The European Health Data Space – what you need to know
On 3 May 2022, the European Commission presented its proposal for the European Health Data Space (EHDS), a milestone for easier and more secure rules, structures, and processes across EU Member States to access and share health data across borders.
Building on legislation such as the GDPR, the proposed Data Governance Act, draft Data Act and the NIS Directive, the EHDS aims at addressing the complexity of present European rules on data sharing in the health sector, unveiled during the COVID-19 pandemic, and foster health digital services across Europe.
To do so, this health specific European ecosystem comprises rules, common standards, and practices, as well as infrastructures and a governance framework for two data purposes.
On the one hand, the EHDS should empower individuals through increased digital access to and control of their electronic personal health data, nationally and cross-borders. Furthermore, it supports citizens’ free movement, fostering a genuine single market for electronic health record systems, relevant medical devices and high risk artificial intelligence (AI) systems (primary use of data).
On the other hand, the EHDS shall provide a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data).
The proposal for the EHDS is accompanied by a Communication from the Commission, resulting from an impact assessment and an open public consultation. The proposal put forward by the European Commission will now be discussed by the Council and the European Parliament.