PACIO Advance Directive Interoperability Implementation Guide
2.1.0 - STU 2 United States of America flag

PACIO Advance Directive Interoperability Implementation Guide, published by HL7 International / Patient Empowerment. This guide is not an authorized publication; it is the continuous build for version 2.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-pacio-adi/ and changes regularly. See the Directory of published versions

Resource Profile: ADIHealthcareAgentConsent - Detailed Descriptions

Active as of 2025-03-12

Definitions for the ADI-HealthcareAgentConsent resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Consent
Definition

A record of a healthcare consumer’s 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.

ShortA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
Comments

Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.

Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
ppc-1: Either a Policy or PolicyRule (policy.exists() or policyRule.exists())
ppc-2: IF Scope=privacy, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not())
ppc-3: IF Scope=research, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='research').exists().not())
ppc-4: IF Scope=adr, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='adr').exists().not())
ppc-5: IF Scope=treatment, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not())
HCA-consent-category: Category must have a ConsentCategory of 'acd' (category.coding.where(code = 'acd').exists())
HCA-provision-purpose: Provision purpose must have a purpose of 'PWATRNY' (provision.purpose.exists().not() or provision.purpose.where(code = 'PWATRNY').exists())
ppc-1: Either a Policy or PolicyRule (policy.exists() or policyRule.exists())
ppc-2: IF Scope=privacy, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not())
ppc-3: IF Scope=research, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='research').exists().not())
ppc-4: IF Scope=adr, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='adr').exists().not())
ppc-5: IF Scope=treatment, there must be a patient (patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not())
2. Consent.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Consent.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control10..1
TypeNarrative
Is Modifierfalse
Must Supporttrue
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Consent.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Consent.status
Definition

Indicates the current state of this consent.

Shortdraft | proposed | active | rejected | inactive | entered-in-error
Comments

This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.

Control1..1
BindingThe codes SHALL be taken from ConsentStatehttp://hl7.org/fhir/ValueSet/consent-state-codes|4.0.1
(required to http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.1)

Indicates the state of the consent.

Typecode
Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.

Pattern Valueactive
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Consent.scope
Definition

A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible.

ShortWhich of the four areas this resource covers (extensible)
Control1..1
BindingUnless not suitable, these codes SHALL be taken from ConsentScopeCodeshttp://hl7.org/fhir/ValueSet/consent-scope
(extensible to http://hl7.org/fhir/ValueSet/consent-scope)

The four anticipated uses for the Consent Resource.

TypeCodeableConcept
Is Modifiertrue because Allows changes to codes based on scope selection
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://loinc.org",
    "code" : "81377-4",
    "display" : "Goals, preferences, and priorities regarding the appointment of healthcare agents [Reported]"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Consent.category
Definition

A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.

ShortClassification of the consent statement - for indexing/retrieval
Control1..1*
BindingUnless not suitable, these codes SHALL be taken from ConsentCategoryCodeshttp://hl7.org/fhir/ValueSet/consent-category
(extensible to http://hl7.org/fhir/ValueSet/consent-category)

A classification of the type of consents found in a consent statement.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
    "code" : "acd"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Consent.patient
Definition

The patient/healthcare consumer to whom this consent applies.

ShortWho the consent applies to
Comments

Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person.

Control10..1
TypeReference(US Core Patient Profile, Patient)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Consent.dateTime
Definition

When this Consent was issued / created / indexed.

ShortWhen this Consent was created or indexed
Comments

This is not the time of the original consent, but the time that this statement was made or derived.

Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Consent.policy
Definition

The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

ShortPolicies covered by this consent
Comments

A URI indicating the policy or jurisdiction that defines the policy for healthcare agents and granted powers and limitations.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Consent.policy.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
22. Consent.provision
Definition

An exception to the base policy of this consent. An exception can be an addition or removal of access permissions.

ShortConstraints to the base Consent.policyRule
Control10..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Consent.provision.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Consent.provision.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 26. Consent.provision.extension:ClauseExtension
    Slice NameClauseExtension
    Definition

    A clause or set of clauses relevant to the resource or element being extended

    ShortClause
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(Clause) (Complex Extension)
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    28. Consent.provision.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    30. Consent.provision.type
    Definition

    Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules.

    Shortdeny | permit
    Control10..1
    BindingThe codes SHALL be taken from ConsentProvisionTypehttp://hl7.org/fhir/ValueSet/consent-provision-type|4.0.1
    (required to http://hl7.org/fhir/ValueSet/consent-provision-type|4.0.1)

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

    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Consent.provision.actor
    Definition

    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').

    ShortWho|what controlled by this rule (or group, by role)
    Control10..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Meaning if MissingThere is no specific actor associated with the exception
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. Consent.provision.actor.extension
    Definition

    An Extension


    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortExtensionAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on Consent.provision.actor.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 36. Consent.provision.actor.extension:ClauseExtension
      Slice NameClauseExtension
      Definition

      A clause or set of clauses relevant to the resource or element being extended

      ShortClause
      Control0..*
      This element is affected by the following invariants: ele-1
      TypeExtension(Clause) (Complex Extension)
      Is Modifierfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      38. Consent.provision.actor.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      40. Consent.provision.actor.role
      Definition

      How the individual is involved in the resources content that is described in the exception.

      ShortHow the actor is involved
      Control1..1
      BindingThe codes SHALL be taken from Unless not suitable, these codes SHALL be taken from Healthcare Agent or Proxy Choices .http://hl7.org/fhir/ValueSet/security-role-type
      (required to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1046.35)
      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. Consent.provision.actor.reference
      Definition

      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').

      ShortResource for the actor (or group, by role)
      Control1..1
      TypeReference(ADI Healthcare Agent Participant, Device, Group, CareTeam, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. Consent.provision.action
      Definition

      Actions controlled by this Rule.

      ShortActions controlled by this rule
      Comments

      Actions without a defined code are placed in action.text.


      Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'.

      Control0..*
      BindingUnless not suitable, these codes SHALL be taken from For example codes, see Healthcare Agent Decisionshttp://hl7.org/fhir/ValueSet/consent-action
      (extensible to http://hl7.org/fhir/us/pacio-adi/ValueSet/ADIHCADecisionsVS)
      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Meaning if Missingall actions
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. Consent.provision.purpose
      Definition

      The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule.

      ShortContext of activities covered by this rule
      Comments

      When the purpose of use tag is on the data, access request purpose of use shall not conflict.

      Control0..*
      BindingThe codes SHALL be taken from Unless not suitable, these codes SHALL be taken from v3 Code System ActReasonhttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse
      (required to http://terminology.hl7.org/ValueSet/v3-ActReason)
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))