The Logging Component of the European Health Data Space (EHDS) Regulation: A Technical Perspective

Abstract

Increasingly, across geographies, citizens are requiring access to and control of their health data. This paper examines the "Logging Component" proposed by the European Health Data Space (EHDS) regulation and its crucial role in facilitating secure and transparent access to electronic health records (EHR) and health data. We analysed the proposal for the five elements of the Logging Component (LC): identification of data accessors, identification of data subjects, categorisation of accessed data, temporal logging, and data origin tracking. Explored how these elements contribute towards enhanced accountability and compliance in health data management. We experimented with distributed ledger technology (DLT) to support the "data origin tracking element", reaching the demonstration level which can be presented. We used hybrid DLT to develop a system for immutable storage of access logs, and for using smart contracts to maintain a self-governing decentralised access control list (ACL) directly integrated with EHR and PHR systems. We found that the LC is more than a regulatory requirement. It can serve as a framework for the integration of advanced technologies, e.g. DLT and others, increasingly mature and potentially foundational to building new networks of trust among stakeholders, while ensuring data privacy in cross-border and intra-border healthcare scenarios. The study also identified shortcomings of the LC, such as the absence of "purpose logging", which was conceptualised and proposed. This study contributes to the understanding of how logging mechanisms can enhance transparency and accountability in electronic health record systems within the European healthcare landscape, but with potential usefulness for the "Global EHR". In conclusion, our findings suggest that the successful implementation of the five elements of the Logging Component are mandatory and can benefit from mature advance technologies, but the sixth element proposed by us would be critical for achieving the EHDS's broader objectives of harmonised health data sharing in Europe and beyond while maintaining robust security standards.