ELF responds to the proposed Regulation on the European Health Data Space

ELF worked with 29 health stakeholders to issue a joint statement with recommendations for policy makers on how to harness digital health data across Europe via the European Health Data Space (EHDS) Regulation.

In response to the proposal for a Regulation on the European Health Data Space (COM 197/2022), a group of 29 health stakeholders created a joint statement “Ensuring the full potential of EHDS: Stakeholders’ recommendations on how to make the digital transformation a success across Europe”. The group includes medical professionals and research organisations, patient representatives, industry associations and data collaborations. They all strongly support the aims of the EHDS as proposed by the European Commission.

This ambitious Regulation has the potential to harness the benefits of the digital age for better health outcomes. It aims to improve the availability and quality of electronic health data. This will ensure that healthcare can safely continue across borders. It will empower patients to have greater access to, and control over, their own health data across Europe.

The statement encourages national and European decision-makers to support this Regulation and to engage with stakeholders. This will help ensure the final Regulation reaches its potential. The statement also outlines several recommendations for when the Regulation is put into practice across EU Member States:

  1. A broad range of stakeholders must be strongly involved from the beginning of the process.
  2. The EHDS must align with all relevant European laws.
  3. The Regulation must be understood and applied in the same way across the EU.
  4. Approvals to use health data to improve services must be the same across Europe.
  5. The scope of electronic health record (EHR) systems must be defined clearly within the Regulation.
  6. There must be enough funds and staffing for a successful roll-out of the EHDS.
  7. Existing health data infrastructures should be used to allow continuity and build on existing expertise.

Read the consensus statement in full.

To endorse the statement on behalf of your organisation, please contact

Learn more about this EU initiative.