NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

Resource Profile: Research Study Consent

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent Version: 0.2.0
Draft as of 2023-06-28 Computable Name: ResearchStudyConsent

A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study.

Key Guidelines

The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model and is intended to be a singular resource that represents the consent signed by a group of participants in a research study.

Added Profile Restrictions

  • The consent’s category MUST be set to the code, research from the system, http://terminology.hl7.org/CodeSystem/consentcategorycodes.
  • All distinct consent restrictions should be added to the consent’s provision.purpose as a separate coding from the NIH Consent CodeSystem.
  • For disease specific restrictions, the code DS must be present in the purpose described above along with appropriate code(s) added via the Research Disease Use Limitation Extension.

This should go within the regular page content, but I want to wait until I have Katie’s verbiage before working it in.

In this model, the consent’s category contains an array of codes for each of the restrictions specified in the given consent. For instance, HMB-NPU Consent, there would be two codes added to the provision’s purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, NIH Consent. For more disease specific restrictions, the code DS is to be used along with a corresponding disease code(s) added via the Research Disease Use Limitation.

Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single Study Group that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the Research Disease Use Limitation.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Consent

NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
... category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: research
..... display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
... provision
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
.... purpose 0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Consent.provision.purposeextensibleNihConsentCodes (a valid code from NIH Consent Codes)

Constraints

IdGradePath(s)DetailsRequirements
completed-consent-codeerrorConsentIf 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ1..1codedraft | proposed | active | rejected | inactive | entered-in-error
Binding: ConsentState (required): Indicates the state of the consent.

... category Σ1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.



Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: research
..... display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Consent.statusrequiredConsentState
Consent.scopeextensibleConsentScopeCodes
Consent.categoryextensiblePattern: research("Research Information Access")

Constraints

IdGradePath(s)DetailsRequirements
completed-consent-codeerrorConsentIf 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()
dom-2errorConsentIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorConsentIf 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-4errorConsentIf 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-5errorConsentIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceConsentA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ppc-1errorConsentEither a Policy or PolicyRule
: policy.exists() or policyRule.exists()
ppc-2errorConsentIF Scope=privacy, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3errorConsentIF Scope=research, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4errorConsentIF Scope=adr, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5errorConsentIF Scope=treatment, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierIdentifier for this record (external references)

Example General: {"system":"urn:ietf:rfc:3986","value":"Local eCMS identifier"}
... status ?!Σ1..1codedraft | proposed | active | rejected | inactive | entered-in-error
Binding: ConsentState (required): Indicates the state of the consent.

... scope ?!Σ1..1CodeableConceptWhich of the four areas this resource covers (extensible)
Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.

... category Σ1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.



Required Pattern: At least the following
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: research
..... display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... patient Σ0..1Reference(Patient)Who the consent applies to
... dateTime Σ0..1dateTimeWhen this Consent was created or indexed
... performer Σ0..*Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)Who is agreeing to the policy and rules
... organization Σ0..*Reference(Organization)Custodian of the consent
... source[x] Σ0..1Source from which this consent is taken
.... sourceAttachmentAttachment
.... sourceReferenceReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
... policy 0..*BackboneElementPolicies covered by this consent
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... authority C0..1uriEnforcement source for policy
.... uri C0..1uriSpecific policy covered by this consent
... policyRule ΣC0..1CodeableConceptRegulation that this consents to
Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.

... verification Σ0..*BackboneElementConsent Verified by patient or family
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... verified Σ1..1booleanHas been verified
.... verifiedWith 0..1Reference(Patient | RelatedPerson)Person who verified
.... verificationDate 0..1dateTimeWhen consent verified
... provision Σ0..1BackboneElementConstraints to the base Consent.policyRule
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1codedeny | permit
Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.

.... period Σ0..1PeriodTimeframe for this rule
.... actor 0..*BackboneElementWho|what controlled by this rule (or group, by role)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... role 1..1CodeableConceptHow the actor is involved
Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.

..... reference 1..1Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)Resource for the actor (or group, by role)
.... action Σ0..*CodeableConceptActions controlled by this rule
Binding: ConsentActionCodes (example): Detailed codes for the consent action.


.... securityLabel Σ0..*CodingSecurity Labels that define affected resources
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... purpose Σ0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)
.... class Σ0..*Codinge.g. Resource Type, Profile, CDA, etc.
Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.


.... code Σ0..*CodeableConcepte.g. LOINC or SNOMED CT code, etc. in the content
Binding: ConsentContentCodes (example): If this code is found in an instance, then the exception applies.


.... dataPeriod Σ0..1PeriodTimeframe for data controlled by this rule
.... data Σ0..*BackboneElementData controlled by this rule
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... meaning Σ1..1codeinstance | related | dependents | authoredby
Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.

..... reference Σ1..1Reference(Resource)The actual data reference
.... provision 0..*See provision (Consent)Nested Exception Rules

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Consent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Consent.statusrequiredConsentState
Consent.scopeextensibleConsentScopeCodes
Consent.categoryextensiblePattern: research("Research Information Access")
Consent.policyRuleextensibleConsentPolicyRuleCodes
Consent.provision.typerequiredConsentProvisionType
Consent.provision.actor.roleextensibleSecurityRoleType
Consent.provision.actionexampleConsentActionCodes
Consent.provision.securityLabelextensibleAll Security Labels
Consent.provision.purposeextensibleNihConsentCodes (a valid code from NIH Consent Codes)
Consent.provision.classextensibleConsentContentClass
Consent.provision.codeexampleConsentContentCodes (a valid code from LOINC)
Consent.provision.data.meaningrequiredConsentDataMeaning

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Consent

Summary

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from Consent

NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
... category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: research
..... display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
... provision
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
.... purpose 0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Consent.provision.purposeextensibleNihConsentCodes (a valid code from NIH Consent Codes)

Constraints

IdGradePath(s)DetailsRequirements
completed-consent-codeerrorConsentIf 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()

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ1..1codedraft | proposed | active | rejected | inactive | entered-in-error
Binding: ConsentState (required): Indicates the state of the consent.

... category Σ1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.



Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: research
..... display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Consent.statusrequiredConsentState
Consent.scopeextensibleConsentScopeCodes
Consent.categoryextensiblePattern: research("Research Information Access")

Constraints

IdGradePath(s)DetailsRequirements
completed-consent-codeerrorConsentIf 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()
dom-2errorConsentIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorConsentIf 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-4errorConsentIf 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-5errorConsentIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceConsentA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ppc-1errorConsentEither a Policy or PolicyRule
: policy.exists() or policyRule.exists()
ppc-2errorConsentIF Scope=privacy, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3errorConsentIF Scope=research, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4errorConsentIF Scope=adr, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5errorConsentIF Scope=treatment, there must be a patient
: patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierIdentifier for this record (external references)

Example General: {"system":"urn:ietf:rfc:3986","value":"Local eCMS identifier"}
... status ?!Σ1..1codedraft | proposed | active | rejected | inactive | entered-in-error
Binding: ConsentState (required): Indicates the state of the consent.

... scope ?!Σ1..1CodeableConceptWhich of the four areas this resource covers (extensible)
Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.

... category Σ1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.



Required Pattern: At least the following
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: research
..... display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... patient Σ0..1Reference(Patient)Who the consent applies to
... dateTime Σ0..1dateTimeWhen this Consent was created or indexed
... performer Σ0..*Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)Who is agreeing to the policy and rules
... organization Σ0..*Reference(Organization)Custodian of the consent
... source[x] Σ0..1Source from which this consent is taken
.... sourceAttachmentAttachment
.... sourceReferenceReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
... policy 0..*BackboneElementPolicies covered by this consent
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... authority C0..1uriEnforcement source for policy
.... uri C0..1uriSpecific policy covered by this consent
... policyRule ΣC0..1CodeableConceptRegulation that this consents to
Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.

... verification Σ0..*BackboneElementConsent Verified by patient or family
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... verified Σ1..1booleanHas been verified
.... verifiedWith 0..1Reference(Patient | RelatedPerson)Person who verified
.... verificationDate 0..1dateTimeWhen consent verified
... provision Σ0..1BackboneElementConstraints to the base Consent.policyRule
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
.... diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1codedeny | permit
Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.

.... period Σ0..1PeriodTimeframe for this rule
.... actor 0..*BackboneElementWho|what controlled by this rule (or group, by role)
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... role 1..1CodeableConceptHow the actor is involved
Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.

..... reference 1..1Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)Resource for the actor (or group, by role)
.... action Σ0..*CodeableConceptActions controlled by this rule
Binding: ConsentActionCodes (example): Detailed codes for the consent action.


.... securityLabel Σ0..*CodingSecurity Labels that define affected resources
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... purpose Σ0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)
.... class Σ0..*Codinge.g. Resource Type, Profile, CDA, etc.
Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.


.... code Σ0..*CodeableConcepte.g. LOINC or SNOMED CT code, etc. in the content
Binding: ConsentContentCodes (example): If this code is found in an instance, then the exception applies.


.... dataPeriod Σ0..1PeriodTimeframe for data controlled by this rule
.... data Σ0..*BackboneElementData controlled by this rule
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... meaning Σ1..1codeinstance | related | dependents | authoredby
Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.

..... reference Σ1..1Reference(Resource)The actual data reference
.... provision 0..*See provision (Consent)Nested Exception Rules

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Consent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Consent.statusrequiredConsentState
Consent.scopeextensibleConsentScopeCodes
Consent.categoryextensiblePattern: research("Research Information Access")
Consent.policyRuleextensibleConsentPolicyRuleCodes
Consent.provision.typerequiredConsentProvisionType
Consent.provision.actor.roleextensibleSecurityRoleType
Consent.provision.actionexampleConsentActionCodes
Consent.provision.securityLabelextensibleAll Security Labels
Consent.provision.purposeextensibleNihConsentCodes (a valid code from NIH Consent Codes)
Consent.provision.classextensibleConsentContentClass
Consent.provision.codeexampleConsentContentCodes (a valid code from LOINC)
Consent.provision.data.meaningrequiredConsentDataMeaning

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Consent

Summary

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron

Notes: