6 September 2023, Brussels – PIONEER 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.
The meeting was held in follow-up to a joint statement issued by the group in June 2023 in which the organisations outlined the challenges of implementing an opt-out mechanism. In that statement, the group agreed that the Commission’s proposal strikes an adequate balance between delivering health-related benefits for patients in the EU and mitigating/eliminating any risks to their rights and interests.
The healthcare community remind that ensuring the trust of patients and other stakeholders in the healthcare system is vital. The group also call on legislators to adopt a consistent, EU-wide approach to unlock the potential value of using health-related data for research and innovation.
The 32 organisations raise their concerns that an opt-out or opt-in mechanism with regard to the secondary use of electronic health data under the EHDS may lead to health data disparities, where datasets underrepresent certain segments of the overall population. This would increase risks and undermine the reliability of data-driven health interventions. Instead of introducing more complexity, such as a general opt-out mechanism, more consideration should be given to ensure transparency and accountability regarding the processing operations performed on electronic health data and the results obtained from secondary use, and to the effectiveness of the safeguards in place.