Lexology January 24, 2025
Freshfields

After long debates between the Commission, Parliament and the Council, the Council has adopted the regulation of the European Health Data Space (EHDS). Given the controverse debates around certain aspects, the final version of the EHDS includes several twists compared to the Commission’s initial proposal dating back to 3 May 2022 (see our analysis of the initial proposal here). From further strengthening patient’s rights to tightening obligations for manufacturers, some of the changes are rather significant.

Key goals of the EHDS

As we have described in more detail in our previous analysis, the EHDS has the overarching goal to improve individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for...

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