AI Transparency on FHIR
1.0.0-current - STU1 Ballot International flag

AI Transparency on FHIR, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 1.0.0-current built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/aitransparency-ig/ and changes regularly. See the Directory of published versions

Resource Profile: AI Provenance - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the 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
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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())
ai-target-aiast: Every target resource shall be labeled with the AIAST (Artificial Intelligence asserted) security label. (target.all(resolve().empty() or resolve().meta.security.where(system = 'http://terminology.hl7.org/CodeSystem/v3-ObservationValue' and code = 'AIAST').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 it's 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 it's meaning or interpretation
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()))
4. 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 manageable, 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
Summaryfalse
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())
6. 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.

ShortTarget Reference(s) (usually version specific)
Comments

The resources that were generated or enhanced by the AI use.


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(Resource)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Provenance.occurred[x]
Definition

The period during which the activity occurred.

ShortWhen the activity occurred
Comments

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

Control0..1
TypeChoice of: Period, dateTime
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. 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.

Control1..1
Typeinstant
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()))
12. Provenance.reason
Definition

The reason that the activity was taking place.

ShortReason the activity is occurring
Control10..*
BindingUnless not suitable, these codes SHALL be taken from PurposeOfUse (3.1.0)http://terminology.hl7.org/ValueSet/v3-PurposeOfUse
(extensible to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse|3.1.0)

The reason the activity took place.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
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.reason. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ $this
  • 14. Provenance.reason:AIReason
    Slice NameAIReason
    Definition

    The reason that the activity was taking place.

    ShortReason the activity is occurring
    Control10..1*
    BindingUnless not suitable, these codes SHALL be taken from PurposeOfUse (3.1.0)http://terminology.hl7.org/ValueSet/v3-PurposeOfUse
    (extensible to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse|3.1.0)

    The reason the activity took place.

    TypeCodeableConcept
    Is Modifierfalse
    Summaryfalse
    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
        "code" : "AIAST"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. 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
    Summaryfalse
    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()))
    SlicingThis element introduces a set of slices on Provenance.agent. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • profile @ who.resolve()
    • 18. 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 manageable, 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())
      20. Provenance.agent.who
      Definition

      The individual, device or organization that participated in the event.

      ShortWho participated
      Comments

      whoIdentity should be used when the agent is not a Resource type.

      Control1..1
      TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Provenance.agent:AIagent
      Slice NameAIagent
      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
      Summaryfalse
      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()))
      24. Provenance.agent:AIagent.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

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

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

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

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

      The participation the agent had with respect to the activity.

      ShortHow the agent participated
      Comments

      The way the AI was used.


      For example: author, performer, enterer, attester, etc.

      Control10..1
      BindingUnless not suitable, these codes SHALL be taken from ProvenanceParticipantTypehttp://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1
      (extensible to http://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1)

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

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. Provenance.agent:AIagent.role
      Definition

      The function of the agent with respect to the activity. The security role enabling the agent with respect to the activity.

      ShortWhat the agents role was
      Comments

      For example: doctor, nurse, clerk, etc.

      Control10..*
      BindingFor example codes, see SecurityRoleTypehttp://hl7.org/fhir/ValueSet/security-role-type|4.0.1
      (example to http://hl7.org/fhir/ValueSet/security-role-type|4.0.1)

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

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      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.agent.role. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ $this
      • 30. Provenance.agent:AIagent.role:AIrole
        Slice NameAIrole
        Definition

        The function of the agent with respect to the activity. The security role enabling the agent with respect to the activity.

        ShortWhat the agents role was
        Comments

        The agent role is set to Artificial Intelligence to indicate that the agent is an AI model.


        For example: doctor, nurse, clerk, etc.

        Control10..1*
        BindingFor example codes, see SecurityRoleTypehttp://hl7.org/fhir/ValueSet/security-role-type|4.0.1
        (example to http://hl7.org/fhir/ValueSet/security-role-type|4.0.1)

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

        TypeCodeableConcept
        Is Modifierfalse
        Summaryfalse
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS",
            "code" : "Artificial-Intelligence"
          }]
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. Provenance.agent:AIagent.who
        Definition

        The individual, device or organization that participated in the event.

        ShortWho participated
        Comments

        The AIDevice resource captures the details of the AI model used.


        whoIdentity should be used when the agent is not a Resource type.

        Control1..1
        TypeReference(AI Device, Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. Provenance.agent:Humanagent
        Slice NameHumanagent
        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.

        Control01..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        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()))
        36. Provenance.agent:Humanagent.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

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

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

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

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

        The participation the agent had with respect to the activity.

        ShortHow the agent participated
        Comments

        The way the human was involved in the AI use.


        For example: author, performer, enterer, attester, etc.

        Control10..1
        BindingUnless not suitable, these codes SHALL be taken from ProvenanceParticipantTypehttp://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1
        (extensible to http://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1)

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

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. Provenance.agent:Humanagent.who
        Definition

        The individual, device or organization that participated in the event.

        ShortWho participated
        Comments

        The human agent captures the details of the human that was involved in the AI use.


        whoIdentity should be used when the agent is not a Resource type.

        Control1..1
        TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient, Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        42. Provenance.entity
        Definition

        An entity used in this activity.

        ShortAn entity used in this activity
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        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.entity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • profile @ what.resolve()
        • 44. 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 manageable, 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())
          46. Provenance.entity.role
          Definition

          How the entity was used during the activity.

          Shortderivation | revision | quotation | source | removal
          Control1..1
          BindingThe codes SHALL be taken from ProvenanceEntityRolehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1
          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1)

          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
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. Provenance.entity.what
          Definition

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

          ShortIdentity of entity
          Comments

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

          Control1..1
          TypeReference(Resource)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. Provenance.entity:modelCard
          Slice NamemodelCard
          Definition

          An entity used in this activity.

          ShortAn entity used in this activity
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. Provenance.entity:modelCard.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 manageable, 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())
          54. Provenance.entity:modelCard.role
          Definition

          How the entity was used during the activity.

          Shortderivation | revision | quotation | source | removal
          Comments

          The role of the model card in the provenance, indicating that it describes the AI model used.

          Control1..1
          BindingThe codes SHALL be taken from ProvenanceEntityRolehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1
          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1)

          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
          Summarytrue
          Fixed Valuederivation
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. Provenance.entity:modelCard.what
          Definition

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

          ShortIdentity of entity
          Comments

          The AIModelCard resource captures the details of the AI model used, including its capabilities, limitations, and intended use.


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

          Control1..1
          TypeReference(AI Model-Card DocumentReference, Resource)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. Provenance.entity:inputPrompt
          Slice NameinputPrompt
          Definition

          An entity used in this activity.

          ShortAn entity used in this activity
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. Provenance.entity:inputPrompt.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 manageable, 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())
          62. Provenance.entity:inputPrompt.role
          Definition

          How the entity was used during the activity.

          Shortderivation | revision | quotation | source | removal
          Comments

          The role of the input data in the provenance, indicating that it was used as input to the AI model.

          Control1..1
          BindingThe codes SHALL be taken from ProvenanceEntityRolehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1
          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1)

          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
          Summarytrue
          Fixed Valuederivation
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. Provenance.entity:inputPrompt.what
          Definition

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

          ShortIdentity of entity
          Comments

          The AIInputPrompt resource captures the details of the input data provided to the AI model.


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

          Control1..1
          TypeReference(AI Input Prompt DocumentReference, Resource)
          Is Modifierfalse
          Must Supporttrue
          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
          Invariantsai-target-aiast: Every target resource shall be labeled with the AIAST (Artificial Intelligence asserted) security label. (target.all(resolve().empty() or resolve().meta.security.where(system = 'http://terminology.hl7.org/CodeSystem/v3-ObservationValue' and code = 'AIAST').exists()))
          2. Provenance.target
          Comments

          The resources that were generated or enhanced by the AI use.

          Must Supporttrue
          4. Provenance.occurred[x]
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Must Supporttrue
          6. Provenance.reason
          Control1..?
          SlicingThis element introduces a set of slices on Provenance.reason. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ $this
          • 8. Provenance.reason:AIReason
            Slice NameAIReason
            Control1..1
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
                "code" : "AIAST"
              }]
            }
            10. Provenance.agent
            SlicingThis element introduces a set of slices on Provenance.agent. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • profile @ who.resolve()
            • 12. Provenance.agent:AIagent
              Slice NameAIagent
              Control1..*
              Must Supporttrue
              14. Provenance.agent:AIagent.type
              Comments

              The way the AI was used.

              Control1..?
              Must Supporttrue
              16. Provenance.agent:AIagent.role
              Control1..?
              SlicingThis element introduces a set of slices on Provenance.agent.role. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ $this
              • 18. Provenance.agent:AIagent.role:AIrole
                Slice NameAIrole
                Comments

                The agent role is set to Artificial Intelligence to indicate that the agent is an AI model.

                Control1..1
                Pattern Value{
                  "coding" : [{
                    "system" : "http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS",
                    "code" : "Artificial-Intelligence"
                  }]
                }
                20. Provenance.agent:AIagent.who
                Comments

                The AIDevice resource captures the details of the AI model used.

                TypeReference(AI Device)
                22. Provenance.agent:Humanagent
                Slice NameHumanagent
                Control0..*
                Must Supporttrue
                24. Provenance.agent:Humanagent.type
                Comments

                The way the human was involved in the AI use.

                Control1..?
                Must Supporttrue
                26. Provenance.agent:Humanagent.who
                Comments

                The human agent captures the details of the human that was involved in the AI use.

                TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient)
                28. Provenance.entity
                Must Supporttrue
                SlicingThis element introduces a set of slices on Provenance.entity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • profile @ what.resolve()
                • 30. Provenance.entity.what
                  Must Supporttrue
                  32. Provenance.entity:modelCard
                  Slice NamemodelCard
                  Control0..*
                  Must Supporttrue
                  34. Provenance.entity:modelCard.role
                  Comments

                  The role of the model card in the provenance, indicating that it describes the AI model used.

                  Fixed Valuederivation
                  36. Provenance.entity:modelCard.what
                  Comments

                  The AIModelCard resource captures the details of the AI model used, including its capabilities, limitations, and intended use.

                  TypeReference(AI Model-Card DocumentReference)
                  38. Provenance.entity:inputPrompt
                  Slice NameinputPrompt
                  Control0..*
                  Must Supporttrue
                  40. Provenance.entity:inputPrompt.role
                  Comments

                  The role of the input data in the provenance, indicating that it was used as input to the AI model.

                  Fixed Valuederivation
                  42. Provenance.entity:inputPrompt.what
                  Comments

                  The AIInputPrompt resource captures the details of the input data provided to the AI model.

                  TypeReference(AI Input Prompt 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
                  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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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())
                  ai-target-aiast: Every target resource shall be labeled with the AIAST (Artificial Intelligence asserted) security label. (target.all(resolve().empty() or resolve().meta.security.where(system = 'http://terminology.hl7.org/CodeSystem/v3-ObservationValue' and code = 'AIAST').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

                  The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                  Control0..1
                  Typeid
                  Is Modifierfalse
                  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
                  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 it's 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 it's meaning or interpretation
                  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()))
                  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 SHOULD be taken from CommonLanguages
                  (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

                  A human language.

                  Additional BindingsPurpose
                  AllLanguagesMax Binding
                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  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 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
                  TypeNarrative
                  Is Modifierfalse
                  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, and nor can they have their own independent transaction scope.

                  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..*
                  TypeResource
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesinline resources, anonymous resources, contained resources
                  14. Provenance.extension
                  Definition

                  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 manageable, 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())
                  16. 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 manageable, 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
                  Summaryfalse
                  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())
                  18. 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.

                  ShortTarget Reference(s) (usually version specific)
                  Comments

                  The resources that were generated or enhanced by the AI use.

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

                  The period during which the activity occurred.

                  ShortWhen the activity occurred
                  Comments

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

                  Control0..1
                  TypeChoice of: Period, dateTime
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Must Support TypesNo must-support rules about the choice of types/profiles
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  22. 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.

                  Control1..1
                  Typeinstant
                  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()))
                  24. 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
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  26. Provenance.location
                  Definition

                  Where the activity occurred, if relevant.

                  ShortWhere the activity occurred, if relevant
                  Control0..1
                  TypeReference(Location)
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  28. Provenance.reason
                  Definition

                  The reason that the activity was taking place.

                  ShortReason the activity is occurring
                  Control1..*
                  BindingUnless not suitable, these codes SHALL be taken from PurposeOfUse (3.1.0)
                  (extensible to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse|3.1.0)

                  The reason the activity took place.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Summaryfalse
                  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.reason. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ $this
                  • 30. Provenance.reason:AIReason
                    Slice NameAIReason
                    Definition

                    The reason that the activity was taking place.

                    ShortReason the activity is occurring
                    Control1..1
                    BindingUnless not suitable, these codes SHALL be taken from PurposeOfUse (3.1.0)
                    (extensible to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse|3.1.0)

                    The reason the activity took place.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summaryfalse
                    Pattern Value{
                      "coding" : [{
                        "system" : "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
                        "code" : "AIAST"
                      }]
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    32. 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
                    BindingUnless not suitable, these codes SHALL be taken from ProvenanceActivityType
                    (extensible to http://hl7.org/fhir/ValueSet/provenance-activity-type|4.0.1)

                    The activity that took place.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    34. 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
                    Summaryfalse
                    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()))
                    SlicingThis element introduces a set of slices on Provenance.agent. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • profile @ who.resolve()
                    • 36. 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
                      Typestring
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      38. 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 manageable, 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())
                      40. 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 manageable, 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.agent.type
                      Definition

                      The participation the agent had with respect to the activity.

                      ShortHow the agent participated
                      Comments

                      For example: author, performer, enterer, attester, etc.

                      Control0..1
                      BindingUnless not suitable, these codes SHALL be taken from ProvenanceParticipantType
                      (extensible to http://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1)

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      44. Provenance.agent.role
                      Definition

                      The function of the agent with respect to the activity. The security role enabling the agent with respect to the activity.

                      ShortWhat the agents role was
                      Comments

                      For example: doctor, nurse, clerk, etc.

                      Control0..*
                      BindingFor example codes, see SecurityRoleType
                      (example to http://hl7.org/fhir/ValueSet/security-role-type|4.0.1)

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      46. Provenance.agent.who
                      Definition

                      The individual, device or organization that participated in the event.

                      ShortWho participated
                      Comments

                      whoIdentity should be used when the agent is not a Resource type.

                      Control1..1
                      TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      48. Provenance.agent.onBehalfOf
                      Definition

                      The individual, device, or organization for whom the change was made.

                      ShortWho the agent is representing
                      Comments

                      onBehalfOfIdentity should be used when the agent is not a Resource type.

                      Control0..1
                      TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      50. Provenance.agent:AIagent
                      Slice NameAIagent
                      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
                      Summaryfalse
                      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()))
                      52. Provenance.agent:AIagent.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
                      Typestring
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      54. Provenance.agent:AIagent.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 manageable, 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())
                      56. Provenance.agent:AIagent.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 manageable, 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())
                      58. Provenance.agent:AIagent.type
                      Definition

                      The participation the agent had with respect to the activity.

                      ShortHow the agent participated
                      Comments

                      The way the AI was used.

                      Control1..1
                      BindingUnless not suitable, these codes SHALL be taken from ProvenanceParticipantType
                      (extensible to http://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1)

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      60. Provenance.agent:AIagent.role
                      Definition

                      The function of the agent with respect to the activity. The security role enabling the agent with respect to the activity.

                      ShortWhat the agents role was
                      Comments

                      For example: doctor, nurse, clerk, etc.

                      Control1..*
                      BindingFor example codes, see SecurityRoleType
                      (example to http://hl7.org/fhir/ValueSet/security-role-type|4.0.1)

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

                      TypeCodeableConcept
                      Is Modifierfalse
                      Summaryfalse
                      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.agent.role. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ $this
                      • 62. Provenance.agent:AIagent.role:AIrole
                        Slice NameAIrole
                        Definition

                        The function of the agent with respect to the activity. The security role enabling the agent with respect to the activity.

                        ShortWhat the agents role was
                        Comments

                        The agent role is set to Artificial Intelligence to indicate that the agent is an AI model.

                        Control1..1
                        BindingFor example codes, see SecurityRoleType
                        (example to http://hl7.org/fhir/ValueSet/security-role-type|4.0.1)

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

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Pattern Value{
                          "coding" : [{
                            "system" : "http://hl7.org/fhir/uv/aitransparency/CodeSystem/AIdeviceTypeCS",
                            "code" : "Artificial-Intelligence"
                          }]
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        64. Provenance.agent:AIagent.who
                        Definition

                        The individual, device or organization that participated in the event.

                        ShortWho participated
                        Comments

                        The AIDevice resource captures the details of the AI model used.

                        Control1..1
                        TypeReference(AI Device)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        66. Provenance.agent:AIagent.onBehalfOf
                        Definition

                        The individual, device, or organization for whom the change was made.

                        ShortWho the agent is representing
                        Comments

                        onBehalfOfIdentity should be used when the agent is not a Resource type.

                        Control0..1
                        TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        68. Provenance.agent:Humanagent
                        Slice NameHumanagent
                        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.

                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supporttrue
                        Summaryfalse
                        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()))
                        70. Provenance.agent:Humanagent.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
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        72. Provenance.agent:Humanagent.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 manageable, 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())
                        74. Provenance.agent:Humanagent.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 manageable, 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())
                        76. Provenance.agent:Humanagent.type
                        Definition

                        The participation the agent had with respect to the activity.

                        ShortHow the agent participated
                        Comments

                        The way the human was involved in the AI use.

                        Control1..1
                        BindingUnless not suitable, these codes SHALL be taken from ProvenanceParticipantType
                        (extensible to http://hl7.org/fhir/ValueSet/provenance-agent-type|4.0.1)

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

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        78. Provenance.agent:Humanagent.role
                        Definition

                        The function of the agent with respect to the activity. The security role enabling the agent with respect to the activity.

                        ShortWhat the agents role was
                        Comments

                        For example: doctor, nurse, clerk, etc.

                        Control0..*
                        BindingFor example codes, see SecurityRoleType
                        (example to http://hl7.org/fhir/ValueSet/security-role-type|4.0.1)

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

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        80. Provenance.agent:Humanagent.who
                        Definition

                        The individual, device or organization that participated in the event.

                        ShortWho participated
                        Comments

                        The human agent captures the details of the human that was involved in the AI use.

                        Control1..1
                        TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        82. Provenance.agent:Humanagent.onBehalfOf
                        Definition

                        The individual, device, or organization for whom the change was made.

                        ShortWho the agent is representing
                        Comments

                        onBehalfOfIdentity should be used when the agent is not a Resource type.

                        Control0..1
                        TypeReference(Practitioner, PractitionerRole, RelatedPerson, Patient, Device, Organization)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        84. Provenance.entity
                        Definition

                        An entity used in this activity.

                        ShortAn entity used in this activity
                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supporttrue
                        Summaryfalse
                        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.entity. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • profile @ what.resolve()
                        • 86. 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
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          88. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

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

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          90. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

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

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

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

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

                          How the entity was used during the activity.

                          Shortderivation | revision | quotation | source | removal
                          Control1..1
                          BindingThe codes SHALL be taken from ProvenanceEntityRole
                          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1)

                          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
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          94. Provenance.entity.what
                          Definition

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

                          ShortIdentity of entity
                          Comments

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

                          Control1..1
                          TypeReference(Resource)
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          96. 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 generated 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
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          98. Provenance.entity:modelCard
                          Slice NamemodelCard
                          Definition

                          An entity used in this activity.

                          ShortAn entity used in this activity
                          Control0..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          100. Provenance.entity:modelCard.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
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          102. Provenance.entity:modelCard.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

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

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          104. Provenance.entity:modelCard.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

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

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

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

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

                          How the entity was used during the activity.

                          Shortderivation | revision | quotation | source | removal
                          Comments

                          The role of the model card in the provenance, indicating that it describes the AI model used.

                          Control1..1
                          BindingThe codes SHALL be taken from ProvenanceEntityRole
                          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1)

                          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
                          Summarytrue
                          Fixed Valuederivation
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          108. Provenance.entity:modelCard.what
                          Definition

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

                          ShortIdentity of entity
                          Comments

                          The AIModelCard resource captures the details of the AI model used, including its capabilities, limitations, and intended use.

                          Control1..1
                          TypeReference(AI Model-Card DocumentReference)
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          110. Provenance.entity:modelCard.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 generated 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
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          112. Provenance.entity:inputPrompt
                          Slice NameinputPrompt
                          Definition

                          An entity used in this activity.

                          ShortAn entity used in this activity
                          Control0..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Must Supporttrue
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          114. Provenance.entity:inputPrompt.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
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          116. Provenance.entity:inputPrompt.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 manageable, 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())
                          118. Provenance.entity:inputPrompt.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 manageable, 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())
                          120. Provenance.entity:inputPrompt.role
                          Definition

                          How the entity was used during the activity.

                          Shortderivation | revision | quotation | source | removal
                          Comments

                          The role of the input data in the provenance, indicating that it was used as input to the AI model.

                          Control1..1
                          BindingThe codes SHALL be taken from ProvenanceEntityRole
                          (required to http://hl7.org/fhir/ValueSet/provenance-entity-role|4.0.1)

                          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
                          Summarytrue
                          Fixed Valuederivation
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          122. Provenance.entity:inputPrompt.what
                          Definition

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

                          ShortIdentity of entity
                          Comments

                          The AIInputPrompt resource captures the details of the input data provided to the AI model.

                          Control1..1
                          TypeReference(AI Input Prompt DocumentReference)
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          124. Provenance.entity:inputPrompt.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 generated 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
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          126. 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
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))