FHIR Genomics Implementation Guide

Notice

Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.

StructureDefinition Consent

Only expected to be used for wrapping Record of Discussion resources within the WGS pathway. Consent for testing is implied through submission of a test to the Genomic Order Management service.

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

Consent	I		DomainResource	Element id Consent Short description A 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. 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. Data type DomainResource Constraints 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
id	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.id Short description Logical 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. 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. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Consent.meta Short description Metadata 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Consent.implicitRules Short description A 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. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Consent.language Short description Language of the resource content Definition The base language in which the resource is written. 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id Consent.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display 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. 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. Data type Narrative Constraints 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?
contained		0..*	Resource	There are no (further) constraints on this element Element id Consent.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained 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. 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. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content 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). 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
identifier	Σ	0..*	Identifier	Element id Consent.identifier Short description Identifier for this record (external references) Definition Unique identifier for this copy of the Consent Statement. 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. Data type Identifier Constraints 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
status	Σ ?!	1..1	codeBinding	Element id Consent.status Short description draft \| proposed \| active \| rejected \| inactive \| entered-in-error Definition Indicates the current state of this consent. 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. Data type code Binding Indicates the state of the consent. ConsentState (required) Constraints 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
scope	Σ ?!	1..1	CodeableConceptBinding	Element id Consent.scope Short description Which 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. 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. Data type CodeableConcept Binding The four anticipated uses for the Consent Resource. ConsentScopeCodes (extensible) Constraints 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
category	Σ	1..*	CodeableConceptBinding	Element id Consent.category Short description Classification 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. 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. Data type CodeableConcept Binding A classification of the type of consents found in a consent statement. ConsentCategoryCodes (extensible) Constraints 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
patient	Σ I	0..1	Reference(Patient)	Element id Consent.patient Short description Who the consent applies to Definition The patient/healthcare consumer to whom this consent applies. Comments Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person. Data type Reference(Patient) Constraints 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
dateTime	Σ	0..1	dateTime	Element id Consent.dateTime Short description When this Consent was created or indexed Definition When this Consent was issued / created / indexed. Comments This is not the time of the original consent, but the time that this statement was made or derived. Data type dateTime Constraints 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
performer	Σ I	0..*	Reference(Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole)	Element id Consent.performer Short description Who is agreeing to the policy and rules Alternate names consentor 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. 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. Data type Reference(Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole) Constraints 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
organization	Σ I	0..*	Reference(Organization)	Element id Consent.organization Short description Custodian of the consent Alternate names custodian Definition The organization that manages the consent, and the framework within which it is executed. 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. Data type Reference(Organization) Constraints 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
source[x]	Σ	0..1		Element id Consent.source[x] Short description Source 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. 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 rim: n/a v2: Field 19 Informational Material Supplied Indicator
sourceAttachment			Attachment	Data type Attachment
sourceReference			Reference(Consent \| DocumentReference \| Contract \| QuestionnaireResponse)	Data type Reference(Consent \| DocumentReference \| Contract \| QuestionnaireResponse)
policy		0..*	BackboneElement	Element id Consent.policy Short description Policies 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.policy.id Short description Unique 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. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.policy.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.policy.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. Data type Extension 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 rim: N/A
authority	I	0..1	uri	Element id Consent.policy.authority Short description Enforcement source for policy Definition Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
uri	I	0..1	uri	Element id Consent.policy.uri Short description Specific 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. Comments This element is for discoverability / documentation and does not modify or qualify the policy rules. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
policyRule	Σ I	0..1	CodeableConceptBinding	Element id Consent.policyRule Short description Regulation that this consents to Definition A reference to the specific base computable regulation or policy. 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. Data type CodeableConcept Binding Regulatory policy examples. ConsentPolicyRuleCodes (extensible) Constraints 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
verification	Σ	0..*	BackboneElement	Element id Consent.verification Short description Consent 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.verification.id Short description Unique 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. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.verification.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.verification.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. Data type Extension 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 rim: N/A
verified	Σ	1..1	boolean	Element id Consent.verification.verified Short description Has been verified Definition Has the instruction been verified. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
verifiedWith	I	0..1	Reference(Patient \| RelatedPerson)	Element id Consent.verification.verifiedWith Short description Person who verified Definition Who verified the instruction (Patient, Relative or other Authorized Person). 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. Data type Reference(Patient \| RelatedPerson) Constraints 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)
verificationDate		0..1	dateTime	Element id Consent.verification.verificationDate Short description When consent verified Definition Date verification was collected. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
provision	Σ	0..1	BackboneElement	Element id Consent.provision Short description Constraints 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.provision.id Short description Unique 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. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. Data type Extension 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 rim: N/A
type	Σ	0..1	codeBinding	Element id Consent.provision.type Short description deny \| permit Definition Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding How a rule statement is applied, such as adding additional consent or removing consent. ConsentProvisionType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
period	Σ I	0..1	Period	Element id Consent.provision.period Short description Timeframe for this rule Definition The timeframe in this rule is valid. 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. Data type Period Constraints 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"]
actor		0..*	BackboneElement	Element id Consent.provision.actor Short description Who\|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'). Meaning when missing There is no specific actor associated with the exception Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.provision.actor.id Short description Unique 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. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.actor.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.actor.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. Data type Extension 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 rim: N/A
role		1..1	CodeableConceptBinding	Element id Consent.provision.actor.role Short description How the actor is involved Definition How the individual is involved in the resources content that is described in the exception. 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. Data type CodeableConcept 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())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
reference	I	1..1	Reference(Device \| Group \| CareTeam \| Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole)	Element id Consent.provision.actor.reference Short description Resource 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'). 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. Data type Reference(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())` 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)
action	Σ	0..*	CodeableConcept	Element id Consent.provision.action Short description Actions controlled by this rule Definition Actions controlled by this Rule. 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 Data type CodeableConcept Binding Detailed codes for the consent action. ConsentActionCodes (example) Constraints 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
securityLabel	Σ	0..*	CodingBinding	Element id Consent.provision.securityLabel Short description Security 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. 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. Data type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. All Security Labels (extensible) Constraints 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
purpose	Σ	0..*	CodingBinding	Element id Consent.provision.purpose Short description Context 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. Comments When the purpose of use tag is on the data, access request purpose of use shall not conflict. Data type Coding 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) Constraints 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
class	Σ	0..*	CodingBinding	Element id Consent.provision.class Short description e.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. 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. Data type Coding Binding The class (type) of information a consent rule covers. ConsentContentClass (extensible) Constraints 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
code	Σ	0..*	CodeableConcept	Element id Consent.provision.code Short description e.g. LOINC or SNOMED CT code, etc. in the content Definition If this code is found in an instance, then the rule applies. Comments Typical use of this is a Document code with class = CDA. Data type CodeableConcept Binding If this code is found in an instance, then the exception applies. ConsentContentCodes (example) Constraints 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
dataPeriod	Σ I	0..1	Period	Element id Consent.provision.dataPeriod Short description Timeframe for data controlled by this rule Definition Clinical or Operational Relevant period of time that bounds the data controlled by this rule. Comments This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement. Data type Period Constraints 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"]
data	Σ	0..*	BackboneElement	Element id Consent.provision.data Short description Data controlled by this rule Definition The resources controlled by this rule if specific resources are referenced. Meaning when missing all data Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role
id		0..1	string	There are no (further) constraints on this element Element id Consent.provision.data.id Short description Unique 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. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.data.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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 rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.data.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. Data type Extension 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 rim: N/A
meaning	Σ	1..1	codeBinding	Element id Consent.provision.data.meaning Short description instance \| related \| dependents \| authoredby Definition How the resource reference is interpreted when testing consent restrictions. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding How a resource reference is interpreted when testing consent restrictions. ConsentDataMeaning (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
reference	Σ I	1..1	Reference(Resource)	Element id Consent.provision.data.reference Short description The actual data reference Definition A reference to a specific resource that defines which resources are covered by this consent. 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. Data type Reference(Resource) Constraints 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)
provision		0..*	see (provision)	There are no (further) constraints on this element Element id Consent.provision.provision Short description Nested Exception Rules Definition Rules which provide exceptions to the base rule or subrules.

FHIR	MDS	HL7v2
Consent.sourceAttachment	RoD - Record of discussion form - copy attached	CON-19 (for OML, included in RoD, referenced from NTE-3)
Consent.status	RoD - Patient conversation taken place, ROD form to follow	Inferred through CON-19 value (for OML, included in RoD, referenced from NTE-3)

status

SHALL be present. 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"
            }
        ]
    },

patient

SHALL be present. Reference to the associated Patient. This MAY be through a resource reference if the ID on the central service is known (or provided within the transaction bundle) or through NHS number where this is known and has been traced through PDS.

"subject": {
        "reference": "Patient/Patient-MeirLieberman-Example",
        "identifier": {
            "system": "https://fhir.nhs.uk/Id/nhs-number",
            "value": "9449307873"
        }
    },

source[x]

SHALL be present for RoD entities. 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"
        }
    ]

provision

Used to reference the ServiceRequest the Consent applies to. SHALL be present where the consent only applies to a specific test.

"provision": {
        "data": [
            {
                "meaning": "instance",
                "reference": { 
                    "reference":  "ServiceRequest/ServiceRequest-WGSTestOrderForm-Example"
                }
            }
        ]
    }