MEPS approve EU Health Data Space
The European Parliament Members approved the establishment of a European Health Data Space, aiming to enhance citizens’ access to their health data and promote secure data sharing for public interest. The agreement allows patients to access their health data electronically, even across different EU member states, and enables healthcare professionals to view patient files with consent, facilitating primary use data sharing. This initiative includes electronic health records containing patient summaries, electronic prescriptions, medical images, and lab results.
Moreover, the Health Data Space will facilitate safe transfer of health data to professionals in other EU countries through the MyHealth@EU infrastructure, particularly beneficial for citizens relocating within the EU. The law ensures free access to download health records and promotes data-sharing for research purposes in an anonymized or pseudonymized format. Data such as health records, clinical trials, genetic information, and public health registry data can be processed for research, statistics, and policy-making, aiding in advancing treatments for rare diseases.
Privacy safeguards are robust under this law, giving individuals control over their data usage and access. Patients can refuse data access by practitioners except in cases of vital interest, and opt-out of research data usage except for specific public-interest purposes. Patients will be notified each time their data are accessed and have the right to request corrections to inaccurate data entries. The legislation aims to bridge gaps in treatment by ensuring cross-border access to patient records while maintaining patient trust and system reliability.
Following the approval by MEPs, the agreement awaits formal confirmation by the Council before entering into force in twenty days after publication in the EU’s Official Journal. The implementation will occur two years later with exceptions for primary and secondary data use categories applying four to six years later. This legislative move aligns with citizens’ demands expressed in the Conference of the Future of Europe conclusions, advocating for a health data space to facilitate exchanges and emphasizing the importance of data and artificial intelligence in shaping the future of healthcare.