Data governance and the European Health Data Space

Posted on 03.03.2021

The EU is advancing on its ambition to harness health data from across Europe to power research and innovation. The Commission proposed a Data Governance Act in November 2020 to serve as the horizontal legal basis of the general European data strategy. In December, an EC impact assessment was the opening salvo for the legislation on the European Health Data Space (EHDS) expected later in 2021. In its comments on the data governance act of 8 February 2021, MedTech Europe voiced support but noted some legal issues and challenges. In the response to the EHDS impact assessment of 3 February 2021, MedTech Europe also expressed support but called to attention issues that need addressing, such as the fragmentation in the implementation of the GDPR, interoperability and cybersecurity barriers, healthcare professionals’ skills and digital literacy, and the conditions for trust and acceptance.

For more information, contact Michael Strübin at [email protected]