FHIR Release 3 (STU) 4

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Community Based Collaborative Care Work Group Maturity Level : 1 2   Trial Use Security Category : Patient Compartments : Patient

Detailed Descriptions for the elements in the Consent resource.

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 Consent.except.actor.role
Consent
Element Id 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.

Control Cardinality 1..1 0..*
Type DomainResource
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.

Invariants :
Defined on this element
ppc-1 : Rule Either a Policy or PolicyRule ( expression policy.exists() or policyRule.exists(), xpath: exists(f:policy) policyRule.exists()
ppc-2 Rule IF Scope=privacy, there must be a patient patient.exists() or exists(f:policyRule)) scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3 Rule IF Scope=research, there must be a patient patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4 Rule IF Scope=adr, there must be a patient patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5 Rule IF Scope=treatment, there must be a patient patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()
Consent.identifier
Element Id Consent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

Note This is a business identifer, identifier, not a resource identifier (see discussion )
Control Cardinality 0..1 0..*
Type Identifier
Summary true
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
Element Id Consent.status
Definition

Indicates the current state of this consent.

Control Cardinality 1..1
Terminology Binding ConsentState ( 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)
Requirements

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

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 Consent.scope
Element Id Consent.scope
Definition

A classification selector of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. being presented: ADR, Privacy, Treatment, Research. This list is now extensible.

Control Cardinality 0..* 1..1
Terminology Binding Consent Category Scope Codes ( Example Extensible )
Type CodeableConcept
Is Modifier true (Reason: Allows changes to codes based on scope selection)
Summary true
Consent.patient Consent.category
Element Id Consent.category
Definition

The patient/healthcare consumer to whom this A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent applies. statements.

Control Cardinality 1..1 1..*
Type Terminology Binding Reference Consent Category Codes ( Patient Extensible )
Summary Type true CodeableConcept
Comments Summary Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person. true
Consent.period Consent.patient
Element Id Consent.patient
Definition

Relevant time or time-period when The patient/healthcare consumer to whom this Consent is applicable. consent applies.

Control Cardinality 0..1
Type Period Reference Meaning if Missing all date ranges included ( Patient )
Summary true
Comments

This can be a subset of Commonly, the period of patient the original statement. consent pertains to is the author, but for young and old people, it may be some other person.

Consent.dateTime
Element Id Consent.dateTime
Definition

When this Consent was issued / created / indexed.

Control Cardinality 0..1
Type dateTime
Summary true
Comments

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

Consent.consentingParty Consent.performer
Element Id Consent.performer
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.

Control Cardinality 0..*
Type Reference ( Organization | Patient | Practitioner | RelatedPerson | PractitionerRole )
Alternate Names consentor
Summary true
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'). Control 0..* Meaning if Missing There is no specific actor associated with the consent Summary true Consent.actor.role Definition How the individual is involved in the resources content that is described in the consent. Control 1..1 Terminology Binding SecurityRoleType ( Extensible ) Type CodeableConcept 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'). Control 1..1 Type Reference ( Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson ) Consent.action Consent.organization
Definition Actions controlled by this consent. Control 0..* Terminology Binding Consent Action Codes ( Example ) Type CodeableConcept Meaning if Missing all actions Summary true Comments Element Id 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.

Control Cardinality 0..*
Type Reference ( Organization )
Alternate Names custodian
Summary true
Consent.source[x]
Element Id 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.

Control Cardinality 0..1
Type Attachment | Identifier | Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse )
[x] Note See Choice of Data Types for further information about how to use [x]
Summary true
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
Element 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.

Control Cardinality 0..*
Consent.policy.authority
Element Id Consent.policy.authority
Definition

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

Control Cardinality 0..1
Type uri
Invariants :
Affect this element
ppc-1 : Rule Either a Policy or PolicyRule ( expression policy.exists() or policyRule.exists(), xpath: exists(f:policy) or exists(f:policyRule)) policyRule.exists()
Consent.policy.uri
Element Id 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.

Control Cardinality 0..1
Type uri
Comments

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

Invariants :
Affect this element
ppc-1 : Rule Either a Policy or PolicyRule ( expression policy.exists() or policyRule.exists(), xpath: exists(f:policy) or exists(f:policyRule)) policyRule.exists()
Consent.policyRule
Element Id Consent.policyRule
Definition

A referece reference to the specific base computable regulation or policy.

Control Cardinality 0..1
Terminology Binding Consent PolicyRule Codes ( Extensible )
Type uri CodeableConcept
Requirements

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

Summary true
Comments

If the policy reference policyRule is not known, the resource cannot absent, computable consent would need to be processed. Where constructed from the reference is absent, there is no particular policy other than what is expressed directly in elements of the consent Consent resource.

Invariants Type Coding
Affect 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 ppc-1 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. Control Rule 0..* Either a Policy or PolicyRule Terminology Binding policy.exists() or policyRule.exists() All Security Labels ( Extensible )
Summary Consent.verification true
Comments Element Id 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 Consent.verification
Definition

The context of the activities Whether a user is taking - why the user is accessing treatment instruction (e.g. artificial respiration yes or no) was verified with the data - that are controlled by this consent. patient, his/her family or another authorized person.

Control Cardinality 0..*
Terminology Binding PurposeOfUse ( Extensible ) Type Summary Coding true
Summary Consent.verification.verified true
Comments Element Id 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 Consent.verification.verified
Definition

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

Control Cardinality 0..1 1..1
Type Period boolean
Summary true
Consent.data Consent.verification.verifiedWith
Definition The resources controlled by this consent, if specific resources are referenced. Control 0..* Meaning if Missing all data Summary Element Id true Consent.data.meaning Consent.verification.verifiedWith
Definition

How Who verified the resource reference is interpreted when testing consent restrictions. instruction (Patient, Relative or other Authorized Person).

Control Cardinality 1..1 0..1
Terminology Binding Type ConsentDataMeaning Reference ( Required Patient | RelatedPerson )
Type code Consent.verification.verificationDate
Summary Element Id true Consent.data.reference Consent.verification.verificationDate
Definition

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

Control Cardinality 1..1 0..1
Type Reference ( Any dateTime )
Summary Consent.provision true
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.

Control Cardinality 0..* 0..1
Summary true
Consent.except.type Consent.provision.type
Element Id Consent.provision.type
Definition

Action to take - permit or deny - when the exception rule conditions are met. Not permitted in root rule, required in all nested rules.

Control Cardinality 1..1 0..1
Terminology Binding ConsentExceptType ConsentProvisionType ( Required )
Type code
Summary true
Consent.except.period Consent.provision.period
Element Id Consent.provision.period
Definition

The timeframe in this exception rule is valid.

Control Cardinality 0..1
Type Period
Summary true
Consent.except.actor Consent.provision.actor
Element Id Consent.provision.actor
Definition

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

Control Cardinality 0..*
Meaning if Missing There is no specific actor associated with the exception
Summary Consent.provision.actor.role true
Element Id Consent.provision.actor.role
Definition

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

Control Cardinality 1..1
Terminology Binding SecurityRoleType ( Extensible )
Type CodeableConcept
Consent.except.actor.reference Consent.provision.actor.reference
Element Id Consent.provision.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').

Control Cardinality 1..1
Type Reference ( Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole )
Consent.except.action Consent.provision.action
Element Id Consent.provision.action
Definition

Actions controlled by this Exception. Rule.

Control 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.except.securityLabel Consent.provision.securityLabel
Element Id Consent.provision.securityLabel
Definition

A set security label, comprised of 0..* security labels that label fields (Privacy tags), which define which resources are controlled by this exception. If more than one label is specified, all resources must have all the specified labels.

Control Cardinality 0..*
Terminology Binding All Security Labels SecurityLabels ( Extensible )
Type Coding
Summary true
Comments

If the consent specifies a security label of "R" "R" then it applies to all resources that are labeled "R" "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. Not all When the purpose of use tag is on the security labels make sense for data, access request purpose of use in this element (may define a narrower value set?). shall not conflict.

Consent.except.purpose 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 exception. rule.

Control Cardinality 0..*
Terminology Binding PurposeOfUse V3 Value SetPurposeOfUse ( Extensible )
Type Coding
Summary true
Comments

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

Consent.except.class Consent.provision.class
Element Id Consent.provision.class
Definition

The class of information covered by this exception. 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.

Control Cardinality 0..*
Terminology Binding Consent Content Class ( Extensible )
Type Coding
Summary true
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 Consent.provision.code
Element Id Consent.provision.code
Definition

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

Control Cardinality 0..*
Terminology Binding Consent Content Codes ( Example )
Type Coding CodeableConcept
Summary true
Comments

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

Consent.except.dataPeriod Consent.provision.dataPeriod
Element Id Consent.provision.dataPeriod
Definition

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

Control 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.except.data Consent.provision.data
Element Id Consent.provision.data
Definition

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

Control Cardinality 0..*
Meaning if Missing all data
Summary true
Consent.except.data.meaning Consent.provision.data.meaning
Element Id Consent.provision.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Control Cardinality 1..1
Terminology Binding ConsentDataMeaning ( Required )
Type code
Summary true
Consent.except.data.reference 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.

Control Cardinality 1..1
Type Reference ( Any )
Summary true
Consent.provision.provision
Element Id Consent.provision.provision
Definition

Rules which provide exceptions to the base rule or subrules.

Cardinality 0..*
Type See Consent.provision