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:
- create new patient rights over their electronic health data, and sets out rules regarding use of electronic health data for primary care;
- establishes a pre-market conformity assessment requirement for electronic health record systems (“EHR systems”);
- sets out rules that apply to digital health services and wellness apps; and
- introduces a harmonized scheme for providing access to electronic health data for secondary use.