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Community Based Collaborative Care icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Patient Compartments: Patient

Detailed Descriptions for the elements in the Consent resource.

Consent
Element IdConsent
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.

Short DisplayA 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
Cardinality0..*
TypeDomainResource
Summaryfalse
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.

Consent.identifier
Element IdConsent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

Short DisplayIdentifier for this record (external references)
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
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.

Consent.status
Element IdConsent.status
Definition

Indicates the current state of this Consent resource.

Short Displaydraft | active | inactive | not-done | entered-in-error | unknown
Cardinality1..1
Terminology BindingConsentState (Required)
Typecode
Is Modifiertrue (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)
Summarytrue
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.

Consent.category
Element IdConsent.category
Definition

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

Short DisplayClassification of the consent statement - for indexing/retrieval
Cardinality0..*
Terminology BindingConsent Category Codes (Example)
TypeCodeableConcept
Summarytrue
Consent.subject
Element IdConsent.subject
Definition

The patient/healthcare practitioner or group of persons to whom this consent applies.

Short DisplayWho the consent applies to
Cardinality0..1
TypeReference(Patient | Practitioner | Group)
Summarytrue
Consent.dateTime
Element IdConsent.dateTime
Definition

Date and time the consent instance was agreed to.

Short DisplayWhen consent was agreed to
Cardinality0..1
TypedateTime
Summarytrue
Consent.grantor
Element IdConsent.grantor
Definition

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

Short DisplayWho is granting rights according to the policy and rules
Cardinality0..*
TypeReference(CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Alternate Namesgrantor
Summarytrue
Consent.grantee
Element IdConsent.grantee
Definition

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

Short DisplayWho is agreeing to the policy and rules
Cardinality0..*
TypeReference(CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Alternate Namesgrantee
Summarytrue
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.

Consent.manager
Element IdConsent.manager
Definition

The actor that manages the consent through its lifecycle.

Short DisplayConsent workflow management
Cardinality0..*
TypeReference(HealthcareService | Organization | Patient | Practitioner)
Alternate Namesmanager
Summaryfalse
Consent.controller
Element IdConsent.controller
Definition

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

Short DisplayConsent Enforcer
Cardinality0..*
TypeReference(HealthcareService | Organization | Patient | Practitioner)
Alternate Namescontroller
Summaryfalse
Consent.sourceAttachment
Element IdConsent.sourceAttachment
Definition

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

Short DisplaySource from which this consent is taken
Cardinality0..*
TypeAttachment
Summaryfalse
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.

Consent.sourceReference
Element IdConsent.sourceReference
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.

Short DisplaySource from which this consent is taken
Cardinality0..*
TypeReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
Summaryfalse
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.

Consent.regulatoryBasis
Element IdConsent.regulatoryBasis
Definition

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

Short DisplayRegulations establishing base Consent
Cardinality0..*
Terminology BindingConsent PolicyRule Codes (Example)
TypeCodeableConcept
Summaryfalse
Consent.policyBasis
Element IdConsent.policyBasis
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.

Short DisplayComputable version of the backing policy
Cardinality0..1
Summaryfalse
Consent.policyBasis.reference
Element IdConsent.policyBasis.reference
Definition

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

Short DisplayReference backing policy resource
Cardinality0..1
TypeReference(Any)
Summaryfalse
Comments

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

Consent.policyBasis.url
Element IdConsent.policyBasis.url
Definition

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

Short DisplayURL to a computable backing policy
Cardinality0..1
Typeurl
Summaryfalse
Consent.policyText
Element IdConsent.policyText
Definition

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

Short DisplayHuman Readable Policy
Cardinality0..*
TypeReference(DocumentReference)
Summaryfalse
Consent.verification
Element IdConsent.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.

Short DisplayConsent Verified by patient or family
Cardinality0..*
Summarytrue
Consent.verification.verified
Element IdConsent.verification.verified
Definition

Has the instruction been verified.

Short DisplayHas been verified
Cardinality1..1
Typeboolean
Summarytrue
Consent.verification.verificationType
Element IdConsent.verification.verificationType
Definition

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

Short DisplayBusiness case of verification
Cardinality0..1
Terminology BindingConsent Vefication Codes (Example)
TypeCodeableConcept
Summaryfalse
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.

Consent.verification.verifiedBy
Element IdConsent.verification.verifiedBy
Definition

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

Short DisplayPerson conducting verification
Cardinality0..1
TypeReference(Organization | Practitioner | PractitionerRole)
Summaryfalse
Consent.verification.verifiedWith
Element IdConsent.verification.verifiedWith
Definition

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

Short DisplayPerson who verified
Cardinality0..1
TypeReference(Patient | RelatedPerson)
Summaryfalse
Consent.verification.verificationDate
Element IdConsent.verification.verificationDate
Definition

Date(s) verification was collected.

Short DisplayWhen consent verified
Cardinality0..*
TypedateTime
Summaryfalse
Comments

Allows for history of verification/validation.

Consent.provision
Element IdConsent.provision
Definition

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

Short DisplayConstraints to the base Consent.policyRule/Consent.policy
Cardinality0..1
Summarytrue
Consent.provision.type
Element IdConsent.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.

Short Displaydeny | permit
Cardinality0..1
Terminology BindingConsentProvisionType (Required)
Typecode
Is Modifiertrue (Reason: Sets context for the other values in .provision)
Summarytrue
Consent.provision.period
Element IdConsent.provision.period
Definition

The timeframe in this rule is valid.

Short DisplayTimeframe for this rule
Cardinality0..1
TypePeriod
Summarytrue
Comments

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

Consent.provision.actor
Element IdConsent.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').

Short DisplayWho|what controlled by this rule (or group, by role)
Cardinality0..*
Meaning if MissingThere is no specific actor associated with the exception
Summaryfalse
Consent.provision.actor.role
Element IdConsent.provision.actor.role
Definition

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

Short DisplayHow the actor is involved
Cardinality0..1
Terminology BindingParticipationRoleType (Extensible)
TypeCodeableConcept
Summaryfalse
Consent.provision.actor.reference
Element IdConsent.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').

Short DisplayResource for the actor (or group, by role)
Cardinality0..1
TypeReference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Summaryfalse
Consent.provision.action
Element IdConsent.provision.action
Definition

Actions controlled by this Rule.

Short DisplayActions controlled by this rule
Cardinality0..*
Terminology BindingConsent Action Codes (Example)
TypeCodeableConcept
Meaning if Missingall actions
Summarytrue
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'.

Consent.provision.securityLabel
Element IdConsent.provision.securityLabel
Definition

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

Short DisplaySecurity Labels that define affected resources
Cardinality0..*
Terminology BindingExample set of Security Labels (Example)
TypeCoding
Summarytrue
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.

Consent.provision.purpose
Element IdConsent.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.

Short DisplayContext of activities covered by this rule
Cardinality0..*
Terminology BindingPurposeOfUse icon (Extensible)
TypeCoding
Summarytrue
Comments

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

Consent.provision.class
Element IdConsent.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.

Short Displaye.g. Resource Type, Profile, CDA, etc.
Cardinality0..*
Terminology BindingConsent Content Class (Extensible)
TypeCoding
Summarytrue
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.

Consent.provision.code
Element IdConsent.provision.code
Definition

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

Short Displaye.g. LOINC or SNOMED CT code, etc. in the content
Cardinality0..*
Terminology BindingConsent Content Codes (Example)
TypeCodeableConcept
Summarytrue
Comments

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

Consent.provision.dataPeriod
Element IdConsent.provision.dataPeriod
Definition

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

Short DisplayTimeframe for data controlled by this rule
Cardinality0..1
TypePeriod
Summarytrue
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.

Consent.provision.data
Element IdConsent.provision.data
Definition

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

Short DisplayData controlled by this rule
Cardinality0..*
Meaning if Missingall data
Summarytrue
Consent.provision.data.meaning
Element IdConsent.provision.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Short Displayinstance | related | dependents | authoredby
Cardinality1..1
Terminology BindingConsentDataMeaning (Required)
Typecode
Summarytrue
Consent.provision.data.reference
Element IdConsent.provision.data.reference
Definition

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

Short DisplayThe actual data reference
Cardinality1..1
TypeReference(Any)
Summarytrue
Consent.provision.expression
Element IdConsent.provision.expression
Definition

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

Short DisplayA computable expression of the consent
Cardinality0..1
TypeExpression
Summaryfalse
Comments

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

Consent.provision.provision
Element IdConsent.provision.provision
Definition

Rules which provide exceptions to the base rule or subrules.

Short DisplayNested Exception Rules
Cardinality0..*
TypeSee Consent.provision
Summaryfalse