Legal Aspects of Data Sharing in the European Health Data Space

Abstract

This article explores the legal framework for data sharing established by the European Health Data Space Regulation (EHDS), the European Union’s first sector-specific data space initiative. The study critically examines the legal implications of the EHDS’s mandatory data sharing mechanism, which aims to address structural imbalances in the data economy by compelling both public and private data holders to grant access to electronic health data. The article analyses the EHDS’s data access model and contrasts it with traditional data contracts governed by private law. Key legal challenges are identified, including the ambiguous scope of the general interest of society, the limitations of data holders’ autonomy and the lack of established legal concepts for electronic data. The author argues that while the EHDS offers significant benefits, such as a unified dataset catalogue and enhanced access to health data for research and innovation, it also raises concerns about legal clarity, liability allocation, and investment incentives. The article concludes that further harmonisation and clarification are necessary to ensure legal certainty and market trust in the evolving European data economy.