On May 3, 2022, the European Commission published its proposal for a regulation on the “European Health Data Space”.

The EHDS is a talismanic European healthtech initiative that could revolutionize access to a deeper pool of EU-wide health data and unlock significant tech, AI and data analytics innovation.  As a core part of the Commission’s European Data Strategy, the EHDS seeks to tackle legacy systemic issues that have hindered lawful access to electronic health data.  The Regulation strives to create a “European Health Union” by strengthening individuals’ access to and portability of their electronic health data and allowing innovators and researchers to process this data through reliable and secure mechanisms.  It is worth noting that the EHDS proposal does not to create (nor could it feasibly do so) a unitary central EU database of electronic health data, but seeks to facilitate multilateral exchange of such health data from decentralized databases through the EHDS’s regulatory infrastructure.

The EHDS proposal builds upon other recent and contemporaneous EU data and healthcare reforms, such as Regulation (EU) 2017/745 on medical devices, the proposed AI Act, the Data Governance Act, and the proposed Data Act.  It presents a welcome opportunity to resolve areas of uncertainty as to the lawful bases for health data processing under Regulation (EU) 2016/679 and fragmented Member State national laws that might otherwise inhibit “big data” innovation in the European healthcare sector.  However, work remains to be done to reconcile areas of legislative interplay and ensure that data subjects’ GDPR rights remain protected.

Please click here to read the full alert memorandum.