STU 3 Ballot

This page is part of the FHIR Specification (v1.6.0: STU 3 Ballot 4). 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

6.4.10 Resource Consent - Detailed Descriptions

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.

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
BindingConsentStatus: Indicates the status of the consent (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 is the status of this consent at the time it was issued / created / indexed.

Consent.category
Definition

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

Control0..*
BindingConsent Category Codes: A classification of the type of consents found in a consent statement (Example)
TypeCodeableConcept
Summarytrue
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.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.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.consentor
Definition

The patient/consumer that is responsible for agreeing to the consent represented by this resource. This is the person (usually) that agreed to the policy, along with the exceptions, e.g. the persion who takes responsibility for the agreement. In the signature this corresponds to the role "Consent Signature".

Control0..*
TypeReference(Organization | Patient | Practitioner | RelatedPerson)
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.organization
Definition

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

Control0..1
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

A reference to the policy that this consents to. Policies may be organizational, but are often defined jurisdictionally, or in law.

Control1..1
Typeuri
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.

Consent.recipient
Definition

Actor whose access is controlled by this consent under the terms of the policy and exceptions.

Control0..*
TypeReference(Device | Group | Organization | Patient | Practitioner | RelatedPerson | CareTeam)
Meaning if MissingThere is no specific actor who is the focus of the consent
Summarytrue
Comments

The Consent recipient is the person/organization who is being granted or denied permission according to the stated policy.

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..*
BindingPurposeOfUse: What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels (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.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
BindingConsentExceptType: How an exception is statement is applied, as adding additional consent, or removing consent (Required)
Typecode
Summarytrue
Consent.except.period
Definition

The timeframe in which data is 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.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 or was involved in the resourcescontent that is described in the exception.

Control1..1
BindingConsent Actor Roles: How an actor is involved in the consent considerations (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..*
BindingConsent Action Codes: Detailed codes for the consent action. (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..*
BindingAll Security Labels: Security Labels from the Healthcare Privacy and Security Classification System. (Extensible)
TypeCoding
Summarytrue
Comments

If the consent specifies a security label of "R" then it applies to all resources that are labelled "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..*
BindingPurposeOfUse: What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels (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..*
BindingConsent Content Class: The class (type) of information a consent rule covers (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. TODO: where do you not have to look? This is a problematic element.

Control0..*
BindingConsent Content Codes: If this code is found in an instance, then the exception applies (Example)
TypeCoding
Summarytrue
Comments

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

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
BindingConsentDataMeaning: How a resource reference is interpreted when testing consent restrictions (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