Release 4B 5

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0: R5 - STU ). The This is the current published version which supercedes in it's permanent home (it will always be available at this version is 5.0.0 . URL). For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R5 R4B R4 R3 R2

6.2 Resource Consent - Content

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

A record of a healthcare consumer’s choices, 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.

6.2.1 Scope and Usage

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:

  • Privacy Consent Directive: Agreement Agreement, Restriction, or Prohibition to collect, access, use or disclose (share) information.
  • Medical Treatment Consent Directive: Consent to undergo a specific treatment (or record of refusal to consent).
  • Research Consent Directive: Consent to participate in research protocol and information sharing required.
    • Advance Care Directives: Consent to instructions for potentially needed medical treatment (e.g. DNR).

This resource is scoped to cover all four three uses, but at this time, only the privacy use case is modeled. 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. A FHIR Consent Directive instance HL7 is considered working on Advance Directives and would welcome participation by 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 community.

Usage of the parties to Provenance icon resource may be the content of an encoded representation of a Consent Form is deemed best way to constitute a legally binding Consent Directive. Some domains accept a notary’s electronic signature over manage the wet or electronic signature tracking of a party to the Consent Directive as the additional identity proofing required changes 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 Consent. In addition, the criteria are for making an encoded FHIR Consent Directive legally binding, anything less than a legally binding representation of a Consent Directive must DocumentReference icon may be identified as such, i.e., used 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, 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 with a party responsible for enforcing the consumer’s choices, which permits or denies identified actors or roles an attachment to perform actions affecting show the consumer within a given context for specific purposes and periods stages of time Consent Form Human readable consent content describing one ceremony with additional or more actions impacting the grantor for which the grantee would updated document(s) attached at each stage. Contract icon may also be authorized used in this fashion where as signatures are gathered or prohibited from performing. It includes the terms, rules, and conditions pertaining to applied, the authorization or restrictions, such as effective time, applicability or scope, purposes of use, obligations Contract resource can be updated and prohibitions attached 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.

6.2.1.1 Simple vs. Computable 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: Represent a Consent Directive Register or index a Consent Directive Query and respond about a Consent Directive Retrieve a Consent Directive Notify authorized entities about Consent Directive status changes Determine entities authorized to collect, access, use or disclose information about the Consent Directive or about the information governed by the Consent Directive. 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

In its simplest form, the legally binding Consent Directive from which it was "transcribed". It resource provides recipients with the full content representation they may require for compliance purposes, and typically include a reference means 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 content and periods of timeA Consent Directive derivative that conveys the minimal set metadata of information needed to register a consent (either implicit consent as an active and revoked Consent Directive, event 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 an explicit consent document). At this level of queries for Consent Resource content. There are several Query/Response patterns that are typically used for obtaining information implementation, basic metadata about consent directive content for the following use cases: Find Active Consent Directive: A query that includes sufficient consent directive content to determine whether a specific party (e.g., status, data and time, patient, and organization) is authorized recorded in the corresponding attributes of the Consent resource to share information governed by a enable consent directive with another specific party. discovery by indexing, searching, and retrieval of consents based on this metadata. The Response is either: “Yes” meaning that both parties are authorized sourceAttachment and/or sourceReference elements can be used to share record the information with one another. “No” meaning that original consent document either in the authorized querier is not permitted form of a pointer to share with another specific party “No information found” meaning that there is no active Consent Directive resource or in which the querier is authorized to share the governed information. Find Consent Directive Authorized Entities: A query that includes sufficient consent directive content to return a list form of entities with which the querier is authorized to share governed information. The response to an authorized querier is the list attachment.

In a more advanced usage of any authorized entities with which the querier is permitted to share governed information. The response to an unauthorized querier is that “no information is found”. Find Consent Directive(s): A query that includes sufficient consent directive content resource, in addition to return a list of Consent Directive recording the metadata for an authorized querier to determine what Consent Directives are available, and to locate and retrieve one or more of those Consent Directives as needed. Policy context Any organizational or jurisdictional policies, which may limit potentially the consumer’s policy choices, and which includes original content, the privacy preferences stated in 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 are encoded directly in the 'Patient' though this word is not used across all contexts form of care 6.2.1.1 Privacy Consent Directive (PCD) Privacy policies define how Individually Identifiable Health Information (IIHI) is to machine-readable rules. These rules can 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 processed by a party responsible for enforcing the patient's choices, which permits or denies identified actors or roles decision engine to perform actions affecting adjudicate whether the patient within consent permits a given context for specific purposes and periods of time. All consent directives have given activity (e.g., sharing the patient information with a policy context, which is any set of organizational requester or jurisdictional policies which may limit enrolling the consumer’s policy choices, and which include patient in a named range of actions allowed. research project). In addition, Privacy Consent Directives provide other words, the ability for a healthcare consumer to delegate authority Consent resource is used directly to a Substitute Decision Maker who may act on behalf of record rules that individual. Alternatively, can be used by a consumer may author/publish their privacy rules engine to understand and enforce the preferences expressed by the consenter as a self-declared Privacy Consent Directive. they were intended.

The current version of the Consent resource on FHIR provides support for alternative representations two different mechanisms for expressing interoperable health information privacy consent directives in recording computable rules:

  • the provision structure which provides a standard form simple structure for the exchange and enforcement by sending, intermediating, or receiving systems of capturing most common 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 rules.
  • the Privacy Consent Directive itself, a Consent Statement, policyBasis attribute which electronically represents provides a Consent Directive, or Consent Metadata, which is the minimum necessary consent content derived from more flexible mechanism to reference a Consent Directive for use policy coded in workflow management. a policy language of choice (e.g., XACML icon, ODRL icon, etc.).

6.2.2 Boundaries and Relationships

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, an inline attachment 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 acknowledge acknowledgement or by being signed - either on paper, or digitally. Consent Signatures will be found in the Provenance resource (example consent and signature ). resource. Implementation Guides will generally make rules about what signatures are required, and how they are to be shared and used.

6.2.3 Background and Context

Change to "The The Consent resource is structured with a base policy (represented as Consent.policy/Consent.policyRule) Consent.decision) which is either opt-in permit or opt-out, deny, 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.

6.2.4 References to this Resource

This resource is referenced by

6.2.5 Resource Content

Structure

Σ I I Σ I

See the Extensions for this resource

UML Diagram ( Legend )

Consent ( DomainResource ) Unique identifier for this copy of the Consent Statement identifier : Identifier [0..*] Indicates the current state of this consent Consent resource (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) ConsentState ! » A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible (this element modifies the meaning of other elements) scope : CodeableConcept [1..1] « null (Strength=Extensible) ConsentScopeCodes + » A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements category : CodeableConcept [1..*] [0..*] « null (Strength=Extensible) (Strength=Example) ConsentCategoryCodes + ?? » The patient/healthcare consumer practitioner or group of persons to whom this consent applies patient subject : Reference [0..1] « Patient | Practitioner | Group » When Date the consent instance was agreed to date : date [0..1] Effective period for this Consent was issued / created / indexed Resource and all provisions unless specified in that provision dateTime period : dateTime Period [0..1] Either the Grantor, which is the The entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the grantor : Reference [0..*] « CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » The entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions performer grantee : Reference [0..*] « CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » The organization actor that manages the consent, and consent through its lifecycle manager : Reference [0..*] « HealthcareService | Organization | Patient | Practitioner » The actor that controls/enforces the framework within which it is executed access according to the consent organization controller : Reference [0..*] « HealthcareService | Organization | Patient | Practitioner » The source on which this consent statement is based. The source might be a scanned original paper form, or a form sourceAttachment : Attachment [0..*] 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 source[x] sourceReference : Element [0..1] « Attachment | Reference ( [0..*] « Consent | DocumentReference | Contract | QuestionnaireResponse ) » A reference to set of codes that indicate the specific base computable regulation or policy regulatory basis (if any) that this consent supports policyRule regulatoryBasis : CodeableConcept [0..1] [0..*] « null (Strength=Extensible) (Strength=Example) ConsentPolicyRuleCodes + ?? » A Reference to the human readable policy explaining the basis for the Consent policyText : Reference [0..*] « DocumentReference » Action to take - permit or deny - as default (this element modifies the meaning of other elements) decision : code [0..1] « Policy null (Strength=Required) ConsentProvisionType ! » PolicyBasis Entity or Organization having regulatory jurisdiction or accountability A Reference that identifies the policy the organization will enforce for enforcing policies pertaining to this Consent Directives authority reference : uri Reference [0..1] « Any » The references A URL that links to a computable version of the policies that are included in policy the organization will enforce for this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law Consent uri url : uri url [0..1] Verification Has the instruction been verified verified : boolean [1..1] Extensible list of verification type starting with verification and re-validation verificationType : CodeableConcept [0..1] « null (Strength=Example) ConsentVerificationCodes ?? » The person who conducted the verification/validation of the Grantor decision verifiedBy : Reference [0..1] « Organization | Practitioner | PractitionerRole » Who verified the instruction (Patient, Relative or other Authorized Person) verifiedWith : Reference [0..1] « Patient | RelatedPerson » Date Date(s) verification was collected verificationDate : dateTime [0..1] [0..*] provision Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules type : code [0..1] « null (Strength=Required) ConsentProvisionType ! » The timeframe in Timeframe for this rule is valid provision period : Period [0..1] Actions controlled by this Rule provision action : CodeableConcept [0..*] « null (Strength=Example) ConsentActionCodes ?? » A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception securityLabel : Coding [0..*] « null (Strength=Extensible) (Strength=Example) All Security Labels SecurityLabelExamples + ?? » The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule provision purpose : Coding [0..*] « null (Strength=Extensible) PurposeOfUse + » The class documentType(s) covered by this provision. The type can be a CDA document, or some other type that indicates what sort of information the consent relates to documentType : Coding [0..*] « null (Strength=Preferred) ConsentContentClass ? » The resourceType(s) covered by this rule. provision. The type can be a FHIR resource type, type or a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to class resourceType : Coding [0..*] « null (Strength=Extensible) ConsentContentClass ResourceType + » If this code is found in an instance, then the rule provision applies code : CodeableConcept [0..*] « null (Strength=Example) ConsentContentCodes ?? » Clinical or Operational Relevant period of time that bounds the data controlled by this rule provision dataPeriod : Period [0..1] A computable (FHIRPath or other) definition of what is controlled by this consent expression : Expression [0..1] provisionActor How the individual is involved in the resources content that is described in the exception role : CodeableConcept [1..1] [0..1] « null (Strength=Extensible) SecurityRoleType ParticipationRoleType + » 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') reference : Reference [1..1] [0..1] « Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » provisionData How the resource reference is interpreted when testing consent restrictions meaning : code [1..1] « null (Strength=Required) ConsentDataMeaning ! » A reference to a specific resource that defines which resources are covered by this consent reference : Reference [1..1] « Any » The references A Reference or URL used to uniquely identify the policies that are included in policy the organization will enforce for this consent scope. Policies may be organizational, but are often defined jurisdictionally, Consent. This Reference or in law URL should be specific to the version of the policy and should be dereferencable to a computable policy of some form policyBasis [0..*] [0..1] Whether a treatment instruction (e.g. artificial respiration respiration: yes or no) was verified with the patient, his/her family or another authorized person verification [0..*] Who or what is controlled by this rule. provision. Use group to identify a set of actors by some property they share (e.g. 'admitting officers') actor [0..*] The resources controlled by this rule provision if specific resources are referenced data [0..*] Rules Provisions which provide exceptions to the base rule provision or subrules subprovisions provision [0..*] An exception to the base policy of this consent. An exception can be an addition or removal of access permissions provision [0..1] [0..*]

XML Template 

<

<Consent xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Identifier for this record (external references) --></identifier>
 <
 <</scope>
 <</category>
 <</patient>
 <
 <|
   </performer>
 <</organization>
 <|
   </source[x]>
 <
  <
  <
 </policy>
 <</policyRule>
 <

 <status value="[code]"/><!-- 1..1 draft | active | inactive | not-done | entered-in-error | unknown -->
 <category><!-- 0..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category>
 <subject><!-- 0..1 Reference(Group|Patient|Practitioner) Who the consent applies to --></subject>
 <date value="[date]"/><!-- 0..1 Fully executed date of the consent -->
 <period><!-- 0..1 Period Effective period for this Consent --></period>
 <grantor><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Who is granting rights according to the policy and rules --></grantor>

 <grantee><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></grantee>

 <manager><!-- 0..* Reference(HealthcareService|Organization|Patient|Practitioner) Consent workflow management --></manager>
 <controller><!-- 0..* Reference(HealthcareService|Organization|Patient|
   Practitioner) Consent Enforcer --></controller>

 <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>

 <regulatoryBasis><!-- 0..* CodeableConcept Regulations establishing base Consent --></regulatoryBasis>
 <policyBasis>  <!-- 0..1 Computable version of the backing policy -->
  <reference><!-- 0..1 Reference(Any) Reference backing policy resource --></reference>
  <url value="[url]"/><!-- 0..1 URL to a computable backing policy -->
 </policyBasis>
 <policyText><!-- 0..* Reference(DocumentReference) Human Readable Policy --></policyText>
 <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>
 <
  <
  <</period>
  <
   <</role>
   <|

 <decision value="[code]"/><!-- 0..1 deny | permit -->
 <provision>  <!-- 0..* Constraints to the base Consent.policyRule/Consent.policy -->
  <period><!-- 0..1 Period Timeframe for this provision --></period>
  <actor>  <!-- 0..* Who|what controlled by this provision (or group, by role) -->
   <role><!-- 0..1 CodeableConcept How the actor is involved --></role>
   <reference><!-- 0..1 Reference(CareTeam|Device|Group|Organization|Patient|

     Practitioner|PractitionerRole|RelatedPerson) Resource for the actor (or group, by role) --></reference>
  </actor>
  <</action>
  <</securityLabel>
  <</purpose>
  <</class>
  <</code>
  <</dataPeriod>
  <

  <action><!-- 0..* CodeableConcept Actions controlled by this provision --></action>
  <securityLabel><!-- 0..* Coding Security Labels that define affected resources --></securityLabel>
  <purpose><!-- 0..* Coding Context of activities covered by this provision icon --></purpose>
  <documentType><!-- 0..* Coding e.g. Resource Type, Profile, CDA, etc --></documentType>
  <resourceType><!-- 0..* Coding e.g. Resource Type, Profile, etc --></resourceType>
  <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 provision --></dataPeriod>
  <data>  <!-- 0..* Data controlled by this provision -->

   <meaning value="[code]"/><!-- 1..1 instance | related | dependents | authoredby -->
   <reference><!-- 1..1 Reference(Any) The actual data reference --></reference>
  </data>
  <</provision>

  <expression><!-- 0..1 Expression A computable expression of the consent --></expression>
  <provision><!-- 0..* Content as for Consent.provision Nested Exception Provisions --></provision>

 </provision>
</Consent>

JSON Template 

{doco
  "resourceType" : "",

  "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 | not-done | entered-in-error | unknown
  "category" : [{ CodeableConcept }], // Classification of the consent statement - for indexing/retrieval
  "subject" : { Reference(Group|Patient|Practitioner) }, // Who the consent applies to
  "date" : "<date>", // Fully executed date of the consent
  "period" : { Period }, // Effective period for this Consent
  "grantor" : [{ Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Who is granting rights according to the policy and rules

  "grantee" : [{ Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules

  "manager" : [{ Reference(HealthcareService|Organization|Patient|Practitioner) }], // Consent workflow management
  "controller" : [{ Reference(HealthcareService|Organization|Patient|
   Practitioner) }], // Consent Enforcer

  "sourceAttachment" : [{ Attachment }], // Source from which this consent is taken
  "sourceReference" : [{ Reference(Consent|Contract|DocumentReference|
   QuestionnaireResponse) }], // Source from which this consent is taken

  "regulatoryBasis" : [{ CodeableConcept }], // Regulations establishing base Consent
  "policyBasis" : { // Computable version of the backing policy
    "reference" : { Reference(Any) }, // Reference backing policy resource
    "url" : "<url>" // URL to a computable backing policy
  },
  "policyText" : [{ Reference(DocumentReference) }], // Human Readable Policy
  "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

  }],
  "
    "
    "
    "
      "

  "decision" : "<code>", // deny | permit
  "provision" : [{ // Constraints to the base Consent.policyRule/Consent.policy
    "period" : { Period }, // Timeframe for this provision
    "actor" : [{ // Who|what controlled by this provision (or group, by role)
      "role" : { CodeableConcept }, // How the actor is involved

      "reference" : { Reference(CareTeam|Device|Group|Organization|Patient|
     

     Practitioner|PractitionerRole|RelatedPerson) } // Resource for the actor (or group, by role)
    }],
    "
    "
    "
    "
    "
    "
    "

    "action" : [{ CodeableConcept }], // Actions controlled by this provision
    "securityLabel" : [{ Coding }], // Security Labels that define affected resources
    "purpose" : [{ Coding }], // Context of activities covered by this provision icon
    "documentType" : [{ Coding }], // e.g. Resource Type, Profile, CDA, etc
    "resourceType" : [{ Coding }], // e.g. Resource Type, Profile, etc
    "code" : [{ CodeableConcept }], // e.g. LOINC or SNOMED CT code, etc. in the content
    "dataPeriod" : { Period }, // Timeframe for data controlled by this provision
    "data" : [{ // Data controlled by this provision

      "meaning" : "<code>", // R!  instance | related | dependents | authoredby
      "reference" : { Reference(Any) } // R!  The actual data reference
    }],
    "
  }

    "expression" : { Expression }, // A computable expression of the consent
    "provision" : [{ Content as for Consent.provision }] // Nested Exception Provisions
  }]

}

Turtle Template 

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  # . One of these 2
    fhir: ]
    fhir:) ]
  fhir:
    fhir:
    fhir:
  ], ...;
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;
  fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:|
  
    ], ...;
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:
    ], ...;
    fhir:
  ];

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Identifier for this record (external references)
  fhir:status [ code ] ; # 1..1 draft | active | inactive | not-done | entered-in-error | unknown
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* Classification of the consent statement - for indexing/retrieval
  fhir:subject [ Reference(Group|Patient|Practitioner) ] ; # 0..1 Who the consent applies to
  fhir:date [ date ] ; # 0..1 Fully executed date of the consent
  fhir:period [ Period ] ; # 0..1 Effective period for this Consent
  fhir:grantor  ( [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ... ) ; # 0..* Who is granting rights according to the policy and rules

  fhir:grantee  ( [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ... ) ; # 0..* Who is agreeing to the policy and rules

  fhir:manager  ( [ Reference(HealthcareService|Organization|Patient|Practitioner) ] ... ) ; # 0..* Consent workflow management
  fhir:controller  ( [ Reference(HealthcareService|Organization|Patient|Practitioner) ] ... ) ; # 0..* Consent Enforcer
  fhir:sourceAttachment  ( [ Attachment ] ... ) ; # 0..* Source from which this consent is taken
  fhir:sourceReference  ( [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ] ... ) ; # 0..* Source from which this consent is taken
  fhir:regulatoryBasis  ( [ CodeableConcept ] ... ) ; # 0..* Regulations establishing base Consent
  fhir:policyBasis [ # 0..1 Computable version of the backing policy
    fhir:reference [ Reference(Any) ] ; # 0..1 Reference backing policy resource
    fhir:url [ url ] ; # 0..1 URL to a computable backing policy
  ] ;
  fhir:policyText  ( [ Reference(DocumentReference) ] ... ) ; # 0..* Human Readable Policy
  fhir:verification ( [ # 0..* Consent Verified by patient or family
    fhir:verified [ boolean ] ; # 1..1 Has been verified
    fhir:verificationType [ CodeableConcept ] ; # 0..1 Business case of verification
    fhir:verifiedBy [ Reference(Organization|Practitioner|PractitionerRole) ] ; # 0..1 Person conducting verification
    fhir:verifiedWith [ Reference(Patient|RelatedPerson) ] ; # 0..1 Person who verified
    fhir:verificationDate  ( [ dateTime ] ... ) ; # 0..* When consent verified
  ] ... ) ;
  fhir:decision [ code ] ; # 0..1 deny | permit
  fhir:provision ( [ # 0..* Constraints to the base Consent.policyRule/Consent.policy
    fhir:period [ Period ] ; # 0..1 Timeframe for this provision
    fhir:actor ( [ # 0..* Who|what controlled by this provision (or group, by role)
      fhir:role [ CodeableConcept ] ; # 0..1 How the actor is involved
      fhir:reference [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ; # 0..1 Resource for the actor (or group, by role)

    ] ... ) ;
    fhir:action  ( [ CodeableConcept ] ... ) ; # 0..* Actions controlled by this provision
    fhir:securityLabel  ( [ Coding ] ... ) ; # 0..* Security Labels that define affected resources
    fhir:purpose  ( [ Coding ] ... ) ; # 0..* Context of activities covered by this provision
    fhir:documentType  ( [ Coding ] ... ) ; # 0..* e.g. Resource Type, Profile, CDA, etc
    fhir:resourceType  ( [ Coding ] ... ) ; # 0..* e.g. Resource Type, Profile, etc
    fhir:code  ( [ CodeableConcept ] ... ) ; # 0..* e.g. LOINC or SNOMED CT code, etc. in the content
    fhir:dataPeriod [ Period ] ; # 0..1 Timeframe for data controlled by this provision
    fhir:data ( [ # 0..* Data controlled by this provision
      fhir:meaning [ code ] ; # 1..1 instance | related | dependents | authoredby
      fhir:reference [ Reference(Any) ] ; # 1..1 The actual data reference
    ] ... ) ;
    fhir:expression [ Expression ] ; # 0..1 A computable expression of the consent
    fhir:provision  ( [ See Consent.provision ] ... ) ; # 0..* Nested Exception Provisions
  ] ... ) ;

]

Changes since from both R4 and R4B

Consent
Consent.status
  • No Changes Remove codes proposed , rejected
  • Add codes not-done , unknown
Consent.category
  • Min Cardinality changed from 1 to 0
  • Remove Binding `http://hl7.org/fhir/ValueSet/consent-category` (extensible)
Consent.subject
  • Renamed from patient to subject
  • Type Reference: Added Target Types Practitioner, Group
Consent.date
  • Renamed from dateTime to date
  • Type changed from dateTime to date
Consent.period
  • Added Element
Consent.grantor
  • Added Element
Consent.grantee
  • Renamed from performer to grantee
  • Type Reference: Added Target Types CareTeam, HealthcareService
Consent.manager
  • Added Element
Consent.controller
  • Added Element
Consent.sourceAttachment
  • Added Element
Consent.sourceReference
  • Added Element
Consent.regulatoryBasis
  • Added Element
Consent.policyBasis
  • Renamed from policy to policyBasis
  • Max Cardinality changed from * to 1
Consent.policyBasis.reference
  • Added Element
Consent.policyBasis.url
  • Added Element
Consent.policyText
  • Added Element
Consent.verification.verificationType
  • Added Element
Consent.verification.verifiedBy
  • Added Element
Consent.verification.verificationDate
  • Max Cardinality changed from 1 to *
Consent.decision
  • Moved from Consent.provision.type to decision
  • Now marked as Modifier
Consent.provision
  • Max Cardinality changed from 1 to *
Consent.provision.actor.role
Consent.provision.actor.reference
  • Min Cardinality changed from 1 to 0
Consent.provision.securityLabel
  • Remove Binding `http://hl7.org/fhir/ValueSet/security-labels` (extensible)
Consent.provision.documentType
  • Added Element
Consent.provision.resourceType
Consent.provision.expression
  • Added Element
Consent.scope
  • Deleted (-> Merged with Consent.category)
Consent.organization
  • Deleted (-> split into Consent.manager and Consent.controller)
Consent.source[x]
  • Deleted
Consent.policy.authority
  • Deleted
Consent.policy.uri
  • Deleted
Consent.policyRule
  • Deleted

See the Full Difference for further information

This analysis is available for R4 as XML or JSON . Conversions between R3 and R4 for R4B as XML or JSON .

See R3 <--> R4 <--> R5 Conversion Maps (status = 12 tests that all execute ok. All tests pass round-trip testing and 12 r3 resources are invalid (0 errors). ) See Conversions Summary .)

Structure

Σ I I Σ I

See the Extensions for this resource

UML Diagram ( Legend )

Consent ( DomainResource ) Unique identifier for this copy of the Consent Statement identifier : Identifier [0..*] Indicates the current state of this consent Consent resource (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) ConsentState ! » A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible (this element modifies the meaning of other elements) scope : CodeableConcept [1..1] « null (Strength=Extensible) ConsentScopeCodes + » A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements category : CodeableConcept [1..*] [0..*] « null (Strength=Extensible) (Strength=Example) ConsentCategoryCodes + ?? » The patient/healthcare consumer practitioner or group of persons to whom this consent applies patient subject : Reference [0..1] « Patient | Practitioner | Group » When Date the consent instance was agreed to date : date [0..1] Effective period for this Consent was issued / created / indexed Resource and all provisions unless specified in that provision dateTime period : dateTime Period [0..1] Either the Grantor, which is the The entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the grantor : Reference [0..*] « CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » The entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions performer grantee : Reference [0..*] « CareTeam | HealthcareService | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » The organization actor that manages the consent, and consent through its lifecycle manager : Reference [0..*] « HealthcareService | Organization | Patient | Practitioner » The actor that controls/enforces the framework within which it is executed access according to the consent organization controller : Reference [0..*] « HealthcareService | Organization | Patient | Practitioner » The source on which this consent statement is based. The source might be a scanned original paper form, or a form sourceAttachment : Attachment [0..*] 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 source[x] sourceReference : Element [0..1] « Attachment | Reference ( [0..*] « Consent | DocumentReference | Contract | QuestionnaireResponse ) » A reference to set of codes that indicate the specific base computable regulation or policy regulatory basis (if any) that this consent supports policyRule regulatoryBasis : CodeableConcept [0..1] [0..*] « null (Strength=Extensible) (Strength=Example) ConsentPolicyRuleCodes + ?? » A Reference to the human readable policy explaining the basis for the Consent policyText : Reference [0..*] « DocumentReference » Action to take - permit or deny - as default (this element modifies the meaning of other elements) decision : code [0..1] « Policy null (Strength=Required) ConsentProvisionType ! » PolicyBasis Entity or Organization having regulatory jurisdiction or accountability A Reference that identifies the policy the organization will enforce for enforcing policies pertaining to this Consent Directives authority reference : uri Reference [0..1] « Any » The references A URL that links to a computable version of the policies that are included in policy the organization will enforce for this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law Consent uri url : uri url [0..1] Verification Has the instruction been verified verified : boolean [1..1] Extensible list of verification type starting with verification and re-validation verificationType : CodeableConcept [0..1] « null (Strength=Example) ConsentVerificationCodes ?? » The person who conducted the verification/validation of the Grantor decision verifiedBy : Reference [0..1] « Organization | Practitioner | PractitionerRole » Who verified the instruction (Patient, Relative or other Authorized Person) verifiedWith : Reference [0..1] « Patient | RelatedPerson » Date Date(s) verification was collected verificationDate : dateTime [0..1] [0..*] provision Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules type : code [0..1] « null (Strength=Required) ConsentProvisionType ! » The timeframe in Timeframe for this rule is valid provision period : Period [0..1] Actions controlled by this Rule provision action : CodeableConcept [0..*] « null (Strength=Example) ConsentActionCodes ?? » A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception securityLabel : Coding [0..*] « null (Strength=Extensible) (Strength=Example) All Security Labels SecurityLabelExamples + ?? » The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule provision purpose : Coding [0..*] « null (Strength=Extensible) PurposeOfUse + » The class documentType(s) covered by this provision. The type can be a CDA document, or some other type that indicates what sort of information the consent relates to documentType : Coding [0..*] « null (Strength=Preferred) ConsentContentClass ? » The resourceType(s) covered by this rule. provision. The type can be a FHIR resource type, type or a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to class resourceType : Coding [0..*] « null (Strength=Extensible) ConsentContentClass ResourceType + » If this code is found in an instance, then the rule provision applies code : CodeableConcept [0..*] « null (Strength=Example) ConsentContentCodes ?? » Clinical or Operational Relevant period of time that bounds the data controlled by this rule provision dataPeriod : Period [0..1] A computable (FHIRPath or other) definition of what is controlled by this consent expression : Expression [0..1] provisionActor How the individual is involved in the resources content that is described in the exception role : CodeableConcept [1..1] [0..1] « null (Strength=Extensible) SecurityRoleType ParticipationRoleType + » 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') reference : Reference [1..1] [0..1] « Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » provisionData How the resource reference is interpreted when testing consent restrictions meaning : code [1..1] « null (Strength=Required) ConsentDataMeaning ! » A reference to a specific resource that defines which resources are covered by this consent reference : Reference [1..1] « Any » The references A Reference or URL used to uniquely identify the policies that are included in policy the organization will enforce for this consent scope. Policies may be organizational, but are often defined jurisdictionally, Consent. This Reference or in law URL should be specific to the version of the policy and should be dereferencable to a computable policy of some form policyBasis [0..*] [0..1] Whether a treatment instruction (e.g. artificial respiration respiration: yes or no) was verified with the patient, his/her family or another authorized person verification [0..*] Who or what is controlled by this rule. provision. Use group to identify a set of actors by some property they share (e.g. 'admitting officers') actor [0..*] The resources controlled by this rule provision if specific resources are referenced data [0..*] Rules Provisions which provide exceptions to the base rule provision or subrules subprovisions provision [0..*] An exception to the base policy of this consent. An exception can be an addition or removal of access permissions provision [0..1] [0..*]

XML Template 

<

<Consent xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Identifier for this record (external references) --></identifier>
 <
 <</scope>
 <</category>
 <</patient>
 <
 <|
   </performer>
 <</organization>
 <|
   </source[x]>
 <
  <
  <
 </policy>
 <</policyRule>
 <

 <status value="[code]"/><!-- 1..1 draft | active | inactive | not-done | entered-in-error | unknown -->
 <category><!-- 0..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category>
 <subject><!-- 0..1 Reference(Group|Patient|Practitioner) Who the consent applies to --></subject>
 <date value="[date]"/><!-- 0..1 Fully executed date of the consent -->
 <period><!-- 0..1 Period Effective period for this Consent --></period>
 <grantor><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Who is granting rights according to the policy and rules --></grantor>

 <grantee><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></grantee>

 <manager><!-- 0..* Reference(HealthcareService|Organization|Patient|Practitioner) Consent workflow management --></manager>
 <controller><!-- 0..* Reference(HealthcareService|Organization|Patient|
   Practitioner) Consent Enforcer --></controller>

 <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>

 <regulatoryBasis><!-- 0..* CodeableConcept Regulations establishing base Consent --></regulatoryBasis>
 <policyBasis>  <!-- 0..1 Computable version of the backing policy -->
  <reference><!-- 0..1 Reference(Any) Reference backing policy resource --></reference>
  <url value="[url]"/><!-- 0..1 URL to a computable backing policy -->
 </policyBasis>
 <policyText><!-- 0..* Reference(DocumentReference) Human Readable Policy --></policyText>
 <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>
 <
  <
  <</period>
  <
   <</role>
   <|

 <decision value="[code]"/><!-- 0..1 deny | permit -->
 <provision>  <!-- 0..* Constraints to the base Consent.policyRule/Consent.policy -->
  <period><!-- 0..1 Period Timeframe for this provision --></period>
  <actor>  <!-- 0..* Who|what controlled by this provision (or group, by role) -->
   <role><!-- 0..1 CodeableConcept How the actor is involved --></role>
   <reference><!-- 0..1 Reference(CareTeam|Device|Group|Organization|Patient|

     Practitioner|PractitionerRole|RelatedPerson) Resource for the actor (or group, by role) --></reference>
  </actor>
  <</action>
  <</securityLabel>
  <</purpose>
  <</class>
  <</code>
  <</dataPeriod>
  <

  <action><!-- 0..* CodeableConcept Actions controlled by this provision --></action>
  <securityLabel><!-- 0..* Coding Security Labels that define affected resources --></securityLabel>
  <purpose><!-- 0..* Coding Context of activities covered by this provision icon --></purpose>
  <documentType><!-- 0..* Coding e.g. Resource Type, Profile, CDA, etc --></documentType>
  <resourceType><!-- 0..* Coding e.g. Resource Type, Profile, etc --></resourceType>
  <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 provision --></dataPeriod>
  <data>  <!-- 0..* Data controlled by this provision -->

   <meaning value="[code]"/><!-- 1..1 instance | related | dependents | authoredby -->
   <reference><!-- 1..1 Reference(Any) The actual data reference --></reference>
  </data>
  <</provision>

  <expression><!-- 0..1 Expression A computable expression of the consent --></expression>
  <provision><!-- 0..* Content as for Consent.provision Nested Exception Provisions --></provision>

 </provision>
</Consent>

JSON Template 

{doco
  "resourceType" : "",

  "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 | not-done | entered-in-error | unknown
  "category" : [{ CodeableConcept }], // Classification of the consent statement - for indexing/retrieval
  "subject" : { Reference(Group|Patient|Practitioner) }, // Who the consent applies to
  "date" : "<date>", // Fully executed date of the consent
  "period" : { Period }, // Effective period for this Consent
  "grantor" : [{ Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Who is granting rights according to the policy and rules

  "grantee" : [{ Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules

  "manager" : [{ Reference(HealthcareService|Organization|Patient|Practitioner) }], // Consent workflow management
  "controller" : [{ Reference(HealthcareService|Organization|Patient|
   Practitioner) }], // Consent Enforcer

  "sourceAttachment" : [{ Attachment }], // Source from which this consent is taken
  "sourceReference" : [{ Reference(Consent|Contract|DocumentReference|
   QuestionnaireResponse) }], // Source from which this consent is taken

  "regulatoryBasis" : [{ CodeableConcept }], // Regulations establishing base Consent
  "policyBasis" : { // Computable version of the backing policy
    "reference" : { Reference(Any) }, // Reference backing policy resource
    "url" : "<url>" // URL to a computable backing policy
  },
  "policyText" : [{ Reference(DocumentReference) }], // Human Readable Policy
  "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

  }],
  "
    "
    "
    "
      "

  "decision" : "<code>", // deny | permit
  "provision" : [{ // Constraints to the base Consent.policyRule/Consent.policy
    "period" : { Period }, // Timeframe for this provision
    "actor" : [{ // Who|what controlled by this provision (or group, by role)
      "role" : { CodeableConcept }, // How the actor is involved

      "reference" : { Reference(CareTeam|Device|Group|Organization|Patient|
     

     Practitioner|PractitionerRole|RelatedPerson) } // Resource for the actor (or group, by role)
    }],
    "
    "
    "
    "
    "
    "
    "

    "action" : [{ CodeableConcept }], // Actions controlled by this provision
    "securityLabel" : [{ Coding }], // Security Labels that define affected resources
    "purpose" : [{ Coding }], // Context of activities covered by this provision icon
    "documentType" : [{ Coding }], // e.g. Resource Type, Profile, CDA, etc
    "resourceType" : [{ Coding }], // e.g. Resource Type, Profile, etc
    "code" : [{ CodeableConcept }], // e.g. LOINC or SNOMED CT code, etc. in the content
    "dataPeriod" : { Period }, // Timeframe for data controlled by this provision
    "data" : [{ // Data controlled by this provision

      "meaning" : "<code>", // R!  instance | related | dependents | authoredby
      "reference" : { Reference(Any) } // R!  The actual data reference
    }],
    "
  }

    "expression" : { Expression }, // A computable expression of the consent
    "provision" : [{ Content as for Consent.provision }] // Nested Exception Provisions
  }]

}

Turtle Template 

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  # . One of these 2
    fhir: ]
    fhir:) ]
  fhir:
    fhir:
    fhir:
  ], ...;
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;
  fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:|
  
    ], ...;
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:
    ], ...;
    fhir:
  ];

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Identifier for this record (external references)
  fhir:status [ code ] ; # 1..1 draft | active | inactive | not-done | entered-in-error | unknown
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* Classification of the consent statement - for indexing/retrieval
  fhir:subject [ Reference(Group|Patient|Practitioner) ] ; # 0..1 Who the consent applies to
  fhir:date [ date ] ; # 0..1 Fully executed date of the consent
  fhir:period [ Period ] ; # 0..1 Effective period for this Consent
  fhir:grantor  ( [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ... ) ; # 0..* Who is granting rights according to the policy and rules

  fhir:grantee  ( [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ... ) ; # 0..* Who is agreeing to the policy and rules

  fhir:manager  ( [ Reference(HealthcareService|Organization|Patient|Practitioner) ] ... ) ; # 0..* Consent workflow management
  fhir:controller  ( [ Reference(HealthcareService|Organization|Patient|Practitioner) ] ... ) ; # 0..* Consent Enforcer
  fhir:sourceAttachment  ( [ Attachment ] ... ) ; # 0..* Source from which this consent is taken
  fhir:sourceReference  ( [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ] ... ) ; # 0..* Source from which this consent is taken
  fhir:regulatoryBasis  ( [ CodeableConcept ] ... ) ; # 0..* Regulations establishing base Consent
  fhir:policyBasis [ # 0..1 Computable version of the backing policy
    fhir:reference [ Reference(Any) ] ; # 0..1 Reference backing policy resource
    fhir:url [ url ] ; # 0..1 URL to a computable backing policy
  ] ;
  fhir:policyText  ( [ Reference(DocumentReference) ] ... ) ; # 0..* Human Readable Policy
  fhir:verification ( [ # 0..* Consent Verified by patient or family
    fhir:verified [ boolean ] ; # 1..1 Has been verified
    fhir:verificationType [ CodeableConcept ] ; # 0..1 Business case of verification
    fhir:verifiedBy [ Reference(Organization|Practitioner|PractitionerRole) ] ; # 0..1 Person conducting verification
    fhir:verifiedWith [ Reference(Patient|RelatedPerson) ] ; # 0..1 Person who verified
    fhir:verificationDate  ( [ dateTime ] ... ) ; # 0..* When consent verified
  ] ... ) ;
  fhir:decision [ code ] ; # 0..1 deny | permit
  fhir:provision ( [ # 0..* Constraints to the base Consent.policyRule/Consent.policy
    fhir:period [ Period ] ; # 0..1 Timeframe for this provision
    fhir:actor ( [ # 0..* Who|what controlled by this provision (or group, by role)
      fhir:role [ CodeableConcept ] ; # 0..1 How the actor is involved
      fhir:reference [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ; # 0..1 Resource for the actor (or group, by role)

    ] ... ) ;
    fhir:action  ( [ CodeableConcept ] ... ) ; # 0..* Actions controlled by this provision
    fhir:securityLabel  ( [ Coding ] ... ) ; # 0..* Security Labels that define affected resources
    fhir:purpose  ( [ Coding ] ... ) ; # 0..* Context of activities covered by this provision
    fhir:documentType  ( [ Coding ] ... ) ; # 0..* e.g. Resource Type, Profile, CDA, etc
    fhir:resourceType  ( [ Coding ] ... ) ; # 0..* e.g. Resource Type, Profile, etc
    fhir:code  ( [ CodeableConcept ] ... ) ; # 0..* e.g. LOINC or SNOMED CT code, etc. in the content
    fhir:dataPeriod [ Period ] ; # 0..1 Timeframe for data controlled by this provision
    fhir:data ( [ # 0..* Data controlled by this provision
      fhir:meaning [ code ] ; # 1..1 instance | related | dependents | authoredby
      fhir:reference [ Reference(Any) ] ; # 1..1 The actual data reference
    ] ... ) ;
    fhir:expression [ Expression ] ; # 0..1 A computable expression of the consent
    fhir:provision  ( [ See Consent.provision ] ... ) ; # 0..* Nested Exception Provisions
  ] ... ) ;

]

Changes since Release 4 from both R4 and R4B

Consent
Consent.status
  • Remove codes proposed , rejected
  • Add codes not-done , unknown
Consent.category
  • No Changes Min Cardinality changed from 1 to 0
  • Remove Binding `http://hl7.org/fhir/ValueSet/consent-category` (extensible)
Consent.subject
  • Renamed from patient to subject
  • Type Reference: Added Target Types Practitioner, Group
Consent.date
  • Renamed from dateTime to date
  • Type changed from dateTime to date
Consent.period
  • Added Element
Consent.grantor
  • Added Element
Consent.grantee
  • Renamed from performer to grantee
  • Type Reference: Added Target Types CareTeam, HealthcareService
Consent.manager
  • Added Element
Consent.controller
  • Added Element
Consent.sourceAttachment
  • Added Element
Consent.sourceReference
  • Added Element
Consent.regulatoryBasis
  • Added Element
Consent.policyBasis
  • Renamed from policy to policyBasis
  • Max Cardinality changed from * to 1
Consent.policyBasis.reference
  • Added Element
Consent.policyBasis.url
  • Added Element
Consent.policyText
  • Added Element
Consent.verification.verificationType
  • Added Element
Consent.verification.verifiedBy
  • Added Element
Consent.verification.verificationDate
  • Max Cardinality changed from 1 to *
Consent.decision
  • Moved from Consent.provision.type to decision
  • Now marked as Modifier
Consent.provision
  • Max Cardinality changed from 1 to *
Consent.provision.actor.role
Consent.provision.actor.reference
  • Min Cardinality changed from 1 to 0
Consent.provision.securityLabel
  • Remove Binding `http://hl7.org/fhir/ValueSet/security-labels` (extensible)
Consent.provision.documentType
  • Added Element
Consent.provision.resourceType
Consent.provision.expression
  • Added Element
Consent.scope
  • Deleted (-> Merged with Consent.category)
Consent.organization
  • Deleted (-> split into Consent.manager and Consent.controller)
Consent.source[x]
  • Deleted
Consent.policy.authority
  • Deleted
Consent.policy.uri
  • Deleted
Consent.policyRule
  • Deleted

See the Full Difference for further information

This analysis is available for R4 as XML or JSON . Conversions between R3 and R4 for R4B as XML or JSON .

See R3 <--> R4 <--> R5 Conversion Maps (status = 12 tests that all execute ok. All tests pass round-trip testing and 12 r3 resources are invalid (0 errors). ) See Conversions Summary .)

 

See the Profiles & Extensions and the alternate Additional definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis

6.2.5.1 Terminology Bindings

Consent.scope Consent.category Consent.policyRule Consent.provision.type Consent.provision.code Consent.provision.data.meaning Expression ppc-1 patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not() ppc-3 (base)
Path Definition ValueSet Type Reference Documentation
Consent.status ConsentState Required ConsentState

Indicates the state of the consent.

Consent.category ConsentCategoryCodes Extensible Example ConsentScopeCodes

This value set includes sample Consent Directive Type codes, including several consent directive related LOINC codes; HL7 VALUE SET: ActConsentType(2.16.840.1.113883.1.11.19897); examples of US realm consent directive legal descriptions and references to online and/or downloadable forms such as the SSA-827 Authorization to Disclose Information to the Social Security Administration; and other anticipated consent directives related to participation in a clinical trial, medical procedures, reproductive procedures; health care directive (Living Will); advance directive, do not resuscitate (DNR); Physician Orders for Life-Sustaining Treatment (POLST)

Consent.regulatoryBasis ConsentPolicyRuleCodes Extensible Example ConsentCategoryCodes

This value set includes sample Regulatory consent policy types from the US and other regions.

Consent.verification.verificationType ConsentVerificationCodes Extensible Example ConsentPolicyRuleCodes

This value set includes base Consent Verification codes.

Consent.decision ConsentProvisionType Required ConsentProvisionType

How a rule statement is applied, such as adding additional consent or removing consent.

Consent.provision.actor.role ParticipationRoleType Extensible SecurityRoleType

This FHIR value set is comprised of Actor participation Type codes, which can be used to value FHIR agents, actors, and other role elements. The codes are intended to express how the agent participated in some activity. Sometimes refered to the agent functional-role relative to the activity.

Consent.provision.action ConsentActionCodes Example ConsentActionCodes

This value set includes sample Consent Action codes.

Consent.provision.securityLabel SecurityLabelExamples Extensible Example All

A sample of security labels from Healthcare Privacy and Security Labels Classification System as the combination of data and event codes.

Consent.provision.purpose PurposeOfUse icon Extensible PurposeOfUse

Supports communication of purpose of use at a general level.

Consent.provision.class Extensible Consent.provision.documentType ConsentContentClass Example Preferred ConsentContentCodes

This value set includes the FHIR resource types, along with some other important content class codes

Consent.provision.resourceType ResourceType Required Extensible ConsentDataMeaning

Concrete FHIR Resource Types

6.2.5.2 Constraints id Level Location Description
Consent.provision.code Rule ConsentContentCodes (base) Either a Policy or PolicyRule policy.exists() or policyRule.exists() ppc-2 Rule Example (base) IF Scope=privacy, there must be a patient

This example value set contains all LOINC code

Consent.provision.data.meaning Rule ConsentDataMeaning (base) IF Scope=research, there must be a patient patient.exists() or scope.coding.where(system='something' and code='research').exists().not() ppc-4 Rule Required (base) 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

How a patient patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not() resource reference is interpreted when testing consent restrictions.

'

6.2.6 Policies

The Consent resource has a reference to a single policyRule PolicyBasis . 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 regulations an exception is make in regard to, the policy RegulatoryBasis may be used.

Policies attached to PolicyBasis 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".

6.2.7 Privacy Consent General Model

The following is the general model of Privacy Consent Directives.

There are context setting parameters:

  1. Who - The patient or third-party grantor
  2. What - The data - specific resources are listed, empty list means all data covered by the consent.
  3. Where Required - The domain and authority - what is the location boundary and authority boundary of this consent policy domain.
  4. Where Accountability Lies - The organization or performer
  5. When - The date issued or captured
  6. When - The timeframe for which the Consent applies
  7. How - The actions covered. (such as purposes of use that are covered)
  8. Whom - The recipient actor are grantees by the consent.

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.

  1. No consent: All settings need a policy for when no consent has been captured. Often this allows treatment only.;
  2. Opt-out: No sharing allowed for the specified domain, location, actions, and purposes ; purposes;
  3. Opt-out with exceptions: No sharing allowed, with some exceptions where it is allowed. Example: Withhold Authorization for Treatment except for Emergency Treatment ; Treatment;
  4. Opt-in: Sharing for some purpose of use is authorized Sharing allowed for Treatment, Payment, and normal Operations ; Operations; and
  5. Opt-in with restrictions: Sharing allowed, but the patient may make exceptions (See the Canadian examples). exceptions.

For each of these patterns (positive or negative pattern), there can be exceptions. These exceptions are explicitly recorded in Consent.provision sub-trees. the provision element.

6.2.8 Realm specifics Provisions

6.2.8.1 US Realm Sample Use-Cases

Five categories of Privacy Consent Directives are described The provision structure provides a mechanism for modeling consent rules in a machine-readable and computable way. This is the Office FHIR Consent's native mechanism for expressing and encoding policy rules within the resource --an alternative to using an external policy language.

The default decision of the National Coordinator for Health Information (ONC) Consent Directives Document released March 31, 2010, consent is stated by the decision attribute ( permit or deny ) and include provisions state the exceptions to the base decision. Each provision may have its own sub-provisions that, in turn, state the exceptions to the rules stated in the parent provision. The following US-specific "Core consent options" figure depicts this structure:

consent provisions

For example, if the base decision for electronic exchange: a consent is permit , the first level of provisions express exceptions to this decision, therefore, the decision when matching these provisions will be a deny . The immediate child provisions to any of these provisions would express exceptions to their deny decision, therefore, their effect, when matched, will be permit .

The provision structure provides a rich mechanism to construct complex rules using logical AND and OR :

  • No consent: Health information Provisions at the same level of patients is automatically included—patients cannot opt out; depth are interpreted as disjunctive (i.e., OR -ed). This means that matching any of the sibling provisions at one level constitutes an exception to the rule stated in the parent provision.
  • Opt-out: Default is for health information of patients Within a provision, the conditions implied by different attributes are interpreted conjunctively (i.e., AND -ed). This means that in order to be included automatically, but match the patient can opt out completely ; provision, all the attributes must match.
  • Opt-out with exceptions: Default Within an attribute, if the attribute is for health information multi-valued, the values are interpreted as disjunctive (i.e., OR -ed). This means that matching any of patients the values listed for the attribute is sufficient for the attribute to match. For single-valued attributes, matching is simply based on matching the value of the attribute.

If the value of an attribute is a code from a hierarchical code structure (e.g., a Confidentiality code icon ), the subsumption relationship between the codes in the hierarchy must be included, but considered in the patient can opt out completely interpretation of the provision:

  • If the (implicit or allow only select data explicit) type of the provision is permit , all the subsumed descending codes (that are below the mentioned code in the hierarchy) are also permitted. For example, if a provision permits access to be included; very restricted ( V ) data, it also permits access to restricted ( R ) data.
  • Opt-in: Default If the (implicit or explicit) type of the provision is deny , all the subsuming parent codes (that are above the mentioned code in the hierarchy) are also denied. For example, if a provision denies access to restricted ( R ) data, it also denies access to very restricted ( V ) data.

The following figure visualizes this in the course of an example.

consent provisions example

The base decision is a deny to which the first exception, expressed in the first provision, states that no patient health information during the time period from 01/01/2020 to 31/12/2022 all access by Org A is included; patients must actively express consent permitted. In order to match this provision, and therefore for this permit decision to be included, but if they do so then their information applicable, the requestor identifier must match Org A AND the current date must be all within the range 01/01/2020-31/12/2022.

The subsequent child provisions state exceptions to this base rule. Matching any of these provisions results in or all out; and a deny since these are exceptions to a permit parent provision.

  • access is denied if the purpose of use is marketing ( HMK ).
  • Opt-in with restrictions: Default access is denied if the requested data is restricted ( R ). Note that no patient health information this implies access is made available, but also denied if the patient may allow a subset of select requested data to be included. is very restricted ( V ).
    • A common exception
  • access is to explicitly exclude or explicitly include a period denied if the purpose of time . use is payment ( PAY ) unless:
    • content type is Claims , OR Claim Responses , OR Accounts .
6.2.8.2

6.2.9 Canada Realm Sample Use-Cases Tracking Changes in Consent

The following scenarios are based on existing jurisdictional policy and are realized Tracking changes in existing systems consent can be managed in Canada. The default policy two possible ways:

  1. Submitting changes to the Consent resource and tracking the changes via a versioning server
  2. Submitting a new Consent resource and marking the old resource as inactive

HL7 does not recommend a specific method.

A FHIR Consent Directive instance is one of implied consent for considered the provision encoded legally binding Consent Directive if it meets requirements of care, so these scenarios all deal with withdrawal or withholding consent a policy domain requirements for that purpose. an enforceable contract. In other jurisdictions, where some domains, electronic signatures of one or both of the parties to the content of an express consent model encoded representation of a Consent Form is used (Opt-In), these examples would contain deemed to constitute a legally binding Consent Directive. Some domains accept a notary’s electronic signature over the phrase "consent to" rather than "withhold" wet or "withdraw" consent for. Withhold 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 withdraw consent might not require the parties’ signatures at all.

Whatever the criteria are for disclosure making an encoded FHIR Consent Directive legally binding, anything less than a legally binding representation of records related 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 domain (e.g. DI, LAB, etc.) Withhold purposes and periods of time
Consent Directive The legal record of a healthcare consumer's agreement or withdraw 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 disclosure 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 specific record (e.g. Lab Order/Result) 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:
  • Represent a Consent Directive
  • Withhold Register or withdraw consent for disclosure to index a specific provider organization Consent Directive
  • Withhold Query and respond about a Consent Directive
  • Retrieve a Consent Directive
  • Notify authorized entities about Consent Directive status changes
  • Determine entities authorized to collect, access, use or withdraw consent disclose information about the Consent Directive or about the information governed by the Consent Directive.

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 disclosure 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 specific provider agent (an individual within an organization) Withhold reference to or withdraw consent an attached unstructured representation for disclosure recipients needing an exact copy of records that were authored by 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 organization (or service delivery location). Combinations purposes and periods of timeA Consent Directive derivative that conveys the above minimal set of information needed to register an active and revoked Consent Directive, or to update Consent status as it changes during its lifecycle.
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
6.2.8.3

6.2.9.1 Non-Treatment Use-Cases Privacy Consent Directive (PCD)

Also shown Privacy policies define how Individually Identifiable Health Information (IIHI) is an example where to be collected, accessed, used and disclosed. A Privacy Consent Directive as a Patient has authorized disclosure 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 specific individual given context for specific purposes directed 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 patient 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.

(possibly not

6.2.10 Optimal Searching

The following steps represent the optimal path for searching for a treatment case). Consent resource.

  1. Request one or more Consent where status=active by Consent.scope (with patient(s), if none specified, get all). Policy will decide how to deal with multiple per patient and how to iterate through (e.g., select most recent).
  2. Locally inspect Consent.provision for base policy acceptance/denial with Consent.policyRule
  3. If policyRule not understandable, refer to Privacy Office
  4. Locally inspect Consent.provision for contexts (e.g., provision.purpose, provision.actor, etc.) as above
  5. Inspect Consent.provision.provision (et.al) for exceptions

6.2.9 6.2.11 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to 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 controller reference Who is agreeing to the policy and rules Consent Enforcer Consent.performer Consent.controller
( Practitioner , Organization , Patient , PractitionerRole , RelatedPerson HealthcareService )
data reference The actual data reference Consent.provision.data.reference
(Any)
date date When this Consent consent was created or indexed agreed to Consent.dateTime Consent.date 27 Resources
grantee reference Who is agreeing to the policy and rules Consent.grantee
( Practitioner , Organization , CareTeam , Patient , HealthcareService , PractitionerRole , RelatedPerson )
identifier token Identifier for this record (external references) Consent.identifier 65 Resources
organization manager reference Custodian of the consent Consent workflow management Consent.organization Consent.manager
( Practitioner , Organization , Patient , HealthcareService )
patient reference Who the consent applies to Consent.patient Consent.subject.where(resolve() is Patient)
( Patient ) 		66 Resources
period date Timeframe for this rule Consent.provision.period
purpose token Context of activities covered by this rule Consent.provision.purpose
scope token security-label 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.source Consent.sourceReference
( Consent , Contract , QuestionnaireResponse , DocumentReference )
status token draft | proposed | active | rejected | inactive | entered-in-error | unknown Consent.status
subject reference Who the consent applies to Consent.subject
( Practitioner , Group , Patient )
verified token Has been verified Consent.verification.verified
verified-date date When consent verified Consent.verification.verificationDate