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6.2 Resource Consent - Content

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

A record of a healthcare consumer’s policy choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time.

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 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 uses, but at this time, only the privacy use case is modeled. The scope of the resource may change when the other possible scopes are investigated, tested, or profiled.

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, signature or may 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, 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 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:
  • 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 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:
  • Find Active Consent Directive: A query that includes sufficient consent directive content to determine whether a specific party is authorized to share information governed by a consent directive with another specific party. The Response is either:
    • “Yes” meaning that both parties are authorized to share the information with one another.
    • “No” meaning that the authorized querier is not permitted to share with another specific party
    • “No information found” meaning that there is no active Consent Directive 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 of entities with which the querier is authorized to share governed information. The response to an authorized querier is the list 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 to return a list of Consent Directive 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 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, source but should not generally assume that they are authorized to do this.

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

The Change to "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. 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, 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 are is not in scope for the Consent resource.

This resource is referenced by researchsubject itself and ResearchSubject .

This resource implements the Event pattern.

Structure

sourceIdentifier Identifier
Name Flags Card. Type Description & Constraints doco
. . Consent I TU DomainResource A healthcare consumer's policy choices to permits permit or denies deny recipients or roles to perform actions for specific purposes and periods of time
+ Rule: Either a Policy or PolicyRule
+ Rule: IF Scope=privacy, there must be a patient
+ Rule: IF Scope=research, there must be a patient
+ Rule: IF Scope=adr, there must be a patient
+ Rule: IF Scope=treatment, there must be a patient
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..1 0..* Identifier Identifier for this record (external references)
. . . status ?! Σ 1..1 code draft | proposed | active | rejected | inactive | entered-in-error
ConsentState ( Required )
. . . category scope ?! Σ 0..* 1..1 CodeableConcept Classification Which of the consent statement - for indexing/retrieval four areas this resource covers (extensible)
Consent Category Scope Codes ( Example Extensible )
. . patient . category Σ 1..1 1..* Reference ( Patient CodeableConcept ) Who Classification of the consent applies to statement - for indexing/retrieval
Consent Category Codes ( Extensible )
. . period . patient Σ 0..1 Period Reference ( Patient ) Period that this Who the consent applies to
. . . dateTime Σ 0..1 dateTime When this Consent was created or indexed
. . . consentingParty performer Σ 0..* Reference ( Organization | Patient | Practitioner | RelatedPerson | PractitionerRole ) Who is agreeing to the policy and exceptions actor Σ 0..* BackboneElement Who|what controlled by this consent (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 ) Resource for the actor (or group, by role) action Σ 0..* CodeableConcept Actions controlled by this consent Consent Action Codes ( Example ) rules
. . . organization Σ 0..* Reference ( Organization ) Custodian of the consent
. . . source[x] Σ 0..1 Source from which this consent is taken
. . . . sourceAttachment Attachment
. . . . sourceReference Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse )
. . . 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 Σ I 0..1 uri CodeableConcept Policy Regulation that this consents to securityLabel Σ 0..* Coding Security Labels that define affected resources
All Security Labels Consent PolicyRule Codes ( Extensible )
. . purpose . verification Σ 0..* Coding BackboneElement Context of activities for which the agreement is made PurposeOfUse ( Extensible ) Consent Verified by patient or family
. dataPeriod Σ 0..1 Period Timeframe for data controlled by this consent . . data . verified Σ 0..* 1..1 BackboneElement boolean Data controlled by this consent Has been verified
. . . meaning . verifiedWith Σ 1..1 code 0..1 instance | related | dependents | authoredby ConsentDataMeaning Reference ( Required Patient | RelatedPerson ) Person who verified
. . . reference . verificationDate Σ 1..1 0..1 Reference ( Any dateTime ) The actual data reference When consent verified
. . . except provision Σ 0..* 0..1 BackboneElement Additional rule - addition or removal of permissions Constraints to the base Consent.policyRule
. . . . type Σ 1..1 0..1 code deny | permit
ConsentExceptType ConsentProvisionType ( Required )
. . . . period Σ 0..1 Period Timeframe for this exception rule
. . . . actor Σ 0..* BackboneElement Who|what controlled by this exception 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 exception rule
Consent Action Codes ( Example )
. . . . securityLabel Σ 0..* Coding Security Labels that define affected resources
All Security Labels SecurityLabels ( Extensible )
. . . . purpose Σ 0..* Coding Context of activities covered by this exception rule
PurposeOfUse V3 Value SetPurposeOfUse ( Extensible )
. . . . class Σ 0..* Coding e.g. Resource Type, Profile, or CDA etc CDA, etc.
Consent Content Class ( Extensible )
. . . . code Σ 0..* Coding CodeableConcept e.g. LOINC or SNOMED CT code, etc etc. in the content
Consent Content Codes ( Example )
. . . . dataPeriod Σ 0..1 Period Timeframe for data controlled by this exception rule
. . . . data Σ 0..* BackboneElement Data controlled by this exception 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

doco Documentation for this format

UML Diagram ( Legend )

Consent ( DomainResource ) Unique identifier for this copy of the Consent Statement identifier : Identifier [0..1] [0..*] Indicates the current state of this consent (this element modifies the meaning of other elements) status : code [1..1] « Indicates the state of the consent consent. (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] « The four anticipated uses for the Consent Resource. (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 [0..*] [1..*] « A classification of the type of consents found in a consent statement (Strength=Example) statement. (Strength=Extensible) Consent Category ConsentCategoryCodes ?? + » The patient/healthcare consumer to whom this consent applies patient : Reference [1..1] [0..1] « Patient » Relevant time or time-period when this Consent is applicable period : Period [0..1] When this Consent was issued / created / indexed dateTime : dateTime [0..1] Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions consentingParty performer : Reference [0..*] « Organization | Patient | Practitioner | RelatedPerson Actions controlled by this consent action : CodeableConcept RelatedPerson [0..*] Detailed codes for the consent action. (Strength=Example) Consent Action | PractitionerRole ?? » The organization that manages the consent, and the framework within which it is executed organization : Reference [0..*] « Organization » The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document source[x] : Type [0..1] « Attachment | Identifier | Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse ) » A referece reference to the specific base computable regulation or policy policyRule : uri [0..1] A set of security labels that define which resources are controlled by this consent. If more than one label is specified, all resources must have all the specified labels securityLabel : Coding [0..*] Security Labels from the Healthcare Privacy and Security Classification System. (Strength=Extensible) All Security Labels + The context of the activities a user is taking - why the user is accessing the data - that are controlled by this consent purpose : Coding [0..*] What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels (Strength=Extensible) PurposeOfUse + Clinical or Operational Relevant period of time that bounds the data controlled by this consent dataPeriod : Period [0..1] Actor How the individual is involved in the resources content that is described in the consent role : CodeableConcept [1..1] [0..1] « How an actor is involved in the consent considerations Regulatory policy examples. (Strength=Extensible) SecurityRoleType ConsentPolicyRuleCodes + The resource that identifies the actor. To identify a actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers') reference : Reference [1..1] Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson » Policy Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives authority : uri [0..1] The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law uri : uri [0..1] Data Verification How Has the resource reference is interpreted when testing consent restrictions instruction been verified meaning verified : code boolean [1..1] How a resource reference is interpreted when testing consent restrictions (Strength=Required) Who verified the instruction (Patient, Relative or other Authorized Person) ConsentDataMeaning ! verifiedWith : Reference [0..1] « Patient | RelatedPerson » A reference to a specific resource that defines which resources are covered by this consent Date verification was collected reference verificationDate : Reference [1..1] Any dateTime [0..1] Except provision Action to take - permit or deny - when the exception rule conditions are met met. Not permitted in root rule, required in all nested rules type : code [1..1] [0..1] « How an exception a rule statement is applied, such as adding additional consent or removing consent consent. (Strength=Required) ConsentExceptType ConsentProvisionType ! » The timeframe in this exception rule is valid period : Period [0..1] Actions controlled by this Exception Rule action : CodeableConcept [0..*] « Detailed codes for the consent action. (Strength=Example) Consent Action ConsentActionCodes ?? » A set security label, comprised of 0..* security labels that label fields (Privacy tags), which define which resources are controlled by this exception. If more than one label is specified, all resources must have all the specified labels exception securityLabel : Coding [0..*] « Security Labels from the Healthcare Privacy and Security Classification System. (Strength=Extensible) All Security Labels + » The context of the activities a user is taking - why the user is accessing the data - that are controlled by this exception rule purpose : Coding [0..*] « What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels labels. (Strength=Extensible) PurposeOfUse v3.PurposeOfUse + » The class of information covered by this exception. rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to class : Coding [0..*] « The class (type) of information a consent rule covers covers. (Strength=Extensible) Consent Content Class ConsentContentClass + » If this code is found in an instance, then the exception rule applies code : Coding CodeableConcept [0..*] « If this code is found in an instance, then the exception applies applies. (Strength=Example) Consent Content ConsentContentCodes ?? » Clinical or Operational Relevant period of time that bounds the data controlled by this exception rule dataPeriod : Period [0..1] ExceptActor provisionActor How the individual is involved in the resources content that is described in the exception role : CodeableConcept [1..1] « How an actor is involved in the consent considerations considerations. (Strength=Extensible) SecurityRoleType + » The resource that identifies the actor. To identify a actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers') reference : Reference [1..1] « Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » ExceptData provisionData How the resource reference is interpreted when testing consent restrictions meaning : code [1..1] « How a resource reference is interpreted when testing consent restrictions restrictions. (Strength=Required) ConsentDataMeaning ! » A reference to a specific resource that defines which resources are covered by this consent reference : Reference [1..1] « Any » Who or what is controlled by this consent. Use group to identify a set of actors by some property they share (e.g. 'admitting officers') actor [0..*] The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law policy [0..*] The resources controlled by this consent, if specific resources are referenced Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person data verification [0..*] Who or what is controlled by this Exception. rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers') actor [0..*] The resources controlled by this exception, rule if specific resources are referenced data [0..*] Rules which provide exceptions to the base rule or subrules provision [0..*] An exception to the base policy of this consent. An exception can be an addition or removal of access permissions except provision [0..*] [0..1]

XML Template

<Consent xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>

 <identifier><!-- 0..* Identifier Identifier for this record (external references) --></identifier>

 <status value="[code]"/><!-- 1..1 draft | proposed | active | rejected | inactive | entered-in-error -->
 <</category>
 <</patient>
 <</period>

 <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>
 <patient><!-- 0..1 Reference(Patient) Who the consent applies to --></patient>

 <dateTime value="[dateTime]"/><!-- 0..1 When this Consent was created or indexed -->
 <|
   </consentingParty>
 <
  <</role>
  <|
    </reference>
 </actor>
 <</action>

 <performer><!-- 0..* Reference(Organization|Patient|Practitioner|
   PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></performer>
 <organization><!-- 0..* Reference(Organization) Custodian of the consent --></organization>
 <|
   </source[x]>

 <source[x]><!-- 0..1 Attachment|Reference(Consent|Contract|DocumentReference|
   QuestionnaireResponse) Source from which this consent is taken --></source[x]>
 <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>
 <
 <</securityLabel>
 <</purpose>
 <</dataPeriod>
 <
  <
  <</reference>
 </data>
 <
  <
  <</period>
  <
   <</role>
   <|
     </reference>

 <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 -->
  <verifiedWith><!-- 0..1 Reference(Patient|RelatedPerson) Person who verified --></verifiedWith>
  <verificationDate value="[dateTime]"/><!-- 0..1 When consent verified -->
 </verification>
 <provision>  <!-- 0..1 Constraints to the base Consent.policyRule -->
  <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>
  <</securityLabel>
  <</purpose>
  <</class>
  <</code>
  <</dataPeriod>
  <
   <
   <</reference>

  <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>
 </except>

  <provision><!-- 0..* Content as for Consent.provision Nested Exception Rules --></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 | proposed | active | rejected | inactive | entered-in-error
  "
  "
  "

  "scope" : { CodeableConcept }, // R!  Which of the four areas this resource covers (extensible)
  "category" : [{ CodeableConcept }], // R!  Classification of the consent statement - for indexing/retrieval
  "patient" : { Reference(Patient) }, // Who the consent applies to

  "dateTime" : "<dateTime>", // When this Consent was created or indexed
  "|
   
  "
    "
    "|
    
  }],
  "

  "performer" : [{ Reference(Organization|Patient|Practitioner|
   PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules
  "organization" : [{ Reference(Organization) }], // Custodian of the consent
  

  // source[x]: Source from which this consent is taken. One of these 2:
  "sourceAttachment" : { Attachment },
  " },
  "|

  "sourceReference" : { Reference(Consent|Contract|DocumentReference|

   QuestionnaireResponse) },
  "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
    "verifiedWith" : { Reference(Patient|RelatedPerson) }, // Person who verified
    "verificationDate" : "<dateTime>" // When consent verified

  }],
  "
    "
    "
    "
      "
      "|
     

  "provision" : { // Constraints to the base Consent.policyRule
    "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/> .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:Consent.identifier [ Identifier ], ... ; # 0..* Identifier for this record (external references)

  fhir:Consent.status [ code ]; # 1..1 draft | proposed | active | rejected | inactive | entered-in-error
  fhir:
  fhir:
  fhir:

  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.patient [ Reference(Patient) ]; # 0..1 Who the consent applies to

  fhir:Consent.dateTime [ dateTime ]; # 0..1 When this Consent was created or indexed
  fhir:
  fhir:
    fhir:
    fhir:
  ], ...;
  fhir:

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

  fhir:Consent.organization [ Reference(Organization) ], ... ; # 0..* Custodian of the consent
  # . One of these 3

  # Consent.source[x] : 0..1 Source from which this consent is taken. One of these 2

    fhir:Consent.sourceAttachment [ Attachment ]
    fhir: ]
    fhir:) ]

    fhir:Consent.sourceReference [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ]

  fhir:Consent.policy [ # 0..* Policies covered by this consent
    fhir:

    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:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:

  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.verifiedWith [ Reference(Patient|RelatedPerson) ]; # 0..1 Person who verified
    fhir:Consent.verification.verificationDate [ dateTime ]; # 0..1 When consent verified

  ], ...;
  fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:

  fhir:Consent.provision [ # 0..1 Constraints to the base Consent.policyRule
    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:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:

    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 DSTU2 R3

Consent
Consent.status
  • Change value set from http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.0 to http://hl7.org/fhir/ValueSet/consent-state-codes|4.1.0
Consent.provision.type
  • Change value set from http://hl7.org/fhir/ValueSet/consent-provision-type|4.0.0 to http://hl7.org/fhir/ValueSet/consent-provision-type|4.1.0
Consent.provision.data.meaning
  • Change value set from http://hl7.org/fhir/ValueSet/consent-data-meaning|4.0.0 to http://hl7.org/fhir/ValueSet/consent-data-meaning|4.1.0

This resource did not exist in Release 2 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

sourceIdentifier Identifier
Name Flags Card. Type Description & Constraints doco
. . Consent I TU DomainResource A healthcare consumer's policy choices to permits permit or denies deny recipients or roles to perform actions for specific purposes and periods of time
+ Rule: Either a Policy or PolicyRule
+ Rule: IF Scope=privacy, there must be a patient
+ Rule: IF Scope=research, there must be a patient
+ Rule: IF Scope=adr, there must be a patient
+ Rule: IF Scope=treatment, there must be a patient
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..1 0..* Identifier Identifier for this record (external references)
. . . status ?! Σ 1..1 code draft | proposed | active | rejected | inactive | entered-in-error
ConsentState ( Required )
. . . category scope ?! Σ 0..* 1..1 CodeableConcept Classification Which of the consent statement - for indexing/retrieval four areas this resource covers (extensible)
Consent Category Scope Codes ( Example Extensible )
. . patient . category Σ 1..1 1..* Reference ( Patient CodeableConcept ) Who Classification of the consent applies to statement - for indexing/retrieval
Consent Category Codes ( Extensible )
. . period . patient Σ 0..1 Period Reference ( Patient ) Period that this Who the consent applies to
. . . dateTime Σ 0..1 dateTime When this Consent was created or indexed
. . . consentingParty performer Σ 0..* Reference ( Organization | Patient | Practitioner | RelatedPerson | PractitionerRole ) Who is agreeing to the policy and exceptions actor Σ 0..* BackboneElement Who|what controlled by this consent (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 ) Resource for the actor (or group, by role) action Σ 0..* CodeableConcept Actions controlled by this consent Consent Action Codes ( Example ) rules
. . . organization Σ 0..* Reference ( Organization ) Custodian of the consent
. . . source[x] Σ 0..1 Source from which this consent is taken
. . . . sourceAttachment Attachment
. . . . sourceReference Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse )
. . . 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 Σ I 0..1 uri CodeableConcept Policy Regulation that this consents to securityLabel Σ 0..* Coding Security Labels that define affected resources
All Security Labels Consent PolicyRule Codes ( Extensible )
. . purpose . verification Σ 0..* Coding BackboneElement Context of activities for which the agreement is made PurposeOfUse ( Extensible ) Consent Verified by patient or family
. dataPeriod Σ 0..1 Period Timeframe for data controlled by this consent . . data . verified Σ 0..* 1..1 BackboneElement boolean Data controlled by this consent Has been verified
. . . meaning . verifiedWith Σ 1..1 0..1 code instance | related | dependents | authoredby ConsentDataMeaning Reference ( Required Patient | RelatedPerson ) Person who verified
. . . reference . verificationDate Σ 1..1 0..1 Reference ( Any dateTime ) The actual data reference When consent verified
. . . except provision Σ 0..* 0..1 BackboneElement Additional rule - addition or removal of permissions Constraints to the base Consent.policyRule
. . . . type Σ 1..1 0..1 code deny | permit
ConsentExceptType ConsentProvisionType ( Required )
. . . . period Σ 0..1 Period Timeframe for this exception rule
. . . . actor Σ 0..* BackboneElement Who|what controlled by this exception 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 exception rule
Consent Action Codes ( Example )
. . . . securityLabel Σ 0..* Coding Security Labels that define affected resources
All Security Labels SecurityLabels ( Extensible )
. . . . purpose Σ 0..* Coding Context of activities covered by this exception rule
PurposeOfUse V3 Value SetPurposeOfUse ( Extensible )
. . . . class Σ 0..* Coding e.g. Resource Type, Profile, or CDA etc CDA, etc.
Consent Content Class ( Extensible )
. . . . code Σ 0..* Coding CodeableConcept e.g. LOINC or SNOMED CT code, etc etc. in the content
Consent Content Codes ( Example )
. . . . dataPeriod Σ 0..1 Period Timeframe for data controlled by this exception rule
. . . . data Σ 0..* BackboneElement Data controlled by this exception 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

doco Documentation for this format

UML Diagram ( Legend )

Consent ( DomainResource ) Unique identifier for this copy of the Consent Statement identifier : Identifier [0..1] [0..*] Indicates the current state of this consent (this element modifies the meaning of other elements) status : code [1..1] « Indicates the state of the consent consent. (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] « The four anticipated uses for the Consent Resource. (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 [0..*] [1..*] « A classification of the type of consents found in a consent statement (Strength=Example) statement. (Strength=Extensible) Consent Category ConsentCategoryCodes ?? + » The patient/healthcare consumer to whom this consent applies patient : Reference [1..1] [0..1] « Patient » Relevant time or time-period when this Consent is applicable period : Period [0..1] When this Consent was issued / created / indexed dateTime : dateTime [0..1] Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions consentingParty performer : Reference [0..*] « Organization | Patient | Practitioner | RelatedPerson Actions controlled by this consent action : CodeableConcept RelatedPerson [0..*] Detailed codes for the consent action. (Strength=Example) Consent Action | PractitionerRole ?? » The organization that manages the consent, and the framework within which it is executed organization : Reference [0..*] « Organization » The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document source[x] : Type [0..1] « Attachment | Identifier | Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse ) » A referece reference to the specific base computable regulation or policy policyRule : uri [0..1] A set of security labels that define which resources are controlled by this consent. If more than one label is specified, all resources must have all the specified labels securityLabel : Coding [0..*] Security Labels from the Healthcare Privacy and Security Classification System. (Strength=Extensible) All Security Labels + The context of the activities a user is taking - why the user is accessing the data - that are controlled by this consent purpose : Coding [0..*] What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels (Strength=Extensible) PurposeOfUse + Clinical or Operational Relevant period of time that bounds the data controlled by this consent dataPeriod : Period [0..1] Actor How the individual is involved in the resources content that is described in the consent role : CodeableConcept [1..1] [0..1] « How an actor is involved in the consent considerations Regulatory policy examples. (Strength=Extensible) SecurityRoleType ConsentPolicyRuleCodes + The resource that identifies the actor. To identify a actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers') reference : Reference [1..1] Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson » Policy Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives authority : uri [0..1] The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law uri : uri [0..1] Data Verification How Has the resource reference is interpreted when testing consent restrictions instruction been verified meaning verified : code boolean [1..1] How a resource reference is interpreted when testing consent restrictions (Strength=Required) Who verified the instruction (Patient, Relative or other Authorized Person) ConsentDataMeaning ! verifiedWith : Reference [0..1] « Patient | RelatedPerson » A reference to a specific resource that defines which resources are covered by this consent Date verification was collected reference verificationDate : Reference [1..1] Any dateTime [0..1] Except provision Action to take - permit or deny - when the exception rule conditions are met met. Not permitted in root rule, required in all nested rules type : code [1..1] [0..1] « How an exception a rule statement is applied, such as adding additional consent or removing consent consent. (Strength=Required) ConsentExceptType ConsentProvisionType ! » The timeframe in this exception rule is valid period : Period [0..1] Actions controlled by this Exception Rule action : CodeableConcept [0..*] « Detailed codes for the consent action. (Strength=Example) Consent Action ConsentActionCodes ?? » A set security label, comprised of 0..* security labels that label fields (Privacy tags), which define which resources are controlled by this exception. If more than one label is specified, all resources must have all the specified labels exception securityLabel : Coding [0..*] « Security Labels from the Healthcare Privacy and Security Classification System. (Strength=Extensible) All Security Labels + » The context of the activities a user is taking - why the user is accessing the data - that are controlled by this exception rule purpose : Coding [0..*] « What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels labels. (Strength=Extensible) PurposeOfUse v3.PurposeOfUse + » The class of information covered by this exception. rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to class : Coding [0..*] « The class (type) of information a consent rule covers covers. (Strength=Extensible) Consent Content Class ConsentContentClass + » If this code is found in an instance, then the exception rule applies code : Coding CodeableConcept [0..*] « If this code is found in an instance, then the exception applies applies. (Strength=Example) Consent Content ConsentContentCodes ?? » Clinical or Operational Relevant period of time that bounds the data controlled by this exception rule dataPeriod : Period [0..1] ExceptActor provisionActor How the individual is involved in the resources content that is described in the exception role : CodeableConcept [1..1] « How an actor is involved in the consent considerations considerations. (Strength=Extensible) SecurityRoleType + » The resource that identifies the actor. To identify a actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers') reference : Reference [1..1] « Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » ExceptData provisionData How the resource reference is interpreted when testing consent restrictions meaning : code [1..1] « How a resource reference is interpreted when testing consent restrictions restrictions. (Strength=Required) ConsentDataMeaning ! » A reference to a specific resource that defines which resources are covered by this consent reference : Reference [1..1] « Any » Who or what is controlled by this consent. Use group to identify a set of actors by some property they share (e.g. 'admitting officers') actor [0..*] The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law policy [0..*] The resources controlled by this consent, if specific resources are referenced Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person data verification [0..*] Who or what is controlled by this Exception. rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers') actor [0..*] The resources controlled by this exception, rule if specific resources are referenced data [0..*] Rules which provide exceptions to the base rule or subrules provision [0..*] An exception to the base policy of this consent. An exception can be an addition or removal of access permissions except provision [0..*] [0..1]

XML Template

<Consent xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>

 <identifier><!-- 0..* Identifier Identifier for this record (external references) --></identifier>

 <status value="[code]"/><!-- 1..1 draft | proposed | active | rejected | inactive | entered-in-error -->
 <</category>
 <</patient>
 <</period>

 <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>
 <patient><!-- 0..1 Reference(Patient) Who the consent applies to --></patient>

 <dateTime value="[dateTime]"/><!-- 0..1 When this Consent was created or indexed -->
 <|
   </consentingParty>
 <
  <</role>
  <|
    </reference>
 </actor>
 <</action>

 <performer><!-- 0..* Reference(Organization|Patient|Practitioner|
   PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></performer>
 <organization><!-- 0..* Reference(Organization) Custodian of the consent --></organization>
 <|
   </source[x]>

 <source[x]><!-- 0..1 Attachment|Reference(Consent|Contract|DocumentReference|
   QuestionnaireResponse) Source from which this consent is taken --></source[x]>
 <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>
 <
 <</securityLabel>
 <</purpose>
 <</dataPeriod>
 <
  <
  <</reference>
 </data>
 <
  <
  <</period>
  <
   <</role>
   <|
     </reference>

 <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 -->
  <verifiedWith><!-- 0..1 Reference(Patient|RelatedPerson) Person who verified --></verifiedWith>
  <verificationDate value="[dateTime]"/><!-- 0..1 When consent verified -->
 </verification>
 <provision>  <!-- 0..1 Constraints to the base Consent.policyRule -->
  <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>
  <</securityLabel>
  <</purpose>
  <</class>
  <</code>
  <</dataPeriod>
  <
   <
   <</reference>

  <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>
 </except>

  <provision><!-- 0..* Content as for Consent.provision Nested Exception Rules --></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 | proposed | active | rejected | inactive | entered-in-error
  "
  "
  "

  "scope" : { CodeableConcept }, // R!  Which of the four areas this resource covers (extensible)
  "category" : [{ CodeableConcept }], // R!  Classification of the consent statement - for indexing/retrieval
  "patient" : { Reference(Patient) }, // Who the consent applies to

  "dateTime" : "<dateTime>", // When this Consent was created or indexed
  "|
   
  "
    "
    "|
    
  }],
  "

  "performer" : [{ Reference(Organization|Patient|Practitioner|
   PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules
  "organization" : [{ Reference(Organization) }], // Custodian of the consent
  

  // source[x]: Source from which this consent is taken. One of these 2:
  "sourceAttachment" : { Attachment },
  " },
  "|

  "sourceReference" : { Reference(Consent|Contract|DocumentReference|

   QuestionnaireResponse) },
  "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
    "verifiedWith" : { Reference(Patient|RelatedPerson) }, // Person who verified
    "verificationDate" : "<dateTime>" // When consent verified

  }],
  "
    "
    "
    "
      "
      "|
     

  "provision" : { // Constraints to the base Consent.policyRule
    "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/> .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:Consent.identifier [ Identifier ], ... ; # 0..* Identifier for this record (external references)

  fhir:Consent.status [ code ]; # 1..1 draft | proposed | active | rejected | inactive | entered-in-error
  fhir:
  fhir:
  fhir:

  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.patient [ Reference(Patient) ]; # 0..1 Who the consent applies to

  fhir:Consent.dateTime [ dateTime ]; # 0..1 When this Consent was created or indexed
  fhir:
  fhir:
    fhir:
    fhir:
  ], ...;
  fhir:

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

  fhir:Consent.organization [ Reference(Organization) ], ... ; # 0..* Custodian of the consent
  # . One of these 3

  # Consent.source[x] : 0..1 Source from which this consent is taken. One of these 2

    fhir:Consent.sourceAttachment [ Attachment ]
    fhir: ]
    fhir:) ]

    fhir:Consent.sourceReference [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ]

  fhir:Consent.policy [ # 0..* Policies covered by this consent
    fhir:

    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:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:

  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.verifiedWith [ Reference(Patient|RelatedPerson) ]; # 0..1 Person who verified
    fhir:Consent.verification.verificationDate [ dateTime ]; # 0..1 When consent verified

  ], ...;
  fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:

  fhir:Consent.provision [ # 0..1 Constraints to the base Consent.policyRule
    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:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:

    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 DSTU2 Release 3

Consent
Consent.status
  • Change value set from http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.0 to http://hl7.org/fhir/ValueSet/consent-state-codes|4.1.0
Consent.provision.type
  • Change value set from http://hl7.org/fhir/ValueSet/consent-provision-type|4.0.0 to http://hl7.org/fhir/ValueSet/consent-provision-type|4.1.0
Consent.provision.data.meaning
  • Change value set from http://hl7.org/fhir/ValueSet/consent-data-meaning|4.0.0 to http://hl7.org/fhir/ValueSet/consent-data-meaning|4.1.0

This resource did not exist in Release 2 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). )

 

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

Consent.securityLabel Consent.except.securityLabel Consent.purpose Consent.except.purpose
Path Definition Type Reference
Consent.status Indicates the state of the consent 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 statement. Example Extensible Consent Category Codes ConsentCategoryCodes
Consent.policyRule Regulatory policy examples. Extensible ConsentPolicyRuleCodes
Consent.provision.type How a rule statement is applied, such as adding additional consent or removing consent. Required ConsentProvisionType
Consent.actor.role Consent.except.actor.role Consent.provision.actor.role How an actor is involved in the consent considerations considerations. Extensible SecurityRoleType
Consent.action Consent.except.action Consent.provision.action Detailed codes for the consent action. Example Consent Action Codes 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 labels. Extensible PurposeOfUse Consent.data.meaning Consent.except.data.meaning How a resource reference is interpreted when testing consent restrictions Required ConsentDataMeaning Consent.except.type How an exception statement is applied, such as adding additional consent or removing consent Required ConsentExceptType v3.PurposeOfUse
Consent.except.class Consent.provision.class The class (type) of information a consent rule covers covers. Extensible Consent Content Class ConsentContentClass
Consent.except.code Consent.provision.code If this code is found in an instance, then the exception applies applies. Example Consent Content Codes ConsentContentCodes
Consent.provision.data.meaning How a resource reference is interpreted when testing consent restrictions. Required ConsentDataMeaning

Policies
id Level Location Description Expression
ppc-1 : Rule (base) Either a Policy or PolicyRule ( expression : policy.exists() or policyRule.exists() ) 6.2.5
ppc-2 Rule (base) IF Scope=privacy, there must be a patient patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not() This specification defines 2 magic values for consent policyRule:
URI ppc-3 Description Rule (base) IF Scope=research, there must be a patient patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
http://hl7.org/fhir/ConsentPolicy/opt-out ppc-4 The basic 'deny' policy is to grant no authority for data access Rule (base) IF Scope=adr, there must be a patient patient.exists() or use. No actions are approved, unless they are explicitly detailed in the exceptions scope.coding.where(system='something' and code='adr').exists().not()
http://hl7.org/fhir/ConsentPolicy/opt-in ppc-5 The basic 'permit' policy is to grant generally acceptable authority for data access Rule (base) IF Scope=treatment, there must be a patient patient.exists() or scope.coding.where(system='something' and use. All generally acceptable actions are approved, unless they are explicitly detailed in the exceptions code='treatment').exists().not()
Other jurisdictions (e.g. HL7 Affiliates) may define their additional lists of consent policy URI values that represent consent policies established by law or regulation

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, 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.

The following is the general model of Privacy Consent Directives.

There are context setting parameters:

  1. Who - The patient
  2. What - The data - specific resources are listed, empty list means all data covered by the consent.
  3. Where - The domain and authority - what is the location boundary and authority boundary of this consent
  4. When - The issued or captured
  5. When - The timeframe for which the Consent applies
  6. How - The actions covered. (such as purposes of use that are covered)
  7. Whom - The recipient 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 ;
  3. Opt-out with exceptions: No sharing allowed, with some exceptions where it is allowed. Example: Withhold Authorization for Treatment except for Emergency Treatment ;
  4. Opt-in: Sharing for some purpose of use is authorized Sharing allowed for Treatment, Payment, and normal Operations ; and
  5. Opt-in with restrictions: Sharing allowed, but the patient may make exceptions (See the Canadian examples).

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

Five categories of Privacy Consent Directives are described in the Office of the National Coordinator for Health Information (ONC) Consent Directives Document released March 31, 2010, and include the following US-specific “Core "Core consent options” options" for electronic exchange:

  1. No consent: Health information of patients is automatically included—patients cannot opt out;
  2. Opt-out: Default is for health information of patients to be included automatically, but the patient can opt out completely ;
  3. Opt-out with exceptions: Default is for health information of patients to be included, but the patient can opt out completely or allow only select data to be included;
  4. Opt-in: Default is that no patient health information is included; patients must actively express consent to be included, but if they do so then their information must be all in or all out; and
  5. Opt-in with restrictions: Default is that no patient health information is made available, but the patient may allow a subset of select data to be included.

A common exception is to explicitly exclude or explicitly include a period of time .

The following scenarios are based on existing jurisdictional policy and are realized in existing systems in Canada. The default policy is one of implied consent for the provision of care, so these scenarios all deal with withdrawal or withholding consent for that purpose. In other jurisdictions, where an express consent model is used (Opt-In), these examples would contain the phrase "consent to" rather than "withhold" or "withdraw" consent for.

  1. Withhold or withdraw consent for disclosure of records related to specific domain (e.g. DI, LAB, etc.)
  2. Withhold or withdraw consent for disclosure of a specific record (e.g. Lab Order/Result)
  3. Withhold or withdraw consent for disclosure to a specific provider organization
  4. Withhold or withdraw consent for disclosure to a specific provider agent (an individual within an organization)
  5. Withhold or withdraw consent for disclosure of records that were authored by a specific organization (or service delivery location).
  6. Combinations of the above

Also shown is an example where a Patient has authorized disclosure to a specific individual for purposes directed by the patient (possibly not a treatment case).

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 consent rule Consent.action | Consent.except.action Consent.provision.action
actor reference Resource for the actor (or group, by role) Consent.actor.reference | Consent.except.actor.reference 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 exceptions rules Consent.consentingParty Consent.performer
( Practitioner , Organization , Patient , PractitionerRole , RelatedPerson )
data reference The actual data reference Consent.data.reference | Consent.except.data.reference Consent.provision.data.reference
(Any)
date date When this Consent was created or indexed Consent.dateTime 18 17 Resources
identifier token Identifier for this record (external references) Consent.identifier 26 30 Resources
organization reference Custodian of the consent Consent.organization
( Organization )
patient reference Who the consent applies to Consent.patient
( Patient )
31 33 Resources
period date Period that Timeframe for this consent applies rule Consent.period Consent.provision.period
purpose token Context of activities for which covered by this rule Consent.provision.purpose
scope token Which of the agreement is made four areas this resource covers (extensible) Consent.purpose | Consent.except.purpose Consent.scope
securitylabel security-label token Security Labels that define affected resources Consent.securityLabel | Consent.except.securityLabel Consent.provision.securityLabel
source source-reference reference Source from which this consent is taken Search by reference to a Consent, DocumentReference, Contract or QuestionnaireResponse Consent.source
( Consent , Contract , QuestionnaireResponse , DocumentReference )
status token draft | proposed | active | rejected | inactive | entered-in-error Consent.status