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.