08 Jan 2024

European Health Data Space (EHDS): key issues to address in trilogues

Executive summary

While the EHDS is essential for digital transformation in healthcare and to advance health R&I in the EU, the interinstitutional negotiations must address outstanding issues in the positions of both co-legislators.

This paper highlights the most significant legislative risks in the EHDS that require attention and recommends solutions to fix those shortcomings:

  • The vague definitions of ‘electronic health data’ and ‘data holder’ could undermine the interpretation of the entire legislation.
  • The ambiguously defined electronic health data categories for secondary use may generate more risks than potential benefits.
  • The proposed IP framework would be in conflict with existing legal safeguards aimed at protecting the scientific and technological potential and interests of researchers and innovators. In addition, the EHDS would fall much lower in its standard of trade secrets protection compared to the Data Act.
  • The introduction of excessive and unclear data localisation and international health data transfer requirements, on top of the GDPR, may block essential data flows and lead to inconsistent implementation of rules across the EU.
  • The proposed rules on EHR systems and wellness applications lack clarity and clear interaction with other legislation, and may lead to a fragmented legal landscape across the EU.
Download the full position paper here
For further information, please contact
Ray Pinto
Senior Director for Digital Transformation Policy
Richard Rak
Manager for Digital Health Policy
Back to
View the complete Position Paper
Our resources on ****
28 Feb 2024 resource
Elevating EU innovation through strategic investments and collaboration
20 Feb 2024 Position Paper
DIGITALEUROPE Executive Council for Health’s recommendations for EU digital health policy (2024-29)
20 Feb 2024 Publication & Brochure
The Single Market Love Story: 10 digital actions to save the 30-year marriage
Hit enter to search or ESC to close
This website uses cookies
We use cookies and similar techonologies to adjust your preferences, analyze traffic and measure the effectiveness of campaigns. You consent to the use of our cookies by continuing to browse this website.