The Council of the European Union has reached a crucial agreement on the establishment of the European Health Data Space, promoting the simplification of exchanges and access to health data among member states.
Simplified Access and Personal Control
The regulation proposal aims to facilitate citizens' access to their electronic health data, regardless of their location within the European Union. The goal is to ensure greater transparency in decisions regarding personal health, allowing citizens to have more control over their data.
Promoting Research and Innovation
The European Health Data Space will open new opportunities for scientific research and the development of more effective treatments. Anonymized data will be accessible to researchers, facilitating the understanding and treatment of various pathologies.
Clarity in Directives
The Council's mandate provides clarity on various aspects, including the scope of the regulation, alignment with GDPR, and criteria for access to electronic health data. The proposal includes the creation of two steering groups for the management of MyHealth@EU and HealthData@EU.
Governance and Interoperability
Member states will have a more active role in the governance of the European Health Data Space, contributing to ensuring transparency and accountability. Additionally, the regulation foresees the adoption of European specifications for electronic health records, promoting interoperability among national systems.
Next Steps
The EU Council Presidency now has the mandate to initiate negotiations with the European Parliament to reach a provisional agreement on the regulation proposal. The final position of the Parliament is expected to be presented on 13th December 2023.
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The regulation represents a significant step towards a more integrated European Union in the digital health sector, promoting accessibility, security, and innovation for all citizens. Stay tuned for updates on this key development.
