In May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (EHDS) aiming to become a key element of the European Health Union and to facilitate better use of data in the European Union. The proposal aims at empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide, and support to their free movement, as well as fostering a genuine single market for electronic health record systems, relevant medical devices and high-risk Artificial Intelligence (AI) systems (primary use of data) and at  providing 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 European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) adopted their Joint opinion on the Proposal of the European Parliament and of the Council on harmonised rules on fair access to and use of data. Additional safeguards, according to the EDPB and EDPS, are necessary to the processing special categories of personal data, such as data concerning health or biometric data, to avoid lowering the protection of the fundamental rights to privacy and to the protection of personal data in practice.

The main concerns are related to topics below:

1. The rights to access, use and share data under the Proposal would likely extend to entities other than the data subjects, including businesses, depending on the legal title under which the device is being used.
2. In case of “exceptional need”, data will be made available to public sector bodies and Union institutions, agencies or bodies.
3. The oversight mechanism established by the Proposal may lead to fragmented and incoherent supervision.