HL7 FHIR consent for healthcare data sharing: challenges, opportunities and integrity implications

OBJECTIVE: To assess whether HL7 FHIR Consent, as currently specified and deployed, is sufficient to support verifiable, regulation-aligned consent governance in distributed and cross-organisational health data sharing. METHODS: We conducted a qualitative critical analysis of FHIR Consent informed by (i) peer-reviewed implementation literature, (ii) national-scale consent exchange initiatives, and (iii) accountability requirements under GDPR and the European Health Data Space (EHDS). The analysis is organized into four dimensions: semantic interpretability, consent lifecycle management, runtime enforcement, and cross-organisational trust/auditability. RESULTS: FHIR Consent provides an interoperable representation of authorisation intent, but large-scale deployments remain limited by (1) non-canonical semantics across implementations, (2) lack of standardized lifecycle versioning and cross-organisational revocation propagation, (3) heterogeneous translation of declarative consent into enforceable access control, and (4) limited capability for independent verification of consent provenance and historical integrity across institutional boundaries. CONCLUSION: We derive an architecture pattern that separates (a) standards-based consent representation (FHIR Consent), (b) local policy interpretation/enforcement, and (c) cross-organisational integrity verification. Cryptographic integrity anchoring is discussed as a complementary mechanism for tamper-evident verification of off-chain consent artifacts and lifecycle events, without externalizing consent semantics or personal data.