The European Commission decided on Tuesday to establish the European Health Data Space (EHDS), calling the proposed space “a health-specific ecosystem made up of common rules, standards and practices.” This is the first set of sector-specific regulations from the European Union (EU) in line with its European Data Strategy 2020.
EHDS will offer Europeans the possibility to control and use their health data in their country of origin as well as in other EU Member States. The proposed regulation that would establish the EHDS promotes the emergence of a global single market for digital health services and products. It also creates a coherent, credible and effective framework for the use of health data in research, innovation, policy-making and regulatory activities, while complying with stringent EU data protection regulations. Datas.
European Commission Vice-President Margaritis Schinas said:
I am proud to announce the first EU common data space in a specific domain. The European Health Data Space will be a “new start” for EU digital health policy, putting health data at the service of citizens and science. Today, we are laying the foundations for secure and reliable access to health data, fully in line with the fundamental values that underpin the EU.
The COVID-19 pandemic has highlighted the importance of digital health services. However, obtaining and transmitting health data in the EU, especially across borders, is a complex undertaking, navigating different rules, organizations and processes in EU member states. In addition, cyberattacks against health systems have increased in recent years.
The General Data Protection Regulation, proposed data governance law, the Data Bill and the Network and Information Systems Directive are all integrated into the EHDS. The EDHS enriches these instruments by setting up more specialized health recommendations. Between May 3 and July 26, 2021, an extensive public consultation on EHDS brought together a range of views that helped shape the legal framework for EHDS. The consultation revealed that 89% of respondents said the European Health Data Area should support and accelerate health research.
The Commission is optimistic about the initiative, highlighting its potential to improve cancer diagnostics and treatment, as well as prevention, detection and response to public health crises. The Commission estimates that more effective secondary use of health data could benefit the EU by more than €3.4 billion ($3.6 billion) for health researchers and innovators digital technology, medical devices and medicines. The Commission also expects the EHDS to reduce the cost of regulatory processes by making access to health data cheaper for agencies.
The European Commission’s EHDS proposal will now be considered by the Council of the European Union and the European Parliament.
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