Release 4 5 Preview #2
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6.2 Resource Consent - Content

Community Based Collaborative Care 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.

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 is considered the encoded legally binding Consent Directive if it meets requirements of a policy domain requirements for an enforceable contract. In some domains, electronic signatures of one or both of the parties to the content of an encoded representation of a Consent Form is deemed to constitute a legally binding Consent Directive. Some domains accept a notary’s electronic signature over the wet or electronic signature of a party to the Consent Directive as the additional identity proofing required to make an encoded Consent Directive legally binding. Other domains may only accept a wet signature or might not require the parties’ signatures at all. Whatever the criteria are for making an encoded FHIR Consent Directive legally binding, anything less than a legally binding representation of a Consent Directive must be identified as such, i.e., as a derivative of the legally binding Consent Directive, which has specific usage in Consent Directive workflow management. Definitions: Consent The record of a healthcare consumer’s policy choices, 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 6.2.1.1 Privacy Consent Directive (PCD) 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 HL7 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 working on FHIR provides support for alternative representations for expressing interoperable health information privacy consent directives in a standard form for the exchange Advance Directives and enforcement by sending, intermediating, or receiving systems of privacy policies that can be enforced would welcome participation 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. community.

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.

Change to "The The Consent resource is structured with a base policy (represented as Consent.policy/Consent.policyRule) 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.

This resource is referenced by itself itself, Permission and ResearchSubject .

This resource implements the Event pattern.

Structure

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] « Indicates the state of the consent. (Strength=Required) ConsentState ! » A selector of the type of consent being presented: ADR, presented with the base being Privacy, Treatment, Research. This list is now extensible or Research (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 [1..*] « A classification of the type of consents found in a consent statement. (Strength=Extensible) ConsentCategoryCodes + » The patient/healthcare consumer practitioner to whom this consent applies patient subject : Reference [0..1] « Patient | Practitioner » When this Consent Date and time the consent instance was issued / created / indexed agreed to 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 performer : 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 : Type [0..1] « Attachment | Reference ( [0..*] « Consent | DocumentReference | Contract | QuestionnaireResponse ) » A reference to the specific base computable regulation or policy policyRule : CodeableConcept [0..1] « Regulatory policy examples. (Strength=Extensible) ConsentPolicyRuleCodes + » 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] 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] « Types of Verification/Validation. (Strength=Extensible) ConsentVerificationCodes + » The person who conducted the verification/validation of the Grantee 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] « How a rule statement is applied, such as adding additional consent or removing consent. (Strength=Required) ConsentProvisionType ! » The timeframe in this rule is valid period : Period [0..1] Actions controlled by this Rule action : CodeableConcept [0..*] « Detailed codes for the consent action. (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..*] « 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 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. (Strength=Extensible) v3.PurposeOfUse + » The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to class : Coding [0..*] « The class (type) of information a consent rule covers. (Strength=Extensible) ConsentContentClass + » If this code is found in an instance, then the rule applies code : CodeableConcept [0..*] « If this code is found in an instance, then the exception applies. (Strength=Example) ConsentContentCodes ?? » Clinical or Operational Relevant period of time that bounds the data controlled by this rule dataPeriod : Period [0..1] 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. (Strength=Extensible) SecurityRoleType + » 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] « Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » 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. (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 to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law policy [0..*] Whether a treatment instruction (e.g. artificial 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. 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 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 provision [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><!-- 0..* Identifier Identifier for this record (external references) --></identifier>
 <
 <</scope>

 <status value="[code]"/><!-- 1..1 draft | active | inactive | entered-in-error | unknown -->
 <scope><!-- 1..1 CodeableConcept Which of the three areas this resource covers (extensible) --></scope>

 <category><!-- 1..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category>
 <</patient>
 <
 <|
   </performer>
 <</organization>
 <|
   </source[x]>

 <subject><!-- 0..1 Reference(Patient|Practitioner) Who the consent applies to --></subject>
 <dateTime value="[dateTime]"/><!-- 0..1 When consent was agreed to -->
 <performer><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></performer>
 <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>
 <policy>  <!-- 0..* Policies covered by this consent -->
  <
  <

  <authority value="[uri]"/><!-- ?? 0..1 Enforcement source for policy -->
  <uri value="[uri]"/><!-- ?? 0..1 Specific policy covered by this consent -->

 </policy>
 <</policyRule>

 <policyRule><!-- ?? 0..1 CodeableConcept Regulation that this consents to --></policyRule>

 <verification>  <!-- 0..* Consent Verified by patient or family -->
  <verified value="[boolean]"/><!-- 1..1 Has been verified -->
  <verificationType><!-- 0..1 CodeableConcept Business case of verification --></verificationType>
  <verifiedBy><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Person conducting verification --></verifiedBy>

  <verifiedWith><!-- 0..1 Reference(Patient|RelatedPerson) Person who verified --></verifiedWith>
  <

  <verificationDate value="[dateTime]"/><!-- 0..* When consent verified -->

 </verification>
 <

 <provision>  <!-- 0..1 Constraints to the base Consent.policyRule/Consent.policy -->

  <type value="[code]"/><!-- 0..1 deny | permit -->
  <period><!-- 0..1 Period Timeframe for this rule --></period>
  <actor>  <!-- 0..* Who|what controlled by this rule (or group, by role) -->
   <role><!-- 1..1 CodeableConcept How the actor is involved --></role>
   <|
     </reference>

   <reference><!-- 1..1 Reference(CareTeam|Device|Group|Organization|Patient|
     Practitioner|PractitionerRole|RelatedPerson) Resource for the actor (or group, by role) --></reference>
  </actor>
  <action><!-- 0..* CodeableConcept Actions controlled by this rule --></action>
  <securityLabel><!-- 0..* Coding Security Labels that define affected resources --></securityLabel>
  <purpose><!-- 0..* Coding Context of activities covered by this rule --></purpose>
  <class><!-- 0..* Coding e.g. Resource Type, Profile, CDA, etc. --></class>
  <code><!-- 0..* CodeableConcept e.g. LOINC or SNOMED CT code, etc. in the content --></code>
  <dataPeriod><!-- 0..1 Period Timeframe for data controlled by this rule --></dataPeriod>
  <data>  <!-- 0..* Data controlled by this rule -->
   <meaning value="[code]"/><!-- 1..1 instance | related | dependents | authoredby -->
   <reference><!-- 1..1 Reference(Any) The actual data reference --></reference>
  </data>
  <provision><!-- 0..* Content as for Consent.provision Nested Exception Rules --></provision>
 </provision>
</Consent>

JSON Template

{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 | entered-in-error | unknown
  "scope" : { CodeableConcept }, // R!  Which of the three areas this resource covers (extensible)

  "category" : [{ CodeableConcept }], // R!  Classification of the consent statement - for indexing/retrieval
  "
  "
  "|
   
  "
  
  " },
  "|
    },

  "subject" : { Reference(Patient|Practitioner) }, // Who the consent applies to
  "dateTime" : "<dateTime>", // When consent was agreed to
  "performer" : [{ Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules
  "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
  "policy" : [{ // Policies covered by this consent
    "
    "

    "authority" : "<uri>", // C? Enforcement source for policy
    "uri" : "<uri>" // C? Specific policy covered by this consent

  }],
  "

  "policyRule" : { CodeableConcept }, // C? Regulation that this consents to

  "verification" : [{ // Consent Verified by patient or family
    "verified" : <boolean>, // R!  Has been verified
    "verificationType" : { CodeableConcept }, // Business case of verification
    "verifiedBy" : { Reference(Organization|Practitioner|PractitionerRole) }, // Person conducting verification

    "verifiedWith" : { Reference(Patient|RelatedPerson) }, // Person who verified
    "

    "verificationDate" : ["<dateTime>"] // When consent verified

  }],
  "

  "provision" : { // Constraints to the base Consent.policyRule/Consent.policy

    "type" : "<code>", // deny | permit
    "period" : { Period }, // Timeframe for this rule
    "actor" : [{ // Who|what controlled by this rule (or group, by role)
      "role" : { CodeableConcept }, // R!  How the actor is involved
      "|
     

      "reference" : { Reference(CareTeam|Device|Group|Organization|Patient|
     Practitioner|PractitionerRole|RelatedPerson) } // R!  Resource for the actor (or group, by role)
    }],
    "action" : [{ CodeableConcept }], // Actions controlled by this rule
    "securityLabel" : [{ Coding }], // Security Labels that define affected resources
    "purpose" : [{ Coding }], // Context of activities covered by this rule
    "class" : [{ Coding }], // e.g. Resource Type, Profile, CDA, etc.
    "code" : [{ CodeableConcept }], // e.g. LOINC or SNOMED CT code, etc. in the content
    "dataPeriod" : { Period }, // Timeframe for data controlled by this rule
    "data" : [{ // Data controlled by this rule
      "meaning" : "<code>", // R!  instance | related | dependents | authoredby
      "reference" : { Reference(Any) } // R!  The actual data reference
    }],
    "provision" : [{ Content as for Consent.provision }] // Nested Exception Rules
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .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:Consent.identifier [ Identifier ], ... ; # 0..* Identifier for this record (external references)
  fhir:
  fhir:

  fhir:Consent.status [ code ]; # 1..1 draft | active | inactive | entered-in-error | unknown
  fhir:Consent.scope [ CodeableConcept ]; # 1..1 Which of the three areas this resource covers (extensible)

  fhir:Consent.category [ CodeableConcept ], ... ; # 1..* Classification of the consent statement - for indexing/retrieval
  fhir:
  fhir:
  fhir:
  fhir:
  # . One of these 2
    fhir: ]
    fhir:) ]

  fhir:Consent.subject [ Reference(Patient|Practitioner) ]; # 0..1 Who the consent applies to
  fhir:Consent.dateTime [ dateTime ]; # 0..1 When consent was agreed to
  fhir:Consent.performer [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ], ... ; # 0..* Who is agreeing to the policy and rules
  fhir:Consent.manager [ Reference(HealthcareService|Organization|Patient|Practitioner) ], ... ; # 0..* Consent workflow management
  fhir:Consent.controller [ Reference(HealthcareService|Organization|Patient|Practitioner) ], ... ; # 0..* Consent Enforcer
  fhir:Consent.sourceAttachment [ Attachment ], ... ; # 0..* Source from which this consent is taken
  fhir:Consent.sourceReference [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ], ... ; # 0..* Source from which this consent is taken

  fhir:Consent.policy [ # 0..* Policies covered by this consent
    fhir:Consent.policy.authority [ uri ]; # 0..1 Enforcement source for policy
    fhir:Consent.policy.uri [ uri ]; # 0..1 Specific policy covered by this consent
  ], ...;
  fhir:Consent.policyRule [ CodeableConcept ]; # 0..1 Regulation that this consents to
  fhir:Consent.verification [ # 0..* Consent Verified by patient or family
    fhir:Consent.verification.verified [ boolean ]; # 1..1 Has been verified
    fhir:Consent.verification.verificationType [ CodeableConcept ]; # 0..1 Business case of verification
    fhir:Consent.verification.verifiedBy [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Person conducting verification

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

    fhir:Consent.verification.verificationDate [ dateTime ], ... ; # 0..* When consent verified

  ], ...;
  fhir:

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

    fhir:Consent.provision.type [ code ]; # 0..1 deny | permit
    fhir:Consent.provision.period [ Period ]; # 0..1 Timeframe for this rule
    fhir:Consent.provision.actor [ # 0..* Who|what controlled by this rule (or group, by role)
      fhir:Consent.provision.actor.role [ CodeableConcept ]; # 1..1 How the actor is involved
      fhir:|
  

      fhir:Consent.provision.actor.reference [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ]; # 1..1 Resource for the actor (or group, by role)
    ], ...;
    fhir:Consent.provision.action [ CodeableConcept ], ... ; # 0..* Actions controlled by this rule
    fhir:Consent.provision.securityLabel [ Coding ], ... ; # 0..* Security Labels that define affected resources
    fhir:Consent.provision.purpose [ Coding ], ... ; # 0..* Context of activities covered by this rule
    fhir:Consent.provision.class [ Coding ], ... ; # 0..* e.g. Resource Type, Profile, CDA, etc.
    fhir:Consent.provision.code [ CodeableConcept ], ... ; # 0..* e.g. LOINC or SNOMED CT code, etc. in the content
    fhir:Consent.provision.dataPeriod [ Period ]; # 0..1 Timeframe for data controlled by this rule
    fhir:Consent.provision.data [ # 0..* Data controlled by this rule
      fhir:Consent.provision.data.meaning [ code ]; # 1..1 instance | related | dependents | authoredby
      fhir:Consent.provision.data.reference [ Reference(Any) ]; # 1..1 The actual data reference
    ], ...;
    fhir:Consent.provision.provision [ See Consent.provision ], ... ; # 0..* Nested Exception Rules
  ];
]

Changes since R3

Consent
Consent.identifier Max Cardinality changed from 1 to * Consent.status
  • Change value set from http://hl7.org/fhir/ValueSet/consent-state-codes http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.0 to http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.1 http://hl7.org/fhir/ValueSet/consent-state-codes|4.4.0
Consent.scope Consent.subject
  • Added Mandatory Element Consent.category Min Cardinality changed from 0 to 1 Add Binding http://hl7.org/fhir/ValueSet/consent-category (extensible)
Consent.patient Min Cardinality changed from 1 to 0 Consent.performer
  • Added Element Consent.source[x] Remove Type Identifier Consent.policyRule Type changed from uri to CodeableConcept Add Binding http://hl7.org/fhir/ValueSet/consent-policy (extensible) Consent.verification Added Element Consent.verification.verified Added Mandatory Element Consent.verification.verifiedWith Added Element Consent.verification.verificationDate Added Element Consent.provision Added Element Consent.provision.type Added Element Consent.provision.period Added Element Consent.provision.actor Added Element Consent.provision.actor.role Reference: Added Mandatory Element Target Types CareTeam, HealthcareService
Consent.provision.actor.reference Consent.manager
  • Added Mandatory Element
Consent.provision.action Consent.controller
  • Added Element
Consent.provision.securityLabel Consent.sourceAttachment
  • Added Element
Consent.provision.purpose Consent.sourceReference
  • Added Element
Consent.provision.class Consent.verification.verificationType
  • Added Element
Consent.provision.code Consent.verification.verifiedBy
  • Added Element
Consent.provision.dataPeriod Consent.verification.verificationDate
  • Added Element Max Cardinality changed from 1 to *
Consent.provision.data Consent.provision.type
  • Added Element Change value set from http://hl7.org/fhir/ValueSet/consent-provision-type|4.0.0 to http://hl7.org/fhir/ValueSet/consent-provision-type|4.4.0
Consent.provision.data.meaning
  • Added Mandatory Element Consent.provision.data.reference Added Mandatory Element Consent.provision.provision Added Element Consent.period deleted Consent.consentingParty deleted Consent.actor deleted Consent.action deleted Consent.securityLabel deleted Consent.purpose deleted Change value set from http://hl7.org/fhir/ValueSet/consent-data-meaning|4.0.0 to http://hl7.org/fhir/ValueSet/consent-data-meaning|4.4.0
Consent.dataPeriod Consent.patient
  • deleted
Consent.data Consent.organization
  • deleted
Consent.except Consent.source[x]
  • deleted

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

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] « Indicates the state of the consent. (Strength=Required) ConsentState ! » A selector of the type of consent being presented: ADR, presented with the base being Privacy, Treatment, Research. This list is now extensible or Research (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 [1..*] « A classification of the type of consents found in a consent statement. (Strength=Extensible) ConsentCategoryCodes + » The patient/healthcare consumer practitioner to whom this consent applies patient subject : Reference [0..1] « Patient | Practitioner » When this Consent Date and time the consent instance was issued / created / indexed agreed to 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 performer : 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 : Type [0..1] « Attachment | Reference ( [0..*] « Consent | DocumentReference | Contract | QuestionnaireResponse ) » A reference to the specific base computable regulation or policy policyRule : CodeableConcept [0..1] « Regulatory policy examples. (Strength=Extensible) ConsentPolicyRuleCodes + » 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] 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] « Types of Verification/Validation. (Strength=Extensible) ConsentVerificationCodes + » The person who conducted the verification/validation of the Grantee 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] « How a rule statement is applied, such as adding additional consent or removing consent. (Strength=Required) ConsentProvisionType ! » The timeframe in this rule is valid period : Period [0..1] Actions controlled by this Rule action : CodeableConcept [0..*] « Detailed codes for the consent action. (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..*] « 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 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. (Strength=Extensible) v3.PurposeOfUse + » The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to class : Coding [0..*] « The class (type) of information a consent rule covers. (Strength=Extensible) ConsentContentClass + » If this code is found in an instance, then the rule applies code : CodeableConcept [0..*] « If this code is found in an instance, then the exception applies. (Strength=Example) ConsentContentCodes ?? » Clinical or Operational Relevant period of time that bounds the data controlled by this rule dataPeriod : Period [0..1] 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. (Strength=Extensible) SecurityRoleType + » 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] « Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole » 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. (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 to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law policy [0..*] Whether a treatment instruction (e.g. artificial 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. 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 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 provision [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><!-- 0..* Identifier Identifier for this record (external references) --></identifier>
 <
 <</scope>

 <status value="[code]"/><!-- 1..1 draft | active | inactive | entered-in-error | unknown -->
 <scope><!-- 1..1 CodeableConcept Which of the three areas this resource covers (extensible) --></scope>

 <category><!-- 1..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category>
 <</patient>
 <
 <|
   </performer>
 <</organization>
 <|
   </source[x]>

 <subject><!-- 0..1 Reference(Patient|Practitioner) Who the consent applies to --></subject>
 <dateTime value="[dateTime]"/><!-- 0..1 When consent was agreed to -->
 <performer><!-- 0..* Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Who is agreeing to the policy and rules --></performer>
 <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>
 <policy>  <!-- 0..* Policies covered by this consent -->
  <
  <

  <authority value="[uri]"/><!-- ?? 0..1 Enforcement source for policy -->
  <uri value="[uri]"/><!-- ?? 0..1 Specific policy covered by this consent -->

 </policy>
 <</policyRule>

 <policyRule><!-- ?? 0..1 CodeableConcept Regulation that this consents to --></policyRule>

 <verification>  <!-- 0..* Consent Verified by patient or family -->
  <verified value="[boolean]"/><!-- 1..1 Has been verified -->
  <verificationType><!-- 0..1 CodeableConcept Business case of verification --></verificationType>
  <verifiedBy><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Person conducting verification --></verifiedBy>

  <verifiedWith><!-- 0..1 Reference(Patient|RelatedPerson) Person who verified --></verifiedWith>
  <

  <verificationDate value="[dateTime]"/><!-- 0..* When consent verified -->

 </verification>
 <

 <provision>  <!-- 0..1 Constraints to the base Consent.policyRule/Consent.policy -->

  <type value="[code]"/><!-- 0..1 deny | permit -->
  <period><!-- 0..1 Period Timeframe for this rule --></period>
  <actor>  <!-- 0..* Who|what controlled by this rule (or group, by role) -->
   <role><!-- 1..1 CodeableConcept How the actor is involved --></role>
   <|
     </reference>

   <reference><!-- 1..1 Reference(CareTeam|Device|Group|Organization|Patient|
     Practitioner|PractitionerRole|RelatedPerson) Resource for the actor (or group, by role) --></reference>
  </actor>
  <action><!-- 0..* CodeableConcept Actions controlled by this rule --></action>
  <securityLabel><!-- 0..* Coding Security Labels that define affected resources --></securityLabel>
  <purpose><!-- 0..* Coding Context of activities covered by this rule --></purpose>
  <class><!-- 0..* Coding e.g. Resource Type, Profile, CDA, etc. --></class>
  <code><!-- 0..* CodeableConcept e.g. LOINC or SNOMED CT code, etc. in the content --></code>
  <dataPeriod><!-- 0..1 Period Timeframe for data controlled by this rule --></dataPeriod>
  <data>  <!-- 0..* Data controlled by this rule -->
   <meaning value="[code]"/><!-- 1..1 instance | related | dependents | authoredby -->
   <reference><!-- 1..1 Reference(Any) The actual data reference --></reference>
  </data>
  <provision><!-- 0..* Content as for Consent.provision Nested Exception Rules --></provision>
 </provision>
</Consent>

JSON Template

{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 | entered-in-error | unknown
  "scope" : { CodeableConcept }, // R!  Which of the three areas this resource covers (extensible)

  "category" : [{ CodeableConcept }], // R!  Classification of the consent statement - for indexing/retrieval
  "
  "
  "|
   
  "
  
  " },
  "|
    },

  "subject" : { Reference(Patient|Practitioner) }, // Who the consent applies to
  "dateTime" : "<dateTime>", // When consent was agreed to
  "performer" : [{ Reference(CareTeam|HealthcareService|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Who is agreeing to the policy and rules
  "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
  "policy" : [{ // Policies covered by this consent
    "
    "

    "authority" : "<uri>", // C? Enforcement source for policy
    "uri" : "<uri>" // C? Specific policy covered by this consent

  }],
  "

  "policyRule" : { CodeableConcept }, // C? Regulation that this consents to

  "verification" : [{ // Consent Verified by patient or family
    "verified" : <boolean>, // R!  Has been verified
    "verificationType" : { CodeableConcept }, // Business case of verification
    "verifiedBy" : { Reference(Organization|Practitioner|PractitionerRole) }, // Person conducting verification

    "verifiedWith" : { Reference(Patient|RelatedPerson) }, // Person who verified
    "

    "verificationDate" : ["<dateTime>"] // When consent verified

  }],
  "

  "provision" : { // Constraints to the base Consent.policyRule/Consent.policy

    "type" : "<code>", // deny | permit
    "period" : { Period }, // Timeframe for this rule
    "actor" : [{ // Who|what controlled by this rule (or group, by role)
      "role" : { CodeableConcept }, // R!  How the actor is involved
      "|
     

      "reference" : { Reference(CareTeam|Device|Group|Organization|Patient|
     Practitioner|PractitionerRole|RelatedPerson) } // R!  Resource for the actor (or group, by role)
    }],
    "action" : [{ CodeableConcept }], // Actions controlled by this rule
    "securityLabel" : [{ Coding }], // Security Labels that define affected resources
    "purpose" : [{ Coding }], // Context of activities covered by this rule
    "class" : [{ Coding }], // e.g. Resource Type, Profile, CDA, etc.
    "code" : [{ CodeableConcept }], // e.g. LOINC or SNOMED CT code, etc. in the content
    "dataPeriod" : { Period }, // Timeframe for data controlled by this rule
    "data" : [{ // Data controlled by this rule
      "meaning" : "<code>", // R!  instance | related | dependents | authoredby
      "reference" : { Reference(Any) } // R!  The actual data reference
    }],
    "provision" : [{ Content as for Consent.provision }] // Nested Exception Rules
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .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:Consent.identifier [ Identifier ], ... ; # 0..* Identifier for this record (external references)
  fhir:
  fhir:

  fhir:Consent.status [ code ]; # 1..1 draft | active | inactive | entered-in-error | unknown
  fhir:Consent.scope [ CodeableConcept ]; # 1..1 Which of the three areas this resource covers (extensible)

  fhir:Consent.category [ CodeableConcept ], ... ; # 1..* Classification of the consent statement - for indexing/retrieval
  fhir:
  fhir:
  fhir:
  fhir:
  # . One of these 2
    fhir: ]
    fhir:) ]

  fhir:Consent.subject [ Reference(Patient|Practitioner) ]; # 0..1 Who the consent applies to
  fhir:Consent.dateTime [ dateTime ]; # 0..1 When consent was agreed to
  fhir:Consent.performer [ Reference(CareTeam|HealthcareService|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ], ... ; # 0..* Who is agreeing to the policy and rules
  fhir:Consent.manager [ Reference(HealthcareService|Organization|Patient|Practitioner) ], ... ; # 0..* Consent workflow management
  fhir:Consent.controller [ Reference(HealthcareService|Organization|Patient|Practitioner) ], ... ; # 0..* Consent Enforcer
  fhir:Consent.sourceAttachment [ Attachment ], ... ; # 0..* Source from which this consent is taken
  fhir:Consent.sourceReference [ Reference(Consent|Contract|DocumentReference|QuestionnaireResponse) ], ... ; # 0..* Source from which this consent is taken

  fhir:Consent.policy [ # 0..* Policies covered by this consent
    fhir:Consent.policy.authority [ uri ]; # 0..1 Enforcement source for policy
    fhir:Consent.policy.uri [ uri ]; # 0..1 Specific policy covered by this consent
  ], ...;
  fhir:Consent.policyRule [ CodeableConcept ]; # 0..1 Regulation that this consents to
  fhir:Consent.verification [ # 0..* Consent Verified by patient or family
    fhir:Consent.verification.verified [ boolean ]; # 1..1 Has been verified
    fhir:Consent.verification.verificationType [ CodeableConcept ]; # 0..1 Business case of verification
    fhir:Consent.verification.verifiedBy [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Person conducting verification

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

    fhir:Consent.verification.verificationDate [ dateTime ], ... ; # 0..* When consent verified

  ], ...;
  fhir:

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

    fhir:Consent.provision.type [ code ]; # 0..1 deny | permit
    fhir:Consent.provision.period [ Period ]; # 0..1 Timeframe for this rule
    fhir:Consent.provision.actor [ # 0..* Who|what controlled by this rule (or group, by role)
      fhir:Consent.provision.actor.role [ CodeableConcept ]; # 1..1 How the actor is involved
      fhir:|
  

      fhir:Consent.provision.actor.reference [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ]; # 1..1 Resource for the actor (or group, by role)
    ], ...;
    fhir:Consent.provision.action [ CodeableConcept ], ... ; # 0..* Actions controlled by this rule
    fhir:Consent.provision.securityLabel [ Coding ], ... ; # 0..* Security Labels that define affected resources
    fhir:Consent.provision.purpose [ Coding ], ... ; # 0..* Context of activities covered by this rule
    fhir:Consent.provision.class [ Coding ], ... ; # 0..* e.g. Resource Type, Profile, CDA, etc.
    fhir:Consent.provision.code [ CodeableConcept ], ... ; # 0..* e.g. LOINC or SNOMED CT code, etc. in the content
    fhir:Consent.provision.dataPeriod [ Period ]; # 0..1 Timeframe for data controlled by this rule
    fhir:Consent.provision.data [ # 0..* Data controlled by this rule
      fhir:Consent.provision.data.meaning [ code ]; # 1..1 instance | related | dependents | authoredby
      fhir:Consent.provision.data.reference [ Reference(Any) ]; # 1..1 The actual data reference
    ], ...;
    fhir:Consent.provision.provision [ See Consent.provision ], ... ; # 0..* Nested Exception Rules
  ];
]

Changes since Release 3

Consent
Consent.identifier Max Cardinality changed from 1 to * Consent.status
  • Change value set from http://hl7.org/fhir/ValueSet/consent-state-codes http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.0 to http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.1 http://hl7.org/fhir/ValueSet/consent-state-codes|4.4.0
Consent.scope Consent.subject
  • Added Mandatory Element
Consent.category Min Cardinality changed from 0 to 1 Add Binding http://hl7.org/fhir/ValueSet/consent-category (extensible) Consent.patient Min Cardinality changed from 1 to 0 Consent.performer
  • Added Element Consent.source[x] Remove Type Identifier Consent.policyRule Type changed from uri to CodeableConcept Add Binding http://hl7.org/fhir/ValueSet/consent-policy (extensible) Consent.verification Added Element Consent.verification.verified Added Mandatory Element Consent.verification.verifiedWith Added Element Consent.verification.verificationDate Added Element Consent.provision Added Element Consent.provision.type Added Element Consent.provision.period Added Element Consent.provision.actor Added Element Consent.provision.actor.role Reference: Added Mandatory Element Target Types CareTeam, HealthcareService
Consent.provision.actor.reference Consent.manager
  • Added Mandatory Element
Consent.provision.action Consent.controller
  • Added Element
Consent.provision.securityLabel Consent.sourceAttachment
  • Added Element
Consent.provision.purpose Consent.sourceReference
  • Added Element
Consent.provision.class Consent.verification.verificationType
  • Added Element
Consent.provision.code Consent.verification.verifiedBy
  • Added Element
Consent.provision.dataPeriod Consent.verification.verificationDate
  • Added Element Max Cardinality changed from 1 to *
Consent.provision.data Consent.provision.type
  • Added Element Change value set from http://hl7.org/fhir/ValueSet/consent-provision-type|4.0.0 to http://hl7.org/fhir/ValueSet/consent-provision-type|4.4.0
Consent.provision.data.meaning
  • Added Mandatory Element Consent.provision.data.reference Added Mandatory Element Consent.provision.provision Added Element Consent.period deleted Consent.consentingParty deleted Consent.actor deleted Consent.action deleted Consent.securityLabel deleted Consent.purpose deleted Change value set from http://hl7.org/fhir/ValueSet/consent-data-meaning|4.0.0 to http://hl7.org/fhir/ValueSet/consent-data-meaning|4.4.0
Consent.dataPeriod Consent.patient
  • deleted
Consent.data Consent.organization
  • deleted
Consent.except Consent.source[x]
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

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

 

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

Path Definition Type Reference
Consent.status Indicates the state of the consent. Required ConsentState
Consent.scope The four anticipated uses for the Consent Resource. Extensible ConsentScopeCodes
Consent.category A classification of the type of consents found in a consent statement. Extensible ConsentCategoryCodes
Consent.policyRule Regulatory policy examples. Extensible ConsentPolicyRuleCodes
Consent.verification.verificationType Types of Verification/Validation. Extensible ConsentVerificationCodes
Consent.provision.type How a rule statement is applied, such as adding additional consent or removing consent. Required ConsentProvisionType
Consent.provision.actor.role How an actor is involved in the consent considerations. Extensible SecurityRoleType
Consent.provision.action Detailed codes for the consent action. Example ConsentActionCodes
Consent.provision.securityLabel Security Labels from the Healthcare Privacy and Security Classification System. Extensible All Security Labels
Consent.provision.purpose What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels. Extensible v3.PurposeOfUse
Consent.provision.class The class (type) of information a consent rule covers. Extensible ConsentContentClass
Consent.provision.code If this code is found in an instance, then the exception applies. Example ConsentContentCodes
Consent.provision.data.meaning How a resource reference is interpreted when testing consent restrictions. Required ConsentDataMeaning

id Level Location Description Expression
ppc-1 Rule (base) Either a Policy or PolicyRule policy.exists() or policyRule.exists() ppc-2 Rule (base) IF Scope=privacy, there Consent.subject must be a patient patient.exists() or scope.coding.where(system='something' (scope = 'privacy' and code='patient-privacy').exists().not() subject.resolve().exists()) implies (subject.resolve() is Patient)
ppc-3 ppc-2 Rule (base) IF Scope=research, there Consent.subject must be a patient patient.exists() or scope.coding.where(system='something' (scope = 'research' and code='research').exists().not() subject.resolve().exists()) implies (subject.resolve() is Patient)
ppc-4 ppc-3 Rule (base) IF Scope=adr, there Scope=treatment, Consent.subject must be a patient patient.exists() or scope.coding.where(system='something' (scope = 'treatment' and code='adr').exists().not() subject.resolve().exists()) implies (subject.resolve() is Patient)
ppc-5 ppc-4 Rule (base) IF Scope=treatment, there must be a patient Scope=research, ResearchStudyContext allowed patient.exists() Consent.provision.extension("http://hl7.org/fhir/StructureDefinition/consent-ResearchStudyContext").exists() or scope.coding.where(system='something' and code='treatment').exists().not() code='research').exists().not()
6.2.5

The Consent resource has a reference to a single policyRule . Many organizations will work in a context where multiple different consent regulations and policies apply. In these cases, the single policy rule reference refers to a policy document that resolves and reconciles the various policies and presents a single policy for patient consent. If it is still necessary to track which of the underlying policies an exception is make in regard to, the policy may be used.

Policies attached to Consent.policyRule language should be written using positive language. For an example, a patient wanting to opt-out will be recorded with an opt-in policy where the Consent.provision[0].type indicates "deny".

6.2.6

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 the except element.

6.2.7 Realm specifics

Five categories of Privacy Consent Directives are described Tracking changes in consent can be managed in two possible ways:

  1. Submitting changes to the Office of Consent resource and tracking the National Coordinator for Health Information (ONC) changes via a versioning server
  2. Submitting a new Consent Directives Document released March 31, 2010, resource and include marking the following US-specific "Core consent options" old resource as inactive

HL7 does not recommend a specific method.

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 exchange: No consent: Health information signatures of patients is automatically included—patients cannot opt out; Opt-out: Default one or both of the parties to the content of an encoded representation of a Consent Form is for health information deemed to constitute a legally binding Consent Directive. Some domains accept a notary’s electronic signature over the wet or electronic signature of patients a party to the Consent Directive as the additional identity proofing required to make an encoded Consent Directive legally binding. Other domains may only accept a wet signature or might not require the parties’ signatures at all.

Whatever the criteria are for making an encoded FHIR Consent Directive legally binding, anything less than a legally binding representation of a Consent Directive must be included automatically, but identified as such, i.e., as a derivative of the patient can opt out completely ; Opt-out with exceptions: Default is 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 health information specific purposes and periods of patients time
Consent Directive The legal record of a healthcare consumer's agreement or agreements made on their behalf with a party responsible for enforcing the consumer’s choices or choices made on their behalf by a third party, which permits or denies identified actors or roles to perform actions affecting the consumer within a given context for specific purposes and periods of time
Consent Form Human readable consent content describing one or more actions impacting the grantor for which the grantee would be included, but authorized or prohibited from performing. It includes the patient can opt out completely terms, rules, and conditions pertaining to the authorization or allow only select data restrictions, such as effective time, applicability or scope, purposes of use, obligations and prohibitions to be included; Opt-in: Default 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 no patient health conveys the minimal set of information is included; patients must actively express consent needed to be included, but if they do so then their information must be all in manage Consent Directive workflow, including providing Consent Directive content sufficient to:
  • Represent a Consent Directive
  • Register or all out; index a Consent Directive
  • Query and respond about a Consent Directive
  • Opt-in with restrictions: Default is that no patient health information is made available, but the patient may allow Retrieve a subset of select data Consent Directive
  • Notify authorized entities about Consent Directive status changes
  • Determine entities authorized to be included. 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 common exception is Consent Directive derivative has less than full fidelity to explicitly exclude or explicitly 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 period reference to or an attached unstructured representation for recipients needing an exact copy of time . 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.
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
6.2.7.2

The following scenarios are based on existing jurisdictional policy and are realized in existing systems in Canada. The default policy Privacy policies define how Individually Identifiable Health Information (IIHI) is one of implied consent for the provision to be collected, accessed, used and disclosed. A Privacy Consent Directive as a legal record of care, so these scenarios all deal a patient's (e.g. a healthcare consumer) agreement with withdrawal or withholding consent a party responsible for that purpose. In other jurisdictions, where an express consent model is used (Opt-In), these examples would contain enforcing the phrase "consent to" rather than "withhold" patient's choices, which permits or "withdraw" consent for. Withhold denies identified actors or withdraw consent for disclosure of records related roles to specific domain (e.g. DI, LAB, etc.) Withhold or withdraw consent for disclosure of perform actions affecting the patient within a given context for specific record (e.g. Lab Order/Result) Withhold or withdraw purposes and periods of time. All consent for disclosure to directives have a specific provider organization Withhold policy context, which is any set of organizational or withdraw consent 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 disclosure a healthcare consumer to delegate authority to a specific provider agent (an individual within an organization) Withhold or withdraw 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 disclosure the exchange and enforcement by sending, intermediating, or receiving systems of records privacy policies that were authored can be enforced by a specific organization (or service delivery location). Combinations 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 above 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.

6.2.7.3

Also shown is an example where a Patient has authorized disclosure to a specific individual The following steps represent the optimal path for purposes directed searching for a Consent resource.

  1. Request one or more Consent where status=active by the Consent.scope (with patient(s), if none specified, get all). Policy will decide how to deal with multiple per patient (possibly 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 a treatment case). 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

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
action token Actions controlled by this rule Consent.provision.action
actor reference Resource for the actor (or group, by role) Consent.provision.actor.reference
( Practitioner , Group , Organization , CareTeam , Device , Patient , PractitionerRole , RelatedPerson )
category token Classification of the consent statement - for indexing/retrieval Consent.category
consentor reference Who is agreeing to the policy and rules Consent.performer
( Practitioner , Organization , CareTeam , Patient , HealthcareService , PractitionerRole , RelatedPerson )
controller reference Consent Enforcer Consent.controller
( Practitioner , Organization , Patient , HealthcareService )
data reference The actual data reference Consent.provision.data.reference
(Any)
date N date When this Consent consent was created or indexed agreed to Consent.dateTime 17 Resources
identifier token Identifier for this record (external references) Consent.identifier 30 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 )
33 Resources
period date Timeframe for this rule Consent.provision.period
policy-uri N uri Search for Consents aligned with a specific policy or policy date/version. URIs should be complete with date/version and not assume the Resource will maintain versioning information Consent.policy.uri
purpose token Context of activities covered by this rule Consent.provision.purpose
scope token Which of the four three 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 N token draft | proposed | active | rejected | inactive | entered-in-error | unknown Consent.status
subject reference Who the consent applies to Consent.subject
( Practitioner , Patient , ResearchSubject )
verified N token Has been verified Consent.verification.verified
verified-date N date When consent verified Consent.verification.verificationDate