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European Health Data Space

Summary
Evaluation
Commission Proposal
Legal Act
Implementation

Overall state of Play:

Evaluation finalised: SWD(2022)131 on 03/05/2022
Commission proposal: adopted COM(2022) 197 on 03/05/2022

State of play, main conclusions, outlook

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at: a) empowering individuals through increased digital access to and control of their electronic personal health data and support to their free movement; b) fostering a genuine single market for electronic health record systems, relevant medical devices and high risk AI systems; c) providing a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities.

State of Play:

Finalised, SWD(2022)131 on 03/05/2022

Evaluation findings:

Article 14 of the Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (‘CBHC Directive’) was the first reference to eHealth in EU legislation. However, as stated in the impact assessment accompanying the EHDS Regulation, the relevant provisions of CBHC Directive are voluntary in nature. This partly explains why this aspect of the Directive has shown limited effectiveness in supporting natural persons’ control over their personal electronic health data at national and cross-border level and very low effectiveness on secondary uses of electronic health data. The COVID-19 pandemic has revealed an urgent need and the high potential for interoperability and harmonisation, building on existing technical expertise at national level. At the same time, digital health products and services, including telemedicine, have become an intrinsic part of the delivery of healthcare.

The evaluation of the digital aspects of the CBHC Directive included the COVID-19 pandemic and Regulation (EU) 2021/953 on the EU Digital COVID Certificate. This time-limited Regulation addresses free movement restrictions imposed due to COVID-19, and it builds upon the interoperability work conducted by eHealth Network experts. The evaluation shows that legal provisions supporting harmonisation and a common EU approach to use of electronic health data for specific purposes (as opposed to voluntary actions only), coupled with EU efforts to ensure legal, semantic and technical interoperability, can deliver substantial benefits. In particular, they can significantly support the free movement of natural persons and can promote the EU as a global standard setter in the field of digital health.

State of Play:

Adopted on 03/05/2022, COM(2022) 197

Which objective(s) does the Commission pursue?

The general objective is to ensure that natural persons in the EU have increased control in practice over their electronic health data. It also aims to ensure a legal framework consisting of trusted EU and Member State governance mechanisms and a secure processing environment. This would allow researchers, innovators, policy-makers and regulators at EU and Member State level to access relevant electronic health data to promote better diagnosis, treatment and well-being of natural persons, and lead to better and well- informed policies. It also aims to contribute to a genuine single market for digital health products and services, by harmonising rules, and so boost healthcare system efficiencies.

Estimated savings and benefits:

Overall, the EHDS is expected to save EUR 11 billion over ten years for the EU from better access and exchange of health data in healthcare (EUR 5.5 billion) and from better use of health data for research, innovation and policy making (EUR 5.4 billion).