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20/10/2022

On 20 October 2022, EHTEL joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space (EHDS). The stakeholders, which include medical professionals' and research organisations, patient representatives, industry associations, and data collaborations, strongly support the aims of the EHDS as proposed by the European Commission.


Healthcare stakeholders statement SM post website

We collectively believe the adoption of new legislation, in the form of the EHDS, “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.

The consensus statement encourages decision-makers to strongly support this Regulation and to engage with stakeholders so as to ensure that the final Regulation optimises its potential.

The joint statement also formulates seven recommendations to be considered when specific implementation plans are developed to put this Regulation into practice across Europe's 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 European Union.
  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 in the Resources section below ⤵️

On 29 November 2022, European MEPs met in the European Parliament to discuss the European Health Data Space. By this date, the number of signatories of the join consensus statement had risen to 35.

Resources

  • Stakeholders’ consensus response to the proposed European Health Data Space (29/11/2022) 28 November 2022 EHTEL & multiple stakeholders PDF*
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