Release 4 5 Preview #3
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Community Based Collaborative Care Work Group Maturity Level : 2   Trial Use Security Category : Patient Compartments : Patient

Detailed Descriptions for the elements in the Consent resource.

Comments This is not the time of the original consent, but the time that this statement was made or derived. Summary
Consent
Element Id Consent
Definition

A record of a healthcare consumer’s choices, 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.

Cardinality 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, treatment and general advance care directives. consent for research participation and data sharing.

Invariants
Defined on this element
ppc-1 Rule Either a Policy or PolicyRule policy.exists() or policyRule.exists() ppc-2 Rule IF Scope=privacy, there Consent.subject must be a patient patient.exists() or scope.coding.where(system='something' (scope = 'privacy' and code='patient-privacy').exists().not() subject.resolve().exists()) implies (subject.resolve() is Patient)
ppc-3 ppc-2 Rule IF Scope=research, there Consent.subject must be a patient patient.exists() or scope.coding.where(system='something' (scope = 'research' and code='research').exists().not() subject.resolve().exists()) implies (subject.resolve() is Patient)
ppc-4 ppc-3 Rule IF Scope=adr, there Scope=treatment, Consent.subject must be a patient patient.exists() or scope.coding.where(system='something' (scope = 'treatment' and code='adr').exists().not() subject.resolve().exists()) implies (subject.resolve() is Patient)
ppc-5 ppc-4 Rule IF Scope=treatment, there must be a patient Scope=research, ResearchStudyContext allowed patient.exists() Consent.provision.extension("http://hl7.org/fhir/StructureDefinition/consent-ResearchStudyContext").exists() or scope.coding.where(system='something' and code='treatment').exists().not() code='research').exists().not()
Consent.identifier
Element Id Consent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

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. Consent resource.

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.scope
Element Id Consent.scope
Definition

A selector of the type of consent being presented: ADR, presented with the base being Privacy, Treatment, or Research. This list is now extensible.

Cardinality 1..1
Terminology Binding Consent Scope Codes ( Extensible )
Type CodeableConcept
Is Modifier true (Reason: Allows changes to codes based on scope selection)
Summary true
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.

Cardinality 1..*
Terminology Binding Consent Category Codes ( Extensible )
Type CodeableConcept
Summary true
Consent.patient Consent.subject
Element Id Consent.patient Consent.subject
Definition

The patient/healthcare consumer practitioner to whom this consent applies.

Cardinality 0..1
Type Reference ( Patient | Practitioner )
Patterns Reference(Patient,Practitioner): Common patterns = Participant , ParticipantContactable , ParticipantLiving
Summary true
Comments

Commonly, the patient subject the 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 Date and time the consent instance was issued / created / indexed. agreed to.

Cardinality 0..1
Type dateTime
Summary true
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.

Cardinality 0..*
Type Reference ( CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole )
Patterns Reference(CareTeam,HealthcareService,Organization,Patient,Practitioner,RelatedPerson,PractitionerRole): Common patterns = Participant
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. Where HealthCareService is listed, some services might not be appropriate based on the type of service and if they can be segmented as an independent or dependent individual entity that might not be eligible to be a grantee.

A Consent without a listed performer may be used as a statement of preference by the subject and is not in force.

Consent.organization Consent.manager
Element Id Consent.organization Consent.manager
Definition

The organization actor that manages the consent, and the framework within which it is executed. consent through its lifecycle.

Cardinality 0..*
Type Reference ( HealthcareService | Organization | Patient | Practitioner )
Patterns Reference(HealthcareService,Organization,Patient,Practitioner): Common patterns = Participant
Alternate Names custodian manager
Consent.controller
Element Id Consent.controller
Definition

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

Cardinality true 0..*
Type Reference ( HealthcareService | Organization | Patient | Practitioner )
Patterns Reference(HealthcareService,Organization,Patient,Practitioner): Common patterns = Participant
Alternate Names controller
Consent.source[x] Consent.sourceAttachment
Element Id Consent.source[x] Consent.sourceAttachment
Definition

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

Cardinality 0..*
Type Attachment
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.

Cardinality 0..1 0..*
Type Attachment | Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse )
[x] Note See Choice of Data Types for further information about how to use [x] Summary Patterns true Reference(Consent,DocumentReference,Contract,QuestionnaireResponse): No common pattern
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.

Cardinality 0..*
Comments

if policy and policyRule are not present, the resource must include the policy being agreed to, or complied with, and that policy and/or policyRule SHOULD be populated as soon as is practical to support workflows that require computability. In addition, the policy could be indicated via the sourceReference or sourceAttachment content.

Alternately, creating an invariant for individual scopes that forces one or more of the elements to be populated as part of a profile or Implementation Guide may be advisable.

Consent.policy.authority
Element Id Consent.policy.authority
Definition

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

Cardinality 0..1
Type uri
Invariants
Affect this element
ppc-1 Rule Either IF Scope=privacy, Consent.subject must be a Policy or PolicyRule patient policy.exists() or policyRule.exists() (scope = 'privacy' and subject.resolve().exists()) implies (subject.resolve() is Patient)
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.

Cardinality 0..1
Type uri
Comments

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

Invariants
Affect this element
ppc-1 Rule Either IF Scope=privacy, Consent.subject must be a Policy or PolicyRule patient policy.exists() or policyRule.exists() (scope = 'privacy' and subject.resolve().exists()) implies (subject.resolve() is Patient)
Consent.policyRule
Element Id Consent.policyRule
Definition

A reference to the specific base computable regulation or policy.

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

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

Summary true
Comments

If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource.

Invariants
Affect this element
ppc-1 Rule Either IF Scope=privacy, Consent.subject must be a Policy or PolicyRule patient policy.exists() or policyRule.exists() (scope = 'privacy' and subject.resolve().exists()) implies (subject.resolve() is Patient)
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.

Cardinality 0..*
Summary true
Consent.verification.verified
Element Id Consent.verification.verified
Definition

Has the instruction 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.

Cardinality 0..1
Terminology Binding Consent Vefication Codes ( Extensible )
Type CodeableConcept
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 Grantee decision.

Cardinality 0..1
Type Reference ( Organization | Practitioner | PractitionerRole )
Patterns Reference(Organization,Practitioner,PractitionerRole): Common patterns = Participant
Consent.verification.verifiedWith
Element Id Consent.verification.verifiedWith
Definition

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

Cardinality 0..1
Type Reference ( Patient | RelatedPerson )
Patterns Reference(Patient,RelatedPerson): Common patterns = Participant , ParticipantContactable , ParticipantLiving
Consent.verification.verificationDate
Element Id Consent.verification.verificationDate
Definition

Date Date(s) verification was collected.

Cardinality 0..1 0..*
Type dateTime
Comments

Allows for history of verification/validation.

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.

Cardinality 0..1
Summary true
Consent.provision.type
Element Id Consent.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.

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

The timeframe in this rule is valid.

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 rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers').

Cardinality 0..*
Meaning if Missing There is no specific actor associated with the exception
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.

Cardinality 1..1
Terminology Binding SecurityRoleType ( Extensible )
Type CodeableConcept
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').

Cardinality 1..1
Type Reference ( Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole )
Patterns Reference(Device,Group,CareTeam,Organization,Patient,Practitioner,RelatedPerson,PractitionerRole): Common patterns = Participant
Consent.provision.action
Element Id Consent.provision.action
Definition

Actions controlled by this Rule.

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.

Cardinality 0..*
Terminology Binding SecurityLabels ( Extensible )
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 rule.

Cardinality 0..*
Terminology Binding V3 Value SetPurposeOfUse PurposeOfUse ( 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.class
Element Id Consent.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.

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

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

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

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

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

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

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 rule if specific resources are referenced.

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.

Cardinality 1..1
Terminology Binding ConsentDataMeaning ( 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.

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