Document paper Digital Health Health Data

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

The European Health Data Space (EHDS) represents a pioneering initiative that will not only empower citizens but also improve healthcare in the EU. The medical device industry is committed to being an active partner and a keen collaborator in this new health data ecosystem. For establishing a truly enabling and implementable framework, we provide the following recommendations: 

  • Consistency and coherence with the existing EU regulatory environment for medical technologies must be ensured (especially with MDR, IVDR, and GDPR). Additionally, the EHDS needs to be future-proof and align clearly with upcoming EU legislation, such as the AI Act, the Data Act, and the Cyber Resilience Act. 
  • The EHDS should have a reasoned and logical scope with clear definitions to achieve its intended objectives. We, therefore, suggest clarifying key terms and aligning definitions across existing legislation.  
  • To encourage access to and sharing of good quality data for secondary use, the EHDS needs to build on the existing trade secrets and IP rights framework. Any IP and trade secret data sharing provisions should build on voluntary disclosure models and data holder-user agreements. Adequate safeguards need to be put in place to allow the protection of IP and trade secrets.  
  • The EHDS governance should ensure strong stakeholder involvement and consultation throughout the design, planning, development, and implementation process and ensure their involvement in its governance structures. 

For a more detailed overview of our sector’s views, please read our position paper below.  

Posted on 23.02.2023

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