On 3 May 2022, the European Commission presented the proposal for a European Health Data Space Regulation (EHDS),(1) which is intended to set up a common framework across EU member states for the sharing and exchange of health data, such as patients' health records. It will address health-specific challenges to electronic health data access and sharing, and is a priority of the European Commission in the area of health.

The EHDS aims to create a common space where people can easily control their electronic health data and will make it possible for researchers, innovators and policy makers to use this data in a trusted and secure way that preserves privacy.

It remains to be seen whether the EDHS will truly lead to an improved healthcare delivery and better health research and innovation, and whether it will be aligned with existing EU legislation, such as the EU Medical Device Regulation(2) and the EU General Data Protection Regulation.(3)

For further information on this topic please contact Malte Scheel or Tobias Maier at Eversheds Sutherland LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland LLP website can be accessed at www.eversheds-sutherland.com.


(1) COM/2022/197 final.

(2) (EU) 2017/745.

(3) (EU) 2016/679.