On 13 December, the European Parliament adopted its position on the creation of a European Health Data Space.  This follows an agreement on 6 December 2023 by EU ambassadors on the Council's mandate for a new law that will make it easier to share and access health data at EU level.

Background: 

In May 2022, the European Commission proposed a regulation to create a digital health space. This new regulation not only aims to improve individuals' access to and control over their health data, but also to facilitate the exchange of health data between EU countries, as EU countries currently differ widely in the level of digitisation of health data. The new regulation will make it easier for medical and pharmaceutical professionals to access health data across borders. Researchers will also be able to benefit from certain types of anonymised and secure health data through the European Digital Health Space. On the patient-facing side, MEPs, however, call for stronger safeguards for sensitive data and propose an opt-out system for the secondary use of some health data, such as genetic and genomic information. 

The European Health Data Space has the potential to bring huge benefits to patients, health professionals and medical research in the EU. At the same time, it involves particularly sensitive health data, the protection of which must be ensured. It remains to be seen what form the final agreement will take.

What happens next?

The EU Parliament will now start talks with Member States on the final shape of the regulation.

We will keep you updated.