2. The European Health Data Space (EHDS)


The European Health Data Space (EHDS)
The European Commission, May 2022 [1]

European health data spate

Data is a key enabler for digital transformation. Health data may be available in various forms; it is not managed in the same way in all EU Member States or within national health systems. In essence, today’s EU health sector is rich in data, but poor in making it work for people and science.


The Commission says: 

“The COVID-19 pandemic has clearly demonstrated the importance of digital services in the health domain. It has shown that up-to-date, reliable and FAIR* health data is key in providing an efficient public health response to crisis and in developing effective treatments and vaccines. It has also significantly accelerated the uptake of digital tools, such as electronic health records (personal medical records or similar documents in digital form), e-prescriptions and digital health applications, as well as the sharing of research data. Digital health products and services are no longer novelties. They are becoming a part of everyday care delivery.”


*FAIR principles: findability, accessibility, interoperability, reusability

In order to enable the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data, without the existing obstacles, the Commission put forward a legislative proposal to create a European Health Data Space, to empower individuals to take control of their own health data and to allow its use for better healthcare delivery.

The European Health Data Space is a health specific legal framework and ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework.

The Commission is presenting a Regulation to set up the European Health Data Space [2] [3].


[1] The European Health Data Space. https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
[2] Proposal for a Regulation of The European Parliament and of the Council on the European Health Data Space. https://eur-lex.europa.eu/resource.html?uri=cellar:dbfd8974-cb79-11ec-b6f4-01aa75ed71a1.0001.02/DOC_1&format=PDF
[3] Annexes to the Regulation of The European Parliament and of the Council on the European Health Data Space. https://eur-lex.europa.eu/resource.html?uri=cellar:dbfd8974-cb79-11ec-b6f4-01aa75ed71a1.0001.02/DOC_2&format=PDF