Call to address key challenges in the final European Health Data Space: MedTech Europe’s recommendations on the EHDS Trilogue negotiations

As the proposed European Health Data Space (EHDS) regulation is currently being discussed in the interinstitutional “Trilogue” negotiations, MedTech Europe would like to reiterate its position and highlight areas of specific importance to the medical technology industry.

Our sector’s mission is to make safe, secure, and performant medical devices, in vitro diagnostic medical devices, and digital health solutions available in the EU. We are committed to being an active partner and a keen collaborator in this new health data ecosystem envisaged by the EHDS.

This pioneering initiative will help to harness the benefits of health data sharing, and we strongly believe that to unlock the full potential of the system and to make it workable, it will be crucial to address outstanding challenges:

1. Create a workable framework for ‘EHR systems’.
2. Clearly specify the scope of electronic health data for secondary use.
3. Avoid the erosion of the existing IP and trade secrets protection.
4. Reinforce the EU’s commitment to international free flow of data.

Please find the full position paper below.