The European Commission has been urged to move quickly on detailed guidance for the European Health Data Space (EHDS), with health sector stakeholders warning that consistent implementation across member states would be critical to the success of the new regulation.
The feedback was published by the Commission following an implementation dialogue on the EHDS Regulation chaired by Commissioner for Health and Animal Welfare Olivér Várhelyi, an event bringing together representatives from healthcare providers, industry, researchers and patient groups.
According to the Commission’s summary, organisations were already preparing for implementation but were looking for the Commission to deliver implementing acts as soon as possible so planning can continue with greater certainty.
Participants also called for a harmonised approach across EU member states, saying differences in implementation could undermine one of the regulation’s key aims of improving cross-border access to health information.
Healthcare providers said implementation would require significant resources – particularly for smaller organisations, while industry representatives sought greater clarity around how the regulation would interact with existing EU legislation.
Concerns were also raised about protecting intellectual property and trade secrets, while information security was identified as another priority requiring continued attention.
The European Health Data Space seeks to establish a common framework for sharing and reusing electronic health data across the European Union. It is intended to give citizens greater access to their health information, support cross-border care and enable the secondary use of health data for research, innovation and policymaking.
Interoperability is one of the central pillars of the regulation, with common requirements for electronic health record systems intended to improve the secure exchange of health information between member states.
The Commission said participants broadly supported the objectives of the EHDS but emphasised that implementation would require ongoing collaboration between policymakers, healthcare providers, technology suppliers and researchers.
The implementation dialogue formed part of a wider Commission initiative to gather feedback from organisations affected by major EU legislation and identify practical issues before implementation progresses further.
The Commission said feedback from the session would help inform the next stages of EHDS implementation.
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