FHIR Release 3 (STU)

This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

Community Based Collaborative Care Work GroupMaturity Level: 1 Trial UseCompartments: Patient

Detailed Descriptions for the elements in the Consent resource.

Consent
Definition

A record of a healthcare consumer’s policy choices, 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.

Control1..1
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 general advance care directives.

InvariantsDefined on this element
ppc-1: Either a Policy or PolicyRule (expression : policy.exists() or policyRule.exists(), xpath: exists(f:policy) or exists(f:policyRule))
Consent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Summarytrue
Comments

This identifier is 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
Definition

Indicates the current state of this consent.

Control1..1
Terminology BindingConsentState (Required)
Typecode
Is Modifiertrue
Requirements

The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.

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
Definition

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

Control0..*
Terminology BindingConsent Category Codes (Example)
TypeCodeableConcept
Summarytrue
Consent.patient
Definition

The patient/healthcare consumer to whom this consent applies.

Control1..1
TypeReference(Patient)
Summarytrue
Comments

Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person.

Consent.period
Definition

Relevant time or time-period when this Consent is applicable.

Control0..1
TypePeriod
Meaning if Missingall date ranges included
Summarytrue
Comments

This can be a subset of the period of the original statement.

Consent.dateTime
Definition

When this Consent was issued / created / indexed.

Control0..1
TypedateTime
Summarytrue
Comments

This is not the time of the original consent, but the time that this statement was made or derived.

Consent.consentingParty
Definition

Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions.

Control0..*
TypeReference(Organization | Patient | Practitioner | RelatedPerson)
Alternate Namesconsentor
Summarytrue
Comments

Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian.

Consent.actor
Definition

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

Control0..*
Meaning if MissingThere is no specific actor associated with the consent
Summarytrue
Consent.actor.role
Definition

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

Control1..1
Terminology BindingSecurityRoleType (Extensible)
TypeCodeableConcept
Consent.actor.reference
Definition

The resource that identifies the actor. To identify a actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').

Control1..1
TypeReference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson)
Consent.action
Definition

Actions controlled by this consent.

Control0..*
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.organization
Definition

The organization that manages the consent, and the framework within which it is executed.

Control0..*
TypeReference(Organization)
Alternate Namescustodian
Summarytrue
Consent.source[x]
Definition

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

Control0..1
TypeAttachment|Identifier|Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
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.policy
Definition

The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

Control0..*
Consent.policy.authority
Definition

Entity or Organization having regulatory jurisdiction or accountability for  enforcing policies pertaining to Consent Directives.

Control0..1
Typeuri
InvariantsAffect this element
ppc-1: Either a Policy or PolicyRule (expression : policy.exists() or policyRule.exists(), xpath: exists(f:policy) or exists(f:policyRule))
Consent.policy.uri
Definition

The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

Control0..1
Typeuri
Comments

This element is for discoverability / documentation, and does not modify or qualify the policy rules.

InvariantsAffect this element
ppc-1: Either a Policy or PolicyRule (expression : policy.exists() or policyRule.exists(), xpath: exists(f:policy) or exists(f:policyRule))
Consent.policyRule
Definition

A referece to the specific computable policy.

Control0..1
Typeuri
Requirements

Might be a unique identifier of a policy set in XACML, or other rules engine.

Summarytrue
Comments

If the policy reference is not known, the resource cannot be processed. Where the reference is absent, there is no particular policy other than what is expressed directly in the consent resource.

InvariantsAffect this element
ppc-1: Either a Policy or PolicyRule (expression : policy.exists() or policyRule.exists(), xpath: exists(f:policy) or exists(f:policyRule))
Consent.securityLabel
Definition

A set of security labels that define which resources are controlled by this consent. If more than one label is specified, all resources must have all the specified labels.

Control0..*
Terminology BindingAll Security Labels (Extensible)
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. Not all of the security labels make sense for use in this element (may define a narrower value set?).

Consent.purpose
Definition

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

Control0..*
Terminology BindingPurposeOfUse (Extensible)
TypeCoding
Summarytrue
Comments

This element is for discoverability / documentation, and does not modify or qualify the policy (e.g. the policy itself describes the purposes for which it applies).

Consent.dataPeriod
Definition

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

Control0..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.data
Definition

The resources controlled by this consent, if specific resources are referenced.

Control0..*
Meaning if Missingall data
Summarytrue
Consent.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Control1..1
Terminology BindingConsentDataMeaning (Required)
Typecode
Summarytrue
Consent.data.reference
Definition

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

Control1..1
TypeReference(Any)
Summarytrue
Consent.except
Definition

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

Control0..*
Summarytrue
Consent.except.type
Definition

Action to take - permit or deny - when the exception conditions are met.

Control1..1
Terminology BindingConsentExceptType (Required)
Typecode
Summarytrue
Consent.except.period
Definition

The timeframe in this exception is valid.

Control0..1
TypePeriod
Summarytrue
Consent.except.actor
Definition

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

Control0..*
Meaning if MissingThere is no specific actor associated with the exception
Summarytrue
Consent.except.actor.role
Definition

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

Control1..1
Terminology BindingSecurityRoleType (Extensible)
TypeCodeableConcept
Consent.except.actor.reference
Definition

The resource that identifies the actor. To identify a actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').

Control1..1
TypeReference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson)
Consent.except.action
Definition

Actions controlled by this Exception.

Control0..*
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.except.securityLabel
Definition

A set of security labels that define which resources are controlled by this exception. If more than one label is specified, all resources must have all the specified labels.

Control0..*
Terminology BindingAll Security Labels (Extensible)
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. Not all of the security labels make sense for use in this element (may define a narrower value set?).

Consent.except.purpose
Definition

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

Control0..*
Terminology BindingPurposeOfUse (Extensible)
TypeCoding
Summarytrue
Comments

E.g. if the purpose is 'research', then the operational context must be research, in order for the consent to apply. Not all of the security labels make sense for use in this element (may define a narrower value set?).

Consent.except.class
Definition

The class of information covered by this exception. 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.

Control0..*
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.except.code
Definition

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

Control0..*
Terminology BindingConsent Content Codes (Example)
TypeCoding
Summarytrue
Comments

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

Consent.except.dataPeriod
Definition

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

Control0..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.except.data
Definition

The resources controlled by this exception, if specific resources are referenced.

Control0..*
Meaning if Missingall data
Summarytrue
Consent.except.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Control1..1
Terminology BindingConsentDataMeaning (Required)
Typecode
Summarytrue
Consent.except.data.reference
Definition

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

Control1..1
TypeReference(Any)
Summarytrue