Consent Definitions — FHIR Core Extract

type: resource-definitionsresource: Consent

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

Definition: A record of a healthcare consumer’s choices or choices made on their behalf by a third party, 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.

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 consent for research participation and data sharing.

Cardinality: 0..*

Mappings: workflow=Event; v2=CON; w5=infrastructure.information

Consent.identifier

Identifier for this record (external references)

Definition: Unique identifier for this copy of the Consent Statement.

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.

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: workflow=Event.identifier; w5=FiveWs.identifier; v2=CON-4 (Consent Form Number – EI) Note: An implementation-specific requirement will be needed

Consent.status

Definition: Indicates the current state of this Consent resource.

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.

Cardinality: 1..1

Type: code

Binding: required:consent-state-codes

Summary: true

Is Modifier: true (Reason: 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)

Mappings: workflow=Event.status; w5=FiveWs.status; v2=CON-11 (Consent Status – CNE using table HL70498)

Consent.category

Classification of the consent statement - for indexing/retrieval

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:consent-category-example

Summary: true

Mappings: workflow=Event.code; w5=FiveWs.class; v2=CON-2 (Consent Type - CWE using table HL70496)

Consent.subject

Who the consent applies to

Definition: The patient, healthcare practitioner, research subject, or a group of persons to whom this consent applies.

Cardinality: 0..1

Type: Reference(Patient, Practitioner, ResearchSubject, Group)

Summary: true

Mappings: workflow=Event.subject; w5=FiveWs.subject

Consent.date

Fully executed date of the consent

Definition: Date the consent instance was agreed to.

Cardinality: 0..1

Type: date

Summary: true

Mappings: workflow=Event.occurrence[x]; w5=FiveWs.recorded; v2=CON-13 (Consent Decision Date/Time – DTM)

Consent.period

Effective period for this Consent

Definition: Effective period for this Consent Resource and all provisions unless specified in that provision.

Aliases: period

Cardinality: 0..1

Type: Period

Summary: true

Consent.grantor

Who is granting rights according to the policy and rules

Definition: The entity responsible for granting the rights listed in a Consent Directive.

Aliases: grantor

Cardinality: 0..*

Type: Reference(CareTeam, Group, HealthcareService, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)

Summary: true

Consent.grantee

Who is agreeing to the policy and rules

Definition: The entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions.

Comments: In a fully computable consent, both grantee and grantor will be listed as actors within the consent. The Grantee and Grantor elements are for ease of search only.

Aliases: grantee

Cardinality: 0..*

Type: Reference(CareTeam, Group, HealthcareService, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)

Summary: true

Consent.manager

Consent workflow management

Definition: The actor that manages the consent through its lifecycle.

Aliases: manager

Cardinality: 0..*

Type: Reference(HealthcareService, Organization, Patient, Practitioner)

Mappings: w5=FiveWs.witness

Consent.controller

Consent Enforcer

Definition: The actor that controls/enforces the access according to the consent.

Aliases: controller

Cardinality: 0..*

Type: Reference(HealthcareService, Organization, Patient, Practitioner)

Consent.sourceAttachment

Source from which this consent is taken

Definition: The source on which this consent statement is based. The source might be a scanned original paper form.

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.

Cardinality: 0..*

Type: Attachment

Mappings: v2=Potential mappings to CON-5,6,7,8,16,19, 20-23

Consent.sourceReference

Source from which this consent is taken

Definition: 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.

Cardinality: 0..*

Type: Reference(Consent, DocumentReference, Contract, QuestionnaireResponse)

Mappings: v2=Potential mappings to CON-5,6,7,8,16,19, 20-23

Consent.regulatoryBasis

Regulations establishing base Consent

Definition: A set of codes that indicate the regulatory basis (if any) that this consent supports.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:consent-policy

Summary: false

Mappings: v2=CON-3 (Consent Form ID and Version – ST) Note: An implementation-specific requirement will be needed

Consent.policyBasis

Computable version of the backing policy

Definition: A Reference or URL used to uniquely identify the policy the organization will enforce for this Consent. This Reference or URL should be specific to the version of the policy and should be dereferencable to a computable policy of some form.

Cardinality: 0..1

Type: BackboneElement

Summary: false

Consent.policyBasis.reference

Reference backing policy resource

Definition: A Reference that identifies the policy the organization will enforce for this Consent.

Comments: While any resource may be used, Consent, PlanDefinition and Contract would be most frequent

Cardinality: 0..1

Type: Reference(Resource)

Summary: false

Consent.policyBasis.uri

URI to a computable backing policy

Definition: A URI that links to a computable version of the policy the organization will enforce for this Consent.

Cardinality: 0..1

Type: uri

Summary: false

Consent.policyText

Human Readable Policy

Definition: A Reference to the human readable policy explaining the basis for the Consent.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: false

Consent.verification

Consent Verified by patient or family

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Consent.verification.verified

Has been verified

Definition: Has the instruction been verified.

Cardinality: 1..1

Type: boolean

Summary: true

Consent.verification.type

Business case of verification

Definition: Extensible list of verification type starting with verification and re-validation.

Comments: This allows the verification element to hold multiple use cases including RelatedPerson verification of the Grantee decision and periodic re-validation of the consent.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:consent-verification

Consent.verification.verifiedBy

Person conducting verification

Definition: The person who conducted the verification/validation of the Grantor decision.

Cardinality: 0..1

Type: Reference(Organization, Practitioner, PractitionerRole)

Consent.verification.verifiedWith

Person who verified

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

Cardinality: 0..1

Type: Reference(Patient, RelatedPerson, Group)

Consent.verification.date

When consent verified

Definition: Date(s) verification was collected.

Comments: Allows for history of verification/validation.

Cardinality: 0..*

Type: dateTime

Consent.decision

deny | permit

Definition: Action to take - permit or deny - as default.

Cardinality: 0..1

Type: code

Binding: required:consent-provision-type

Summary: true

Is Modifier: true (Reason: Sets context for the values in .provision)

Consent.provision

Constraints to the base Consent.policyRule/Consent.policy

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Consent.provision.period

Timeframe for this provision

Definition: Timeframe for this provision.

Comments: This is the bound effective time of the consent and should be in the base provision in the Consent resource.

Cardinality: 0..1

Type: Period

Summary: true

Mappings: v2=CON-14&15 (Consent Effective Date Time, Consent End DateTime)

Consent.provision.actor

Who|what controlled by this provision (or group, by role)

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

Meaning if Missing: There is no specific actor associated with the exception

Cardinality: 0..*

Type: BackboneElement

Consent.provision.actor.role

How the actor is involved

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

Cardinality: 0..1

Type: CodeableConcept

Binding: extensible:participation-role-type

Consent.provision.actor.reference

Resource for the actor (or group, by role)

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').

Cardinality: 0..1

Type: Reference(Device, Group, CareTeam, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)

Consent.provision.action

Actions controlled by this provision

Definition: Actions controlled by this provision.

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'.

Meaning if Missing: all actions

Cardinality: 0..*

Type: CodeableConcept

Binding: example:consent-action

Summary: true

Consent.provision.securityLabel

Security Labels that define affected resources

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

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.

Cardinality: 0..*

Type: Coding

Binding: example:security-label-example

Summary: true

Consent.provision.purpose

Context of activities covered by this provision

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

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

Cardinality: 0..*

Type: Coding

Binding: extensible:v3-PurposeOfUse

Summary: true

Consent.provision.documentType

e.g. Resource Type, Profile, CDA, etc

Definition: The documentType(s) covered by this provision. The type can be a CDA document, or some other type that indicates what sort of information the consent relates to.

Comments: Multiple types are or'ed together. The intention of the documentType element is that the codes refer to document types defined in a standard somewhere.

Cardinality: 0..*

Type: Coding

Binding: preferred:consent-content-class

Summary: true

Consent.provision.resourceType

e.g. Resource Type, Profile, etc

Definition: The resourceType(s) covered by this provision. The type can be a FHIR resource type or a profile on a type that indicates what information the consent relates to.

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

Cardinality: 0..*

Type: Coding

Binding: extensible:resource-types

Summary: true

Consent.provision.code

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

Definition: If this code is found in an instance, then the provision applies.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:consent-content-code

Summary: true

Consent.provision.dataPeriod

Timeframe for data controlled by this provision

Definition: Clinical or Operational Relevant period of time that bounds the data controlled by this provision.

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.

Cardinality: 0..1

Type: Period

Summary: true

Consent.provision.data

Data controlled by this provision

Definition: The resources controlled by this provision if specific resources are referenced.

Meaning if Missing: all data

Cardinality: 0..*

Type: BackboneElement

Summary: true

Consent.provision.data.meaning

instance | related | dependents | authoredby

Definition: How the resource reference is interpreted when testing consent restrictions.

Cardinality: 1..1

Type: code

Binding: required:consent-data-meaning

Summary: true

Consent.provision.data.reference

The actual data reference

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

Cardinality: 1..1

Type: Reference(Resource)

Summary: true

Consent.provision.expression

A computable expression of the consent

Definition: A computable (FHIRPath or other) definition of what is controlled by this consent.

Comments: Constraining the expression type for a specific implementation via profile is recommended

Cardinality: 0..1

Type: Expression

Consent.provision.provision

Nested Exception Provisions

Definition: Provisions which provide exceptions to the base provision or subprovisions.

Cardinality: 0..*