EU: Impact of proposed European Health Data Space Regulation on use of health data for secondary research

On May 3 2022, the European Commission issued its proposal for a Proposal for a Regulation of the European Parliament and of the Council on the European Health Data Space (“the Draft Regulation”). At a high level, the Draft Regulation – which is expected to come into force in 2025– seeks to: (i) provide individuals with increased control over, and access to, their electronic health data (“EHD”); (ii) enable the secure cross-border sharing of such EHD between national EU healthcare systems; and (iii) facilitate the trustworthy and secure sharing of EHD for secondary research purposes. Read here as Sidley's William RM Long, Francesca Blythe, and Zina Chatzidimitriadou discuss certain key issues presented by the Draft Regulation, such as what data qualifies as EHD and the international data transfers.