On May 3, 2022 a Proposal for a Regulation on the European Health Data Space has been published. The proposed European Health Data Space draws from the premise that access and sharing of health data within and across Member States is difficult due to the complexity and divergence of rues, structures and processes. The European Health Data Space aims at “harnessing the power of health data for people, patients and innovation” by pushing towards health data science that will transform public health and foster innovation, while empowering individuals to take control of their health data. This proposed legislation is also a product of the Covid-19 pandemic, where the role of up-to-date, reliable and FAIR health data (i.e., data that is based on principles of Findability, Accessibility, Interoperability and Reusability) have been key in responding to the crisis and developing cures and vaccines. The ultimate goal is to build a European Health Union[1] that would strengthen resiliency of health systems and deliver to each Union citizen.

The European Health Data Space Communication supports both primary and secondary use of health data. With regard to primary health data, patients will have their health data available through access points established by Member States, but connected through a cross-border digital infrastructure, will be able to control and share their health data and mandatory requirements on interoperability, security, safety and privacy will apply. Electronic health record systems are subject to mandatory self-certification schemes, which must comply with essential requirements related to interoperability and security. The European Health Data Space promises to “make continuity of care across EU a reality”[2].

Secondary use of data (i.e., health data used for research, innovation and public health) will also be supported by a European framework. Permit to use the data will obtained by health data access bodies, designated by Member States, which will establish how the data will be used and for which purposes (charges may apply), but always requiring closed secure environments, anonymous or pseudonymised data and transparency in their use. The platform HealthData@EU will facilitate cross border studies.

Governance of the European Health Data Space will be up to a new body, named European Health Data Space Board, chaired by the Commission. The Communication does not forget that investments in digitalization are costly and has made available 810 million euros to support the European Health Data Space.

Benefits of the European Health Data Space are expected for citizens, health professionals, researchers, regulators and policy-makers and for the industry.

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[1] Bucher, A. (2022) ‘Does Europe need a Health Union?’ Policy Contribution 02/2022, Bruegel

[2] See page 12 of https://ec.europa.eu/health/publications/communication-commission-european-health-data-space-harnessing-power-health-data-people-patients-and_en