News - May 3, 2022

On the upcoming Regulation Proposal on the European Health Data Space (EHDS)


On 16 September 2020, Ursula von der Leyen, European Commission President, announced a new legislative proposal to create a European Health Data Space in her State of the Union address. The European Health Data Space (EHDS) is a key element of the European Health Union that aims to reinforce the EU’s preparedness and response during health crises.

A common European Health Data Space bears great potential for the future of healthcare in general and for developers and rare diseases patients, in particular. The EHDS will enable better exchange and access to different types of health data (genomics data, data from patient registries, electronic health records, etc.), and will foster healthcare delivery (primary use of data) as well as health research data (secondary use of data).

Currently, due to the fragmented landscape, the data, when available, can be of disparate quality and complexity.  According to the European Commission, the European Health Data Space will:

  • promote safe exchange of patients’ data (including when they travel abroad) and citizens’ control over their health data;
  • support research on treatments, medicines, medical devices and outcomes;
  • encourage the access to and use of health data for research, policy-making and regulation, with a trusted governance framework and upholding data-protection rules;
  • support digital health services; and
  • clarify the safety and liability of artificial intelligence in health.

Representing small and medium-sized companies active in pharmaceuticals, biotechnologies and medical technologies, EUCOPE shares the Commission’s ambition to see the EU becoming a leader in digital innovation.

In view of the upcoming Regulation proposal of the European Health Data Space on 3 May, we want to reiterate EUCOPE’s position:

  • We recommend the adoption of EU-level data collection standards and the promotion of data interoperability and exchange protocol, based on the experience of ERNs.
  • We stress the need for an appropriate legal and governance framework to cover the access to and exchange of health data for healthcare provision, research, policy-making and regulatory activities
  • A multi-level governance approach is vital to make the EHDS a success.

It is imperative, to streamline regulations and guidance documents so that they can act as an accelerator to stimulate innovation, that increases EU competitiveness, and ultimately benefits European patients.