MedTech Europe Response to the European Commission’s call for feedback on the European Health Data Space

MedTech Europe welcomes the opportunity to provide feedback on the proposed European Health Data Space (EHDS) regulation, published on 3 May 2022.

As expressed through previous statements (including our statement on the European Strategy for Data in May 2020 and our press release in May 2022), MedTech Europe welcomes the Commission’s goal of creating an environment which fosters access to health data and health data sharing across the European Union. As the voice of the medical technology industry, it is our view that the EHDS is a pioneering initiative and has the potential to empower patients, accelerate the European Single Market for digital health and data by tackling barriers to cross-border data sharing.

While the proposal represents a tangible first step toward a European health data ecosystem, MedTech Europe sees several areas of improvements to achieve a truly enabling EHDS:

• It should maintain a reasoned and logical scope to achieve its intended objectives.
• Its requirements and provisions need to be clear and consistent.
• It should not simply enable, but also encourage access to good quality data for secondary use while ensuring compliance with the General Data Protection Regulation (GDPR), for example, by providing additional clarifications.
• Finally, it needs to be consistent and coherent with the existing EU regulatory environment, and in particular with sectoral legislation.