A Blockchain-Based Architecture for Dynamic and Auditable Patient Consent in Secondary Use of Health Data

Area of Science:

• Health Informatics
• Blockchain Technology
• Data Privacy

Background:

• Secondary use of patient health data is vital for research and innovation.
• Traditional consent models lack transparency and patient control.
• GDPR and EHDS necessitate improved consent management for health data.

Purpose of the Study:

• Design a secure, transparent, and revocable blockchain architecture for health data consent.
• Ensure alignment with European legal frameworks and interoperability standards.
• Enhance patient autonomy and trust in health data sharing.

Main Methods:

• Developed a multilayered architecture integrating blockchain, DIDs, VCs, and HL7-FHIR.
• Implemented a patient-controlled digital wallet and off-chain data storage.
• Utilized smart contracts for on-chain consent policy enforcement and derived requirements from GDPR/EHDS.

Main Results:

• Enabled secure, immutable logging of consent creation, delegation, and revocation.
• Ensured tamper-evident consent records with off-chain sensitive data storage.
• Modeled consent attributes (purpose, duration, scope) for GDPR/EHDS compliance, with theoretical scalability on Ethereum.

Conclusions:

• Presents a modular, standards-based framework for dynamic health data consent management.
• Enhances patient autonomy, regulatory compliance, and governance for secondary data use.
• Addresses key legal and technical challenges through blockchain, digital identity, and interoperability standards.