{ "resourceType": "StructureDefinition", "id": "NHSEngland-Consent-GenomicsPCF", "url": "https://fhir.nhs.uk/StructureDefinition/NHSEngland-Consent-GenomicsPCF", "version": "0.3.0", "name": "NHSEngland_Consent_GenomicsPCF", "title": "NHSEngland Consent GenomicsPCF", "status": "active", "date": "2026-04-16", "publisher": "NHS England", "contact": [ { "name": "NHS England", "telecom": [ { "system": "email", "value": "interoperabilityteam@nhs.net", "use": "work", "rank": 1 } ] } ], "description": "This profile defines the Genomics constraints and extensions on the Privacy and Consent on FHIR FHIR resource [Intermediate Consent](https://profiles.ihe.net/ITI/PCF/StructureDefinition/IHE.PCF.consentIntermediate).", "purpose": "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.\r\n\r\nOnly a minimal amount of mandatory information needs to be populated for Order Management recording of RoDs.", "copyright": "Copyright © 2026+ NHS England Licensed under the Apache License, Version 2.0 (the \\\\\\\"License\\\\\\\"); you may not use this file except in compliance with the License. You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an \\\\\\\"AS IS\\\\\\\" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License. HL7® FHIR® standard Copyright © 2011+ HL7 The HL7® FHIR® standard is used under the FHIR license. You may obtain a copy of the FHIR license at https://www.hl7.org/fhir/license.html.", "fhirVersion": "4.0.1", "kind": "resource", "abstract": false, "type": "Consent", "baseDefinition": "https://profiles.ihe.net/ITI/PCF/StructureDefinition/IHE.PCF.consentIntermediate", "derivation": "constraint", "differential": { "element": [ { "id": "Consent.status", "path": "Consent.status", "definition": "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)." }, { "id": "Consent.scope.coding", "path": "Consent.scope.coding", "slicing": { "discriminator": [ { "type": "pattern", "path": "$this" } ], "rules": "open" } }, { "id": "Consent.scope.coding:codingGenomics", "path": "Consent.scope.coding", "sliceName": "codingGenomics", "definition": "For WGS RoD this SHALL be fixed to the below code:" }, { "id": "Consent.scope.coding:codingGenomics.system", "path": "Consent.scope.coding.system", "fixedUri": "http://terminology.hl7.org/CodeSystem/consentscope" }, { "id": "Consent.scope.coding:codingGenomics.code", "path": "Consent.scope.coding.code", "fixedCode": "patient-privacy" }, { "id": "Consent.scope.coding:codingGenomics.display", "path": "Consent.scope.coding.display", "fixedString": "Privacy Consent" }, { "id": "Consent.category", "path": "Consent.category", "slicing": { "discriminator": [ { "type": "pattern", "path": "$this" } ], "rules": "open" } }, { "id": "Consent.category:categoryRoD", "path": "Consent.category", "sliceName": "categoryRoD", "definition": "Fixed to `http://terminology.hl7.org/CodeSystem/v3-ActCode|RESEARCH (research information access)` for Order Management Consent for NGRL/RoD.", "max": "1", "fixedCodeableConcept": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v3-ActCode", "code": "RESEARCH", "display": "research information access" } ] } }, { "id": "Consent.category:categoryUGRDataAccess", "path": "Consent.category", "sliceName": "categoryUGRDataAccess", "definition": "Fixed to `http://terminology.hl7.org/CodeSystem/v3-ActCode|INFA (information access)` for providing access to the patient's UGR for specific purposes, as described by the UGR lenses below.", "max": "1", "fixedCodeableConcept": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v3-ActCode", "code": "INFA", "display": "information access" } ] } }, { "id": "Consent.category:categoryUGRDataSharing", "path": "Consent.category", "sliceName": "categoryUGRDataSharing", "definition": "Fixed to `http://terminology.hl7.org/CodeSystem/v3-ActCode|IDSCL (information disclosure)` for providing access to a relative's healthcare professional, to inform their care, e.g. in the case of familial/cascade testing.", "max": "1", "fixedCodeableConcept": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v3-ActCode", "code": "IDSCL", "display": "information disclosure" } ] } }, { "id": "Consent.patient", "path": "Consent.patient", "definition": "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.", "type": [ { "code": "Reference", "targetProfile": [ "https://fhir.nhs.uk/StructureDefinition/NHSEngland-Patient-Genomics", "http://hl7.org/fhir/StructureDefinition/Patient" ], "aggregation": [ "referenced", "bundled" ] } ] }, { "id": "Consent.dateTime", "path": "Consent.dateTime", "definition": "SHALL be the time the Consent record was created. For UGR Consent, likely auto-populated by the system." }, { "id": "Consent.performer", "path": "Consent.performer", "definition": "MAY reference a RelatedPerson/Patient or potentially PractitionerRole if consent is being provided via another individual e.g. a proxy, otherwise SHOULD reference the patient themself", "type": [ { "code": "Reference", "targetProfile": [ "https://fhir.nhs.uk/StructureDefinition/NHSEngland-PractitionerRole-Genomics", "http://hl7.org/fhir/StructureDefinition/Organization", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ], "aggregation": [ "referenced", "bundled" ] } ] }, { "id": "Consent.organization", "path": "Consent.organization", "slicing": { "discriminator": [ { "type": "pattern", "path": "$this" } ], "rules": "open" } }, { "id": "Consent.organization:organizationUGR", "path": "Consent.organization", "sliceName": "organizationUGR", "definition": "SHALL be fixed to the ODS code for NHS England (X26) as this is the managing organisation for the UGR consents.", "max": "1", "fixedReference": { "identifier": { "system": "https://fhir.nhs.uk/Id/ods-organization-code", "value": "X26" } } }, { "id": "Consent.source[x]", "path": "Consent.source[x]", "definition": "SHALL be present for RoD entities (where the Consent resource provides metadata wrapping around a [Record of Discussion Form](https://www.england.nhs.uk/publication/nhs-genomic-medicine-service-record-of-discussion-form/). The Source element MAY either be:\r\nA pointer to the location of the PDF version of the RoD, either hosted by the source/client system\r\nAccessed via NRL (via a DocumentReference resource)\r\nEmbedded within the message payload, base64 encoded (using sourceAttachment)\r\nA reference to a QuestionnaireResponse resource (using sourceReference), if this has been collected in a structured format, using the Questionnaire-Genomic Testing RoD template.\r\n\r\nNot relevant for UGR consent resources as this is generated automatically on creation of a UGR, though IHE PCF requires a reference or attachment. This MAY be a reference to a QuestionnaireResponse representing the patients consent selections, e.g. via the NHS App." }, { "id": "Consent.policy", "path": "Consent.policy", "slicing": { "discriminator": [ { "type": "pattern", "path": "$this" } ], "rules": "open" } }, { "id": "Consent.policy:policyRoD", "path": "Consent.policy", "sliceName": "policyRoD" }, { "id": "Consent.policy:policyRoD.authority", "path": "Consent.policy.authority", "fixedUri": "https://www.england.nhs.uk" }, { "id": "Consent.policy:policyRoD.uri", "path": "Consent.policy.uri", "fixedUri": "https://www.england.nhs.uk/publication/nhs-genomic-medicine-service-record-of-discussion-form" }, { "id": "Consent.policy:policyUGR", "path": "Consent.policy", "sliceName": "policyUGR", "definition": "MAY be used to reference the NHS England Privacy Policy" }, { "id": "Consent.policy:policyUGR.uri", "path": "Consent.policy.uri", "fixedUri": "https://www.england.nhs.uk/wp-content/uploads/2018/05/nhs-england-privacy-notice-v1.77.pdf" }, { "id": "Consent.provision", "path": "Consent.provision", "definition": "Within Order Management used to reference the ServiceRequest the Consent applies to. SHALL be present where the consent only applies to a specific test.\r\n\r\nIn the context of the UGR, the top level `type` SHOULD represent the patient's overall consent to use of their data e.g. as indicated via their National Data Opt-Out selection. Sub-level `provision` elements SHOULD be used to represent exceptions to the higher level provision, though MAY be used to explicitly permit usage of data for specific purposes, where the higher-level provision is of type 'permit'. " }, { "id": "Consent.provision.data:iData", "path": "Consent.provision.data", "sliceName": "iData" }, { "id": "Consent.provision.data:iData.reference", "path": "Consent.provision.data.reference", "type": [ { "code": "Reference", "targetProfile": [ "https://fhir.nhs.uk/StructureDefinition/NHSEngland-ServiceRequest-Genomics", "http://hl7.org/fhir/StructureDefinition/Resource" ], "aggregation": [ "referenced", "bundled" ] } ] }, { "id": "Consent.provision.provision", "path": "Consent.provision.provision", "slicing": { "discriminator": [ { "type": "pattern", "path": "$this" } ], "rules": "open" } }, { "id": "Consent.provision.provision:provisionUGR", "path": "Consent.provision.provision", "sliceName": "provisionUGR" }, { "id": "Consent.provision.provision:provisionUGR.type", "path": "Consent.provision.provision.type", "min": 1 }, { "id": "Consent.provision.provision:provisionUGR.period", "path": "Consent.provision.provision.period", "max": "0" }, { "id": "Consent.provision.provision:provisionUGR.actor", "path": "Consent.provision.provision.actor", "definition": "MAY be used to specify a class of individuals included within the consent statement, e.g. access for direct care by healthcare professionals, or for individuals, e.g. access to patient proxy." }, { "id": "Consent.provision.provision:provisionUGR.action", "path": "Consent.provision.provision.action", "max": "0" }, { "id": "Consent.provision.provision:provisionUGR.securityLabel", "path": "Consent.provision.provision.securityLabel", "max": "0" }, { "id": "Consent.provision.provision:provisionUGR.purpose", "path": "Consent.provision.provision.purpose", "slicing": { "discriminator": [ { "type": "value", "path": "code" } ], "rules": "open" }, "definition": "SHALL be used for encoding the four lenses of data access", "min": 1, "binding": { "strength": "required" } }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeDirectCare", "path": "Consent.provision.provision.purpose", "sliceName": "purposeDirectCare", "max": "1" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeDirectCare.system", "path": "Consent.provision.provision.purpose.system", "min": 1, "fixedUri": "http://terminology.hl7.org/CodeSystem/v3-ActReason" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeDirectCare.code", "path": "Consent.provision.provision.purpose.code", "min": 1, "fixedCode": "TREAT" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeResearch", "path": "Consent.provision.provision.purpose", "sliceName": "purposeResearch", "max": "1" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeResearch.system", "path": "Consent.provision.provision.purpose.system", "min": 1, "fixedUri": "http://terminology.hl7.org/CodeSystem/v3-ActReason" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeResearch.code", "path": "Consent.provision.provision.purpose.code", "min": 1, "fixedCode": "HRESCH" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposePopulationHealth", "path": "Consent.provision.provision.purpose", "sliceName": "purposePopulationHealth", "max": "1" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposePopulationHealth.system", "path": "Consent.provision.provision.purpose.system", "min": 1, "fixedUri": "http://terminology.hl7.org/CodeSystem/v3-ActReason" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposePopulationHealth.code", "path": "Consent.provision.provision.purpose.code", "min": 1, "fixedCode": "POPHLTH" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeManagementInformation", "path": "Consent.provision.provision.purpose", "sliceName": "purposeManagementInformation", "max": "1" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeManagementInformation.system", "path": "Consent.provision.provision.purpose.system", "min": 1, "fixedUri": "http://terminology.hl7.org/CodeSystem/v3-ActReason" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeManagementInformation.code", "path": "Consent.provision.provision.purpose.code", "min": 1, "fixedCode": "HOPERAT" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeFamilyLinkage", "path": "Consent.provision.provision.purpose", "sliceName": "purposeFamilyLinkage", "max": "1" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeFamilyLinkage.system", "path": "Consent.provision.provision.purpose.system", "min": 1, "fixedUri": "http://terminology.hl7.org/CodeSystem/v3-ActReason" }, { "id": "Consent.provision.provision:provisionUGR.purpose:purposeFamilyLinkage.code", "path": "Consent.provision.provision.purpose.code", "min": 1, "fixedCode": "FAMRQT" }, { "id": "Consent.provision.provision:provisionUGR.class", "path": "Consent.provision.provision.class", "definition": "MAY be used to indicate the classes of data the provision applies to, where whole classes of data, e.g. DiagnosticReports, are consented to, rather than specific instances. " }, { "id": "Consent.provision.provision:provisionUGR.code", "path": "Consent.provision.provision.code", "max": "0" }, { "id": "Consent.provision.provision:provisionUGR.dataPeriod", "path": "Consent.provision.provision.dataPeriod", "max": "0" }, { "id": "Consent.provision.provision:provisionUGR.data", "path": "Consent.provision.provision.data", "definition": "SHOULD be used where the consent applies to specific instances of data, such as a single report or sequence.\r\n\r\n`data.meaning` MAY use any of the codes specified in the [consent-data-meaning ValueSet](https://www.hl7.org/fhir/R4/valueset-consent-data-meaning.html), as data may not be useful in isolation, e.g. a report without the referenced observations. However, the `authoredBy` code is not expected to be used for the UGR." } ] } }