Taking initial steps towards a data union

The European Health Data Space is a significant part of the European Health Union and is expected to improve the health of EU citizens. Since September 2022, a pilot project has tested how it can be put into practice.

Text: Dietmar Schobel

The COVID-19 pandemic has focused political interest on the topic of health. At a European level, early protectionist reactions by the Member States of the European Union (EU), such as border closures and export bans, were gradually followed with a coordinated and collaborative approach. And in September 2020, in her first annual State of the Union Address before the European Parliament in Strasbourg, newly elected President of the EU Commission Ursula von der Leyen said: “For me, it is crystal clear – we need to build a stronger European Health Union”.

Since then, for the first time in the history of the EU, debts have been taken out jointly to cope with the financial consequences of the COVID-19 pandemic. The mandates of the existing EU health authorities have been bolstered, and the Health Emergency Preparedness and Response Authority (HERA) was established in autumn 2021 as a new authority with a budget of one billion euros per year until 2027, or even more in an acute health crisis.

However, the initial steps that have been taken towards achieving a European Health Union go beyond merely ensuring that the countries are better prepared for an outbreak of infectious diseases. The pharmaceutical strategy aims to modernise EU pharmaceutical legislation to better support innovations and also make medicines more affordable and supply chains more resilient. And Europe’s Beating Cancer Plan intends to improve cancer screening and also increase the quality of life for cancer patients and survivors, their families and carers.

A pillar of the Health Union

According to the European Commission, the European Health Data Space (EHDS) is expected to become a key pillar of a strong European Health Union. In May 2022, the European Commission presented a regulation to set up the EHDS, which is intended to support both the primary and also the secondary use of health data. Primary use is by the patients themselves and also health professionals, and secondary use is for research purposes.

Both of these have the fundamental goal of ultimately improving prevention, diagnoses and therapies, and ultimately healthcare overall. The biggest challenges on the road to accomplishing this are ensuring data protection, and persuading the citizens and doubtless also the governments of the EU Member States to share their data and ultimately enable the systems to operate with each other. This interoperability involves implementing standardised content-related and technical specifications to allow data to be comparable and easily accessible, which is the basic prerequisite of sharing digital data within the EU. The potentially crucial importance of this measure was shown recently by the COVID-19 pandemic.

Varying starting points

The starting points in the individual Member States of the European Union are currently very different when it comes to the digitalisation of health data. A working paper published by the OECD in 2021 takes a look at results from a survey in 24 countries and reports that Denmark and Finland are already in an excellent position, both with regard to availability, maturity and use of health datasets, and also in view of their governance policies and practices. Among the EU Member States in this ranking, they are followed by France, Latvia, Netherlands, Slovenia and Sweden.

Since as early as January 2016, France has benefitted from the largest and probably also most comprehensive healthcare data resource in Europe, the SNDS databases (Système National des Données de Santé or SNDS) of the national healthcare insurances. These databases contain the pseudonymised socio-demographic data, medical histories, drug prescriptions and other therapies, hospital stays and a wealth of other health data for 65 million French people. This is almost the entire population of France, and corresponds to around 15 percent of the EU population.

The demand is huge, and we already support national and international research projects.


Goldmine for researchers

Portrait of Emmanuel Bacry, Scientific director of the Health Data Hub, France
Emmanuel Bacry, Photo: Health Data Hub

The French platform Health Data Hub, with its 56 partners, was used to link the SNDS database with other databases and develop a user-friendly interface for secondary use, i.e. for research purposes, as explained above. Researchers will find this data a veritable goldmine, and – after submission of the necessary application – it is openly accessible to scientists around the world. Scientific director of the Health Data Hub Emmanuel Bacry reports: “The demand is huge, and we already support national and international research projects.”

In future, this number is expected to grow because the Health Data Hub is also the leader of a consortium of 16 partners from 10 European countries, which has been commissioned by the European Commission since September with implementing a pilot project for the European Health Data Space within the next two years. It will deliver practical solutions to challenges that arise during implementation across Europe, and show the potential of transnational reuse of health data for research, innovation, development of regulations and policies and, ultimately, personalised healthcare. Specifically, there are plans to link the platforms of the project partners on a technical and content level, and also test applications through research projects. This could be used to enable a rapid exchange of data in a wave of infections, better therapies for rare diseases, or the application of artificial intelligence in the field of medicine, for example.