Secondary use of health data and its regulation: Impact assessment of the proposed European Health Data Space on scientific research

Abstract

The proposed regulation (adopted by the EU Parliament) on the European Health Data Space provides for a simplified mechanism - to be managed by newly established bodies, responsible for access to health data and charged with a guarantee function - to make health data easily accessible and marketable for research purposes. This procedure would enable the sale of health data for secondary uses with scientific research purposes, without the direct involvement of the data subject. However, the data that can be shared must necessarily be anonymized or pseudonymised and their use must take place within secure processing environments.

The research questions the contribution aims to address is whether the model outlined in the regulation is compliant with the fundamental principles laid down in the GDPR – especially with regards to the rights of the data subject and the relevant safeguards – what consequences will this new paradigm produce on the market and if, after the entry into force of the regulation, there may still be any room for secondary use of fully personal health data.