The proposal provides a uniform basis for secondary research and clarifies uncertainty over implementation and interpretation of the GDPR but also raises many questions.
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.
Among other goals, the Regulation aims to facilitate secondary use of clinical data for research purposes by requiring “data holders” to make data available and enabling “data users” to access that data in secure processing environments and based on permits issued by “health data access bodies”.
Read the full article that focuses on secondary processing and the issues that the Commission’s proposals raise.