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As part of the EU Health Coalition, ECHAlliance welcomes the European Commission’s proposal for a Regulation on the European Health Data Space (EHDS) as an important step towards a more patient-centric, harmonised, interoperable, safe, and reliable environment for health data.

In our view, the proper use of health data is key to developing sustainable health systems. It has the potential to enable patient access to their own health data, more coordinated care as well as research and innovation that can: (i) prevent diseases; (ii) increase the quality, safety, and patient centredness of healthcare; (iii) decrease healthcare costs; and (iv) transform care into a more participatory process.

We have recently learned that the Committee on Civil Liberties, Justice and Home Affairs (LIBE) will lead on the EHDS dossier. We agree that the protection of patients’ data is key and that the General Data Protection Regulation (GDPR) needs adapting when it applies to patients’ involvement in research studies. Furthermore, we are convinced that the EHDS should be set up with a clear health perspective in mind, recognising the specificities of the health sector, to meet the objectives of strengthening cooperation, improving research, and ensuring more equality for patients.

With this in mind, we would strongly recommend that the Committee on Environment, Public Health and Food Safety (ENVI) should be given shared competence within the European Parliament on this legislative file.

This would ensure a patient-focused approach to the debate around the Regulation on the EHDS — inclusive of their needs, preferences, and goals — and would consider the views of healthcare professionals and the wider health community.