Leveraging Distributed Ledger Technology for Patient Opt-Out Management in the Context of the European Health Data...

Area of Science:

• Health Informatics
• Blockchain Technology
• Regulatory Science

Background:

• The European Health Data Space (EHDS) Regulation grants patients the right to opt-out of the secondary use of their health data.
• Current implementations struggle with fragmented registries and inadequate tamper-proof mechanisms for managing patient opt-out preferences.
• Effective patient-centric governance is crucial for secondary health data utilization.

Purpose of the Study:

• To propose and develop a novel distributed ledger technology (DLT)-based architecture for enhancing patient opt-out management within the EHDS framework.
• To address the limitations of current fragmented registries and weak tamper-proof systems.
• To ensure compliance with EHDS requirements for data integrity and patient control.

Main Methods:

• Conducted design research and regulatory analysis of the EHDS and the TEHDAS framework.
• Developed a proof-of-concept utilizing permissioned DLT, smart contracts, and decentralized identifiers.
• Focused on creating an immutable registry for robust opt-out management.

Main Results:

• A DLT-based architecture was successfully developed as a proof-of-concept.
• The proposed system provides an immutable registry for managing patient opt-out preferences.
• The architecture demonstrates alignment with EHDS requirements for tamper-evident audit trails and cross-border verification.

Conclusions:

• The DLT-based architecture offers a viable solution for enhancing patient opt-out management under the EHDS Regulation.
• This approach strengthens patient-centric governance and data security for secondary health data use.
• The developed system bridges regulatory mandates with practical, technologically advanced patient data control mechanisms across the EU.