Blockchain-Enabled Consent Management in FHIR-Compliant Oncology Platforms

Abstract

Oncology care and research demand robust patient consent management to balance data sharing with privacy. This article explores a theoretical framework for implementing blockchain-based patient consent management within FHIR-compliant oncology platforms. The proposed approach integrates distributed ledger technology (using frameworks such as Hyperledger Fabric and Ethereum) with HL7 FHIR standards (including SMART on FHIR for authorization) to create a tamper-proof, interoperable consent system. We describe how patient consent directives can be recorded as smart contracts or transactions on a blockchain while remaining aligned with FHIR's Consent resource, enabling seamless data exchange across clinical and research systems. We discuss technical integration points, such as using OAuth2 (SMART on FHIR) for patient-facing consent apps and leveraging blockchain to serve as a decentralized consent registry. Key issues are examined, notably interoperability (ensuring compatibility with existing health IT and standards), privacy (protecting patient data and complying with regulations), patient empowerment (giving patients greater control and transparency), and alignment with national/international healthcare data standards and policies. Real-world examples from current literature are cited to substantiate the feasibility and advantages of this approach. The analysis indicates that a blockchain-enabled consent management system could enhance trust, security, and patient-centric control in oncology data sharing, though challenges in scalability, governance, and regulatory acceptance remain.