Ensuring the full potential of EHDS: Stakeholders’ recommendations on how to make the digital transformation a success across Europe

November 30th 2022


In a joint statement, EHN joins 34 stakeholders in welcoming the proposal for a Regulation on the European Health Data Space (EHDS; COM 197/2022).

This regulation has the potential to harness digital health for better health outcomes and to be an enabler for important EU health initiatives such as the Healthier Together Non-Communicable Diseases initiative. “It 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 purposes for better health outcomes.”

This joint statement outlines several recommendations for consideration when developing the implementation plans for putting this Regulation into practice across the Member States, including:

  • A broad range of stakeholders must be strongly involved from the outset of the process to guarantee the success of the EHDS.
  • The EHDS must align with all relevant horizontal and sectoral European laws.
    There must be harmonised interpretation and implementation of the Regulation across the EU.
  • Approvals for secondary use of health data must be consistent and harmonised across Europe.
  • The scope of EHR systems must be defined clearly within the Regulation.
  • The successful implementation of the EHDS must be adequately resourced.
  • Existing health data infrastructures must be leveraged to allow continuity and build on existing expertise.
  • The signatory organisations petition all Member State and European decision-makers to strongly support this Regulation and to enable multi-stakeholder engagement to maximise the final Regulation’s potential.

Read the full statement here.