This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). 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 R2
Community Based Collaborative Care Work Group | Maturity Level: 2 | Trial Use | Security Category: Patient | Compartments: Patient |
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.
The purpose of this Resource is to be used to express a Consent regarding Healthcare. There are four anticipated uses for the Consent Resource, all of which are written or verbal agreements by a healthcare consumer [grantor] or a personal representative, made to an authorized entity [grantee] concerning authorized or restricted actions with any limitations on purpose of use, and handling instructions to which the authorized entity must comply:
This resource is scoped to cover all three uses, but at this time, only the privacy use case is fully modeled, others are being used but no formal modelling exists. The scope of the resource may change when the other possible scopes are investigated, tested, or profiled. HL7 is working on Advance Directives and would welcome participation by the community.
A FHIR Consent Directive instance is considered the encoded legally binding Consent Directive if it meets requirements of a policy domain requirements for an enforceable contract. In some domains, electronic signatures of one or both of the parties to the content of an encoded representation of a Consent Form is deemed to constitute a legally binding Consent Directive. Some domains accept a notary’s electronic signature over the wet or electronic signature of a party to the Consent Directive as the additional identity proofing required to make an encoded Consent Directive legally binding. Other domains may only accept a wet signature or might not require the parties’ signatures at all.
Whatever the criteria are for making an encoded FHIR Consent Directive legally binding, anything less than a legally binding representation of a Consent Directive must be identified as such, i.e., as a derivative of the legally binding Consent Directive, which has specific usage in Consent Directive workflow management.
Definitions:
Consent | The record of a healthcare consumer’s policy 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 |
Consent Directive | The legal record of a healthcare consumer's agreement or agreements made on their behalf with a party responsible for enforcing the consumer’s choices or choices made on their behalf by a third party, which permits or denies identified actors or roles to perform actions affecting the consumer within a given context for specific purposes and periods of time |
Consent Form | Human readable consent content describing one or more actions impacting the grantor for which the grantee would be authorized or prohibited from performing. It includes the terms, rules, and conditions pertaining to the authorization or restrictions, such as effective time, applicability or scope, purposes of use, obligations and prohibitions to which the grantee must comply. Once a Consent Form is “executed” by means required by policy, such as verbal agreement, wet signature, or electronic/digital signature, it becomes a legally binding Consent Directive. |
Consent Directive Derivative | Consent Content that conveys the minimal set of information needed to manage Consent Directive workflow, including providing Consent Directive content sufficient to:
Derived Consent content includes the Security Labels encoding the applicable privacy and security policies. Consent Security Labels inform recipients about specific access control measures required for compliance. |
Consent Statement | A Consent Directive derivative has less than full fidelity to the legally binding Consent Directive from which it was "transcribed". It provides recipients with the full content representation they may require for compliance purposes, and typically include a reference to or an attached unstructured representation for recipients needing an exact copy of the legal agreement. |
Consent Registration | The legal record of a healthcare consumer's agreement with a party responsible for enforcing the consumer’s choices, which permits or denies identified actors or roles to perform actions affecting the consumer within a given context for specific purposes and periods of timeA Consent Directive derivative that conveys the minimal set of information needed to register an active and revoked Consent Directive, or to update Consent status as it changes during its lifecycle. |
Consent Query/Response Types | The FHIR Consent Resource specifies multiple Consent Search parameters, which support many types of queries for Consent Resource content. There are several Query/Response patterns that are typically used for obtaining information about consent directive content for the following use cases:
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Policy context | Any organizational or jurisdictional policies, which may limit the consumer’s policy choices, and which includes the named range of actions allowed |
Healthcare Consumer | The individual establishing his/her personal consent (i.e. Consenter). In FHIR, this is referred to as the 'Patient' though this word is not used across all contexts of care |
Privacy policies define how Individually Identifiable Health Information (IIHI) is to be collected, accessed, used and disclosed. A Privacy Consent Directive as a legal record of a patient's (e.g. a healthcare consumer) agreement with a party responsible for enforcing the patient's choices, which permits or denies identified actors or roles to perform actions affecting the patient within a given context for specific purposes and periods of time. All consent directives have a policy context, which is any set of organizational or jurisdictional policies which may limit the consumer’s policy choices, and which include a named range of actions allowed. In addition, Privacy Consent Directives provide the ability for a healthcare consumer to delegate authority to a Substitute Decision Maker who may act on behalf of that individual. Alternatively, a consumer may author/publish their privacy preferences as a self-declared Privacy Consent Directive.
The Consent resource on FHIR provides support for alternative representations for expressing interoperable health information privacy consent directives in a standard form for the exchange and enforcement by sending, intermediating, or receiving systems of privacy policies that can be enforced by consuming systems (e.g., scanned documents, of computable structured entries elements, FHIR structures with optional attached, or referenced unstructured representations.) It may be used to represent the Privacy Consent Directive itself, a Consent Statement, which electronically represents a Consent Directive, or Consent Metadata, which is the minimum necessary consent content derived from a Consent Directive for use in workflow management.
Consent management - particularly privacy consent - is complicated by the fact that consent to share is often itself necessary to protect. The need to protect the privacy of the privacy statement itself competes with the execution of the consent statement. For this reason, it is common to deal with 'consent statements' that are only partial representations of the full consent statement that the patient provided.
For this reason, the consent resource contains two elements that refer back to the source: a master identifier, and a direct reference to content from which this Consent Statement was derived. That reference can be one of several things:
The consent statements represent a chain that refers back to the original source consent directive. Applications may be able to follow the chain back to the source but should not generally assume that they are authorized to do this.
Consent Directives are executed by verbal acknowledgement or by being signed - either on paper, or digitally. Consent Signatures will be found in the Provenance resource. Implementation Guides will generally make rules about what signatures are required, and how they are to be shared and used.
The Consent resource is structured with a base policy (represented as Consent.policy/Consent.policyRule) which is either opt-in or opt-out, followed by a listing of exceptions to that policy (represented as Consent.provision(s)). The exceptions can be additional positive or negative exceptions upon the base policy. The set of exceptions include a list of data objects, list of authors, list of recipients, list of Organizations, list of purposeOfUse, and Date Range.
The enforcement of the Privacy Consent Directive is not included but is expected that enforcement can be done using a mix of the various Access Control enforcement methodologies (e.g. OAuth, UMA, XACML). This enforcement includes the details of the enforcement meaning of the elements of the Privacy Consent Directive, such as the rules in place when there is an opt-in consent would be specific about which organizational roles have access to what kinds of resources (e.g. RBAC, ABAC). The specification of these details is not in scope for the Consent resource.
This resource is referenced by itself, Permission and ResearchSubject.
This resource implements the Event pattern.
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Consent | TU | DomainResource | 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 + Rule: IF Scope=privacy, Consent.subject must be a patient + Rule: IF Scope=research, Consent.subject must be a patient + Rule: IF Scope=treatment, Consent.subject must be a patient + Rule: IF Scope=research, ResearchStudyContext allowed Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | Σ | 0..* | Identifier | Identifier for this record (external references) |
status | ?!Σ | 1..1 | code | draft | active | inactive | entered-in-error | unknown ConsentState (Required) |
scope | ?!Σ | 1..1 | CodeableConcept | Which of the four areas this resource covers (extensible) Consent Scope Codes (Extensible) |
category | Σ | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Consent Category Codes (Extensible) |
subject | Σ | 0..1 | Reference(Patient | Practitioner) | Who the consent applies to |
dateTime | Σ | 0..1 | dateTime | When consent was agreed to |
performer | Σ | 0..* | Reference(CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Who is agreeing to the policy and rules |
organization | Σ | 0..* | Reference(Organization) | Custodian of the consent |
sourceAttachment | 0..* | Attachment | Source from which this consent is taken | |
sourceReference | 0..* | Reference(Consent | DocumentReference | Contract | QuestionnaireResponse) | Source from which this consent is taken | |
policy | 0..* | BackboneElement | Policies covered by this consent | |
authority | I | 0..1 | uri | Enforcement source for policy |
uri | I | 0..1 | uri | Specific policy covered by this consent |
policyRule | ΣI | 0..1 | CodeableConcept | Regulation that this consents to Consent PolicyRule Codes (Extensible) |
verification | Σ | 0..* | BackboneElement | Consent Verified by patient or family |
verified | Σ | 1..1 | boolean | Has been verified |
verificationType | 0..1 | CodeableConcept | Business case of verification Consent Vefication Codes (Extensible) | |
verifiedBy | 0..1 | Reference(Organization | Practitioner | PractitionerRole) | Person conducting verification | |
verifiedWith | 0..1 | Reference(Patient | RelatedPerson) | Person who verified | |
verificationDate | 0..* | dateTime | When consent verified | |
provision | Σ | 0..1 | BackboneElement | Constraints to the base Consent.policyRule/Consent.policy |
type | Σ | 0..1 | code | deny | permit ConsentProvisionType (Required) |
period | Σ | 0..1 | Period | Timeframe for this rule |
actor | 0..* | BackboneElement | Who|what controlled by this rule (or group, by role) | |
role | 1..1 | CodeableConcept | How the actor is involved SecurityRoleType (Extensible) | |
reference | 1..1 | Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Resource for the actor (or group, by role) | |
action | Σ | 0..* | CodeableConcept | Actions controlled by this rule Consent Action Codes (Example) |
securityLabel | Σ | 0..* | Coding | Security Labels that define affected resources SecurityLabels (Extensible) |
purpose | Σ | 0..* | Coding | Context of activities covered by this rule V3 Value SetPurposeOfUse (Extensible) |
class | Σ | 0..* | Coding | e.g. Resource Type, Profile, CDA, etc. Consent Content Class (Extensible) |
code | Σ | 0..* | CodeableConcept | e.g. LOINC or SNOMED CT code, etc. in the content Consent Content Codes (Example) |
dataPeriod | Σ | 0..1 | Period | Timeframe for data controlled by this rule |
data | Σ | 0..* | BackboneElement | Data controlled by this rule |
meaning | Σ | 1..1 | code | instance | related | dependents | authoredby ConsentDataMeaning (Required) |
reference | Σ | 1..1 | Reference(Any) | The actual data reference |
provision | 0..* | see provision | Nested Exception Rules | |
Documentation for this format |
UML Diagram (Legend)
XML Template
<Consent xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Identifier for this record (external references) --></identifier> <status value="[code]"/><!-- 1..1 draft | active | inactive | entered-in-error | unknown --> <scope><!-- 1..1 CodeableConcept Which of the four areas this resource covers (extensible) --></scope> <category><!-- 1..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category> <subject><!-- 0..1 Reference(Patient|Practitioner) Who the consent applies to --></subject> <dateTime value="[dateTime]"/><!-- 0..1 When consent was agreed to --> <performer><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></performer> <organization><!-- 0..* Reference(Organization) Custodian of the consent --></organization> <sourceAttachment><!-- 0..* Attachment Source from which this consent is taken --></sourceAttachment> <sourceReference><!-- 0..* Reference(Consent|Contract|DocumentReference| QuestionnaireResponse) Source from which this consent is taken --></sourceReference> <policy> <!-- 0..* Policies covered by this consent --> <authority value="[uri]"/><!-- 0..1 Enforcement source for policy --> <uri value="[uri]"/><!-- 0..1 Specific policy covered by this consent --> </policy> <policyRule><!-- 0..1 CodeableConcept Regulation that this consents to --></policyRule> <verification> <!-- 0..* Consent Verified by patient or family --> <verified value="[boolean]"/><!-- 1..1 Has been verified --> <verificationType><!-- 0..1 CodeableConcept Business case of verification --></verificationType> <verifiedBy><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Person conducting verification --></verifiedBy> <verifiedWith><!-- 0..1 Reference(Patient|RelatedPerson) Person who verified --></verifiedWith> <verificationDate value="[dateTime]"/><!-- 0..* When consent verified --> </verification> <provision> <!-- 0..1 Constraints to the base Consent.policyRule/Consent.policy --> <type value="[code]"/><!-- 0..1 deny | permit --> <period><!-- 0..1 Period Timeframe for this rule --></period> <actor> <!-- 0..* Who|what controlled by this rule (or group, by role) --> <role><!-- 1..1 CodeableConcept How the actor is involved --></role> <reference><!-- 1..1 Reference(CareTeam|Device|Group|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) Resource for the actor (or group, by role) --></reference> </actor> <action><!-- 0..* CodeableConcept Actions controlled by this rule --></action> <securityLabel><!-- 0..* Coding Security Labels that define affected resources --></securityLabel> <purpose><!-- 0..* Coding Context of activities covered by this rule --></purpose> <class><!-- 0..* Coding e.g. Resource Type, Profile, CDA, etc. --></class> <code><!-- 0..* CodeableConcept e.g. LOINC or SNOMED CT code, etc. in the content --></code> <dataPeriod><!-- 0..1 Period Timeframe for data controlled by this rule --></dataPeriod> <data> <!-- 0..* Data controlled by this rule --> <meaning value="[code]"/><!-- 1..1 instance | related | dependents | authoredby --> <reference><!-- 1..1 Reference(Any) The actual data reference --></reference> </data> <provision><!-- 0..* Content as for Consent.provision Nested Exception Rules --></provision> </provision> </Consent>
JSON Template
{ "resourceType" : "Consent", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // Identifier for this record (external references) "status" : "<code>", // R! draft | active | inactive | entered-in-error | unknown "scope" : { CodeableConcept }, // R! Which of the four areas this resource covers (extensible) "category" : [{ CodeableConcept }], // R! Classification of the consent statement - for indexing/retrieval "subject" : { Reference(Patient|Practitioner) }, // Who the consent applies to "dateTime" : "<dateTime>", // When consent was agreed to "performer" : [{ Reference(CareTeam|HealthcareService|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules "organization" : [{ Reference(Organization) }], // Custodian of the consent "sourceAttachment" : [{ Attachment }], // Source from which this consent is taken "sourceReference" : [{ Reference(Consent|Contract|DocumentReference| QuestionnaireResponse) }], // Source from which this consent is taken "policy" : [{ // Policies covered by this consent "authority" : "<uri>", // C? Enforcement source for policy "uri" : "<uri>" // C? Specific policy covered by this consent }], "policyRule" : { CodeableConcept }, // C? Regulation that this consents to "verification" : [{ // Consent Verified by patient or family "verified" : <boolean>, // R! Has been verified "verificationType" : { CodeableConcept }, // Business case of verification "verifiedBy" : { Reference(Organization|Practitioner|PractitionerRole) }, // Person conducting verification "verifiedWith" : { Reference(Patient|RelatedPerson) }, // Person who verified "verificationDate" : ["<dateTime>"] // When consent verified }], "provision" : { // Constraints to the base Consent.policyRule/Consent.policy "type" : "<code>", // deny | permit "period" : { Period }, // Timeframe for this rule "actor" : [{ // Who|what controlled by this rule (or group, by role) "role" : { CodeableConcept }, // R! How the actor is involved "reference" : { Reference(CareTeam|Device|Group|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) } // R! Resource for the actor (or group, by role) }], "action" : [{ CodeableConcept }], // Actions controlled by this rule "securityLabel" : [{ Coding }], // Security Labels that define affected resources "purpose" : [{ Coding }], // Context of activities covered by this rule "class" : [{ Coding }], // e.g. Resource Type, Profile, CDA, etc. "code" : [{ CodeableConcept }], // e.g. LOINC or SNOMED CT code, etc. in the content "dataPeriod" : { Period }, // Timeframe for data controlled by this rule "data" : [{ // Data controlled by this rule "meaning" : "<code>", // R! instance | related | dependents | authoredby "reference" : { Reference(Any) } // R! The actual data reference }], "provision" : [{ Content as for Consent.provision }] // Nested Exception Rules } }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:Consent; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:Consent.identifier [ Identifier ], ... ; # 0..* Identifier for this record (external references) fhir:Consent.status [ code ]; # 1..1 draft | active | inactive | entered-in-error | unknown fhir:Consent.scope [ CodeableConcept ]; # 1..1 Which of the four areas this resource covers (extensible) fhir:Consent.category [ CodeableConcept ], ... ; # 1..* Classification of the consent statement - for indexing/retrieval fhir:Consent.subject [ Reference(Patient|Practitioner) ]; # 0..1 Who the consent applies to fhir:Consent.dateTime [ dateTime ]; # 0..1 When consent was agreed to fhir:Consent.performer [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole| RelatedPerson) ], ... ; # 0..* Who is agreeing to the policy and rules fhir:Consent.organization [ Reference(Organization) ], ... ; # 0..* Custodian of the consent fhir:Consent.sourceAttachment [ Attachment ], ... ; # 0..* Source from which this consent is taken fhir:Consent.sourceReference [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ], ... ; # 0..* Source from which this consent is taken fhir:Consent.policy [ # 0..* Policies covered by this consent fhir:Consent.policy.authority [ uri ]; # 0..1 Enforcement source for policy fhir:Consent.policy.uri [ uri ]; # 0..1 Specific policy covered by this consent ], ...; fhir:Consent.policyRule [ CodeableConcept ]; # 0..1 Regulation that this consents to fhir:Consent.verification [ # 0..* Consent Verified by patient or family fhir:Consent.verification.verified [ boolean ]; # 1..1 Has been verified fhir:Consent.verification.verificationType [ CodeableConcept ]; # 0..1 Business case of verification fhir:Consent.verification.verifiedBy [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Person conducting verification fhir:Consent.verification.verifiedWith [ Reference(Patient|RelatedPerson) ]; # 0..1 Person who verified fhir:Consent.verification.verificationDate [ dateTime ], ... ; # 0..* When consent verified ], ...; fhir:Consent.provision [ # 0..1 Constraints to the base Consent.policyRule/Consent.policy fhir:Consent.provision.type [ code ]; # 0..1 deny | permit fhir:Consent.provision.period [ Period ]; # 0..1 Timeframe for this rule fhir:Consent.provision.actor [ # 0..* Who|what controlled by this rule (or group, by role) fhir:Consent.provision.actor.role [ CodeableConcept ]; # 1..1 How the actor is involved fhir:Consent.provision.actor.reference [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole| RelatedPerson) ]; # 1..1 Resource for the actor (or group, by role) ], ...; fhir:Consent.provision.action [ CodeableConcept ], ... ; # 0..* Actions controlled by this rule fhir:Consent.provision.securityLabel [ Coding ], ... ; # 0..* Security Labels that define affected resources fhir:Consent.provision.purpose [ Coding ], ... ; # 0..* Context of activities covered by this rule fhir:Consent.provision.class [ Coding ], ... ; # 0..* e.g. Resource Type, Profile, CDA, etc. fhir:Consent.provision.code [ CodeableConcept ], ... ; # 0..* e.g. LOINC or SNOMED CT code, etc. in the content fhir:Consent.provision.dataPeriod [ Period ]; # 0..1 Timeframe for data controlled by this rule fhir:Consent.provision.data [ # 0..* Data controlled by this rule fhir:Consent.provision.data.meaning [ code ]; # 1..1 instance | related | dependents | authoredby fhir:Consent.provision.data.reference [ Reference(Any) ]; # 1..1 The actual data reference ], ...; fhir:Consent.provision.provision [ See Consent.provision ], ... ; # 0..* Nested Exception Rules ]; ]
Changes since R3
Consent | |
Consent.status |
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Consent.subject |
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Consent.performer |
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Consent.sourceAttachment |
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Consent.sourceReference |
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Consent.verification.verificationType |
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Consent.verification.verifiedBy |
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Consent.verification.verificationDate |
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Consent.provision.type |
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Consent.provision.data.meaning |
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Consent.patient |
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Consent.source[x] |
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See the Full Difference for further information
This analysis is available as XML or JSON.
See R3 <--> R4 Conversion Maps (status = 12 tests that all execute ok. All tests pass round-trip testing and 12 r3 resources are invalid (0 errors).)
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Consent | TU | DomainResource | 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 + Rule: IF Scope=privacy, Consent.subject must be a patient + Rule: IF Scope=research, Consent.subject must be a patient + Rule: IF Scope=treatment, Consent.subject must be a patient + Rule: IF Scope=research, ResearchStudyContext allowed Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | Σ | 0..* | Identifier | Identifier for this record (external references) |
status | ?!Σ | 1..1 | code | draft | active | inactive | entered-in-error | unknown ConsentState (Required) |
scope | ?!Σ | 1..1 | CodeableConcept | Which of the four areas this resource covers (extensible) Consent Scope Codes (Extensible) |
category | Σ | 1..* | CodeableConcept | Classification of the consent statement - for indexing/retrieval Consent Category Codes (Extensible) |
subject | Σ | 0..1 | Reference(Patient | Practitioner) | Who the consent applies to |
dateTime | Σ | 0..1 | dateTime | When consent was agreed to |
performer | Σ | 0..* | Reference(CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Who is agreeing to the policy and rules |
organization | Σ | 0..* | Reference(Organization) | Custodian of the consent |
sourceAttachment | 0..* | Attachment | Source from which this consent is taken | |
sourceReference | 0..* | Reference(Consent | DocumentReference | Contract | QuestionnaireResponse) | Source from which this consent is taken | |
policy | 0..* | BackboneElement | Policies covered by this consent | |
authority | I | 0..1 | uri | Enforcement source for policy |
uri | I | 0..1 | uri | Specific policy covered by this consent |
policyRule | ΣI | 0..1 | CodeableConcept | Regulation that this consents to Consent PolicyRule Codes (Extensible) |
verification | Σ | 0..* | BackboneElement | Consent Verified by patient or family |
verified | Σ | 1..1 | boolean | Has been verified |
verificationType | 0..1 | CodeableConcept | Business case of verification Consent Vefication Codes (Extensible) | |
verifiedBy | 0..1 | Reference(Organization | Practitioner | PractitionerRole) | Person conducting verification | |
verifiedWith | 0..1 | Reference(Patient | RelatedPerson) | Person who verified | |
verificationDate | 0..* | dateTime | When consent verified | |
provision | Σ | 0..1 | BackboneElement | Constraints to the base Consent.policyRule/Consent.policy |
type | Σ | 0..1 | code | deny | permit ConsentProvisionType (Required) |
period | Σ | 0..1 | Period | Timeframe for this rule |
actor | 0..* | BackboneElement | Who|what controlled by this rule (or group, by role) | |
role | 1..1 | CodeableConcept | How the actor is involved SecurityRoleType (Extensible) | |
reference | 1..1 | Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole) | Resource for the actor (or group, by role) | |
action | Σ | 0..* | CodeableConcept | Actions controlled by this rule Consent Action Codes (Example) |
securityLabel | Σ | 0..* | Coding | Security Labels that define affected resources SecurityLabels (Extensible) |
purpose | Σ | 0..* | Coding | Context of activities covered by this rule V3 Value SetPurposeOfUse (Extensible) |
class | Σ | 0..* | Coding | e.g. Resource Type, Profile, CDA, etc. Consent Content Class (Extensible) |
code | Σ | 0..* | CodeableConcept | e.g. LOINC or SNOMED CT code, etc. in the content Consent Content Codes (Example) |
dataPeriod | Σ | 0..1 | Period | Timeframe for data controlled by this rule |
data | Σ | 0..* | BackboneElement | Data controlled by this rule |
meaning | Σ | 1..1 | code | instance | related | dependents | authoredby ConsentDataMeaning (Required) |
reference | Σ | 1..1 | Reference(Any) | The actual data reference |
provision | 0..* | see provision | Nested Exception Rules | |
Documentation for this format |
XML Template
<Consent xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Identifier for this record (external references) --></identifier> <status value="[code]"/><!-- 1..1 draft | active | inactive | entered-in-error | unknown --> <scope><!-- 1..1 CodeableConcept Which of the four areas this resource covers (extensible) --></scope> <category><!-- 1..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category> <subject><!-- 0..1 Reference(Patient|Practitioner) Who the consent applies to --></subject> <dateTime value="[dateTime]"/><!-- 0..1 When consent was agreed to --> <performer><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></performer> <organization><!-- 0..* Reference(Organization) Custodian of the consent --></organization> <sourceAttachment><!-- 0..* Attachment Source from which this consent is taken --></sourceAttachment> <sourceReference><!-- 0..* Reference(Consent|Contract|DocumentReference| QuestionnaireResponse) Source from which this consent is taken --></sourceReference> <policy> <!-- 0..* Policies covered by this consent --> <authority value="[uri]"/><!-- 0..1 Enforcement source for policy --> <uri value="[uri]"/><!-- 0..1 Specific policy covered by this consent --> </policy> <policyRule><!-- 0..1 CodeableConcept Regulation that this consents to --></policyRule> <verification> <!-- 0..* Consent Verified by patient or family --> <verified value="[boolean]"/><!-- 1..1 Has been verified --> <verificationType><!-- 0..1 CodeableConcept Business case of verification --></verificationType> <verifiedBy><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Person conducting verification --></verifiedBy> <verifiedWith><!-- 0..1 Reference(Patient|RelatedPerson) Person who verified --></verifiedWith> <verificationDate value="[dateTime]"/><!-- 0..* When consent verified --> </verification> <provision> <!-- 0..1 Constraints to the base Consent.policyRule/Consent.policy --> <type value="[code]"/><!-- 0..1 deny | permit --> <period><!-- 0..1 Period Timeframe for this rule --></period> <actor> <!-- 0..* Who|what controlled by this rule (or group, by role) --> <role><!-- 1..1 CodeableConcept How the actor is involved --></role> <reference><!-- 1..1 Reference(CareTeam|Device|Group|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) Resource for the actor (or group, by role) --></reference> </actor> <action><!-- 0..* CodeableConcept Actions controlled by this rule --></action> <securityLabel><!-- 0..* Coding Security Labels that define affected resources --></securityLabel> <purpose><!-- 0..* Coding Context of activities covered by this rule --></purpose> <class><!-- 0..* Coding e.g. Resource Type, Profile, CDA, etc. --></class> <code><!-- 0..* CodeableConcept e.g. LOINC or SNOMED CT code, etc. in the content --></code> <dataPeriod><!-- 0..1 Period Timeframe for data controlled by this rule --></dataPeriod> <data> <!-- 0..* Data controlled by this rule --> <meaning value="[code]"/><!-- 1..1 instance | related | dependents | authoredby --> <reference><!-- 1..1 Reference(Any) The actual data reference --></reference> </data> <provision><!-- 0..* Content as for Consent.provision Nested Exception Rules --></provision> </provision> </Consent>
JSON Template
{ "resourceType" : "Consent", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // Identifier for this record (external references) "status" : "<code>", // R! draft | active | inactive | entered-in-error | unknown "scope" : { CodeableConcept }, // R! Which of the four areas this resource covers (extensible) "category" : [{ CodeableConcept }], // R! Classification of the consent statement - for indexing/retrieval "subject" : { Reference(Patient|Practitioner) }, // Who the consent applies to "dateTime" : "<dateTime>", // When consent was agreed to "performer" : [{ Reference(CareTeam|HealthcareService|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules "organization" : [{ Reference(Organization) }], // Custodian of the consent "sourceAttachment" : [{ Attachment }], // Source from which this consent is taken "sourceReference" : [{ Reference(Consent|Contract|DocumentReference| QuestionnaireResponse) }], // Source from which this consent is taken "policy" : [{ // Policies covered by this consent "authority" : "<uri>", // C? Enforcement source for policy "uri" : "<uri>" // C? Specific policy covered by this consent }], "policyRule" : { CodeableConcept }, // C? Regulation that this consents to "verification" : [{ // Consent Verified by patient or family "verified" : <boolean>, // R! Has been verified "verificationType" : { CodeableConcept }, // Business case of verification "verifiedBy" : { Reference(Organization|Practitioner|PractitionerRole) }, // Person conducting verification "verifiedWith" : { Reference(Patient|RelatedPerson) }, // Person who verified "verificationDate" : ["<dateTime>"] // When consent verified }], "provision" : { // Constraints to the base Consent.policyRule/Consent.policy "type" : "<code>", // deny | permit "period" : { Period }, // Timeframe for this rule "actor" : [{ // Who|what controlled by this rule (or group, by role) "role" : { CodeableConcept }, // R! How the actor is involved "reference" : { Reference(CareTeam|Device|Group|Organization|Patient| Practitioner|PractitionerRole|RelatedPerson) } // R! Resource for the actor (or group, by role) }], "action" : [{ CodeableConcept }], // Actions controlled by this rule "securityLabel" : [{ Coding }], // Security Labels that define affected resources "purpose" : [{ Coding }], // Context of activities covered by this rule "class" : [{ Coding }], // e.g. Resource Type, Profile, CDA, etc. "code" : [{ CodeableConcept }], // e.g. LOINC or SNOMED CT code, etc. in the content "dataPeriod" : { Period }, // Timeframe for data controlled by this rule "data" : [{ // Data controlled by this rule "meaning" : "<code>", // R! instance | related | dependents | authoredby "reference" : { Reference(Any) } // R! The actual data reference }], "provision" : [{ Content as for Consent.provision }] // Nested Exception Rules } }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:Consent; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:Consent.identifier [ Identifier ], ... ; # 0..* Identifier for this record (external references) fhir:Consent.status [ code ]; # 1..1 draft | active | inactive | entered-in-error | unknown fhir:Consent.scope [ CodeableConcept ]; # 1..1 Which of the four areas this resource covers (extensible) fhir:Consent.category [ CodeableConcept ], ... ; # 1..* Classification of the consent statement - for indexing/retrieval fhir:Consent.subject [ Reference(Patient|Practitioner) ]; # 0..1 Who the consent applies to fhir:Consent.dateTime [ dateTime ]; # 0..1 When consent was agreed to fhir:Consent.performer [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole| RelatedPerson) ], ... ; # 0..* Who is agreeing to the policy and rules fhir:Consent.organization [ Reference(Organization) ], ... ; # 0..* Custodian of the consent fhir:Consent.sourceAttachment [ Attachment ], ... ; # 0..* Source from which this consent is taken fhir:Consent.sourceReference [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ], ... ; # 0..* Source from which this consent is taken fhir:Consent.policy [ # 0..* Policies covered by this consent fhir:Consent.policy.authority [ uri ]; # 0..1 Enforcement source for policy fhir:Consent.policy.uri [ uri ]; # 0..1 Specific policy covered by this consent ], ...; fhir:Consent.policyRule [ CodeableConcept ]; # 0..1 Regulation that this consents to fhir:Consent.verification [ # 0..* Consent Verified by patient or family fhir:Consent.verification.verified [ boolean ]; # 1..1 Has been verified fhir:Consent.verification.verificationType [ CodeableConcept ]; # 0..1 Business case of verification fhir:Consent.verification.verifiedBy [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Person conducting verification fhir:Consent.verification.verifiedWith [ Reference(Patient|RelatedPerson) ]; # 0..1 Person who verified fhir:Consent.verification.verificationDate [ dateTime ], ... ; # 0..* When consent verified ], ...; fhir:Consent.provision [ # 0..1 Constraints to the base Consent.policyRule/Consent.policy fhir:Consent.provision.type [ code ]; # 0..1 deny | permit fhir:Consent.provision.period [ Period ]; # 0..1 Timeframe for this rule fhir:Consent.provision.actor [ # 0..* Who|what controlled by this rule (or group, by role) fhir:Consent.provision.actor.role [ CodeableConcept ]; # 1..1 How the actor is involved fhir:Consent.provision.actor.reference [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole| RelatedPerson) ]; # 1..1 Resource for the actor (or group, by role) ], ...; fhir:Consent.provision.action [ CodeableConcept ], ... ; # 0..* Actions controlled by this rule fhir:Consent.provision.securityLabel [ Coding ], ... ; # 0..* Security Labels that define affected resources fhir:Consent.provision.purpose [ Coding ], ... ; # 0..* Context of activities covered by this rule fhir:Consent.provision.class [ Coding ], ... ; # 0..* e.g. Resource Type, Profile, CDA, etc. fhir:Consent.provision.code [ CodeableConcept ], ... ; # 0..* e.g. LOINC or SNOMED CT code, etc. in the content fhir:Consent.provision.dataPeriod [ Period ]; # 0..1 Timeframe for data controlled by this rule fhir:Consent.provision.data [ # 0..* Data controlled by this rule fhir:Consent.provision.data.meaning [ code ]; # 1..1 instance | related | dependents | authoredby fhir:Consent.provision.data.reference [ Reference(Any) ]; # 1..1 The actual data reference ], ...; fhir:Consent.provision.provision [ See Consent.provision ], ... ; # 0..* Nested Exception Rules ]; ]
Changes since Release 3
Consent | |
Consent.status |
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Consent.subject |
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Consent.performer |
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Consent.sourceAttachment |
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Consent.sourceReference |
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Consent.verification.verificationType |
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Consent.verification.verifiedBy |
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Consent.verification.verificationDate |
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Consent.provision.type |
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Consent.provision.data.meaning |
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Consent.patient |
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Consent.source[x] |
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See the Full Difference for further information
This analysis is available as XML or JSON.
See R3 <--> R4 Conversion Maps (status = 12 tests that all execute ok. All tests pass round-trip testing and 12 r3 resources are invalid (0 errors).)
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a
Path | Definition | Type | Reference |
---|---|---|---|
Consent.status | Indicates the state of the consent. | Required | ConsentState |
Consent.scope | The four anticipated uses for the Consent Resource. | Extensible | ConsentScopeCodes |
Consent.category | A classification of the type of consents found in a consent statement. | Extensible | ConsentCategoryCodes |
Consent.policyRule | Regulatory policy examples. | Extensible | ConsentPolicyRuleCodes |
Consent.verification.verificationType | Types of Verification/Validation. | Extensible | ConsentVerificationCodes |
Consent.provision.type | How a rule statement is applied, such as adding additional consent or removing consent. | Required | ConsentProvisionType |
Consent.provision.actor.role | How an actor is involved in the consent considerations. | Extensible | SecurityRoleType |
Consent.provision.action | Detailed codes for the consent action. | Example | ConsentActionCodes |
Consent.provision.securityLabel | Security Labels from the Healthcare Privacy and Security Classification System. | Extensible | All Security Labels |
Consent.provision.purpose | What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels. | Extensible | v3.PurposeOfUse |
Consent.provision.class | The class (type) of information a consent rule covers. | Extensible | ConsentContentClass |
Consent.provision.code | If this code is found in an instance, then the exception applies. | Example | ConsentContentCodes |
Consent.provision.data.meaning | How a resource reference is interpreted when testing consent restrictions. | Required | ConsentDataMeaning |
id | Level | Location | Description | Expression |
ppc-1 | Rule | (base) | IF Scope=privacy, Consent.subject must be a patient | (scope = 'privacy' and subject.resolve().exists()) implies (subject.resolve() is Patient) |
ppc-2 | Rule | (base) | IF Scope=research, Consent.subject must be a patient | (scope = 'research' and subject.resolve().exists()) implies (subject.resolve() is Patient) |
ppc-3 | Rule | (base) | IF Scope=treatment, Consent.subject must be a patient | (scope = 'treatment' and subject.resolve().exists()) implies (subject.resolve() is Patient) |
ppc-4 | Rule | (base) | IF Scope=research, ResearchStudyContext allowed | Consent.provision.extension("http://hl7.org/fhir/StructureDefinition/consent-ResearchStudyContext").exists() or scope.coding.where(system='something' and code='research').exists().not() |
The Consent resource has a reference to a single policyRule
. Many organizations will work in a context where multiple different consent regulations and policies apply.
In these cases, the single policy rule reference refers to a policy document that resolves and reconciles the various policies and presents a single policy for patient
consent. If it is still necessary to track which of the underlying policies an exception is make in regard to, the policy
may be used.
Policies attached to Consent.policyRule language should be written using positive language. For an example, a patient wanting to opt-out will be recorded with an opt-in policy where the Consent.provision[0].type indicates "deny".
The following is the general model of Privacy Consent Directives.
There are context setting parameters:
A Privacy Consent may transition through many states including: that no consent has been sought, consent has been proposed, consent has been rejected, and consent approved.
There are set of patterns.
For each of these patterns (positive or negative pattern), there can be exceptions. These exceptions are explicitly recorded in the except element.
Tracking changes in consent can be managed in two possible ways:
HL7 does not recommend a specific method.
The following steps represent the optimal path for searching for a Consent resource.
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
Name | Type | Description | Expression | In Common |
action | token | Actions controlled by this rule | Consent.provision.action | |
actor | reference | Resource for the actor (or group, by role) | Consent.provision.actor.reference (Practitioner, Group, Organization, CareTeam, Device, Patient, PractitionerRole, RelatedPerson) | |
category | token | Classification of the consent statement - for indexing/retrieval | Consent.category | |
consentor | reference | Who is agreeing to the policy and rules | Consent.performer (Practitioner, Organization, CareTeam, Patient, HealthcareService, PractitionerRole, RelatedPerson) | |
data | reference | The actual data reference | Consent.provision.data.reference (Any) | |
date N | date | When consent was agreed to | Consent.dateTime | 17 Resources |
identifier | token | Identifier for this record (external references) | Consent.identifier | 30 Resources |
organization | reference | Custodian of the consent | Consent.organization (Organization) | |
patient | reference | Who the consent applies to | Consent.subject.where(resolve() is Patient) (Patient) | 33 Resources |
period | date | Timeframe for this rule | Consent.provision.period | |
policy-uri N | uri | Search for Consents aligned with a specific policy or policy date/version. URIs should be complete with date/version and not assume the Resource will maintain versioning information | Consent.policy.uri | |
purpose | token | Context of activities covered by this rule | Consent.provision.purpose | |
scope | token | Which of the four areas this resource covers (extensible) | Consent.scope | |
security-label | token | Security Labels that define affected resources | Consent.provision.securityLabel | |
source-reference | reference | Search by reference to a Consent, DocumentReference, Contract or QuestionnaireResponse | Consent.sourceReference (Consent, Contract, QuestionnaireResponse, DocumentReference) | |
status N | token | draft | active | inactive | entered-in-error | unknown | Consent.status | |
subject | reference | Who the consent applies to | Consent.subject (Practitioner, Patient) | |
verified N | token | Has been verified | Consent.verification.verified | |
verified-date N | date | When consent verified | Consent.verification.verificationDate |