StructureDefinition-UKCore-Consent

Canonical_URLStatusCurrent_VersionLast_UpdatedDescription
https://fhir.hl7.org.uk/StructureDefinition/UKCore-Consentdraft2.4.02023-12-16

This profile defines the UK constraints and extensions on the International FHIR resource Consent.


Profile_Purpose

The purpose of this profile is to be used to express a Consent regarding Healthcare. There are four anticipated uses for the Consent Resource, all of which are written or verbal agreements by a healthcare consumer [grantor] or a personal representative, made to an authorised entity [grantee] concerning authorised or restricted actions with any limitations on purpose of use, and handling instructions to which the authorised entity SHALL comply:

  • Privacy Consent Directive: Agreement to collect, access, use or disclose (share) information.
  • Medical Treatment Consent Directive: Consent to undergo a specific treatment (or record of refusal to consent).
  • Research Consent Directive: Consent to participate in research protocol and information sharing required.
  • Advance Care Directives: Consent to instructions for potentially needed medical treatment (e.g. DNR).
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionC0..*Extension
modifierExtension?! C0..*Extension
identifierΣ0..*Identifier
statusS Σ ?!1..1codeBinding
scopeS Σ ?!1..1CodeableConceptBinding
categoryS Σ1..*CodeableConceptBinding
patientS Σ0..1Reference(Patient)
dateTimeS Σ0..1dateTime
performerS Σ0..*Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
organizationS Σ0..*Reference(Organization)
sourceAttachmentAttachment
sourceReferenceReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
authorityC0..1uri
uriC0..1uri
policyRuleΣ C0..1CodeableConceptBinding
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
verifiedΣ1..1boolean
verifiedWith0..1Reference(Patient | RelatedPerson)
verificationDate0..1dateTime
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
typeΣ0..1codeBinding
periodΣ0..1Period
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
role1..1CodeableConceptBinding
reference1..1Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
actionΣ0..*CodeableConcept
securityLabelΣ0..*CodingBinding
purposeΣ0..*CodingBinding
classΣ0..*CodingBinding
codeΣ0..*CodeableConceptBinding
dataPeriodΣ0..1Period
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
meaningΣ1..1codeBinding
referenceΣ1..1Reference(Resource)
provision0..*see (provision)

Detailed Descriptions

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

Cardinality0..*
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.

Constraints
  • dom-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()
Mappings
  • rim: Entity. Role, or Act
  • workflow: Event
  • v2: CON
  • rim: FinancialConsent
Consent.id
ShortLogical id of this artifact
Definition

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

Cardinality0..1
Typestring
SummaryTrue
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.

Consent.meta
ShortMetadata about the resource
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.

Cardinality0..1
TypeMeta
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.implicitRules
ShortA set of rules under which this content was created
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.

Cardinality0..1
Typeuri
ModifierTrue
SummaryTrue
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.language
ShortLanguage of the resource content
Definition

The base language in which the resource is written.

Cardinality0..1
Typecode
Binding

A human language.

CommonLanguages (preferred)

Binding extensions
maxValueSetAllLanguages
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).

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.text
ShortText summary of the resource, for human interpretation
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.

Cardinality0..1
TypeNarrative
Aliasnarrative, html, xhtml, display
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: Act.text?
Consent.contained
ShortContained, inline Resources
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.

Cardinality0..*
TypeResource
Aliasinline resources, anonymous resources, contained 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.

Mappings
  • rim: N/A
Consent.extension
ShortAdditional content defined by implementations
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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.modifierExtension
ShortExtensions that cannot be ignored
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).

Cardinality0..*
TypeExtension
ModifierTrue
Aliasextensions, user content
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.

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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.identifier
ShortIdentifier for this record (external references)
Definition

Unique identifier for this copy of the Consent Statement.

Cardinality0..*
TypeIdentifier
SummaryTrue
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
ExamplesGeneral
{
  "system": "urn:ietf:rfc:3986",
  "value": "Local eCMS identifier"
}
Mappings
  • workflow: Event.identifier
  • w5: FiveWs.identifier
  • rim: .id
Consent.status
Shortdraft | proposed | active | rejected | inactive | entered-in-error
Definition

Indicates the current state of this consent.

Cardinality1..1
Typecode
Binding

Indicates the state of the consent.

ConsentState (required)

Must SupportTrue
ModifierTrue
SummaryTrue
Requirements

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

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • workflow: Event.status
  • w5: FiveWs.status
  • v2: HL7 Table 0498 - Consent Status
  • rim: .statusCode
Consent.scope
ShortWhich of the four areas this resource covers (extensible)
Definition

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

Cardinality1..1
TypeCodeableConcept
Binding

The four anticipated uses for the Consent Resource.

ConsentScopeCodes (extensible)

Must SupportTrue
ModifierTrue
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.category
ShortClassification of the consent statement - for indexing/retrieval
Definition

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

Cardinality1..*
TypeCodeableConcept
Binding

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

ConsentCategoryCodes (extensible)

Must SupportTrue
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • workflow: Event.code
  • w5: FiveWs.class
  • v2: HL7 Table 0497 - Consent Type
  • rim: CNTRCT
Consent.patient
ShortWho the consent applies to
Definition

The patient/healthcare consumer to whom this consent applies.

Cardinality0..1
TypeReference(Patient)
Must SupportTrue
SummaryTrue
Comments

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

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • workflow: Event.subject
  • w5: FiveWs.subject[x]
  • rim: Role
  • w5: FiveWs.subject
Consent.dateTime
ShortWhen this Consent was created or indexed
Definition

When this Consent was issued / created / indexed.

Cardinality0..1
TypedateTime
Must SupportTrue
SummaryTrue
Comments

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

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • workflow: Event.occurrence[x]
  • w5: FiveWs.recorded
  • v2: Field 13/ Consent Decision Date
  • rim: FinancialConsent effectiveTime
Consent.performer
ShortWho is agreeing to the policy and rules
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.

Cardinality0..*
TypeReference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Must SupportTrue
SummaryTrue
Aliasconsentor
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • workflow: Event.performer
  • w5: FiveWs.actor
  • v2: Field 24/ ConsenterID
Consent.organization
ShortCustodian of the consent
Definition

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

Cardinality0..*
TypeReference(Organization)
Must SupportTrue
SummaryTrue
Aliascustodian
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • workflow: Event.performer
  • w5: FiveWs.witness
Consent.source[x]
ShortSource from which this consent is taken
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.

Cardinality0..1
TypeAttachment, Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
Must SupportTrue
SummaryTrue
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • v2: Field 19 Informational Material Supplied Indicator
Consent.policy
ShortPolicies covered by this consent
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.

Cardinality0..*
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.policy.id
ShortUnique id for inter-element referencing
Definition

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

Cardinality0..1
Typestring
Mappings
  • rim: n/a
Consent.policy.extension
ShortAdditional content defined by implementations
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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
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.

Constraints
  • ele-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()
Mappings
  • rim: n/a
Consent.policy.modifierExtension
ShortExtensions that cannot be ignored even if unrecognized
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).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.policy.authority
ShortEnforcement source for policy
Definition

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

Cardinality0..1
Typeuri
ConditionsThe cardinality or value of this element may be affected by these constraints: ppc-1
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.policy.uri
ShortSpecific policy covered by this consent
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.

Cardinality0..1
Typeuri
Comments

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

ConditionsThe cardinality or value of this element may be affected by these constraints: ppc-1
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.policyRule
ShortRegulation that this consents to
Definition

A reference to the specific base computable regulation or policy.

Cardinality0..1
TypeCodeableConcept
Binding

Regulatory policy examples.

ConsentPolicyRuleCodes (extensible)

SummaryTrue
Requirements

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

Comments

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

ConditionsThe cardinality or value of this element may be affected by these constraints: ppc-1
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.verification
ShortConsent Verified by patient or family
Definition

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

Cardinality0..*
TypeBackboneElement
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.verification.id
ShortUnique id for inter-element referencing
Definition

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

Cardinality0..1
Typestring
Mappings
  • rim: n/a
Consent.verification.extension
ShortAdditional content defined by implementations
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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
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.

Constraints
  • ele-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()
Mappings
  • rim: n/a
Consent.verification.modifierExtension
ShortExtensions that cannot be ignored even if unrecognized
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).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.verification.verified
ShortHas been verified
Definition

Has the instruction been verified.

Cardinality1..1
Typeboolean
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.verification.verifiedWith
ShortPerson who verified
Definition

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

Cardinality0..1
TypeReference(Patient | RelatedPerson)
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.verification.verificationDate
ShortWhen consent verified
Definition

Date verification was collected.

Cardinality0..1
TypedateTime
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision
ShortConstraints to the base Consent.policyRule
Definition

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

Cardinality0..1
TypeBackboneElement
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.id
ShortUnique id for inter-element referencing
Definition

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

Cardinality0..1
Typestring
Mappings
  • rim: n/a
Consent.provision.extension
ShortAdditional content defined by implementations
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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
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.

Constraints
  • ele-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()
Mappings
  • rim: n/a
Consent.provision.modifierExtension
ShortExtensions that cannot be ignored even if unrecognized
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).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.provision.type
Shortdeny | permit
Definition

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

Cardinality0..1
Typecode
Binding

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

ConsentProvisionType (required)

SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.period
ShortTimeframe for this rule
Definition

The timeframe in this rule is valid.

Cardinality0..1
TypePeriod
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.actor
ShortWho|what controlled by this rule (or group, by role)
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').

Cardinality0..*
TypeBackboneElement
Meaning when missing

There is no specific actor associated with the exception

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.actor.id
ShortUnique id for inter-element referencing
Definition

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

Cardinality0..1
Typestring
Mappings
  • rim: n/a
Consent.provision.actor.extension
ShortAdditional content defined by implementations
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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
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.

Constraints
  • ele-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()
Mappings
  • rim: n/a
Consent.provision.actor.modifierExtension
ShortExtensions that cannot be ignored even if unrecognized
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).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.provision.actor.role
ShortHow the actor is involved
Definition

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

Cardinality1..1
TypeCodeableConcept
Binding

How an actor is involved in the consent considerations.

SecurityRoleType (extensible)

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.actor.reference
ShortResource for the actor (or group, by role)
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').

Cardinality1..1
TypeReference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.action
ShortActions controlled by this rule
Definition

Actions controlled by this Rule.

Cardinality0..*
TypeCodeableConcept
Binding

Detailed codes for the consent action.

ConsentActionCodes (example)

SummaryTrue
Comments

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'.

Meaning when missing

all actions

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.securityLabel
ShortSecurity Labels that define affected resources
Definition

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

Cardinality0..*
TypeCoding
Binding

Security Labels from the Healthcare Privacy and Security Classification System.

All Security Labels (extensible)

SummaryTrue
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.purpose
ShortContext of activities covered by this rule
Definition

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

Cardinality0..*
TypeCoding
Binding

What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.

v3.PurposeOfUse (extensible)

SummaryTrue
Comments

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

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.class
Shorte.g. Resource Type, Profile, CDA, etc.
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.

Cardinality0..*
TypeCoding
Binding

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

ConsentContentClass (extensible)

SummaryTrue
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.code
Shorte.g. LOINC or SNOMED CT code, etc. in the content
Definition

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

Cardinality0..*
TypeCodeableConcept
Binding

A code from the SNOMED Clinical Terminology UK coding system that describes a trigger for an exception to a base policy.

UKCoreConsentException (preferred)

SummaryTrue
Comments

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

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.dataPeriod
ShortTimeframe for data controlled by this rule
Definition

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

Cardinality0..1
TypePeriod
SummaryTrue
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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.data
ShortData controlled by this rule
Definition

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

Cardinality0..*
TypeBackboneElement
SummaryTrue
Meaning when missing

all data

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: Role
Consent.provision.data.id
ShortUnique id for inter-element referencing
Definition

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

Cardinality0..1
Typestring
Mappings
  • rim: n/a
Consent.provision.data.extension
ShortAdditional content defined by implementations
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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
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.

Constraints
  • ele-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()
Mappings
  • rim: n/a
Consent.provision.data.modifierExtension
ShortExtensions that cannot be ignored even if unrecognized
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).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

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.

Constraints
  • ele-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()
Mappings
  • rim: N/A
Consent.provision.data.meaning
Shortinstance | related | dependents | authoredby
Definition

How the resource reference is interpreted when testing consent restrictions.

Cardinality1..1
Typecode
Binding

How a resource reference is interpreted when testing consent restrictions.

ConsentDataMeaning (required)

SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.data.reference
ShortThe actual data reference
Definition

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

Cardinality1..1
TypeReference(Resource)
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Consent.provision.provision
ShortNested Exception Rules
Definition

Rules which provide exceptions to the base rule or subrules.

Cardinality0..*
Typesee (provision)
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())

Table View

Consent..
Consent.status..
Consent.scope..
Consent.category..
Consent.patient..
Consent.dateTime..
Consent.performer..
Consent.organization..
Consent.source[x]..
Consent.provision..
Consent.provision.code..

XML View

<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="UKCore-Consent" />
<url value="https://fhir.hl7.org.uk/StructureDefinition/UKCore-Consent" />
<version value="2.4.0" />
<name value="UKCoreConsent" />
<title value="UK Core Consent" />
<status value="draft" />
<date value="2023-12-16" />
<publisher value="HL7 UK" />
<name value="HL7 UK" />
<system value="email" />
<value value="ukcore@hl7.org.uk" />
<use value="work" />
<rank value="1" />
</telecom>
</contact>
<description value="This profile defines the UK constraints and extensions on the International FHIR resource [Consent](https://hl7.org/fhir/R4/Consent.html)." />
<purpose value="The purpose of this profile is to be used to express a Consent regarding Healthcare. There are four anticipated uses for the Consent Resource, all of which are written or verbal agreements by a healthcare consumer [grantor] or a personal representative, made to an authorised entity [grantee] concerning authorised or restricted actions with any limitations on purpose of use, and handling instructions to which the authorised entity SHALL comply: \n- **Privacy Consent Directive**: Agreement to collect, access, use or disclose (share) information. \n- **Medical Treatment Consent Directive**: Consent to undergo a specific treatment (or record of refusal to consent). \n- **Research Consent Directive**: Consent to participate in research protocol and information sharing required. \n- **Advance Care Directives**: Consent to instructions for potentially needed medical treatment (e.g. DNR)." />
<copyright value="Copyright © 2021+ HL7 UK Licensed under the Apache License, Version 2.0 (the "License"); you may not use this file except in compliance with the License. You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an "AS IS" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License. HL7® FHIR® standard Copyright © 2011+ HL7 The HL7® FHIR® standard is used under the FHIR license. You may obtain a copy of the FHIR license at https://www.hl7.org/fhir/license.html." />
<fhirVersion value="4.0.1" />
<identity value="workflow" />
<uri value="http://hl7.org/fhir/workflow" />
<name value="Workflow Pattern" />
</mapping>
<identity value="v2" />
<uri value="http://hl7.org/v2" />
<name value="HL7 v2 Mapping" />
</mapping>
<identity value="rim" />
<uri value="http://hl7.org/v3" />
<name value="RIM Mapping" />
</mapping>
<identity value="w5" />
<uri value="http://hl7.org/fhir/fivews" />
<name value="FiveWs Pattern Mapping" />
</mapping>
<kind value="resource" />
<abstract value="false" />
<type value="Consent" />
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Consent" />
<derivation value="constraint" />
<element id="Consent.status">
<path value="Consent.status" />
<mustSupport value="true" />
</element>
<element id="Consent.scope">
<path value="Consent.scope" />
<mustSupport value="true" />
</element>
<element id="Consent.category">
<path value="Consent.category" />
<mustSupport value="true" />
</element>
<element id="Consent.patient">
<path value="Consent.patient" />
<mustSupport value="true" />
</element>
<element id="Consent.dateTime">
<path value="Consent.dateTime" />
<mustSupport value="true" />
</element>
<element id="Consent.performer">
<path value="Consent.performer" />
<mustSupport value="true" />
</element>
<element id="Consent.organization">
<path value="Consent.organization" />
<mustSupport value="true" />
</element>
<element id="Consent.source[x]">
<path value="Consent.source[x]" />
<mustSupport value="true" />
</element>
<element id="Consent.provision.code">
<path value="Consent.provision.code" />
<strength value="preferred" />
<description value="A code from the SNOMED Clinical Terminology UK coding system that describes a trigger for an exception to a base policy." />
<valueSet value="https://fhir.hl7.org.uk/ValueSet/UKCore-ConsentException" />
</binding>
</element>
</differential>
</StructureDefinition>

JSON View

{
"resourceType": "StructureDefinition",
"id": "UKCore-Consent",
"url": "https://fhir.hl7.org.uk/StructureDefinition/UKCore-Consent",
"version": "2.4.0",
"name": "UKCoreConsent",
"title": "UK Core Consent",
"status": "draft",
"date": "2023-12-16",
"publisher": "HL7 UK",
"contact": [
{
"name": "HL7 UK",
"telecom": [
{
"system": "email",
"value": "ukcore@hl7.org.uk",
"use": "work",
"rank": 1
}
]
}
],
"description": "This profile defines the UK constraints and extensions on the International FHIR resource [Consent](https://hl7.org/fhir/R4/Consent.html).",
"purpose": "The purpose of this profile is to be used to express a Consent regarding Healthcare. There are four anticipated uses for the Consent Resource, all of which are written or verbal agreements by a healthcare consumer [grantor] or a personal representative, made to an authorised entity [grantee] concerning authorised or restricted actions with any limitations on purpose of use, and handling instructions to which the authorised entity SHALL comply: \n- **Privacy Consent Directive**: Agreement to collect, access, use or disclose (share) information. \n- **Medical Treatment Consent Directive**: Consent to undergo a specific treatment (or record of refusal to consent). \n- **Research Consent Directive**: Consent to participate in research protocol and information sharing required. \n- **Advance Care Directives**: Consent to instructions for potentially needed medical treatment (e.g. DNR).",
"copyright": "Copyright © 2021+ HL7 UK Licensed under the Apache License, Version 2.0 (the \"License\"); you may not use this file except in compliance with the License. You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an \"AS IS\" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License. HL7® FHIR® standard Copyright © 2011+ HL7 The HL7® FHIR® standard is used under the FHIR license. You may obtain a copy of the FHIR license at https://www.hl7.org/fhir/license.html.",
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "workflow",
"uri": "http://hl7.org/fhir/workflow",
"name": "Workflow Pattern"
},
{
"identity": "v2",
"uri": "http://hl7.org/v2",
"name": "HL7 v2 Mapping"
},
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
},
{
"identity": "w5",
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "Consent",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Consent",
"derivation": "constraint",
"element": [
{
"id": "Consent.status",
"path": "Consent.status",
"mustSupport": true
},
{
"id": "Consent.scope",
"path": "Consent.scope",
"mustSupport": true
},
{
"id": "Consent.category",
"path": "Consent.category",
"mustSupport": true
},
{
"id": "Consent.patient",
"path": "Consent.patient",
"mustSupport": true
},
{
"id": "Consent.dateTime",
"path": "Consent.dateTime",
"mustSupport": true
},
{
"id": "Consent.performer",
"path": "Consent.performer",
"mustSupport": true
},
{
"id": "Consent.organization",
"path": "Consent.organization",
"mustSupport": true
},
{
"id": "Consent.source[x]",
"path": "Consent.source[x]",
"mustSupport": true
},
{
"id": "Consent.provision.code",
"path": "Consent.provision.code",
"binding": {
"strength": "preferred",
"description": "A code from the SNOMED Clinical Terminology UK coding system that describes a trigger for an exception to a base policy.",
"valueSet": "https://fhir.hl7.org.uk/ValueSet/UKCore-ConsentException"
}
}
]
}
}

Usage

This Profile has the following derived profiles:


This Profile is referenced in the following Extensions:


This Profile is referenced in the following Profiles:

Feedback

Click here to:

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Examples

For Information Access - An example to illustrate a patient giving consent for information access.
Example UKCore-Consent-ForInformationAccess

Example Usage Scenarios

The following are example usage scenarios for the UK Core Consent profile:

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

Profile Specific Implementation Guidance:

Minimum Viable Content

A minimum viable content that all provider and consumer systems SHALL support are the following elements.

Element Reason
Consent.status Indicates the current state of this consent.
Consent.scope A selector of the type of consent being presented: ADR, Privacy, Treatment, Research.
Consent.category The classification of the consent statement - for indexing/retrieval
Consent.patient The patient/healthcare consumer to whom this consent applies.
Consent.dateTime When this consent was issued / created / indexed.
Consent.performer Who is agreeing to the policy and rules
Consent.organization The custodian of the consent
Consent.source[x] The source from which this consent is taken

Bindings (differential)

More information about the bindings to UK Core ValueSets can be found below.

Context Strength Link
Consent.provision.code Preferred ValueSet UKCore-ConsentException

patient

The resource being referenced SHALL conform to the following Profile UKCore-Patient.


organization

The resource being referenced SHALL conform to the following Profile UKCore-Organization.


source[x]

The source on which this consent statement is based, either as an inline Attachment, or as a reference. The resource being referenced SHALL conform to one of the following:


verification

verification.verifiedWith

The resource being referenced SHALL conform to one of the following:


provision

provision.actor.reference

The resource being referenced SHOULD conform to one of the following:

provision.data.reference

Where a UK Core profile exists the resource being referenced SHOULD conform to the profile.

provision.code

This element has a binding to ValueSet UKCore-ConsentException.