Stakeholders’ consensus response to the proposed European Health Data Space

On 20 October, OPTIMA joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space.

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. We 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 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 to put this Regulation into practice across the 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.

OPTIMA News
Information Leaflet for Data Providers – fresh out of the press!

Information Leaflet for Data Providers – fresh out of the press!

The OPTIMA consortium has developed a leaflet to inform potential data providers on how they might get involved in the OPTIMA project.
Please check out the attached leaflet to learn more about our vision, challenges and solutions of the project, the progress we made so far, why you should become part of OPTIMA and how data providers can contribute to OPTIMA.

read more
Public communications of EHDS stakeholder meeting with EU officials (6 Sep 2023)

Public communications of EHDS stakeholder meeting with EU officials (6 Sep 2023)

​6 September 2023, Brussels – OPTIMA, as part of a multi-stakeholder group consisting of 32 European patient organisations, medical associations, research organisations, data collaborations and industry associations met EU officials, including MEP Tomislav Sokol, Co-Rapporteur, as well as several permanent representations that will hold upcoming Presidencies of the Council of the European Union, to discuss how the European Health Data Space (EHDS) can facilitate health research and innovation to create tangible benefits for patients in the EU.

read more

Tackling Cancer through Real World Data
and Artificial Intelligence