On 3 May 2022, the European Commission launched its proposal for a Regulation for the European Health Data Space to “unleash the full potential of health data”. However, questions arise as to whether this proposal is a welcome facilitator of innovation or another burden for research-focussed businesses.

The stated goals of the Regulation are threefold:

..supporting individuals in taking control of their own health data;

..supporting the use of health data for better healthcare delivery, research, innovation, and policy-making; and

..enabling the EU to make full use of the potential from a safe and secure exchange, use and reuse of health data.