In May 2022, the European Commission launched the European Health Data Space (EHDS), which aims to regulate and improve the use of health data in the EU, for the benefit of citizens and patients, as well as for research, innovation, and policy and regulatory purposes. Last October, she presented five use cases demonstrating the feasibility and impact of this space.

The primary use of health data in the EHDS will allow any EU citizen to share his or her data with health professionals in his or her own country, but also across borders. They will be able to add data, rectify it, and even restrict access to others. The EDHS also aims to establish a common European legal framework on the secondary use of health data: science, innovation and public policy making.

France is participating in the negotiation of the text in the Council of the European Union with its European counterparts, which covers all aspects of the collection, processing and use of health data. The establishment of the French position is open to public consultation in order to take into account various national expertises and to better take into account the real needs of the field. The consultation on the ” certification of electronic medical record systems and voluntary labelling of wellness applications” is open until mid-2024.

Coordination of the Health Data Hub

In March 2021, the European Commission launched the €5.1 billion “EU4Health” program to strengthen European health systems to better respond to cross-border health crises, such as the Covid-19 pandemic. Within the framework of this program, it launched a call for applications for the creation of a European Space pilot for the secondary use of health data.

One of the objectives of the Health Data Hub is to ” position France as a leader in the use of health data,” and it formed a consortium bringing together the national health data platforms of several member states (Germany, Belgium, Denmark, Finland and Norway), as well as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) and research infrastructures, which responded to this call and won.

The five selected use cases

The Health Data hub has been entrusted with the creation of this test version of HEDS. The aim is to overcome ” the persistent obstacles to the exploitation of health data, which are currently fragmented across Europe and access to which remains difficult for research” .

The consortium will therefore connect health data platforms, whether national infrastructures, European agencies or research infrastructures, in a network of “nodes” and will link this network to central services, available at the European level.

To demonstrate the feasibility and potential of reusing data from several European countries, the European Commission has selected five use cases among those proposed by the consortium covering different research topics:

• The European Centre for Disease Prevention and Control (ECDC) will demonstrate the feasibility of using the EHDS network of data platforms for antimicrobial resistance surveillance. This surveillance is one of the missions of the ECDC at the European level.
  The project will mobilize Finnish and Belgian data;
• The European Medicines Agency (EMA), aims to identify the risk of bleeding disorders in patients with COVID-19. This will demonstrate the possibility for the EMA to conduct studies as part of its regulatory mission using the EHDS data platform network. This project will mobilize data from Denmark, Finland, Croatia and France as well as the Darwin Eu network;
• Sciensano, will also focus on Covid-19 and will aim to compare test use, hospitalizations and vaccination adherence at the general population level but also at the level of vulnerable populations, and by socio-economic indicators. This use case will mobilize data from Belgium, Denmark, Croatia, Norway, Finland, Hungary and France;
• The Health Data Hub will compare care pathways in different countries, including France, Finland, Hungary and Denmark for cardio-metabolic diseases and predict trajectories using AI. The project will mobilize French, Finnish, Danish and Hungarian data;
• The ELIXIR research institute will mobilize and link clinical and genomic data to answer research questions in colorectal cancer. This use case will allow the research and validation of genomic signatures characteristic of different types of colorectal cancers. It will mobilize Belgian, Hungarian and Danish data.

Translated from IA et données de santé : focus sur cinq cas d’usage de l’espace européen des données de santé