Towards a stronger European Health Union
On March 15, 2024, the European Parliament and the Belgian Presidency of the Council reached a provisional political agreement on the European Health Data Space (EHDS) which is considered one of the central building blocks towards a stronger European Health Union. The upcoming EHDS aims to harness the full potential offered by the sharing, use, and re-use of health data, while ensuring full compliance with the data protection standards in the EU. This marks a significant milestone in the EU’s health data regulation.
The EHDS implies better EU-wide digital access to electronic health data by patients and health professionals where relevant. The regulation outlines rules on data quality, security and ensures interoperability of electronic health data as all electronic health record (EHR) systems are required to comply with the specifications of the European electronic health record exchange format. Overall, the upcoming rules contribute to improving the efficiency and high quality of healthcare provision in the EU.
Further, the EHDS is set for promoting scientific medical research and public health surveillance, as well as support policy-making. The regulation will facilitate the sharing of health data to research which is expected to boost medical research and innovation in the EU and promote the development of new life-saving treatments and personalised medicines.
Key elements of the agreement reached on the 15th of March are:
- Opt-out possibility: patients may opt-out on the use of their personal electronic health data for secondary use except in, inter alia, purposes in the public interest. Member states can allow patients to opt-out on the use of their data, both for primary and secondary purposes.
- Right to restrict access: patients may choose to restrict access to their personal electronic health data in which cases health professionals may only access restricted health data in situations of vital interest.
- Sensitive health data: member states may implement stricter measures concerning access to sensitive health data, such as genetic data, for research purposes.
- Trusted health data holders: member states may also establish a procedure to designate trusted health data holders that can securely process requests for access to electronic health data in order to reduce administrative burdens.
- Clinically significant findings: researchers must inform Health Data Access Bodies (HDABs) about clinically significant findings that may impact the health of a patient whose data was used in the research. The HDAB shall ensure that patients or their treating health professionals are informed about these findings.
The agreement strikes a balance between the sharing of electronic health data for life-saving treatment and important medical research and protecting the privacy of patients.
Single market for digital health services and products
The proposal for a regulation on the European Health Data Space was initially given by the Commission in May 2022. The main objectives of the EHDS are to improve access to and control by patients over their personal electronic health data in the context of healthcare (primary use of electronic health data) and to achieve purposes in the health care sector that benefit society, such as, research, innovation and policy-making (secondary use of electronic health data). The EHDS is the first of nine European sector-specific data spaces set out by the Commission in the European Data Strategy1 and builds on the Data Act and the Data Governance Act.
The EHDS intends to address the limited use of health data in the EU due to varying standards of cross-border access to health data among member states and limited interoperability. Further, the upcoming regulation promotes the functioning of the internal market by laying down a uniform legal and technical framework. The harmonisation of access to electronic health data within the EU fosters a single market for digital health services and products. The digital health market is estimated to have an additional growth potential of up to 20-30%.2
Member states are required to designate one or more digital health authorities responsible for the implementation regarding the access rights with respect to electronic health data and enforcement thereof coupled with the power to issue fines in case of shortcomings. In addition, member states must designate national contact points for digital health to HealthData@EU – an infrastructure for facilitating the cross-border sharing of electronic health data.
What’s next?
The provisional agreement will now need to be formally adopted by both, the European Parliament and the Council of the EU.
The regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union. The EHDS is set to apply in different stages according to use case and data type.
1Communication from the Commission to the European Parliament, the Council, The European Economic and Social Committee and the Committee of the Regions, ‘A European strategy for data’, COM/2020/66 final
2European Commission: European Health Data Space Factsheet, available at: https://ec.europa.eu/commission/presscorner/api/files/attachment/877807/Factsheet%20on%20European%20Health%20Data%20Space_EN.pdf
