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 Group | Maturity Level: 1 | Trial Use | Compartments: 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. |
Control | 1..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. |
Invariants | Defined 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. |
Note | This is a business identifer, not a resource identifier (see discussion) |
Control | 0..1 |
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 | |
Definition | Indicates the current state of this consent. |
Control | 1..1 |
Terminology Binding | ConsentState (Required) |
Type | code |
Is Modifier | true |
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 | |
Definition | A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. |
Control | 0..* |
Terminology Binding | Consent Category Codes (Example) |
Type | CodeableConcept |
Summary | true |
Consent.patient | |
Definition | The patient/healthcare consumer to whom this consent applies. |
Control | 1..1 |
Type | Reference(Patient) |
Summary | true |
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. |
Control | 0..1 |
Type | Period |
Meaning if Missing | all date ranges included |
Summary | true |
Comments | This can be a subset of the period of the original statement. |
Consent.dateTime | |
Definition | When this Consent was issued / created / indexed. |
Control | 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 | |
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 | 0..* |
Type | Reference(Organization | Patient | Practitioner | RelatedPerson) |
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 | |
Definition | Actions controlled by this consent. |
Control | 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.organization | |
Definition | The organization that manages the consent, and the framework within which it is executed. |
Control | 0..* |
Type | Reference(Organization) |
Alternate Names | custodian |
Summary | true |
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 | 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 | |
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 | 0..* |
Consent.policy.authority | |
Definition | Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives. |
Control | 0..1 |
Type | uri |
Invariants | 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.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 | 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: 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. |
Control | 0..1 |
Type | uri |
Requirements | Might be a unique identifier of a policy set in XACML, or other rules engine. |
Summary | true |
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. |
Invariants | 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 | |
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 | 0..* |
Terminology Binding | All Security Labels (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. 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. |
Control | 0..* |
Terminology Binding | PurposeOfUse (Extensible) |
Type | Coding |
Summary | true |
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. |
Control | 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.data | |
Definition | The resources controlled by this consent, if specific resources are referenced. |
Control | 0..* |
Meaning if Missing | all data |
Summary | true |
Consent.data.meaning | |
Definition | How the resource reference is interpreted when testing consent restrictions. |
Control | 1..1 |
Terminology Binding | ConsentDataMeaning (Required) |
Type | code |
Summary | true |
Consent.data.reference | |
Definition | A reference to a specific resource that defines which resources are covered by this consent. |
Control | 1..1 |
Type | Reference(Any) |
Summary | true |
Consent.except | |
Definition | An exception to the base policy of this consent. An exception can be an addition or removal of access permissions. |
Control | 0..* |
Summary | true |
Consent.except.type | |
Definition | Action to take - permit or deny - when the exception conditions are met. |
Control | 1..1 |
Terminology Binding | ConsentExceptType (Required) |
Type | code |
Summary | true |
Consent.except.period | |
Definition | The timeframe in this exception is valid. |
Control | 0..1 |
Type | Period |
Summary | true |
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'). |
Control | 0..* |
Meaning if Missing | There is no specific actor associated with the exception |
Summary | true |
Consent.except.actor.role | |
Definition | How the individual is involved in the resources content that is described in the exception. |
Control | 1..1 |
Terminology Binding | SecurityRoleType (Extensible) |
Type | CodeableConcept |
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'). |
Control | 1..1 |
Type | Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson) |
Consent.except.action | |
Definition | Actions controlled by this Exception. |
Control | 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 | |
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. |
Control | 0..* |
Terminology Binding | All Security Labels (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. 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. |
Control | 0..* |
Terminology Binding | PurposeOfUse (Extensible) |
Type | Coding |
Summary | true |
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. |
Control | 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 | |
Definition | If this code is found in an instance, then the exception applies. |
Control | 0..* |
Terminology Binding | Consent Content Codes (Example) |
Type | Coding |
Summary | true |
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. |
Control | 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 | |
Definition | The resources controlled by this exception, if specific resources are referenced. |
Control | 0..* |
Meaning if Missing | all data |
Summary | true |
Consent.except.data.meaning | |
Definition | How the resource reference is interpreted when testing consent restrictions. |
Control | 1..1 |
Terminology Binding | ConsentDataMeaning (Required) |
Type | code |
Summary | true |
Consent.except.data.reference | |
Definition | A reference to a specific resource that defines which resources are covered by this consent. |
Control | 1..1 |
Type | Reference(Any) |
Summary | true |