The European Commission Tuesday moved to establish the European Health Data Space (EHDS), calling the proposed space “a health specific ecosystem comprised of rules, common standards and practices.” It is the European Union’s (EU) first sector-specific set of regulations pursuant to its 2020 European data strategy.
The EHDS will provide Europeans with the option to control and utilize their health data in their home country as well as in other EU member states. The proposed regulation which would establish the EHDS promotes the emergence of a comprehensive single market for digital health services and products. It also creates a consistent, credible, and efficient framework for using health data in research, innovation, policymaking, and regulatory activities, all while adhering to the EU’s rigorous data protection regulations.
Vice-president of the European Commission, Margaritis Schinas said:
I am proud to announce the first common EU data space in a specific area. The European Health Data Space will be a ‘new beginning’ for the EU’s digital health policy, making health data work for citizens and science. Today, we are laying down the foundations for secure and trustworthy access to health data that is fully in line with the fundamental values underpinning the EU.
The COVID-19 pandemic has emphasized the importance of digital health services. However, obtaining and transmitting health data in the EU, especially cross-border, is a complex undertaking, navigating different rules, organizations, and processes across EU member states. In addition, cyberattacks on health systems have become more prevalent in recent years.
The General Data Protection Regulation , proposed Data Governance Act, draft Data Act, and Network and Information Systems Directive are all incorporated within the EHDS. The EDHS enhances these instruments by implementing more specialized healthcare guidelines. Between 3 May and 26 July 2021, an extensive public consultation on the EHDS gathered a spectrum of viewpoints that helped shape the legal framework of the EHDS. The consultation found that 89% of respondents said the European Health Data Space should support and accelerate research in health.
The Commission is optimistic about the initiative, highlighting its potential to enhance cancer diagnoses and treatment, as well as the prevention, detection, and response to public health crises. The Commission estimates that more efficient secondary use of health data could benefit the EU by more than €3.4 billion ($3.6 billion) for researchers and innovators in digital health, medical devices, and medicinal products. The Commission also expects EHDS to cut the cost of regulatory processes by making it cheaper for agencies to access health data.
The European Commission’s EHDS proposal will now be considered by the Council of the European Union and the European Parliament.