MedTech Europe’s position on the proposed European Health data Space Regulation

Posted on 02.03.2023

MedTech Europe believes that the European Health Data Space (EHDS) represents a pioneering initiative that will not only empower citizens but also contribute to improving healthcare in the EU and accelerate a single European market for digital health. The medical technology industry is committed to being an active partner and a keen collaborator in this new health data ecosystem.

In its position paper, MedTech Europe calls for consistency and coherence with the existing EU regulatory environment for medical technologies and remains future-proof with upcoming EU legislation. The EHDS must also have a reasoned scope with clear definitions while ensuring strong stakeholder involvement and consultation throughout its governance structure and implementation process. Furthermore, the EHDS needs to build on the existing trade secrets and IP rights framework to encourage access to and share good quality data for secondary use. Read our complete position paper here.

For more information, please contact Verena Thaler, Manager Digital Health.