Universal API Implementation Guide
1.1.20 - ci-build

Universal API Implementation Guide - Local Development build (v1.1.20) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Release 2026 Sep 04

Announcements


  • The Genentech Access Solutions Universal Patient Consent form has been updated to capture Patient HIPAA Consent, which now requires a patient signature. New Patient Consent version M-US-00002802(v4.0).
  • New (Patient) Consent Resource: To support this update, a new Consent Resource containing the "Patient HIPAA Consent" has been added to the "Consent Only" and "Enrollment + Consent" patient bundles.
  • New (Patient) Provenance Resource: A new Provenance Resource containing the captured image of the enrolled patient's signature has also been added to these same bundles.
  • Current Form Validity: The existing Universal Patient Consent form (M-US-00002802(v3.0)) remains valid until May 31, 2027.
  • Legacy Bundle Acceptance: "Consent only" and "Enrollment + Consent" bundles submitted without the new Consent and Provenance resources will also be accepted until May 31, 2027.

Updated Mapping for Patient Consent & New Patient Provenance

Refer to the Enrollment Mapping page for complete Patient & Prescriber Consent & Provenance resource mapping.


Provenance Resource for PATIENT (NEW)

Field Name Enrollment Type Resource-ElementID Business Rules/Format Accepted Values
Agent Required for both AS & Patient Foundation Provenance.agent.who.reference
Provenance.agent.who.type		 The reference uuid should point to either the Patient or RelatedPerson "type" value will be "Patient" or
"RelatedPerson"

"who": [{ "reference" : "urn:uuid:047fc715-b22b-2756-beec-e2ee83c33b3e"
"type": "Patient"
Target Required for both AS & Patient Foundation Provenance.target.reference The reference uuid should point to the Consent resource (for "Patient HIPAA Consent") "target" : [{"reference" : "urn:uuid:0a157840-f8a6-4e48-90d1-1252c49d6261"
"type" : "Consent"
Who Signed Required for both AS & Patient Foundation Provenance.signature.who.reference
Provenance.signature.who.type		 The reference uuid should point to either the Patient or RelatedPerson "who" : {"reference" : "urn:uuid:1b315218-49b7-4264-816e-05d4b92ecbaa",
"type" : "Patient"



Consent Resource for Patient HIPAA Consent (NEW)

Purpose Resource-ElementID Business Rules/Format Accepted Values
Category Consent.category.coding.code Consent.category.coding.display Indicate what type of consent or signature type is being provided:

-Patient Authorization Signature (REQUIRED)

- Patient HIPAA Consent (REQUIRED)		 code: "59284-0"
display: "Patient Authorization Signature"

code: "59284-0"
display: "Patient HIPAA Consent"
Performer Consent.performer The reference uuid should point to either the Patient or RelatedPerson value will be "Patient" or
"RelatedPerson"

"performer": [{ "reference": "urn:uuid:047fc715-b22b-2756-beec-e2ee83c33b3e",
"type": "Patient"


When to Include Consent & Provenance Resources

The table below outlines when the Consent and Provenance resources should be included in bundles:

Resource Consent Only Enrollment + Consent
(No Prescriber Sig)		 Enrollment + Consent
(Needs Prescriber Sig)		 Enrollment Only
(No Prescriber Sig)		 Enrollment Only
(Needs Prescriber Sig)
Patient Consent: Patient Authorization Signature Required Required Required - -
Patient Consent: Patient HIPAA Consent (NEW) Required Required Required - -
Patient Provenance: Consent Signature (NEW) Required Required Required - -
Prescriber Provenance - - Required - Required
Prescriber Consent: Signature - - Required - Required



Example of New Patient HIPAA Consent Resource

{
      "fullUrl" : "urn:uuid:0a157840-f8a6-4e48-90d1-1252c49d6261",
      "resource" : {
        "resourceType" : "Consent",
        "id" : "0a157840-f8a6-4e48-90d1-1252c49d6261",
        "meta" : {
          "profile" : [
            🔗 "https://fhir.developer.gene.com/StructureDefinition/uapi-consent"
          ]
        },
        "status" : "active",
        "scope" : {
          "coding" : [
            {
              "system" : "http://terminology.hl7.org/CodeSystem/consentscope",
              "code" : "patient-privacy",
              "display" : "Privacy Consent"
            }
          ]
        },
        "category" : [
          {
            "coding" : [
              {
                "system" : "http://loinc.org",
                "code" : "59284-0",
                "display" : "Patient HIPAA Consent"
              }
            ]
          }
        ],
        "patient" : {
          "reference" : "urn:uuid:1b315218-49b7-4264-816e-05d4b92ecbaa",
          "type" : "Patient"
        },
        "dateTime" : "2026-09-02T16:24:45Z",
        "performer" : [
          {
            "reference" : "urn:uuid:1b315218-49b7-4264-816e-05d4b92ecbaa",
            "type" : "Patient"
          }
        ],
        "policyRule" : {
          "coding" : [
            {
              "system" : "http://terminology.hl7.org/CodeSystem/consentpolicycodes",
              "code" : "hipaa-auth",
              "display" : "HIPAA Authorization"
            }
          ]
        },
        "provision" : {
          "type" : "permit"
        }
      }
    }


Ocrevus BIPA Enrollment+Consent
Itovebi GPF Enrollment+Consent


Example New Patient Provenance Resource

 {
      "fullUrl" : "urn:uuid:5e524c9f-48f2-4fa1-98c1-8b8ece1c0178",
      "resource" : {
        "resourceType" : "Provenance",
        "id" : "5e524c9f-48f2-4fa1-98c1-8b8ece1c0178",
        "meta" : {
          "profile" : [
            🔗 "https://fhir.developer.gene.com/StructureDefinition/uapi-provenance"
          ]
        },
        "target" : [
          {
            "reference" : "urn:uuid:0a157840-f8a6-4e48-90d1-1252c49d6261",
            "type" : "Consent"
          }
        ],
        "recorded" : "2026-09-02T09:49:39.382941+00:00",
        "agent" : [
          {
            "who" : {
              "reference" : "urn:uuid:1b315218-49b7-4264-816e-05d4b92ecbaa",
              "type" : "Patient"
            }
          }
        ],
        "signature" : [
          {
            "type" : [
              {
                "system" : "urn:iso-astm:E1762-95:2013",
                "code" : "1.2.840.10065.1.12.1.7",
                "display" : "Consent Signature"
              }
            ],
            "when" : "2024-04-02T09:49:39.382897+00:00",
            "who" : {
              "reference" : "urn:uuid:1b315218-49b7-4264-816e-05d4b92ecbaa",
              "type" : "Patient"
            },
            "sigFormat" : "image/*",
            "data" : "bQ=="
          }
        ]
      }
    }