Genomics-Consent

Only expected to be used for wrapping Record of Discussion resources within the WGS pathway.

Only a minimal amount of mandatory information needs to be populated.

Profile url FHIR Module Normative Status
http://hl7.org/fhir/StructureDefinition/Consent HL7 International trial-use



idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
identifierΣ0..*Identifier
statusΣ ?!1..1codeBinding
scopeΣ ?!1..1CodeableConceptBinding
categoryΣ1..*CodeableConceptBinding
patientΣ I0..1Reference(Patient)
dateTimeΣ0..1dateTime
performerΣ I0..*Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
organizationΣ I0..*Reference(Organization)
sourceAttachmentAttachment
sourceReferenceReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
authorityI0..1uri
uriI0..1uri
policyRuleΣ I0..1CodeableConceptBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
verifiedΣ1..1boolean
verifiedWithI0..1Reference(Patient | RelatedPerson)
verificationDate0..1dateTime
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
typeΣ0..1codeBinding
periodΣ I0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
role1..1CodeableConceptBinding
referenceI1..1Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
actionΣ0..*CodeableConcept
securityLabelΣ0..*CodingBinding
purposeΣ0..*CodingBinding
classΣ0..*CodingBinding
codeΣ0..*CodeableConcept
dataPeriodΣ I0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
meaningΣ1..1codeBinding
referenceΣ I1..1Reference(Resource)
provision0..*see (provision)

Differential from Consent

idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
identifierΣ0..*Identifier
statusΣ ?!1..1codeBinding
scopeΣ ?!1..1CodeableConceptBinding
categoryΣ1..*CodeableConceptBinding
patientΣ I0..1Reference(Patient)
dateTimeΣ0..1dateTime
performerΣ I0..*Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
organizationΣ I0..*Reference(Organization)
sourceAttachmentAttachment
sourceReferenceReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
authorityI0..1uri
uriI0..1uri
policyRuleΣ I0..1CodeableConceptBinding
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
verifiedΣ1..1boolean
verifiedWithI0..1Reference(Patient | RelatedPerson)
verificationDate0..1dateTime
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
typeΣ0..1codeBinding
periodΣ I0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
role1..1CodeableConceptBinding
referenceI1..1Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
actionΣ0..*CodeableConcept
securityLabelΣ0..*CodingBinding
purposeΣ0..*CodingBinding
classΣ0..*CodingBinding
codeΣ0..*CodeableConcept
dataPeriodΣ I0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
meaningΣ1..1codeBinding
referenceΣ I1..1Reference(Resource)
provision0..*see (provision)

Consent
DefinitionA 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.

Invariants
  • dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    contained.contained.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-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-6: A resource should have narrative for robust management
    text.`div`.exists()
  • dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    contained.meta.security.empty()
  • 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()
  • 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-1: Either a Policy or PolicyRule
    policy.exists() or policyRule.exists()
Mappings
  • rim: Entity. Role, or Act
  • workflow: Event
  • v2: CON
  • rim: FinancialConsent
Consent.id
DefinitionThe 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
DefinitionThe 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
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: N/A
Consent.implicitRules
DefinitionA 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.language
DefinitionThe base language in which the resource is written.
Cardinality0...1
Typecode
Binding

A human language.

CommonLanguages (preferred)
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).

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.text
DefinitionA 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: N/A
  • rim: Act.text?
Consent.contained
DefinitionThese 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: Entity. Role, or Act
  • rim: N/A
Consent.extension
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.modifierExtension
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.identifier
DefinitionUnique 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Examples
General

{
  "system": "urn:ietf:rfc:3986",
  "value": "Local eCMS identifier"
}


Mappings
  • rim: n/a
  • v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
  • rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
  • servd: Identifier
  • workflow: Event.identifier
  • w5: FiveWs.identifier
  • rim: .id
Consent.status
DefinitionIndicates the current state of this consent.
Cardinality1...1
Typecode
Binding

Indicates the state of the consent.

ConsentState (required)
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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • workflow: Event.status
  • w5: FiveWs.status
  • v2: HL7 Table 0498 - Consent Status
  • rim: .statusCode
Consent.scope
DefinitionA 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)
ModifierTrue
SummaryTrue
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
Consent.category
DefinitionA 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)
SummaryTrue
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
  • workflow: Event.code
  • w5: FiveWs.class
  • v2: HL7 Table 0497 - Consent Type
  • rim: CNTRCT
Consent.patient
DefinitionThe patient/healthcare consumer to whom this consent applies.
Cardinality0...1
TypeReference(Patient)
SummaryTrue
Comments

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

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • workflow: Event.subject
  • w5: FiveWs.subject[x]
  • rim: Role
  • w5: FiveWs.subject
Consent.dateTime
DefinitionWhen this Consent was issued / created / indexed.
Cardinality0...1
TypedateTime
SummaryTrue
Comments

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

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • workflow: Event.occurrence[x]
  • w5: FiveWs.recorded
  • v2: Field 13/ Consent Decision Date
  • rim: FinancialConsent effectiveTime
Consent.performer
DefinitionEither 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)
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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • workflow: Event.performer
  • w5: FiveWs.actor
  • v2: Field 24/ ConsenterID
Consent.organization
DefinitionThe organization that manages the consent, and the framework within which it is executed.
Cardinality0...*
TypeReference(Organization)
SummaryTrue
Aliascustodian
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • workflow: Event.performer
  • w5: FiveWs.witness
Consent.source[x]
DefinitionThe 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
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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: Field 19 Informational Material Supplied Indicator
Consent.policy
DefinitionThe 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
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.policy.id
DefinitionUnique 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
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.policy.modifierExtension
DefinitionMay 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.

Invariants
  • 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
  • rim: N/A
Consent.policy.authority
DefinitionEntity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives.
Cardinality0...1
Typeuri
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.policy.uri
DefinitionThe 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.policyRule
DefinitionA 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
Consent.verification
DefinitionWhether 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
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.verification.id
DefinitionUnique 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
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.verification.modifierExtension
DefinitionMay 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.

Invariants
  • 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
  • rim: N/A
Consent.verification.verified
DefinitionHas the instruction been verified.
Cardinality1...1
Typeboolean
SummaryTrue
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.verification.verifiedWith
DefinitionWho verified the instruction (Patient, Relative or other Authorized Person).
Cardinality0...1
TypeReference(Patient | RelatedPerson)
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
Consent.verification.verificationDate
DefinitionDate verification was collected.
Cardinality0...1
TypedateTime
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.provision
DefinitionAn exception to the base policy of this consent. An exception can be an addition or removal of access permissions.
Cardinality0...1
TypeBackboneElement
SummaryTrue
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.provision.id
DefinitionUnique 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
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.provision.modifierExtension
DefinitionMay 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.

Invariants
  • 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
  • rim: N/A
Consent.provision.type
DefinitionAction 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
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.provision.period
DefinitionThe timeframe in this rule is valid.
Cardinality0...1
TypePeriod
SummaryTrue
Comments

A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").

Period is not used for a duration (a measure of elapsed time). See Duration.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • per-1: If present, start SHALL have a lower value than end
    start.hasValue().not() or end.hasValue().not() or (start <= end)
Mappings
  • rim: n/a
  • v2: DR
  • rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
Consent.provision.actor
DefinitionWho 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
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.provision.actor.id
DefinitionUnique 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
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.provision.actor.modifierExtension
DefinitionMay 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.

Invariants
  • 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
  • rim: N/A
Consent.provision.actor.role
DefinitionHow 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)
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
Consent.provision.actor.reference
DefinitionThe 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)
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
Consent.provision.action
DefinitionActions 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'.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
Consent.provision.securityLabel
DefinitionA 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
  • rim: CV
  • orim: fhir:Coding rdfs:subClassOf dt:CDCoding
Consent.provision.purpose
DefinitionThe 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
  • rim: CV
  • orim: fhir:Coding rdfs:subClassOf dt:CDCoding
Consent.provision.class
DefinitionThe 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
  • rim: CV
  • orim: fhir:Coding rdfs:subClassOf dt:CDCoding
Consent.provision.code
DefinitionIf this code is found in an instance, then the rule applies.
Cardinality0...*
TypeCodeableConcept
Binding

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

ConsentContentCodes (example)
SummaryTrue
Comments

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

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
Consent.provision.dataPeriod
DefinitionClinical 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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • per-1: If present, start SHALL have a lower value than end
    start.hasValue().not() or end.hasValue().not() or (start <= end)
Mappings
  • rim: n/a
  • v2: DR
  • rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
Consent.provision.data
DefinitionThe resources controlled by this rule if specific resources are referenced.
Cardinality0...*
TypeBackboneElement
SummaryTrue
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: Role
Consent.provision.data.id
DefinitionUnique 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
DefinitionMay 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.

SlicingUnordered, Open, by url(Value)
Invariants
  • 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
  • rim: N/A
Consent.provision.data.modifierExtension
DefinitionMay 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.

Invariants
  • 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
  • rim: N/A
Consent.provision.data.meaning
DefinitionHow 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
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
Consent.provision.data.reference
DefinitionA reference to a specific resource that defines which resources are covered by this consent.
Cardinality1...1
TypeReference(Resource)
SummaryTrue
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
Consent.provision.provision
DefinitionRules which provide exceptions to the base rule or subrules.
Cardinality0...*
Typesee (provision)


FHIRMDSHL7v2
Consent.sourceAttachmentRoD - Record of discussion form - copy attachedCON-19
Consent.statusRoD - Patient conversation taken place, ROD form to followInferred through CON-19 value

Constraint Profiles

Profiles indicating preferred element cardinality for use in Genomics, not to be used for validation

nameprofile
NHSDigital_Consent_Genomicshttps://fhir.nhs.uk/StructureDefinition/NHSDigital-Consent-Genomics

Additional Guidance

status

Fixed code of 'proposed' where consent discussion has taken place but RoD form has not been provided alongside test order. 'draft' if discussion has not yet taken place and 'active' for completed RoD, regardless of whether the patient has consented to information sharing (responses to specific consent statements SHOULD be recorded in the RoD itself).

"status": "proposed",

scope

For WGS RoD this SHALL be fixed to the below code:

"scope": {
        "coding":  [
            {
                "system": "http://terminology.hl7.org/CodeSystem/consentscope",
                "code": "research",
                "display": "Research"
            }
        ]
    },

category

For WGS RoD this SHALL be fixed to the below code:

"category":  [
        {
            "coding":  [
                {
                    "system": "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
                    "code": "research",
                    "display": "Research Information Access"
                }
            ]
        }
    ],

source[x]

The Source element MAY either be a pointer to the location of the PDF version of the RoD, either hosted by the source/client system, accessed via NRL or embedded within the message payload, base64 encoded (using sourceAttachment), or a reference to a QuestionnaireResponse resource (using sourceReference), if this has been collected in a structured format, using the Questionnaire-Genomic Testing RoD template.

"sourceReference": {
        "reference": "QuestionnaireResponse/QuestionnaireResponse-RoD-Example"
    },

policy

For WGS RoD this SHALL be fixed to the below uris:

"policy":  [
        {
            "authority": "https://www.england.nhs.uk",
            "uri": "https://www.england.nhs.uk/publication/nhs-genomic-medicine-service-record-of-discussion-form"
        }
    ]