EATRIS’ reaction to the European Commission’s proposal for a Regulation on the European Health Data Space

In May 2022, the European Commission (EC) published a proposal for a Regulation introducing the European Health Data Space (EHDS) and welcomed feedback from the community through a public consultation until July 28, 2022. The EHDS is a Commission priority that aims at making the most of the potential of digital health to provide high-quality healthcare, reduce inequalities and promote access to health data for research and innovation on new preventive strategies, diagnosis and treatment. At the same time, it should ensure that individuals have control over their own personal data.

Innovative solutions that make use of health data and digital technologies, among others digital health solutions based on data analytics and artificial intelligence, can contribute to the transformation and sustainability of healthcare systems, while improving people’s health and enabling personalised medicine. The development of these technologies requires access by researchers and innovators to substantial amounts of (health) data.

The Proposal, which strives to promote innovation by improving access to European citizens health data for secondary use, is of strong interest to EATRIS’ community of Member States, institutes, and users. EATRIS welcomes the publication of the Proposal and the design of a framework that seeks to address, at least some of, the blockages and obstacles for efficient, secure, and ethical access to health data for secondary use at pan-European scale. The Proposal sets forward an ambitious framework to alleviate some of the challenges for access to such data that have been difficult to navigate in recent years not least due to the, somewhat unintentional, obstructions imposed by the General Data Protection Act (GDPR). From our perspective many of the actions raised in the Proposal represent significant steps to fostering research, innovation, policy-making, and regulatory activities based upon a standardised framework of health data access for secondary use.

In our response, EATRIS formulates recommendations in four specific areas that we hope the European Commission, the Council and the European Parliament will consider in future versions of the Regulation:

  1. Implementation of a permit-based approach to access health data for secondary use
  2. EHDS regulation interplay with the GDPR
  3. Interoperability of the healthdata@eu infrastructure
  4. Consent as the basis for access to citizens health data for secondary use

Our response is publicly accessible through the EC’s consultation page here.

For more information, please contact Gary Saunders, EATRIS Data Director: garysaunders@eatris.eu

Contact

Gary Saunders
Data Director