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. Consent for Data Access as part of the UGR SHOULD follow guidance provided within Consent guidance page and the IHE PCF Framework.

Only a minimal amount of mandatory information needs to be populated for Order Management recording of RoDs.

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
extensionC0..*Extension
modifierExtension?! C0..*Extension
identifierΣ0..*Identifier
statusΣ ?!1..1codeBinding
scopeΣ ?!1..1CodeableConceptBinding
categoryΣ1..*CodeableConceptBinding
patientΣ C0..1Reference(Patient)
dateTimeΣ0..1dateTime
performerΣ C0..*Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
organizationΣ C0..*Reference(Organization)
sourceAttachmentAttachment
sourceReferenceReference(Consent | DocumentReference | Contract | QuestionnaireResponse)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
authorityC0..1uri
uriC0..1uri
policyRuleΣ C0..1CodeableConceptBinding
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
verifiedΣ1..1boolean
verifiedWithC0..1Reference(Patient | RelatedPerson)
verificationDate0..1dateTime
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
typeΣ0..1codeBinding
periodΣ C0..1Period
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
role1..1CodeableConceptBinding
referenceC1..1Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)
actionΣ0..*CodeableConcept
securityLabelΣ0..*CodingBinding
purposeΣ0..*CodingBinding
classΣ0..*CodingBinding
codeΣ0..*CodeableConcept
dataPeriodΣ C0..1Period
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
meaningΣ1..1codeBinding
referenceΣ C1..1Reference(Resource)
provision0..*see (provision)


FHIRMDSHL7v2
Consent.sourceAttachmentRoD - Record of discussion form - copy attachedCON-19 (for OML, included in RoD, referenced from NTE-3)
Consent.statusRoD - Patient conversation taken place, ROD form to followInferred through CON-19 value (for OML, included in RoD, referenced from NTE-3)

Additional Guidance

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"
            }
        ]
    },

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"
                }
            ]
        }
    ],

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"
                }
            }
        ]
    }