European Union of Private Hospitals

Major milestones towards the European Health Data Space

Isabelle ZABLIT-SCHMITZ, Director Europe and International at the Ministerial Delegation for Digital Health, Ministry of Prevention and Health, France

What has happened during the French Presidency with regard to the European Health Data Area?

I would mention two major dates, which represent major milestones towards the European Health Data Area:

– Firstly, the date of 2 February 2022, the date of the ministerial conference “Citizenship, ethics and health data” organised under the French Presidency of the Council of the European Union. Indeed, the European principles for digital health ethics adopted at the initiative of France were presented there and the ministers of the Member States committed themselves to their implementation.

– Then, on 3 May, the European Commission presented its draft regulation on the future European Health Data Space, which includes the EU’s main guiding principles for sharing health data in Europe.

From 20 May, the examination of this text has started, and is taking place during meetings between the permanent representatives of the Member States in Brussels. France, like many other Member States, wants this investigation to be effective and efficient. The aim is that it should not lose its substance along the way and that it should enter into force in the Member States as quickly as possible; there is currently a one-year instruction period before a year of implementation to prepare for its entry into force.

Why was work on ethics in this context essential?

The objective of the French Presidency of the European Union (FPEU) is to get the work on the European Health Data Area on track. We therefore decided to work upstream on the ethical framework before the communication of the text proposal by the European Commission, as a foundation and prerequisite. Along with interoperability and security, ethics is the third essential pillar for developing digital health uses. It was essential upstream to understand what level of consideration was given in the national roadmaps of the Member States to prepare this European text. We therefore carried out research and surveys, supported by an international audit firm and in cooperation with the Ministries of Health of the 29(1) Member States and the European Commission. Each European country does not necessarily understand the same thing in the word ethics and does not integrate it in the same way in its national roadmap. It was therefore essential to have this transversal knowledge. This study provided us with answers, which was welcomed by all our colleagues who took part in the discussions. Establishing a strong ethical basis for digital health in Europe is a commitment to citizens, and it provides a framework of shared values that is essential for the adoption of the text on the European Health Data Area.

The Covid crisis had already triggered reflection on the ethics of digital health. The health pass helped to raise awareness of the importance of this subject. In the end, the challenge is to allow European citizens to control their own health data, to set out the conditions for the use of digital health and to set limits on the use of health data.

It should be emphasised that the proposal for a European regulation now incorporates, as mentioned, the European principles for the ethics of digital health that have been adopted. The European Health Data Space must be based on a virtuous framework, adopted by all member countries, in order to win the support of citizens. This framework will evolve.

What are the European principles for digital health ethics?

This has been a fascinating reflection!

These principles are grouped into four dimensions. Each dimension has 4 principles, so there are 16 principles in total. The four dimensions are: placing digital health within a framework of humanistic values; giving people control over digital health and their health data; developing an inclusive digital health system; and implementing an environmentally responsible digital health system.

We wanted these ethical principles to be a concise text written in a simple and direct style: they fit on an A4 page (a longer version is currently being written and the aim is to make them accessible to the public.

The fourth dimension is particularly innovative; it concerns eco-responsibility. The aim is to limit the environmental impact of digital health, so as not to harm health. This would obviously be paradoxical.

View the European ethical principles for digital health

(1) 27 countries of the European Union, plus Iceland and Norway, which voluntarily participate in the work of the eHealth Network, which brings together representatives of the digital health directorates of European health ministries.