---
type: "resource-definitions"
title: "Consent Definitions"
resource: "Consent"
---

# Consent Definitions

<a id="Consent"></a>

## 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


<a id="Consent.identifier"></a>

## 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](/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


<a id="Consent.status"></a>

## Consent.status
draft | active | inactive | not-done | entered-in-error | unknown

**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](/code)

**Binding:** required:[consent-state-codes](/valueset-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)


<a id="Consent.category"></a>

## 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](/CodeableConcept)

**Binding:** example:[consent-category-example](/valueset-consent-category-example)

**Summary:** true

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


<a id="Consent.subject"></a>

## 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](/Patient), [Practitioner](/Practitioner), [ResearchSubject](/ResearchSubject), [Group](/Group))

**Summary:** true

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


<a id="Consent.date"></a>

## Consent.date
Fully executed date of the consent

**Definition:** Date the consent instance was agreed to.

**Cardinality:** 0..1

**Type:** [date](/date)

**Summary:** true

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


<a id="Consent.period"></a>

## 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](/Period)

**Summary:** true


<a id="Consent.grantor"></a>

## 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](/CareTeam), [Group](/Group), [HealthcareService](/HealthcareService), [Organization](/Organization), [Patient](/Patient), [Practitioner](/Practitioner), [RelatedPerson](/RelatedPerson), [PractitionerRole](/PractitionerRole))

**Summary:** true


<a id="Consent.grantee"></a>

## 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](/CareTeam), [Group](/Group), [HealthcareService](/HealthcareService), [Organization](/Organization), [Patient](/Patient), [Practitioner](/Practitioner), [RelatedPerson](/RelatedPerson), [PractitionerRole](/PractitionerRole))

**Summary:** true


<a id="Consent.manager"></a>

## Consent.manager
Consent workflow management

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

**Aliases:** manager

**Cardinality:** 0..*

**Type:** Reference([HealthcareService](/HealthcareService), [Organization](/Organization), [Patient](/Patient), [Practitioner](/Practitioner))

**Mappings:** w5=FiveWs.witness


<a id="Consent.controller"></a>

## Consent.controller
Consent Enforcer

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

**Aliases:** controller

**Cardinality:** 0..*

**Type:** Reference([HealthcareService](/HealthcareService), [Organization](/Organization), [Patient](/Patient), [Practitioner](/Practitioner))


<a id="Consent.sourceAttachment"></a>

## 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](/Attachment)

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


<a id="Consent.sourceReference"></a>

## 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.

**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:** Reference([Consent](/Consent), [DocumentReference](/DocumentReference), [Contract](/Contract), [QuestionnaireResponse](/QuestionnaireResponse))

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


<a id="Consent.regulatoryBasis"></a>

## 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](/CodeableConcept)

**Binding:** example:[consent-policy](/valueset-consent-policy)

**Summary:** false

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


<a id="Consent.policyBasis"></a>

## 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](/BackboneElement)

**Summary:** false


<a id="Consent.policyBasis.reference"></a>

## 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](/Resource))

**Summary:** false


<a id="Consent.policyBasis.uri"></a>

## 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](/uri)

**Summary:** false


<a id="Consent.policyText"></a>

## Consent.policyText
Human Readable Policy

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

**Cardinality:** 0..*

**Type:** Reference([DocumentReference](/DocumentReference))

**Summary:** false


<a id="Consent.verification"></a>

## 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](/BackboneElement)

**Summary:** true


<a id="Consent.verification.verified"></a>

## Consent.verification.verified
Has been verified

**Definition:** Has the instruction been verified.

**Cardinality:** 1..1

**Type:** [boolean](/boolean)

**Summary:** true


<a id="Consent.verification.type"></a>

## 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](/CodeableConcept)

**Binding:** example:[consent-verification](/valueset-consent-verification)


<a id="Consent.verification.verifiedBy"></a>

## Consent.verification.verifiedBy
Person conducting verification

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

**Cardinality:** 0..1

**Type:** Reference([Organization](/Organization), [Practitioner](/Practitioner), [PractitionerRole](/PractitionerRole))


<a id="Consent.verification.verifiedWith"></a>

## Consent.verification.verifiedWith
Person who verified

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

**Cardinality:** 0..1

**Type:** Reference([Patient](/Patient), [RelatedPerson](/RelatedPerson), [Group](/Group))


<a id="Consent.verification.date"></a>

## Consent.verification.date
When consent verified

**Definition:** Date(s) verification was collected.

**Comments:** Allows for history of verification/validation.

**Cardinality:** 0..*

**Type:** [dateTime](/dateTime)


<a id="Consent.decision"></a>

## Consent.decision
deny | permit

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

**Cardinality:** 0..1

**Type:** [code](/code)

**Binding:** required:[consent-provision-type](/valueset-consent-provision-type)

**Summary:** true

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


<a id="Consent.provision"></a>

## 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](/BackboneElement)

**Summary:** true


<a id="Consent.provision.period"></a>

## 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](/Period)

**Summary:** true

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


<a id="Consent.provision.actor"></a>

## 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](/BackboneElement)


<a id="Consent.provision.actor.role"></a>

## 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](/CodeableConcept)

**Binding:** extensible:[participation-role-type](/valueset-participation-role-type)


<a id="Consent.provision.actor.reference"></a>

## 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](/Device), [Group](/Group), [CareTeam](/CareTeam), [Organization](/Organization), [Patient](/Patient), [Practitioner](/Practitioner), [RelatedPerson](/RelatedPerson), [PractitionerRole](/PractitionerRole))


<a id="Consent.provision.action"></a>

## 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](/CodeableConcept)

**Binding:** example:[consent-action](/valueset-consent-action)

**Summary:** true


<a id="Consent.provision.securityLabel"></a>

## 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](/Coding)

**Binding:** example:[security-label-example](/valueset-security-label-example)

**Summary:** true


<a id="Consent.provision.purpose"></a>

## 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](/Coding)

**Binding:** extensible:[v3-PurposeOfUse](/valueset-v3-PurposeOfUse)

**Summary:** true


<a id="Consent.provision.documentType"></a>

## 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](/Coding)

**Binding:** preferred:[consent-content-class](/valueset-consent-content-class)

**Summary:** true


<a id="Consent.provision.resourceType"></a>

## 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](/Coding)

**Binding:** extensible:[resource-types](/valueset-resource-types)

**Summary:** true


<a id="Consent.provision.code"></a>

## 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](/CodeableConcept)

**Binding:** example:[consent-content-code](/valueset-consent-content-code)

**Summary:** true


<a id="Consent.provision.dataPeriod"></a>

## 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](/Period)

**Summary:** true


<a id="Consent.provision.data"></a>

## 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](/BackboneElement)

**Summary:** true


<a id="Consent.provision.data.meaning"></a>

## Consent.provision.data.meaning
instance | related | dependents | authoredby

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

**Cardinality:** 1..1

**Type:** [code](/code)

**Binding:** required:[consent-data-meaning](/valueset-consent-data-meaning)

**Summary:** true


<a id="Consent.provision.data.reference"></a>

## 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](/Resource))

**Summary:** true


<a id="Consent.provision.expression"></a>

## 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](/Expression)


<a id="Consent.provision.provision"></a>

## Consent.provision.provision
Nested Exception Provisions

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

**Cardinality:** 0..*