Cybersecurity Policy Report, EU Lawmakers Reach Agreement on European Health Care Space, (Mar 15, 2024)

By Tony Foley

The European Commission (EC) announced today that it welcomed a political agreement reached among the EC, European Parliament, and Council of the European Union on the European Health Data Space (EHDS).

The EDHS was originally launched by the EC in May of 2022 as a repository that would empower EU citizens to control and utilize their health data in their home countries and in other EU member states (CPR, May 3, 2022). As today’s EC announcement points out, the EDHS aims to put citizens at the center of health care, giving them full control over their data, and to open up data for research and public health uses.

“The European Health Data Space is a game changing moment for health in Europe and for the care our citizens receive. It will enable patients to share health data, such as their medical history, test results, or prescriptions with hospitals and medical practitioners within and across Member States, as they wish,” said EC Commissioner for Health and Food Safety Stella Kyriakides. “At the same time, it will unleash the potential of health data for the development of innovative and lifesaving treatments and devices, as well as for better health policy making, all with strong data protection and security safeguards. “

The agreement on the EDHS reached by the co-legislators establishes clear rules for the use of health data for better health care delivery, research, innovation and policy-making. The EC added that the rules established for the EDHS will help realize the potential offered by the safe and secure exchange, use, and reuse of personal data, while ensuring full compliance with data protection law.

Specifically, the new rules will give citizens immediate access to their digital health data, no matter where they are in the EU. In addition, health professionals will be able to access medical records of a patient for treatment in a different member state while still affording data protection principles to the records. Finally, by creating a strong legal framework for the reuse of health data for research, innovation, and public health purposes, the EC said the EDHS would help develop life-saving treatments, while also improving crisis preparedness under strict data security and access conditions.

The EDHS regulation now must be formally adopted by the Parliament and Council. Once approved, it will become applicable in different stages according to use case and data type. More information on the parameters of the EDHS can be found at this webpage.

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