The European Health Data Space (EHDS) stands as a cornerstone for fostering innovation and revolutionising healthcare within the European Union. As negotiations unfold, the current state of play reveals a divergence between the European Parliament (EP) and the Council of the EU, underscoring the challenges in crafting a harmonised EHDS framework.
By facilitating access to anonymised health data, the EHDS has the potential to empower startups to provide the best and most innovative solutions for patients. However, the approach divergence between the European Parliament and the Council complicates the path forward. The EP advocates for patients to be able to opt-out from the system, while the Council is advocating for Member States to decide whether such opt-outs would apply. Both positions, as they stand, pose challenges for startups aiming to leverage health data for groundbreaking solutions.
The European Commission’s original proposal omitted any form of patient opt-out (or opt-in procedure): it envisioned anonymised and pseudonymised health data accessible by third parties under specific existing rules, supporting research, innovation, and public health policymaking. The Director-General of the Commission’s DG SANTE, Sandra Gallina, even acknowledged the complexity and cost that introducing opt-outs would impose on Member States. The European Parliament nevertheless advocated for universal opt-outs that risk impeding startups’ access to valuable anonymised health data, limiting their potential for innovation, especially for rare diseases. The Council’s stance isn’t much better as it seeks to allow Member States to decide on opt-out circumstances, thus introducing complexity and potential fragmentation. To foster a seamless and supportive environment for startups in the digital health space, harmonisation is key.
In response to the current impasse, a balanced approach, resembling the Commission’s proposal, should be reached – a harmonised EHDS framework that respects individual privacy rights while facilitating startup access to essential health data. This envisioned solution involves a harmonised EHDS framework where startups can access anonymised health data. Fortunately, the General Data Protection Regulation (GDPR) already protects patients’ privacy as health data are fully anonymised. Maximising the pool of high quality health data and preserving patients’ privacy is consequently possible considering that these data would be anonymised and shared in a secure, GDPR-compliant way.
As the trilogue discussions progress, AFS remains committed to championing a dynamic digital health ecosystem within the EHDS framework. The challenges posed by the current divide between the EP and the Council underscore the need for innovative solutions that prioritise both patient privacy and startup growth. This framework will not only respect patient privacy, as provided for by the GDPR, but it will also propel the European digital health landscape into a new era of innovation and excellence. The next steps involve ongoing engagement with policymakers, advocating for a solution that ensures startups can leverage health data effectively, contributing to a brighter and healthier future for Europe.