Summary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi

The Implementation dialogue on the European Health Data Space Regulation (EHDS Regulation) was held in Brussels on 10 June 2026 with the participation of industry, researchers, healthcare providers and patient organisations.

The dialogue pursued two principal objectives. First, it aimed to take stock of the stakeholders’ state of preparations for the EHDS, including by gathering evidence on measures already being taken to ensure compliance with the Regulation and on the main challenges expected. Second, it sought to collect views on possible measures to facilitate and simplify the forthcoming implementation of the EHDS Regulation and to foster innovation, including through actions beyond the scope of the EHDS that could contribute to enhanced efficiency and competitiveness in the digital health sector.

Industry representatives reported having started their preparations for the implementation of the EHDS while underlining the importance of the timely adoption of the relevant implementing acts. Healthcare providers pointed out resource constraints and a perceived lack of urgency, particularly for smaller healthcare providers.

In terms of challenges, many participants asked for harmonised implementation of the EHDS across the EU as much as possible and for further clarification of certain notions and concepts. They also asked for clarification of the interplay with other Union rules. Industry participants asked for reassurance about the protection of intellectual property and trade secrets. Participants stressed that ensuring information security was key.

Despite those concerns, participants generally expressed a positive view of the potential of the EHDS to support and advance research.

Regarding the facilitation and simplification of implementation, many participants stressed the need for harmonised implementation to avoid fragmentation. Industry participants welcomed efforts aimed at simplifying compliance with Union rules and stressed the need to build on existing standards. Some participants also stressed the need for autonomous European computing infrastructures. More generally, participants called for further guidance from the Commission to support and steer implementation.

In concluding the dialogue, Commissioner Várhelyi summarised the contributions, and indicated the stakeholder feedback would be taken into account for the next stages of implementation. He stressed the importance of maintaining patient trust, in relation to both for primary and secondary use of health data.

Stakeholder participation

Århus University, member of The Guild of European Research-Intensive Universities

Austrian Institute of Technology, member of the European Organisation of Research & Technology Organisations - EARTO

Standing Committee of European Doctors - CPME

Dedalus, member of COCIR

Docplanner, repres member of enting DigitalEurope

European Patient Forum - EPF

European University Hospital Alliance - EUHAlliance

Galmeon, member of MedTech Europe