Kristof Van Quathem, Sam Jungyun Choi, and Anna Oberschelp de Meneses of Covington and Burling write:
On March 3, 2022, a leaked version of the proposal for a regulation setting up the European Health Data Space was published. The draft regulation will set up a common framework across EU Member States for the sharing and exchange of quality health data (such as electronic health records, patient registries and genomic data). The European Commission has not yet released an official version of the proposal. It is expected to do so on May 3.
The leaked proposal is a lengthy document (126 pages, excluding annexes) that contains within it a number of different sets of rules. Key requirements that are likely to be of interest to organizations in the life sciences sector are that the draft regulation proposes to:
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