• EU Monitor  7 December 2023

Digital 

 

EUCOPE calls for legislative finetuning of the EHDS 

Following last week’s Committee adoption of the European Health Data Space (EHDS) report in the European Parliament, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) issued a  joint statement  to alert on the significant legislative shortcomings and uncertainties in the proposed Regulation for a European Health Data Space. EUCOPE argues that there remain serious legislative problems with the EHDS, which is now being fast-tracked through both the European Parliament and Council, which could ultimately pose risks for the protection of patient data as well as health research collaborations. The organisation notably calls for setting clear and coherent definitions of terms such as “data holder”, clarifying its interaction with other legal frameworks (e.g., General Data Protection Regulation (GDPR), and specifying the scope of electronic health data categories for secondary use, amongst others.

 

 

 

 

 

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