Multi-Stakeholder Contract Governance for Medical Data Access Using Distributed Ledgers

Abstract

Abstract—The secure and controlled access to medical data is a critical challenge in modern clinical research. Regulatory frameworks such as the GDPR and the EU AI Act impose strict requirements on data access, privacy, and transparency, making conventional data-sharing processes inefficient and administratively burdensome. Our proposed HyperAccess platform aims to digitise and streamline the contractual access management of medical data through Hyperledger Fabric, an enterprise-grade, permissioned blockchain framework. The project introduces a semi-automated access control system that minimizes administrative efforts while maximizing trust among stakeholders, including data holders, data owners, and data users. By employing exclusive channels on Hyperledger Fabric, only stakeholders involved in an agreement are part of the dedicated channel. This paper presents the design principles, technological framework, and potential impact of HyperAccess on multicentre clinical research, offering a scalable, privacypreserving, and practically validated solution through an initial prototypical implementation.