EHDEN joins stakeholders’ consensus response to the proposed European Health Data Space

On 20 October, EHDEN joined a group of 29 diverse and representative European stakeholders in welcoming the European Commission’s proposal on the European Health Data Space (EHDS). The stakeholders, which include medical professional and research organisations, patient representatives, industry associations and data collaborations strongly support the aims of the EHDS as proposed by the European Commission. The group believe the adoption of the new legislation “can bring important European alignment to, and rapidly scale up, well-governed access to health data sets for the delivery of healthcare services but also for a wide range of secondary use, research, purposes for better health outcomes.”

The consensus statement encourages decision-makers to strongly support this Regulation and to engage with stakeholders to ensure the final Regulation optimises its potential. The statement also formulates several recommendations to consider when developing the more specific implementation plans as the Regulation transitions into reality across EU Member States:

  1. A broad range of stakeholders must be strongly involved from the outset of the process to guarantee the success of the EHDS
  2. The EHDS must align with all relevant horizontal and sectoral European laws
  3. There must be harmonised interpretation and implementation of the Regulation across the EU
  4. Approvals for secondary use of health data must be consistent and harmonised across Europe
  5. The scope of EHR systems must be defined clearly within the Regulation
  6. The successful implementation of the EHDS must be adequately resourced
  7. Existing health data infrastructures must be leveraged to allow continuity and build on existing expertise


Read the full statement here and support our stakeholder group's recommendations in your engagement with EHDS implementation