The European Health Data Space (EHDS) Regulation aims to provide a consistent framework for secondary use of data keeping the right balance between safeguarding the privacy of citizens and unlocking the value of data to benefit society.

The text proposes an “opt-out”, which consists of the right for data subjects to opt-out from the secondary use of their personal electronic health data within the EHDS framework. In this paper, EFPIA highlights key challenges and suggestions that should be taken into account when implementing the opt-out mechanism in EU Member States. In particular, EFPIA stresses the importance of avoiding fragmentation and bias, clarifying the scope of the opt-out by limiting it to personal data and creating a centralised system for the exercise of the opt-out.

This is with a view to ensuring an appropriate balance between individuals’ privacy and access to high quality, unfragmented, and representative data for research and innovation in Europe.

Read more here.