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 2023-06-09 | Computable Name: ResearchStudyConsent | |||
A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study
Usage:
- Refer to this Resource Profile: Research Study Subject Consent
- Examples for this Resource Profile: Consent/ds-bav-consent, Consent/gru-consent, Consent/hmb-irb-npu-consent and Consent/hmb-npu-consent
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Consent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Consent | 0..* | Consent | A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time | |
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 diseaseAbbreviation | 0..1 | string | Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation | |
  category | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Binding: NIH Consent Code ValueSet (extensible) | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Conformance | ValueSet |
| Consent.category | extensible | NihConsentCodes (a valid code from NIH Consent Codes) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Consent | C | 0..* | Consent | A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| diseaseAbbreviation | C | 0..1 | string | Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!Σ | 1..1 | code | draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent. |
 scope | ?!Σ | 1..1 | CodeableConcept | Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource. |
| category | Σ | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Binding: NIH Consent Code ValueSet (extensible) |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet |
| Consent.status | required | ConsentState |
| Consent.scope | extensible | ConsentScopeCodes |
| Consent.category | extensible | NihConsentCodes (a valid code from NIH Consent Codes) |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| disease-specific-consent-code | error | Consent.extension:diseaseAbbreviation | Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code. : valueString.matches('DS-[A-Z]+') | |
| dom-2 | error | Consent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Consent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Consent | 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 | error | Consent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Consent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ppc-1 | error | Consent | Either a Policy or PolicyRule : policy.exists() or policyRule.exists() | |
| ppc-2 | error | Consent | IF Scope=privacy, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not() | |
| ppc-3 | error | Consent | IF Scope=research, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='research').exists().not() | |
| ppc-4 | error | Consent | IF Scope=adr, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='adr').exists().not() | |
| ppc-5 | error | Consent | IF Scope=treatment, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Consent | C | 0..* | Consent | A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| diseaseAbbreviation | C | 0..1 | string | Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation | ||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Identifier for this record (external references) Example General: {"system":"urn:ietf:rfc:3986","value":"Local eCMS identifier"} | ||||
| status | ?!Σ | 1..1 | code | draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent. | ||||
| scope | ?!Σ | 1..1 | CodeableConcept | Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource. | ||||
| category | Σ | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Binding: NIH Consent Code ValueSet (extensible) | ||||
 patient | Σ | 0..1 | Reference(Patient) | Who the consent applies to | ||||
| dateTime | Σ | 0..1 | dateTime | When this Consent was created or indexed | ||||
| performer | Σ | 0..* | Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Who is agreeing to the policy and rules | ||||
| organization | Σ | 0..* | Reference(Organization) | Custodian of the consent | ||||
  source[x] | Σ | 0..1 | Source from which this consent is taken | |||||
 sourceAttachment | Attachment | |||||||
| sourceReference | Reference(Consent | DocumentReference | Contract | QuestionnaireResponse) | |||||||
| policy | 0..* | BackboneElement | Policies covered by this consent | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | C | 0..1 | uri | Enforcement source for policy | ||||
| uri | C | 0..1 | uri | Specific policy covered by this consent | ||||
| policyRule | ΣC | 0..1 | CodeableConcept | Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples. | ||||
| verification | Σ | 0..* | BackboneElement | Consent Verified by patient or family | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| verified | Σ | 1..1 | boolean | Has been verified | ||||
| verifiedWith | 0..1 | Reference(Patient | RelatedPerson) | Person who verified | |||||
| verificationDate | 0..1 | dateTime | When consent verified | |||||
 provision | Σ | 0..1 | BackboneElement | Constraints to the base Consent.policyRule | ||||
 id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | code | deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent. | ||||
| period | Σ | 0..1 | Period | Timeframe for this rule | ||||
| actor | 0..* | BackboneElement | Who|what controlled by this rule (or group, by role) | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| role | 1..1 | CodeableConcept | How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations. | |||||
| reference | 1..1 | Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Resource for the actor (or group, by role) | |||||
| action | Σ | 0..* | CodeableConcept | Actions controlled by this rule Binding: ConsentActionCodes (example): Detailed codes for the consent action. | ||||
| securityLabel | Σ | 0..* | Coding | Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| purpose | Σ | 0..* | Coding | Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels. | ||||
| class | Σ | 0..* | Coding | e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers. | ||||
| code | Σ | 0..* | CodeableConcept | e.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 | Σ | 0..1 | Period | Timeframe for data controlled by this rule | ||||
| data | Σ | 0..* | BackboneElement | Data controlled by this rule | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| meaning | Σ | 1..1 | code | instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions. | ||||
| reference | Σ | 1..1 | Reference(Resource) | The actual data reference | ||||
| provision | 0..* | See provision (Consent) | Nested Exception Rules | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | ||||
| Consent.language | preferred | CommonLanguages
| ||||
| Consent.status | required | ConsentState | ||||
| Consent.scope | extensible | ConsentScopeCodes | ||||
| Consent.category | extensible | NihConsentCodes (a valid code from NIH Consent Codes) | ||||
| Consent.policyRule | extensible | ConsentPolicyRuleCodes | ||||
| Consent.provision.type | required | ConsentProvisionType | ||||
| Consent.provision.actor.role | extensible | SecurityRoleType | ||||
| Consent.provision.action | example | ConsentActionCodes | ||||
| Consent.provision.securityLabel | extensible | All Security Labels | ||||
| Consent.provision.purpose | extensible | PurposeOfUse | ||||
| Consent.provision.class | extensible | ConsentContentClass | ||||
| Consent.provision.code | example | ConsentContentCodes (a valid code from LOINC) | ||||
| Consent.provision.data.meaning | required | ConsentDataMeaning |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| disease-specific-consent-code | error | Consent.extension:diseaseAbbreviation | Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code. : valueString.matches('DS-[A-Z]+') | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Consent
Differential View
This structure is derived from Consent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Consent | 0..* | Consent | A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| diseaseAbbreviation | 0..1 | string | Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation | |
| category | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Binding: NIH Consent Code ValueSet (extensible) | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Conformance | ValueSet |
| Consent.category | extensible | NihConsentCodes (a valid code from NIH Consent Codes) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Consent | C | 0..* | Consent | A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| diseaseAbbreviation | C | 0..1 | string | Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!Σ | 1..1 | code | draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent. |
| scope | ?!Σ | 1..1 | CodeableConcept | Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource. |
| category | Σ | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Binding: NIH Consent Code ValueSet (extensible) |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet |
| Consent.status | required | ConsentState |
| Consent.scope | extensible | ConsentScopeCodes |
| Consent.category | extensible | NihConsentCodes (a valid code from NIH Consent Codes) |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| disease-specific-consent-code | error | Consent.extension:diseaseAbbreviation | Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code. : valueString.matches('DS-[A-Z]+') | |
| dom-2 | error | Consent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Consent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Consent | 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 | error | Consent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Consent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ppc-1 | error | Consent | Either a Policy or PolicyRule : policy.exists() or policyRule.exists() | |
| ppc-2 | error | Consent | IF Scope=privacy, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not() | |
| ppc-3 | error | Consent | IF Scope=research, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='research').exists().not() | |
| ppc-4 | error | Consent | IF Scope=adr, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='adr').exists().not() | |
| ppc-5 | error | Consent | IF Scope=treatment, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Consent | C | 0..* | Consent | A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| diseaseAbbreviation | C | 0..1 | string | Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation | ||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Identifier for this record (external references) Example General: {"system":"urn:ietf:rfc:3986","value":"Local eCMS identifier"} | ||||
| status | ?!Σ | 1..1 | code | draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent. | ||||
| scope | ?!Σ | 1..1 | CodeableConcept | Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource. | ||||
| category | Σ | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Binding: NIH Consent Code ValueSet (extensible) | ||||
| patient | Σ | 0..1 | Reference(Patient) | Who the consent applies to | ||||
| dateTime | Σ | 0..1 | dateTime | When this Consent was created or indexed | ||||
| performer | Σ | 0..* | Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Who is agreeing to the policy and rules | ||||
| organization | Σ | 0..* | Reference(Organization) | Custodian of the consent | ||||
| source[x] | Σ | 0..1 | Source from which this consent is taken | |||||
| sourceAttachment | Attachment | |||||||
| sourceReference | Reference(Consent | DocumentReference | Contract | QuestionnaireResponse) | |||||||
| policy | 0..* | BackboneElement | Policies covered by this consent | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | C | 0..1 | uri | Enforcement source for policy | ||||
| uri | C | 0..1 | uri | Specific policy covered by this consent | ||||
| policyRule | ΣC | 0..1 | CodeableConcept | Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples. | ||||
| verification | Σ | 0..* | BackboneElement | Consent Verified by patient or family | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| verified | Σ | 1..1 | boolean | Has been verified | ||||
| verifiedWith | 0..1 | Reference(Patient | RelatedPerson) | Person who verified | |||||
| verificationDate | 0..1 | dateTime | When consent verified | |||||
| provision | Σ | 0..1 | BackboneElement | Constraints to the base Consent.policyRule | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | code | deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent. | ||||
| period | Σ | 0..1 | Period | Timeframe for this rule | ||||
| actor | 0..* | BackboneElement | Who|what controlled by this rule (or group, by role) | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| role | 1..1 | CodeableConcept | How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations. | |||||
| reference | 1..1 | Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Resource for the actor (or group, by role) | |||||
| action | Σ | 0..* | CodeableConcept | Actions controlled by this rule Binding: ConsentActionCodes (example): Detailed codes for the consent action. | ||||
| securityLabel | Σ | 0..* | Coding | Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| purpose | Σ | 0..* | Coding | Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels. | ||||
| class | Σ | 0..* | Coding | e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers. | ||||
| code | Σ | 0..* | CodeableConcept | e.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 | Σ | 0..1 | Period | Timeframe for data controlled by this rule | ||||
| data | Σ | 0..* | BackboneElement | Data controlled by this rule | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| meaning | Σ | 1..1 | code | instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions. | ||||
| reference | Σ | 1..1 | Reference(Resource) | The actual data reference | ||||
| provision | 0..* | See provision (Consent) | Nested Exception Rules | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | ||||
| Consent.language | preferred | CommonLanguages
| ||||
| Consent.status | required | ConsentState | ||||
| Consent.scope | extensible | ConsentScopeCodes | ||||
| Consent.category | extensible | NihConsentCodes (a valid code from NIH Consent Codes) | ||||
| Consent.policyRule | extensible | ConsentPolicyRuleCodes | ||||
| Consent.provision.type | required | ConsentProvisionType | ||||
| Consent.provision.actor.role | extensible | SecurityRoleType | ||||
| Consent.provision.action | example | ConsentActionCodes | ||||
| Consent.provision.securityLabel | extensible | All Security Labels | ||||
| Consent.provision.purpose | extensible | PurposeOfUse | ||||
| Consent.provision.class | extensible | ConsentContentClass | ||||
| Consent.provision.code | example | ConsentContentCodes (a valid code from LOINC) | ||||
| Consent.provision.data.meaning | required | ConsentDataMeaning |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| disease-specific-consent-code | error | Consent.extension:diseaseAbbreviation | Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code. : valueString.matches('DS-[A-Z]+') | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Consent
Other representations of profile: CSV, Excel, Schematron