PACIO Advance Directive Interoperability Implementation Guide
1.0.0 - STU 1 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 1.0.0 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: ADIParticipantConsent - Detailed Descriptions

Active as of 2024-01-11

Definitions for the ADI-ParticipantConsent resource profile.

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

0. Consent
InvariantsHCA-authority-scope-provisionType: Scope indicates powers granted and provision type is permit or scope indicates limitations placed and provision type is deny or scope indicates no powers/limitations and no provisions type and no action exist ((scope.coding.where(code = '75786-4').exists() and provision.type = 'permit') or (scope.coding.where(code = '81346-9').exists() and provision.type = 'deny') or (scope.coding.where(code = '81335-2').exists() and provision.type.exists().not() and provision.action.exists().not() and provision.provision.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())
2. Consent.text
Control1..?
Must Supporttrue
4. Consent.status
Must Supporttrue
Pattern Valueactive
6. Consent.scope
BindingThe codes SHALL be taken from Consent Type
8. Consent.category
BindingUnless not suitable, these codes SHALL be taken from ConsentCategoryCodes
10. Consent.patient
Control1..?
TypeReference(US Core Patient Profile)
Must Supporttrue
12. Consent.dateTime
Must Supporttrue
14. Consent.policy
Comments

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

Must Supporttrue
16. Consent.provision
Control1..?
Must Supporttrue
18. Consent.provision.extension
SlicingThis element introduces a set of slices on Consent.provision.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
20. Consent.provision.extension:ClauseExtension
Slice NameClauseExtension
Control0..*
TypeExtension(Clause) (Complex Extension)
22. Consent.provision.type
Control1..?
Must Supporttrue
24. Consent.provision.actor
Control1..?
Must Supporttrue
26. Consent.provision.actor.extension
SlicingThis element introduces a set of slices on Consent.provision.actor.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
28. Consent.provision.actor.extension:ClauseExtension
Slice NameClauseExtension
Control0..*
TypeExtension(Clause) (Complex Extension)
30. Consent.provision.actor.role
BindingThe codes SHALL be taken from Healthcare Agent or Proxy Choices
32. Consent.provision.actor.reference
TypeReference(ADI Participant)
34. Consent.provision.action
Comments

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

BindingUnless not suitable, these codes SHALL be taken from Healthcare Agent Decisions
36. Consent.provision.purpose
BindingThe codes SHALL be taken from v3 Code System ActReason

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-authority-scope-provisionType: Scope indicates powers granted and provision type is permit or scope indicates limitations placed and provision type is deny or scope indicates no powers/limitations and no provisions type and no action exist ((scope.coding.where(code = '75786-4').exists() and provision.type = 'permit') or (scope.coding.where(code = '81346-9').exists() and provision.type = 'deny') or (scope.coding.where(code = '81335-2').exists() and provision.type.exists().not() and provision.action.exists().not() and provision.provision.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

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
BindingThe codes SHALL be taken from Unless not suitable, these codes SHALL be taken from Consent Typehttp://hl7.org/fhir/ValueSet/consent-scope
TypeCodeableConcept
Is Modifiertrue because Allows changes to codes based on scope selection
Summarytrue
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..*
BindingUnless not suitable, these codes SHALL be taken from ConsentCategoryCodeshttp://hl7.org/fhir/ValueSet/consent-category
TypeCodeableConcept
Is Modifierfalse
Summarytrue
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 are unordered 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

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 are unordered 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 Choiceshttp://hl7.org/fhir/ValueSet/security-role-type
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 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
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
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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-authority-scope-provisionType: Scope indicates powers granted and provision type is permit or scope indicates limitations placed and provision type is deny or scope indicates no powers/limitations and no provisions type and no action exist ((scope.coding.where(code = '75786-4').exists() and provision.type = 'permit') or (scope.coding.where(code = '81346-9').exists() and provision.type = 'deny') or (scope.coding.where(code = '81335-2').exists() and provision.type.exists().not() and provision.action.exists().not() and provision.provision.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())
2. Consent.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. Consent.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. 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()))
8. Consent.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. 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.

Control1..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()))
12. Consent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Control0..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. Consent.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. 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.

ShortAdditional 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())
16. 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())
18. Consent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

ShortIdentifier for this record (external references)
Comments

This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Summarytrue
Example<br/><b>General</b>:&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://acme.org/identifier/local/eCMS&quot;/&gt;<br/>&nbsp;&nbsp;&lt;value&nbsp;value=&quot;Local&nbsp;eCMS&nbsp;identifier&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. 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 ConsentState

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()))
22. 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
BindingThe codes SHALL be taken from Consent Type
TypeCodeableConcept
Is Modifiertrue because Allows changes to codes based on scope selection
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. 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..*
BindingUnless not suitable, these codes SHALL be taken from ConsentCategoryCodes
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. 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.

Control1..1
TypeReference(US Core Patient Profile)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. 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()))
30. Consent.performer
Definition

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.

ShortWho is agreeing to the policy and rules
Comments

Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian.

Control0..*
TypeReference(Organization, Patient, Practitioner, RelatedPerson, PractitionerRole)
Is Modifierfalse
Summarytrue
Alternate Namesconsentor
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Consent.organization
Definition

The organization that manages the consent, and the framework within which it is executed.

ShortCustodian of the consent
Control0..*
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Alternate Namescustodian
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Consent.source[x]
Definition

The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document.

ShortSource from which this consent is taken
Comments

The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id.

Control0..1
TypeChoice of: Attachment, Reference(Consent, DocumentReference, Contract, QuestionnaireResponse)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. 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()))
38. Consent.policy.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
40. Consent.policy.extension
Definition

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.

ShortAdditional 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())
42. 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())
44. Consent.policy.authority
Definition

Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives.

ShortEnforcement source for policy
Control0..1
This element is affected by the following invariants: ppc-1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Consent.policy.uri
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.

ShortSpecific policy covered by this consent
Comments

This element is for discoverability / documentation and does not modify or qualify the policy rules.

Control0..1
This element is affected by the following invariants: ppc-1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Consent.policyRule
Definition

A reference to the specific base computable regulation or policy.

ShortRegulation that this consents to
Comments

If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource.

Control0..1
This element is affected by the following invariants: ppc-1
BindingUnless not suitable, these codes SHALL be taken from ConsentPolicyRuleCodes

Regulatory policy examples.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Might be a unique identifier of a policy set in XACML, or other rules engine.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Consent.verification
Definition

Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person.

ShortConsent Verified by patient or family
Control0..*
TypeBackboneElement
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Consent.verification.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
54. Consent.verification.extension
Definition

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.

ShortAdditional 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())
56. Consent.verification.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())
58. Consent.verification.verified
Definition

Has the instruction been verified.

ShortHas been verified
Control1..1
Typeboolean
Is Modifierfalse
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()))
60. Consent.verification.verifiedWith
Definition

Who verified the instruction (Patient, Relative or other Authorized Person).

ShortPerson who verified
Control0..1
TypeReference(Patient, RelatedPerson)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Consent.verification.verificationDate
Definition

Date verification was collected.

ShortWhen consent verified
Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. 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
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Consent.provision.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
68. Consent.provision.extension
Definition

An Extension

ShortExtension
Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
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 are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
70. 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())
72. 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())
74. 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
Control1..1
BindingThe codes SHALL be taken from ConsentProvisionType

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()))
76. Consent.provision.period
Definition

The timeframe in this rule is valid.

ShortTimeframe for this rule
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. 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)
Control1..*
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()))
80. Consent.provision.actor.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
82. Consent.provision.actor.extension
Definition

An Extension

ShortExtension
Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
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 are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
84. 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())
86. 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())
88. 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 Healthcare Agent or Proxy Choices
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. 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 Participant)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. 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.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from Healthcare Agent Decisions
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()))
94. Consent.provision.securityLabel
Definition

A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception.

ShortSecurity Labels that define affected resources
Comments

If the consent specifies a security label of "R" then it applies to all resources that are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from All Security Labels

Security Labels from the Healthcare Privacy and Security Classification System.

TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. 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 v3 Code System ActReason
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Consent.provision.class
Definition

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.

Shorte.g. Resource Type, Profile, CDA, etc.
Comments

Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from ConsentContentClass

The class (type) of information a consent rule covers.

TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. Consent.provision.code
Definition

If this code is found in an instance, then the rule applies.

Shorte.g. LOINC or SNOMED CT code, etc. in the content
Comments

Typical use of this is a Document code with class = CDA.

Control0..*
BindingFor example codes, see ConsentContentCodes

If this code is found in an instance, then the exception applies.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. Consent.provision.dataPeriod
Definition

Clinical or Operational Relevant period of time that bounds the data controlled by this rule.

ShortTimeframe for data controlled by this rule
Comments

This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement.

Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. Consent.provision.data
Definition

The resources controlled by this rule if specific resources are referenced.

ShortData controlled by this rule
Control0..*
TypeBackboneElement
Is Modifierfalse
Summarytrue
Meaning if Missingall data
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. Consent.provision.data.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
108. Consent.provision.data.extension
Definition

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.

ShortAdditional 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())
110. Consent.provision.data.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())
112. Consent.provision.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Shortinstance | related | dependents | authoredby
Control1..1
BindingThe codes SHALL be taken from ConsentDataMeaning

How a resource reference is interpreted when testing consent restrictions.

Typecode
Is Modifierfalse
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()))
114. Consent.provision.data.reference
Definition

A reference to a specific resource that defines which resources are covered by this consent.

ShortThe actual data reference
Control1..1
TypeReference(Resource)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. Consent.provision.provision
Definition

Rules which provide exceptions to the base rule or subrules.

ShortNested Exception Rules
Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Consent#Consent.provision
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))