R6 Ballot (2nd Draft)

Publish-box (todo)

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 Id Consent
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 Display 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
Cardinality 0..*
Type DomainResource
Summary false
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 Id Consent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

Short Display Identifier for this record (external references)
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Summary true
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 Id Consent.status
Definition

Indicates the current state of this Consent resource.

Short Display draft | active | inactive | not-done | entered-in-error | unknown
Cardinality 1..1
Terminology Binding Consent State (Required)
Type code
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)
Summary true
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 Id Consent.category
Definition

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

Short Display Classification of the consent statement - for indexing/retrieval
Cardinality 0..*
Terminology Binding Consent Category Codes (Example)
Type CodeableConcept
Summary true
Consent.subject
Element Id Consent.subject
Definition

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

Short Display Who the consent applies to
Cardinality 0..1
Type Reference(Patient | Practitioner | Group)
Summary true
Consent.date
Element Id Consent.date
Definition

Date the consent instance was agreed to.

Short Display Fully executed date of the consent
Cardinality 0..1
Type date
Summary true
Consent.period
Element Id Consent.period
Definition

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

Short Display Effective period for this Consent
Cardinality 0..1
Type Period
Alternate Names period
Summary true
Consent.grantor
Element Id Consent.grantor
Definition

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

Short Display Who is granting rights according to the policy and rules
Cardinality 0..*
Type Reference(CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Alternate Names grantor
Summary true
Consent.grantee
Element Id Consent.grantee
Definition

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

Short Display Who is agreeing to the policy and rules
Cardinality 0..*
Type Reference(CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Alternate Names grantee
Summary true
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 Id Consent.manager
Definition

The actor that manages the consent through its lifecycle.

Short Display Consent workflow management
Cardinality 0..*
Type Reference(HealthcareService | Organization | Patient | Practitioner)
Alternate Names manager
Summary false
Consent.controller
Element Id Consent.controller
Definition

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

Short Display Consent Enforcer
Cardinality 0..*
Type Reference(HealthcareService | Organization | Patient | Practitioner)
Alternate Names controller
Summary false
Consent.sourceAttachment
Element Id Consent.sourceAttachment
Definition

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

Short Display Source from which this consent is taken
Cardinality 0..*
Type Attachment
Summary false
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 Id Consent.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 Display Source from which this consent is taken
Cardinality 0..*
Type Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
Summary false
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 Id Consent.regulatoryBasis
Definition

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

Short Display Regulations establishing base Consent
Cardinality 0..*
Terminology Binding Consent PolicyRule Codes (Example)
Type CodeableConcept
Summary false
Consent.policyBasis
Element Id Consent.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 Display Computable version of the backing policy
Cardinality 0..1
Summary false
Consent.policyBasis.reference
Element Id Consent.policyBasis.reference
Definition

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

Short Display Reference backing policy resource
Cardinality 0..1
Type Reference(Any)
Summary false
Comments

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

Consent.policyBasis.url
Element Id Consent.policyBasis.url
Definition

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

Short Display URL to a computable backing policy
Cardinality 0..1
Type url
Summary false
Consent.policyText
Element Id Consent.policyText
Definition

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

Short Display Human Readable Policy
Cardinality 0..*
Type Reference(DocumentReference)
Summary false
Consent.verification
Element Id Consent.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 Display Consent Verified by patient or family
Cardinality 0..*
Summary true
Consent.verification.verified
Element Id Consent.verification.verified
Definition

Has the instruction been verified.

Short Display Has been verified
Cardinality 1..1
Type boolean
Summary true
Consent.verification.verificationType
Element Id Consent.verification.verificationType
Definition

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

Short Display Business case of verification
Cardinality 0..1
Terminology Binding Consent Vefication Codes (Example)
Type CodeableConcept
Summary false
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 Id Consent.verification.verifiedBy
Definition

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

Short Display Person conducting verification
Cardinality 0..1
Type Reference(Organization | Practitioner | PractitionerRole)
Summary false
Consent.verification.verifiedWith
Element Id Consent.verification.verifiedWith
Definition

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

Short Display Person who verified
Cardinality 0..1
Type Reference(Patient | RelatedPerson)
Summary false
Consent.verification.verificationDate
Element Id Consent.verification.verificationDate
Definition

Date(s) verification was collected.

Short Display When consent verified
Cardinality 0..*
Type dateTime
Summary false
Comments

Allows for history of verification/validation.

Consent.decision
Element Id Consent.decision
Definition

Action to take - permit or deny - as default.

Short Display deny | permit
Cardinality 0..1
Terminology Binding Consent Provision Type (Required)
Type code
Is Modifier true (Reason: Sets context for the values in .provision)
Summary true
Consent.provision
Element Id Consent.provision
Definition

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

Short Display Constraints to the base Consent.policyRule/Consent.policy
Cardinality 0..*
Summary true
Consent.provision.period
Element Id Consent.provision.period
Definition

Timeframe for this provision.

Short Display Timeframe for this provision
Cardinality 0..1
Type Period
Summary true
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 Id Consent.provision.actor
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').

Short Display Who|what controlled by this provision (or group, by role)
Cardinality 0..*
Meaning if Missing There is no specific actor associated with the exception
Summary false
Consent.provision.actor.role
Element Id Consent.provision.actor.role
Definition

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

Short Display How the actor is involved
Cardinality 0..1
Terminology Binding Participation Role Type (Extensible)
Type CodeableConcept
Summary false
Consent.provision.actor.reference
Element Id Consent.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 Display Resource for the actor (or group, by role)
Cardinality 0..1
Type Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Summary false
Consent.provision.action
Element Id Consent.provision.action
Definition

Actions controlled by this provision.

Short Display Actions controlled by this provision
Cardinality 0..*
Terminology Binding Consent Action Codes (Example)
Type CodeableConcept
Meaning if Missing all actions
Summary true
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 Id Consent.provision.securityLabel
Definition

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

Short Display Security Labels that define affected resources
Cardinality 0..*
Terminology Binding Example set of Security Labels (Example)
Type Coding
Summary true
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 Id Consent.provision.purpose
Definition

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

Short Display Context of activities covered by this provision
Cardinality 0..*
Terminology Binding PurposeOfUse icon (Extensible)
Type Coding
Summary true
Comments

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

Consent.provision.documentType
Element Id Consent.provision.documentType
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.

Short Display e.g. Resource Type, Profile, CDA, etc
Cardinality 0..*
Terminology Binding Consent Content Class (Preferred)
Type Coding
Summary true
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.

Consent.provision.resourceType
Element Id Consent.provision.resourceType
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.

Short Display e.g. Resource Type, Profile, etc
Cardinality 0..*
Terminology Binding Resource Types (Extensible)
Type Coding
Summary true
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.

Consent.provision.code
Element Id Consent.provision.code
Definition

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

Short Display e.g. LOINC or SNOMED CT code, etc. in the content
Cardinality 0..*
Terminology Binding Consent Content Codes (Example)
Type CodeableConcept
Summary true
Consent.provision.dataPeriod
Element Id Consent.provision.dataPeriod
Definition

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

Short Display Timeframe for data controlled by this provision
Cardinality 0..1
Type Period
Summary true
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 Id Consent.provision.data
Definition

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

Short Display Data controlled by this provision
Cardinality 0..*
Meaning if Missing all data
Summary true
Consent.provision.data.meaning
Element Id Consent.provision.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Short Display instance | related | dependents | authoredby
Cardinality 1..1
Terminology Binding Consent Data Meaning (Required)
Type code
Summary true
Consent.provision.data.reference
Element Id Consent.provision.data.reference
Definition

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

Short Display The actual data reference
Cardinality 1..1
Type Reference(Any)
Summary true
Consent.provision.expression
Element Id Consent.provision.expression
Definition

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

Short Display A computable expression of the consent
Cardinality 0..1
Type Expression
Summary false
Comments

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

Consent.provision.provision
Element Id Consent.provision.provision
Definition

Provisions which provide exceptions to the base provision or subprovisions.

Short Display Nested Exception Provisions
Cardinality 0..*
Type See Consent.provision
Summary false