine (e.g. XACML) holds policy logic, the unique policy identifier is placed into the policy element.

              Control0..*
              Typeuri
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Requirements

              This value is used retrospectively to determine the authorization policies.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              80. AuditEvent.agent.network[x]
              Definition

              When the event utilizes a network there should be an agent describing the local system, and an agent describing remote system, with the network interface details.

              ShortThis agent network location for the activity
              Comments

              When remote network endpoint is known, another agent representing the remote agent would indicate the remote network endpoint used. Convention is to indicate data flowing from Source to Destination. The convention for Search, given data flows both ways (query parameters vs results), is to have the Source as the initiator of the Search Transaction, and the Destination the responder to the Search transaction.

              Control0..1
              TypeChoice of: Reference(Endpoint), uri, string
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Requirements

              When a network protocol is used the endpoint is associated with the agent most directly using the endpoint. This is usually the software agent that has implemented the application level protocol. Preference is to define network in terms of a Reference(Endpoint), or URI; use string only when address or hostname is all that is known. When encoding using string it is best to encode using the formal canonical host name, but if you can't, then you can encode numeric in Literal address form using square brackets '[]' as a v4 string (in dotted notation), or v6 string (in colon notation).

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              82. AuditEvent.agent.authorization
              Definition

              The authorization (e.g., PurposeOfUse) that was used during the event being recorded.

              ShortAllowable authorization for this agent
              Comments

              Use AuditEvent.agent.authorization when you know that is specific to the agent, otherwise use AuditEvent.authorization. For example, during a machine-to-machine transfer it might not be obvious to the audit system who caused the event, but it does know why.

              Control0..*
              BindingFor example codes, see PurposeOfUse
              (example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

              The reason the activity took place.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

              Alternate NamesPurposeOfUse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              84. AuditEvent.source
              Definition

              The actor that is reporting the event.

              ShortAudit Event Reporter
              Comments

              Events are reported by the actor that detected them. This may be one of the participating actors, but may also be different. The actor may be a human such as a medical-records clerk disclosing data manually, that clerk would be the source for the record of disclosure.

              Control1..1
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Requirements

              The event is reported by one source.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              86. AuditEvent.source.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              88. AuditEvent.source.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              90. AuditEvent.source.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              92. AuditEvent.source.site
              Definition

              Logical source location within the healthcare enterprise network. For example, a hospital or other provider location within a multi-entity provider group.

              ShortLogical source location within the enterprise
              Control0..1
              TypeReference(Location)
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              This value differentiates among the sites in a multi-site enterprise health information system.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              94. AuditEvent.source.observer
              Definition

              Identifier of the source where the event was detected.

              ShortAI system that generated this audit record
              Control1..1
              TypeReference(EU AI System Device)
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

              This field ties the event to a specific source system. It may be used to group events for analysis according to where the event was detected.

              Alternate NamesSourceId
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              96. AuditEvent.source.type
              Definition

              Code specifying the type of source where event originated.

              ShortThe type of source where event originated
              Control0..*
              BindingThe codes SHOULD be taken from AuditEventSourceType
              (preferred to http://hl7.org/fhir/ValueSet/security-source-type|5.0.0)

              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.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              This field indicates which type of source is identified by the Audit Source ID. It is an optional value that may be used to group events for analysis according to the type of source where the event occurred.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              98. AuditEvent.entity
              Definition

              Specific instances of data or objects that have been accessed.

              ShortData or objects used
              Comments

              Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

              Control1..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

              The event may have other entities involved.

              Alternate NamesParticipantObject
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on AuditEvent.entity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ role
              • 100. AuditEvent.entity.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                102. AuditEvent.entity.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                104. AuditEvent.entity.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                106. AuditEvent.entity.what
                Definition

                Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

                ShortSpecific instance of resource
                Comments

                Use .what.display when all you have is a string (e.g. ParticipantObjectName).

                Control0..1
                TypeReference(Resource)
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                108. AuditEvent.entity.role
                Definition

                Code representing the role the entity played in the event being audited.

                ShortWhat role the entity played
                Control0..1
                BindingFor example codes, see AuditEventEntityRole
                (example to http://hl7.org/fhir/ValueSet/object-role|5.0.0)

                DICOM Audit Event Entity Role

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                110. AuditEvent.entity.securityLabel
                Definition

                Security labels for the identified entity.

                ShortSecurity labels on the entity
                Comments

                Copied from entity meta security tags.

                Control0..*
                BindingFor example codes, see SecurityLabelExamples
                (example to http://hl7.org/fhir/ValueSet/security-label-examples|5.0.0)

                Example Security Labels from the Healthcare Privacy and Security Classification System.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. AuditEvent.entity.query
                Definition

                The query parameters for a query-type entities.

                ShortQuery parameters
                Comments

                The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, and AuditEvent.entity.role. The base64 is a general-use and safe container for event specific data blobs regardless of the encoding used by the transaction being recorded. An AuditEvent consuming application must understand the event it is consuming and the formats used by the event. For example, if auditing an Oracle network database access, the Oracle formats must be understood as they will be simply encoded in the base64binary blob.

                The DICOM AuditMessage schema does not support both .name and .query being populated.

                Control0..1
                Typebase64Binary
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Requirements

                For query events, it may be necessary to capture the actual query input to the query process in order to identify the specific event. Because of differences among query implementations and data encoding for them, this is a base 64 encoded data blob. It may be subsequently decoded or interpreted by downstream audit analysis processing.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                114. AuditEvent.entity.detail
                Definition

                Tagged value pairs for conveying additional information about the entity.

                ShortAdditional Information about the entity
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                Implementation-defined data about specific details of the object accessed or used.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                116. AuditEvent.entity.detail.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                118. AuditEvent.entity.detail.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                120. AuditEvent.entity.detail.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                122. AuditEvent.entity.detail.type
                Definition

                The type of extra detail provided in the value.

                ShortName of the property
                Control1..1
                BindingFor example codes, see AuditEventID
                (example to http://hl7.org/fhir/ValueSet/audit-event-type|5.0.0)

                Additional detail about an entity used in an event.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                124. AuditEvent.entity.detail.value[x]
                Definition

                The value of the extra detail.

                ShortProperty value
                Control1..1
                TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period, base64Binary
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summaryfalse
                Requirements

                Should not duplicate the entity value unless absolutely necessary.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                126. AuditEvent.entity.agent
                Definition

                The entity is attributed to an agent to express the agent's responsibility for that entity in the activity. This is most used to indicate when persistence media (the entity) are used by an agent. For example when importing data from a device, the device would be described in an entity, and the user importing data from that media would be indicated as the entity.agent.

                ShortEntity is attributed to this agent
                Comments

                A usecase where one AuditEvent.entity.agent is used where the Entity that was used in the creation/updating of a target resource, is not in the context of the same custodianship as the target resource, and thus the meaning of AuditEvent.entity.agent is to say that the entity referenced is managed elsewhere and that this Agent provided access to it. This would be similar to where the Entity being referenced is managed outside FHIR, such as through HL7 V2, v3, or XDS. This might be where the Entity being referenced is managed in another FHIR resource server. Thus it explains the provenance of that Entity's use in the context of this AuditEvent activity.

                Control0..*
                TypeSeettp://hl7.org/fhir/StructureDefinition/AuditEvent#AuditEvent.agent
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                128. AuditEvent.entity:referenceDb
                Slice NamereferenceDb
                Definition

                Specific instances of data or objects that have been accessed.

                ShortReference database or knowledge source used by the AI system
                Comments

                Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                The event may have other entities involved.

                Alternate NamesParticipantObject
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                130. AuditEvent.entity:referenceDb.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                132. AuditEvent.entity:referenceDb.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                134. AuditEvent.entity:referenceDb.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                136. AuditEvent.entity:referenceDb.what
                Definition

                Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

                ShortSpecific instance of resource
                Comments

                Use .what.display when all you have is a string (e.g. ParticipantObjectName).

                Control1..1
                TypeReference(Resource)
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                138. AuditEvent.entity:referenceDb.role
                Definition

                Code representing the role the entity played in the event being audited.

                ShortWhat role the entity played
                Control1..1
                BindingFor example codes, see AuditEventEntityRole
                (example to http://hl7.org/fhir/ValueSet/object-role|5.0.0)

                DICOM Audit Event Entity Role

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.

                Pattern Value{
                  "coding" : [{
                    "system" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-audit-entity-role",
                    "code" : "reference-database"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                140. AuditEvent.entity:referenceDb.securityLabel
                Definition

                Security labels for the identified entity.

                ShortSecurity labels on the entity
                Comments

                Copied from entity meta security tags.

                Control0..*
                BindingFor example codes, see SecurityLabelExamples
                (example to http://hl7.org/fhir/ValueSet/security-label-examples|5.0.0)

                Example Security Labels from the Healthcare Privacy and Security Classification System.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                142. AuditEvent.entity:referenceDb.query
                Definition

                The query parameters for a query-type entities.

                ShortQuery parameters
                Comments

                The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, and AuditEvent.entity.role. The base64 is a general-use and safe container for event specific data blobs regardless of the encoding used by the transaction being recorded. An AuditEvent consuming application must understand the event it is consuming and the formats used by the event. For example, if auditing an Oracle network database access, the Oracle formats must be understood as they will be simply encoded in the base64binary blob.

                The DICOM AuditMessage schema does not support both .name and .query being populated.

                Control0..1
                Typebase64Binary
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Requirements

                For query events, it may be necessary to capture the actual query input to the query process in order to identify the specific event. Because of differences among query implementations and data encoding for them, this is a base 64 encoded data blob. It may be subsequently decoded or interpreted by downstream audit analysis processing.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                144. AuditEvent.entity:referenceDb.detail
                Definition

                Tagged value pairs for conveying additional information about the entity.

                ShortAdditional Information about the entity
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                Implementation-defined data about specific details of the object accessed or used.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                146. AuditEvent.entity:referenceDb.detail.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                148. AuditEvent.entity:referenceDb.detail.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                150. AuditEvent.entity:referenceDb.detail.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                152. AuditEvent.entity:referenceDb.detail.type
                Definition

                The type of extra detail provided in the value.

                ShortName of the property
                Control1..1
                BindingFor example codes, see AuditEventID
                (example to http://hl7.org/fhir/ValueSet/audit-event-type|5.0.0)

                Additional detail about an entity used in an event.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                154. AuditEvent.entity:referenceDb.detail.value[x]
                Definition

                The value of the extra detail.

                ShortProperty value
                Control1..1
                TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period, base64Binary
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summaryfalse
                Requirements

                Should not duplicate the entity value unless absolutely necessary.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                156. AuditEvent.entity:referenceDb.agent
                Definition

                The entity is attributed to an agent to express the agent's responsibility for that entity in the activity. This is most used to indicate when persistence media (the entity) are used by an agent. For example when importing data from a device, the device would be described in an entity, and the user importing data from that media would be indicated as the entity.agent.

                ShortEntity is attributed to this agent
                Comments

                A usecase where one AuditEvent.entity.agent is used where the Entity that was used in the creation/updating of a target resource, is not in the context of the same custodianship as the target resource, and thus the meaning of AuditEvent.entity.agent is to say that the entity referenced is managed elsewhere and that this Agent provided access to it. This would be similar to where the Entity being referenced is managed outside FHIR, such as through HL7 V2, v3, or XDS. This might be where the Entity being referenced is managed in another FHIR resource server. Thus it explains the provenance of that Entity's use in the context of this AuditEvent activity.

                Control0..*
                TypeSeettp://hl7.org/fhir/StructureDefinition/AuditEvent#AuditEvent.agent
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                158. AuditEvent.entity:outputData
                Slice NameoutputData
                Definition

                Specific instances of data or objects that have been accessed.

                ShortA FHIR resource representing an output generated by the AI system during the audited execution
                Comments

                Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

                Control1..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                The event may have other entities involved.

                Alternate NamesParticipantObject
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                160. AuditEvent.entity:outputData.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                162. AuditEvent.entity:outputData.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                164. AuditEvent.entity:outputData.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                166. AuditEvent.entity:outputData.what
                Definition

                Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

                ShortSpecific instance of resource
                Comments

                Use .what.display when all you have is a string (e.g. ParticipantObjectName).

                Control1..1
                TypeReference(Resource)
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                168. AuditEvent.entity:outputData.role
                Definition

                Code representing the role the entity played in the event being audited.

                ShortWhat role the entity played
                Control1..1
                BindingFor example codes, see AuditEventEntityRole
                (example to http://hl7.org/fhir/ValueSet/object-role|5.0.0)

                DICOM Audit Event Entity Role

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.

                Pattern Value{
                  "coding" : [{
                    "system" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/eu-ai-audit-entity-role",
                    "code" : "ai-output"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                170. AuditEvent.entity:outputData.securityLabel
                Definition

                Security labels for the identified entity.

                ShortSecurity labels on the entity
                Comments

                Copied from entity meta security tags.

                Control0..*
                BindingFor example codes, see SecurityLabelExamples
                (example to http://hl7.org/fhir/ValueSet/security-label-examples|5.0.0)

                Example Security Labels from the Healthcare Privacy and Security Classification System.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                172. AuditEvent.entity:outputData.query
                Definition

                The query parameters for a query-type entities.

                ShortQuery parameters
                Comments

                The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, and AuditEvent.entity.role. The base64 is a general-use and safe container for event specific data blobs regardless of the encoding used by the transaction being recorded. An AuditEvent consuming application must understand the event it is consuming and the formats used by the event. For example, if auditing an Oracle network database access, the Oracle formats must be understood as they will be simply encoded in the base64binary blob.

                The DICOM AuditMessage schema does not support both .name and .query being populated.

                Control0..1
                Typebase64Binary
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Requirements

                For query events, it may be necessary to capture the actual query input to the query process in order to identify the specific event. Because of differences among query implementations and data encoding for them, this is a base 64 encoded data blob. It may be subsequently decoded or interpreted by downstream audit analysis processing.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                174. AuditEvent.entity:outputData.detail
                Definition

                Tagged value pairs for conveying additional information about the entity.

                ShortAdditional Information about the entity
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

                Implementation-defined data about specific details of the object accessed or used.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                176. AuditEvent.entity:outputData.detail.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                178. AuditEvent.entity:outputData.detail.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                180. AuditEvent.entity:outputData.detail.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                182. AuditEvent.entity:outputData.detail.type
                Definition

                The type of extra detail provided in the value.

                ShortName of the property
                Control1..1
                BindingFor example codes, see AuditEventID
                (example to http://hl7.org/fhir/ValueSet/audit-event-type|5.0.0)

                Additional detail about an entity used in an event.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                184. AuditEvent.entity:outputData.detail.value[x]
                Definition

                The value of the extra detail.

                ShortProperty value
                Control1..1
                TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period, base64Binary
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summaryfalse
                Requirements

                Should not duplicate the entity value unless absolutely necessary.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                186. AuditEvent.entity:outputData.agent
                Definition

                The entity is attributed to an agent to express the agent's responsibility for that entity in the activity. This is most used to indicate when persistence media (the entity) are used by an agent. For example when importing data from a device, the device would be described in an entity, and the user importing data from that media would be indicated as the entity.agent.

                ShortEntity is attributed to this agent
                Comments

                A usecase where one AuditEvent.entity.agent is used where the Entity that was used in the creation/updating of a target resource, is not in the context of the same custodianship as the target resource, and thus the meaning of AuditEvent.entity.agent is to say that the entity referenced is managed elsewhere and that this Agent provided access to it. This would be similar to where the Entity being referenced is managed outside FHIR, such as through HL7 V2, v3, or XDS. This might be where the Entity being referenced is managed in another FHIR resource server. Thus it explains the provenance of that Entity's use in the context of this AuditEvent activity.

                Control0..*
                TypeSeettp://hl7.org/fhir/StructureDefinition/AuditEvent#AuditEvent.agent
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))