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_AIProvenance - Detailed Descriptions

Draft as of 2026-06-18

Definitions for the eu-ai-provenance resource profile.

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

0. Provenance
Definition

Provenance of a resource is a record that describes entities and processes involved in producing and delivering or otherwise influencing that resource. Provenance provides a critical foundation for assessing authenticity, enabling trust, and allowing reproducibility. Provenance assertions are a form of contextual metadata and can themselves become important records with their own provenance. Provenance statement indicates clinical significance in terms of confidence in authenticity, reliability, and trustworthiness, integrity, and stage in lifecycle (e.g. Document Completion - has the artifact been legally authenticated), all of which may impact security, privacy, and trust policies.

ShortWho, What, When for a set of resources
Comments

Some parties may be duplicated between the target resource and its provenance. For instance, the prescriber is usually (but not always) the author of the prescription resource. This resource is defined with close consideration for W3C Provenance.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesHistory, Event, Activity
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. Provenance.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. Provenance.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. Provenance.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.

Control10..*
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 Provenance.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. Provenance.extension:usageCategory
    Slice NameusageCategory
    Definition

    Categorizes the data processing as Primary Care or Secondary Use according to the EHDS.

    ShortPrimary vs. Secondary Use Category
    Control1..1
    TypeExtension(EHDS Usage Category) (Extension Type: CodeableConcept)
    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. Provenance.extension:secondaryUsePurpose
    Slice NamesecondaryUsePurpose
    Definition

    Documents the permitted purpose for secondary use of electronic health data under the EHDS.

    ShortEHDS Secondary Use Purpose
    Control0..*
    TypeExtension(EHDS Secondary Use Purpose) (Extension Type: CodeableConcept)
    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())
    12. Provenance.extension:dataPermit
    Slice NamedataPermit
    Definition

    The unique ID of the Health Data Access Body permit (required if secondary use).

    ShortReference to the EHDS Data Access Permit
    Control0..1
    TypeExtension(EHDS Data Permit) (Extension Type: Identifier)
    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())
    14. Provenance.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())
    16. Provenance.target
    Definition

    The Reference(s) that were generated or updated by the activity described in this resource. A provenance can point to more than one target if multiple resources were created/updated by the same activity.

    ShortLink to the generated AI clinical resultTarget Reference(s) (usually version specific)
    Comments

    Target references are usually version specific, but might not be, if a version has not been assigned or if the provenance information is part of the set of resources being maintained (i.e. a document). When using the RESTful API, the identity of the resource might not be known (especially not the version specific one); the client may either submit the resource first, and then the provenance, or it may submit both using a single transaction. See the notes on transaction for further discussion.

    Control1..*
    TypeReference(EU AI Generated Observation, Resource)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Provenance.occurred[x]
    Definition

    The period during which the activity occurred.

    ShortExact execution period (Start/End) of the AI modelWhen the activity occurred
    Comments

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

    Control10..1
    TypePeriod, dateTime
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. Provenance.authorization
    Definition

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

    ShortAuthorization (purposeOfUse) related to the event
    Control20..*
    BindingFor example codes, see PurposeOfUsehttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse
    (example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

    The authorized purposeOfUse for the activity.

    TypeCodeableReference
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    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()))
    SlicingThis element introduces a set of slices on Provenance.authorization. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ concept.coding.system
    • 22. Provenance.authorization:gdprBasis
      Slice NamegdprBasis
      Definition

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

      ShortAuthorization (purposeOfUse) related to the event
      Control10..1*
      BindingThe codes SHALL be taken from For example codes, see GDPR Article 6 Legal Basis ValueSethttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse
      (required to http://example.org/fhir/eu-ai-transparency/ValueSet/gdpr-art6-legal-basis-vs)
      TypeCodeableReference
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      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()))
      24. Provenance.authorization:gdprBasis.concept
      Definition

      A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.

      ShortReference to a concept (by class)
      Control10..1
      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. Provenance.authorization:gdprException
      Slice NamegdprException
      Definition

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

      ShortAuthorization (purposeOfUse) related to the event
      Control10..1*
      BindingThe codes SHALL be taken from For example codes, see GDPR Article 9 Exception ValueSethttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse
      (required to http://example.org/fhir/eu-ai-transparency/ValueSet/gdpr-art9-exception-vs)
      TypeCodeableReference
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      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()))
      28. Provenance.authorization:gdprException.concept
      Definition

      A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.

      ShortReference to a concept (by class)
      Control10..1
      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. Provenance.agent
      Definition

      An actor taking a role in an activity for which it can be assigned some degree of responsibility for the activity taking place.

      ShortActor involved
      Comments

      Several agents may be associated (i.e. has some responsibility for an activity) with an activity and vice-versa.

      Control1..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

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

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      prov-1: Who and onBehalfOf cannot be the same (who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve())
      prov-2: If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner (who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve())
      prov-3: If who is an organization, onBehalfOf can't be a PractitionerRole within that organization (who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve())
      32. Provenance.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())
      34. Provenance.agent.who
      Definition

      Indicates who or what performed in the event.

      ShortLink to the AI Device that executed the actionThe agent that participated in the event
      Control1..1
      This element is affected by the following invariants: prov-1, prov-2, prov-3
      TypeReference(EU AI System Device, Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. Provenance.agent.onBehalfOf
      Definition

      The agent that delegated authority to perform the activity performed by the agent.who element.

      ShortThe agent that delegated
      Control0..1
      This element is affected by the following invariants: prov-1, prov-2, prov-3
      TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient)
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. Provenance.entity
      Definition

      An entity used in this activity.

      ShortAn entity used in this activity
      Control10..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. Provenance.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())
      42. Provenance.entity.role
      Definition

      How the entity was used during the activity.

      Shortrevision | quotation | source | instantiates | removal
      Control1..1
      BindingThe codes SHALL be taken from ProvenanceEntityRolehttp://hl7.org/fhir/ValueSet/provenance-entity-role|5.0.0
      (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|5.0.0)

      How an entity was used in an activity.

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Pattern Valuesource
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. Provenance.entity.what
      Definition

      Identity of the Entity used. May be a logical or physical uri and maybe absolute or relative.

      ShortSource data processed by the AIIdentity of entity
      Comments

      whatIdentity should be used for entities that are not a Resource type.

      Control1..1
      TypeReference(Observation, ImagingStudy, DocumentReference, Resource)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      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. Provenance
      2. Provenance.extension
      Control1..?
      SlicingThis element introduces a set of slices on Provenance.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 4. Provenance.extension:usageCategory
        Slice NameusageCategory
        ShortPrimary vs. Secondary Use Category
        Control1..1
        TypeExtension(EHDS Usage Category) (Extension Type: CodeableConcept)
        Must Supporttrue
        6. Provenance.extension:secondaryUsePurpose
        Slice NamesecondaryUsePurpose
        Control0..*
        TypeExtension(EHDS Secondary Use Purpose) (Extension Type: CodeableConcept)
        Must Supporttrue
        8. Provenance.extension:dataPermit
        Slice NamedataPermit
        ShortReference to the EHDS Data Access Permit
        Control0..1
        TypeExtension(EHDS Data Permit) (Extension Type: Identifier)
        Must Supporttrue
        10. Provenance.target
        ShortLink to the generated AI clinical result
        TypeReference(EU AI Generated Observation)
        Must Supporttrue
        12. Provenance.occurred[x]
        ShortExact execution period (Start/End) of the AI model
        Control1..?
        TypePeriod, dateTime
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        14. Provenance.authorization
        Control2..?
        Must Supporttrue
        SlicingThis element introduces a set of slices on Provenance.authorization. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ concept.coding.system
        • 16. Provenance.authorization:gdprBasis
          Slice NamegdprBasis
          Control1..1
          BindingThe codes SHALL be taken from GDPR Article 6 Legal Basis ValueSet
          (required to http://example.org/fhir/eu-ai-transparency/ValueSet/gdpr-art6-legal-basis-vs)
          Must Supporttrue
          18. Provenance.authorization:gdprBasis.concept
          Control1..?
          20. Provenance.authorization:gdprBasis.concept.coding
          22. Provenance.authorization:gdprBasis.concept.coding.system
          Control1..?
          Pattern Valuehttp://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art6-codesystem
          24. Provenance.authorization:gdprException
          Slice NamegdprException
          Control1..1
          BindingThe codes SHALL be taken from GDPR Article 9 Exception ValueSet
          (required to http://example.org/fhir/eu-ai-transparency/ValueSet/gdpr-art9-exception-vs)
          Must Supporttrue
          26. Provenance.authorization:gdprException.concept
          Control1..?
          28. Provenance.authorization:gdprException.concept.coding
          30. Provenance.authorization:gdprException.concept.coding.system
          Control1..?
          Pattern Valuehttp://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art9-codesystem
          32. Provenance.agent
          Must Supporttrue
          34. Provenance.agent.who
          ShortLink to the AI Device that executed the action
          TypeReference(EU AI System Device)
          36. Provenance.entity
          Control1..?
          Must Supporttrue
          38. Provenance.entity.role
          Pattern Valuesource
          40. Provenance.entity.what
          ShortSource data processed by the AI
          TypeReference(Observation, ImagingStudy, DocumentReference)

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

          0. Provenance
          Definition

          Provenance of a resource is a record that describes entities and processes involved in producing and delivering or otherwise influencing that resource. Provenance provides a critical foundation for assessing authenticity, enabling trust, and allowing reproducibility. Provenance assertions are a form of contextual metadata and can themselves become important records with their own provenance. Provenance statement indicates clinical significance in terms of confidence in authenticity, reliability, and trustworthiness, integrity, and stage in lifecycle (e.g. Document Completion - has the artifact been legally authenticated), all of which may impact security, privacy, and trust policies.

          ShortWho, What, When for a set of resources
          Comments

          Some parties may be duplicated between the target resource and its provenance. For instance, the prescriber is usually (but not always) the author of the prescription resource. This resource is defined with close consideration for W3C Provenance.

          Control0..*
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate NamesHistory, Event, Activity
          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. Provenance.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. Provenance.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. Provenance.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. Provenance.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. Provenance.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. Provenance.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. Provenance.extension
          Definition

          An Extension

          ShortExtension
          Control1..*
          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 Provenance.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 16. Provenance.extension:usageCategory
            Slice NameusageCategory
            Definition

            Categorizes the data processing as Primary Care or Secondary Use according to the EHDS.

            ShortPrimary vs. Secondary Use Category
            Control1..1
            TypeExtension(EHDS Usage Category) (Extension Type: CodeableConcept)
            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. Provenance.extension:secondaryUsePurpose
            Slice NamesecondaryUsePurpose
            Definition

            Documents the permitted purpose for secondary use of electronic health data under the EHDS.

            ShortEHDS Secondary Use Purpose
            Control0..*
            TypeExtension(EHDS Secondary Use Purpose) (Extension Type: CodeableConcept)
            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())
            20. Provenance.extension:dataPermit
            Slice NamedataPermit
            Definition

            The unique ID of the Health Data Access Body permit (required if secondary use).

            ShortReference to the EHDS Data Access Permit
            Control0..1
            TypeExtension(EHDS Data Permit) (Extension Type: Identifier)
            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())
            22. Provenance.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())
            24. Provenance.target
            Definition

            The Reference(s) that were generated or updated by the activity described in this resource. A provenance can point to more than one target if multiple resources were created/updated by the same activity.

            ShortLink to the generated AI clinical result
            Comments

            Target references are usually version specific, but might not be, if a version has not been assigned or if the provenance information is part of the set of resources being maintained (i.e. a document). When using the RESTful API, the identity of the resource might not be known (especially not the version specific one); the client may either submit the resource first, and then the provenance, or it may submit both using a single transaction. See the notes on transaction for further discussion.

            Control1..*
            TypeReference(EU AI Generated Observation)
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. Provenance.occurred[x]
            Definition

            The period during which the activity occurred.

            ShortExact execution period (Start/End) of the AI model
            Comments

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

            Control1..1
            TypePeriod
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            28. Provenance.recorded
            Definition

            The instant of time at which the activity was recorded.

            ShortWhen the activity was recorded / updated
            Comments

            This can be a little different from the time stamp on the resource if there is a delay between recording the event and updating the provenance and target resource.

            Control0..1
            Typeinstant
            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()))
            30. Provenance.policy
            Definition

            Policy or plan the activity was defined by. Typically, a single activity may have multiple applicable policy documents, such as patient consent, guarantor funding, etc.

            ShortPolicy or plan the activity was defined by
            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
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. Provenance.location
            Definition

            Where the activity occurred, if relevant.

            ShortWhere the activity occurred, if relevant
            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()))
            34. Provenance.authorization
            Definition

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

            ShortAuthorization (purposeOfUse) related to the event
            Control2..*
            BindingFor example codes, see PurposeOfUse
            (example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

            The authorized purposeOfUse for the activity.

            TypeCodeableReference
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            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()))
            SlicingThis element introduces a set of slices on Provenance.authorization. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ concept.coding.system
            • 36. Provenance.authorization:gdprBasis
              Slice NamegdprBasis
              Definition

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

              ShortAuthorization (purposeOfUse) related to the event
              Control1..1
              BindingThe codes SHALL be taken from GDPR Article 6 Legal Basis ValueSet
              (required to http://example.org/fhir/eu-ai-transparency/ValueSet/gdpr-art6-legal-basis-vs)
              TypeCodeableReference
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              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()))
              38. Provenance.authorization:gdprBasis.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
              40. Provenance.authorization:gdprBasis.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 Provenance.authorization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 42. Provenance.authorization:gdprBasis.concept
                Definition

                A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.

                ShortReference to a concept (by class)
                Control1..1
                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                44. Provenance.authorization:gdprBasis.concept.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
                46. Provenance.authorization:gdprBasis.concept.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 Provenance.authorization.concept.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 48. Provenance.authorization:gdprBasis.concept.coding
                  Definition

                  A reference to a code defined by a terminology system.

                  ShortCode defined by a terminology system
                  Comments

                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                  Control0..*
                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Requirements

                  Allows for alternative encodings within a code system, and translations to other code systems.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  50. Provenance.authorization:gdprBasis.concept.coding.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
                  52. Provenance.authorization:gdprBasis.concept.coding.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 Provenance.authorization.concept.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 54. Provenance.authorization:gdprBasis.concept.coding.system
                    Definition

                    The identification of the code system that defines the meaning of the symbol in the code.

                    ShortIdentity of the terminology system
                    Comments

                    The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

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

                    Need to be unambiguous about the source of the definition of the symbol.

                    Pattern Valuehttp://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art6-codesystem
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    56. Provenance.authorization:gdprBasis.concept.coding.version
                    Definition

                    The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                    ShortVersion of the system - if relevant
                    Comments

                    Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                    NoteThis is a business version Id, not a resource version Id (see discussion)
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    58. Provenance.authorization:gdprBasis.concept.coding.code
                    Definition

                    A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                    ShortSymbol in syntax defined by the system
                    Control0..1
                    This element is affected by the following invariants: cod-1
                    Typecode
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

                    Need to refer to a particular code in the system.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    60. Provenance.authorization:gdprBasis.concept.coding.display
                    Definition

                    A representation of the meaning of the code in the system, following the rules of the system.

                    ShortRepresentation defined by the system
                    Control0..1
                    This element is affected by the following invariants: cod-1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

                    Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    62. Provenance.authorization:gdprBasis.concept.coding.userSelected
                    Definition

                    Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                    ShortIf this coding was chosen directly by the user
                    Comments

                    Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                    This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    64. Provenance.authorization:gdprBasis.concept.text
                    Definition

                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                    ShortPlain text representation of the concept
                    Comments

                    Very often the text is the same as a displayName of one of the codings.

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

                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    66. Provenance.authorization:gdprBasis.reference
                    Definition

                    A reference to a resource the provides exact details about the information being referenced.

                    ShortReference to a resource (by instance)
                    Control0..1
                    TypeReference
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    68. Provenance.authorization:gdprException
                    Slice NamegdprException
                    Definition

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

                    ShortAuthorization (purposeOfUse) related to the event
                    Control1..1
                    BindingThe codes SHALL be taken from GDPR Article 9 Exception ValueSet
                    (required to http://example.org/fhir/eu-ai-transparency/ValueSet/gdpr-art9-exception-vs)
                    TypeCodeableReference
                    Is Modifierfalse
                    Must Supporttrue
                    Summaryfalse
                    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()))
                    70. Provenance.authorization:gdprException.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
                    72. Provenance.authorization:gdprException.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 Provenance.authorization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 74. Provenance.authorization:gdprException.concept
                      Definition

                      A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.

                      ShortReference to a concept (by class)
                      Control1..1
                      TypeCodeableConcept
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      76. Provenance.authorization:gdprException.concept.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
                      78. Provenance.authorization:gdprException.concept.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 Provenance.authorization.concept.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 80. Provenance.authorization:gdprException.concept.coding
                        Definition

                        A reference to a code defined by a terminology system.

                        ShortCode defined by a terminology system
                        Comments

                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                        Control0..*
                        TypeCoding
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        Allows for alternative encodings within a code system, and translations to other code systems.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        82. Provenance.authorization:gdprException.concept.coding.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
                        84. Provenance.authorization:gdprException.concept.coding.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 Provenance.authorization.concept.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 86. Provenance.authorization:gdprException.concept.coding.system
                          Definition

                          The identification of the code system that defines the meaning of the symbol in the code.

                          ShortIdentity of the terminology system
                          Comments

                          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

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

                          Need to be unambiguous about the source of the definition of the symbol.

                          Pattern Valuehttp://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art9-codesystem
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          88. Provenance.authorization:gdprException.concept.coding.version
                          Definition

                          The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                          ShortVersion of the system - if relevant
                          Comments

                          Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                          NoteThis is a business version Id, not a resource version Id (see discussion)
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          90. Provenance.authorization:gdprException.concept.coding.code
                          Definition

                          A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                          ShortSymbol in syntax defined by the system
                          Control0..1
                          This element is affected by the following invariants: cod-1
                          Typecode
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          Need to refer to a particular code in the system.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          92. Provenance.authorization:gdprException.concept.coding.display
                          Definition

                          A representation of the meaning of the code in the system, following the rules of the system.

                          ShortRepresentation defined by the system
                          Control0..1
                          This element is affected by the following invariants: cod-1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          94. Provenance.authorization:gdprException.concept.coding.userSelected
                          Definition

                          Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                          ShortIf this coding was chosen directly by the user
                          Comments

                          Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                          This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          96. Provenance.authorization:gdprException.concept.text
                          Definition

                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                          ShortPlain text representation of the concept
                          Comments

                          Very often the text is the same as a displayName of one of the codings.

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

                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          98. Provenance.authorization:gdprException.reference
                          Definition

                          A reference to a resource the provides exact details about the information being referenced.

                          ShortReference to a resource (by instance)
                          Control0..1
                          TypeReference
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          100. Provenance.activity
                          Definition

                          An activity is something that occurs over a period of time and acts upon or with entities; it may include consuming, processing, transforming, modifying, relocating, using, or generating entities.

                          ShortActivity that occurred
                          Control0..1
                          BindingFor example codes, see ProvenanceActivityType
                          (example to http://hl7.org/fhir/ValueSet/provenance-activity-type|5.0.0)

                          The activity that took place.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          102. Provenance.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()))
                          104. Provenance.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 created/updated (.target) by 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 target data. The .patient shall not be populated when the target data created/updated (.target) 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()))
                          106. Provenance.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()))
                          108. Provenance.agent
                          Definition

                          An actor taking a role in an activity for which it can be assigned some degree of responsibility for the activity taking place.

                          ShortActor involved
                          Comments

                          Several agents may be associated (i.e. has some responsibility for an activity) with an activity and vice-versa.

                          Control1..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          prov-1: Who and onBehalfOf cannot be the same (who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve())
                          prov-2: If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner (who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve())
                          prov-3: If who is an organization, onBehalfOf can't be a PractitionerRole within that organization (who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve())
                          110. Provenance.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
                          112. Provenance.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())
                          114. Provenance.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())
                          116. Provenance.agent.type
                          Definition

                          The Functional Role of the agent with respect to the activity.

                          ShortHow the agent participated
                          Comments

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

                          Control0..1
                          BindingFor example codes, see ParticipationRoleType
                          (example to http://hl7.org/fhir/ValueSet/participation-role-type|5.0.0)

                          The type of participation that a provenance agent played with respect to the activity.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          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()))
                          118. Provenance.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.

                          ShortWhat the agents role was
                          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)

                          The role that a provenance agent played with respect to the activity.

                          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()))
                          120. Provenance.agent.who
                          Definition

                          Indicates who or what performed in the event.

                          ShortLink to the AI Device that executed the action
                          Control1..1
                          This element is affected by the following invariants: prov-1, prov-2, prov-3
                          TypeReference(EU AI System Device)
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          122. Provenance.agent.onBehalfOf
                          Definition

                          The agent that delegated authority to perform the activity performed by the agent.who element.

                          ShortThe agent that delegated
                          Control0..1
                          This element is affected by the following invariants: prov-1, prov-2, prov-3
                          TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient)
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          124. Provenance.entity
                          Definition

                          An entity used in this activity.

                          ShortAn entity used in this activity
                          Control1..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          126. Provenance.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
                          128. Provenance.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())
                          130. Provenance.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())
                          132. Provenance.entity.role
                          Definition

                          How the entity was used during the activity.

                          Shortrevision | quotation | source | instantiates | removal
                          Control1..1
                          BindingThe codes SHALL be taken from ProvenanceEntityRole
                          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|5.0.0)

                          How an entity was used in an activity.

                          Typecode
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supportfalse
                          Summarytrue
                          Pattern Valuesource
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          134. Provenance.entity.what
                          Definition

                          Identity of the Entity used. May be a logical or physical uri and maybe absolute or relative.

                          ShortSource data processed by the AI
                          Comments

                          whatIdentity should be used for entities that are not a Resource type.

                          Control1..1
                          TypeReference(Observation, ImagingStudy, DocumentReference)
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          136. Provenance.entity.agent
                          Definition

                          The entity is attributed to an agent to express the agent's responsibility for that entity, possibly along with other agents. This description can be understood as shorthand for saying that the agent was responsible for the activity which used the entity.

                          ShortEntity is attributed to this agent
                          Comments

                          A usecase where one Provenance.entity.agent is used where the Entity that was used in the creation/updating of the Target, is not in the context of the same custodianship as the Target, and thus the meaning of Provenance.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 Provenance activity.

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

                          A digital signature on the target Reference(s). The signer should match a Provenance.agent. The purpose of the signature is indicated.

                          ShortSignature on target
                          Control0..*
                          TypeSignature
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))