European Health Data Space Regulation

European Commission

Health data
Policy type icon
Regulative proposal
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Private and public sector

Policy overview

The European Health Data Space Regulation (EHDSR) proposal, published on May 3, 2022, is presently in the midst of the legislative process. Once the Regulation enters into force, it will stand as the most significant piece of European Union legislation governing health data. The implementation of EHDS regulation seeks to improve patient rights concerning their health data and enhance accessibility to electronic health data repositories, fostering improved utilisation for individuals as well as the wider population. This initiative regulates both the primary and secondary data usage and builds upon the principles of the General Data Protection Regulation (GDPR) and the NIS 2 Directive.

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