Commission launches European Health Data Space
On May 3, the European Commission launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. The EHDS will help the EU to achieve a quantum leap forward in the way healthcare is provided to people across Europe. It will empower people to control and utilise their health data in their home country or in other Member States. It fosters a genuine single market for digital health services and products. And it offers a consistent, trustworthy and efficient framework to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU’s high data protection standards.
Putting people in control of their own health data, in their country and cross-border
- Thanks to the EHDS, people will have immediate, and easy access to the data in electronic form, free of charge. They can easily share these data with other health professionals in and across Member States to improve health care delivery. Citizens will be in full control of their data and will be able to add information, rectify wrong data, restrict access to others and obtain information on how their data are used and for which purpose.
- Member States will ensure that patient summaries, ePrescriptions, images and image reports, laboratory results, discharge reports are issued and accepted in a common European format.
- Interoperability and security will become mandatory requirements. Manufacturers of electronic health record systems will need to certify compliance with these standards.
- To ensure that citizens’ rights are safeguarded, all Member States have to appoint digital health authorities. These authorities will participate in the cross-border digital infrastructure (MyHealth@EU) that will support patients to share their data across borders.
The EHDS builds further on the GDPR, proposed Data Governance Act, draft Data Act and NIS Directive. It complements these initiatives and provides more tailor-made rules for the health sector. An open public consultation on the EHDS ran between 3 May and 26 July 2021 and gathered a wide range of views that contributed to the design of this legal framework.
The EHDS will make use of the on-going and forthcoming deployment of public digital goods in the EU, such as Artificial Intelligence, High Performance Computing, cloud and smart middleware. In addition, frameworks for AI, e-Identity and cybersecurity, will support the EHDS.
