NCPI FHIR Implementation Guide v2
0.1.0 - ci-build

NCPI FHIR Implementation Guide v2 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: NcpiResearchAccessPolicy - Detailed Descriptions

Draft as of 2024-03-21

Definitions for the ncpi-research-access-policy resource profile.

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

0. Consent
Invariantscompleted-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation (provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists())
2. Consent.extension
Control1..?
SlicingThis element introduces a set of slices on Consent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. Consent.extension:description
    Slice Namedescription
    ShortDescriptive text summarizing the policy restrictions and other details associated with this access provision.
    Control0..1
    TypeExtension(Access Policy Description) (Extension Type: markdown)
    6. Consent.extension:accessType
    Slice NameaccessType
    ShortType of access restrictions on file downloads ( open | registered | controlled )
    Control1..1
    TypeExtension(Access Type) (Extension Type: CodeableConcept)
    8. Consent.extension:website
    Slice Namewebsite
    ShortURL describing the policy restrictions in detail.
    Control0..1
    TypeExtension(Research Web Link) (Extension Type: url)
    10. Consent.category
    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
        "code" : "research",
        "display" : "Research Information Access"
      }]
    }
    12. Consent.provision
    14. Consent.provision.extension
    SlicingThis element introduces a set of slices on Consent.provision.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 16. Consent.provision.extension:diseaseUseLimitation
      Slice NamediseaseUseLimitation
      ShortConsent Code Disease Abbreviation
      Control0..1
      TypeExtension(Research Usage Limitation Disease Code) (Extension Type: CodeableConcept)
      18. Consent.provision.purpose
      BindingUnless not suitable, these codes SHALL be taken from Research Data Access Codes
      (extensible to https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/research-data-access-code-vs)

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

      0. Consent
      Definition

      A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time.

      ShortA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
      Comments

      Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.

      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where(((id.exists() and ('#'+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(uri) = '#').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())
      ppc-1: Either a Policy or PolicyRule (policy.exists() or policyRule.exists())
      ppc-2: IF Scope=privacy, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not())
      ppc-3: IF Scope=research, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='research').exists().not())
      ppc-4: IF Scope=adr, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='adr').exists().not())
      ppc-5: IF Scope=treatment, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not())
      completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation (provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists())
      2. Consent.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
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      4. Consent.extension
      Definition

      An Extension


      May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and 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.

      ShortExtensionAdditional content defined by implementations
      Comments

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

      Control10..*
      TypeExtension
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Consent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 6. Consent.extension:description
        Slice Namedescription
        Definition

        Descriptive text summarizing the policy restrictions and other details associated with this access provision.

        ShortDescriptive text summarizing the policy restrictions and other details associated with this access provision.
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeExtension(Access Policy Description) (Extension Type: markdown)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-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())
        8. Consent.extension:accessType
        Slice NameaccessType
        Definition

        Access type code associated with downloads affected by this Access Policy ( open | registered | controlled )

        ShortType of access restrictions on file downloads ( open | registered | controlled )
        Control1..1
        This element is affected by the following invariants: ele-1
        TypeExtension(Access Type) (Extension Type: CodeableConcept)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        10. Consent.extension:website
        Slice Namewebsite
        Definition

        A URL pointing to a either a research study's website, an online document or other research related site or document.

        ShortURL describing the policy restrictions in detail.
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeExtension(Research Web Link) (Extension Type: url)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        12. Consent.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
        Must Supportfalse
        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())
        14. Consent.status
        Definition

        Indicates the current state of this consent.

        Shortdraft | proposed | active | rejected | inactive | entered-in-error
        Comments

        This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.

        Control1..1
        BindingThe codes SHALL be taken from ConsentStatehttp://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0
        (required to http://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0)

        Indicates the state of the consent.

        Typecode
        Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Requirements

        The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. Consent.scope
        Definition

        A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible.

        ShortWhich of the four areas this resource covers (extensible)
        Control1..1
        BindingUnless not suitable, these codes SHALL be taken from ConsentScopeCodeshttp://hl7.org/fhir/ValueSet/consent-scope
        (extensible to http://hl7.org/fhir/ValueSet/consent-scope)

        The four anticipated uses for the Consent Resource.

        TypeCodeableConcept
        Is Modifiertrue because Allows changes to codes based on scope selection
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        18. Consent.category
        Definition

        A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.

        ShortClassification of the consent statement - for indexing/retrieval
        Control1..*
        BindingUnless not suitable, these codes SHALL be taken from ConsentCategoryCodeshttp://hl7.org/fhir/ValueSet/consent-category
        (extensible to http://hl7.org/fhir/ValueSet/consent-category)

        A classification of the type of consents found in a consent statement.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
            "code" : "research",
            "display" : "Research Information Access"
          }]
        }
        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 found here

        0. Consent
        Definition

        A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time.

        ShortA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
        Comments

        Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.

        Control0..*
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where(((id.exists() and ('#'+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(uri) = '#').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())
        ppc-1: Either a Policy or PolicyRule (policy.exists() or policyRule.exists())
        ppc-2: IF Scope=privacy, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not())
        ppc-3: IF Scope=research, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='research').exists().not())
        ppc-4: IF Scope=adr, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='adr').exists().not())
        ppc-5: IF Scope=treatment, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not())
        completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation (provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists())
        2. Consent.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
        Must Supportfalse
        Summarytrue
        4. Consent.meta
        Definition

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

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

        IETF language tag

        Additional BindingsPurpose
        AllLanguagesMax Binding
        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        10. Consent.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
        Must Supportfalse
        Summaryfalse
        Alternate Namesnarrative, html, xhtml, display
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        12. Consent.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
        Must Supportfalse
        Summaryfalse
        Alternate Namesinline resources, anonymous resources, contained resources
        Invariantsdom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic))
        14. Consent.extension
        Definition

        An Extension

        ShortExtension
        Control1..*
        TypeExtension
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Consent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 16. Consent.extension:description
          Slice Namedescription
          Definition

          Descriptive text summarizing the policy restrictions and other details associated with this access provision.

          ShortDescriptive text summarizing the policy restrictions and other details associated with this access provision.
          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Access Policy Description) (Extension Type: markdown)
          Is Modifierfalse
          Must Supportfalse
          Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          18. Consent.extension:accessType
          Slice NameaccessType
          Definition

          Access type code associated with downloads affected by this Access Policy ( open | registered | controlled )

          ShortType of access restrictions on file downloads ( open | registered | controlled )
          Control1..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Access Type) (Extension Type: CodeableConcept)
          Is Modifierfalse
          Must Supportfalse
          Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          20. Consent.extension:website
          Slice Namewebsite
          Definition

          A URL pointing to a either a research study's website, an online document or other research related site or document.

          ShortURL describing the policy restrictions in detail.
          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Research Web Link) (Extension Type: url)
          Is Modifierfalse
          Must Supportfalse
          Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          22. Consent.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
          Must Supportfalse
          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())
          24. Consent.identifier
          Definition

          Unique identifier for this copy of the Consent Statement.

          ShortIdentifier for this record (external references)
          Comments

          This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same.

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..*
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. Consent.status
          Definition

          Indicates the current state of this consent.

          Shortdraft | proposed | active | rejected | inactive | entered-in-error
          Comments

          This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.

          Control1..1
          BindingThe codes SHALL be taken from ConsentState
          (required to http://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0)

          Indicates the state of the consent.

          Typecode
          Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Requirements

          The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. Consent.scope
          Definition

          A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible.

          ShortWhich of the four areas this resource covers (extensible)
          Control1..1
          BindingUnless not suitable, these codes SHALL be taken from ConsentScopeCodes
          (extensible to http://hl7.org/fhir/ValueSet/consent-scope)

          The four anticipated uses for the Consent Resource.

          TypeCodeableConcept
          Is Modifiertrue because Allows changes to codes based on scope selection
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. Consent.category
          Definition

          A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.

          ShortClassification of the consent statement - for indexing/retrieval
          Control1..*
          BindingUnless not suitable, these codes SHALL be taken from ConsentCategoryCodes
          (extensible to http://hl7.org/fhir/ValueSet/consent-category)

          A classification of the type of consents found in a consent statement.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
              "code" : "research",
              "display" : "Research Information Access"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. Consent.patient
          Definition

          The patient/healthcare consumer to whom this consent applies.

          ShortWho the consent applies to
          Comments

          Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person.

          Control0..1
          TypeReference(Patient)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Consent.dateTime
          Definition

          When this Consent was issued / created / indexed.

          ShortWhen this Consent was created or indexed
          Comments

          This is not the time of the original consent, but the time that this statement was made or derived.

          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. Consent.performer
          Definition

          Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions.

          ShortWho is agreeing to the policy and rules
          Comments

          Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian.

          Control0..*
          TypeReference(Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Alternate Namesconsentor
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. Consent.organization
          Definition

          The organization that manages the consent, and the framework within which it is executed.

          ShortCustodian of the consent
          Control0..*
          TypeReference(Organization)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Alternate Namescustodian
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. Consent.source[x]
          Definition

          The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document.

          ShortSource from which this consent is taken
          Comments

          The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id.

          Control0..1
          TypeChoice of: Attachment, Reference(Consent, DocumentReference, Contract, QuestionnaireResponse)
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. Consent.policy
          Definition

          The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

          ShortPolicies covered by this consent
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          44. Consent.policy.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
          46. Consent.policy.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())
          48. Consent.policy.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())
          50. Consent.policy.authority
          Definition

          Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives.

          ShortEnforcement source for policy
          Control0..1
          This element is affected by the following invariants: ppc-1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. Consent.policy.uri
          Definition

          The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

          ShortSpecific policy covered by this consent
          Comments

          This element is for discoverability / documentation and does not modify or qualify the policy rules.

          Control0..1
          This element is affected by the following invariants: ppc-1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. Consent.policyRule
          Definition

          A reference to the specific base computable regulation or policy.

          ShortRegulation that this consents to
          Comments

          If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource.

          Control0..1
          This element is affected by the following invariants: ppc-1
          BindingUnless not suitable, these codes SHALL be taken from ConsentPolicyRuleCodes
          (extensible to http://hl7.org/fhir/ValueSet/consent-policy)

          Regulatory policy examples.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Requirements

          Might be a unique identifier of a policy set in XACML, or other rules engine.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. Consent.verification
          Definition

          Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person.

          ShortConsent Verified by patient or family
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          58. Consent.verification.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
          60. Consent.verification.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())
          62. Consent.verification.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())
          64. Consent.verification.verified
          Definition

          Has the instruction been verified.

          ShortHas been verified
          Control1..1
          Typeboolean
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. Consent.verification.verifiedWith
          Definition

          Who verified the instruction (Patient, Relative or other Authorized Person).

          ShortPerson who verified
          Control0..1
          TypeReference(Patient, RelatedPerson)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. Consent.verification.verificationDate
          Definition

          Date verification was collected.

          ShortWhen consent verified
          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          70. Consent.provision
          Definition

          An exception to the base policy of this consent. An exception can be an addition or removal of access permissions.

          ShortConstraints to the base Consent.policyRule
          Control0..1
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          72. Consent.provision.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
          74. Consent.provision.extension
          Definition

          An Extension

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

            Coding associated with limitation on what research can be performed this data.

            ShortConsent Code Disease Abbreviation
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(Research Usage Limitation Disease Code) (Extension Type: CodeableConcept)
            Is Modifierfalse
            Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            78. Consent.provision.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())
            80. Consent.provision.type
            Definition

            Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules.

            Shortdeny | permit
            Control0..1
            BindingThe codes SHALL be taken from ConsentProvisionType
            (required to http://hl7.org/fhir/ValueSet/consent-provision-type|4.3.0)

            How a rule statement is applied, such as adding additional consent or removing consent.

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

            The timeframe in this rule is valid.

            ShortTimeframe for this rule
            Control0..1
            TypePeriod
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. Consent.provision.actor
            Definition

            Who or what is controlled by this rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers').

            ShortWho|what controlled by this rule (or group, by role)
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Meaning if MissingThere is no specific actor associated with the exception
            Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
            86. Consent.provision.actor.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. Consent.provision.actor.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. Consent.provision.actor.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. Consent.provision.actor.role
            Definition

            How the individual is involved in the resources content that is described in the exception.

            ShortHow the actor is involved
            Control1..1
            BindingUnless not suitable, these codes SHALL be taken from SecurityRoleType
            (extensible to http://hl7.org/fhir/ValueSet/security-role-type)

            How an actor is involved in the consent considerations.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            94. Consent.provision.actor.reference
            Definition

            The resource that identifies the actor. To identify actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').

            ShortResource for the actor (or group, by role)
            Control1..1
            TypeReference(Device, Group, CareTeam, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            96. Consent.provision.action
            Definition

            Actions controlled by this Rule.

            ShortActions controlled by this rule
            Comments

            Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'.

            Control0..*
            BindingFor example codes, see ConsentActionCodes
            (example to http://hl7.org/fhir/ValueSet/consent-action)

            Detailed codes for the consent action.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Meaning if Missingall actions
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            98. Consent.provision.securityLabel
            Definition

            A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception.

            ShortSecurity Labels that define affected resources
            Comments

            If the consent specifies a security label of "R" then it applies to all resources that are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict.

            Control0..*
            BindingUnless not suitable, these codes SHALL be taken from All Security Labels
            (extensible to http://hl7.org/fhir/ValueSet/security-labels)

            Security Labels from the Healthcare Privacy and Security Classification System.

            TypeCoding
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            100. Consent.provision.purpose
            Definition

            The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule.

            ShortContext of activities covered by this rule
            Comments

            When the purpose of use tag is on the data, access request purpose of use shall not conflict.

            Control0..*
            BindingUnless not suitable, these codes SHALL be taken from Research Data Access Codes
            (extensible to https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/research-data-access-code-vs)
            TypeCoding
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            102. Consent.provision.class
            Definition

            The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to.

            Shorte.g. Resource Type, Profile, CDA, etc.
            Comments

            Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere.

            Control0..*
            BindingUnless not suitable, these codes SHALL be taken from ConsentContentClass
            (extensible to http://hl7.org/fhir/ValueSet/consent-content-class)

            The class (type) of information a consent rule covers.

            TypeCoding
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            104. Consent.provision.code
            Definition

            If this code is found in an instance, then the rule applies.

            Shorte.g. LOINC or SNOMED CT code, etc. in the content
            Comments

            Typical use of this is a Document code with class = CDA.

            Control0..*
            BindingFor example codes, see ConsentContentCodes
            (example to http://hl7.org/fhir/ValueSet/consent-content-code)

            If this code is found in an instance, then the exception applies.

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

            Clinical or Operational Relevant period of time that bounds the data controlled by this rule.

            ShortTimeframe for data controlled by this rule
            Comments

            This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement.

            Control0..1
            TypePeriod
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            108. Consent.provision.data
            Definition

            The resources controlled by this rule if specific resources are referenced.

            ShortData controlled by this rule
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Meaning if Missingall data
            Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
            110. Consent.provision.data.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
            112. Consent.provision.data.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())
            114. Consent.provision.data.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())
            116. Consent.provision.data.meaning
            Definition

            How the resource reference is interpreted when testing consent restrictions.

            Shortinstance | related | dependents | authoredby
            Control1..1
            BindingThe codes SHALL be taken from ConsentDataMeaning
            (required to http://hl7.org/fhir/ValueSet/consent-data-meaning|4.3.0)

            How a resource reference is interpreted when testing consent restrictions.

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

            A reference to a specific resource that defines which resources are covered by this consent.

            ShortThe actual data reference
            Control1..1
            TypeReference(Resource)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            120. Consent.provision.provision
            Definition

            Rules which provide exceptions to the base rule or subrules.

            ShortNested Exception Rules
            Control0..*
            TypeSee ttp://hl7.org/fhir/StructureDefinition/Consent#Consent.provision
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))