Why we need a European Health Data Space

It sounds like an ambitious goal – and it certainly is: By 2024, the European Union aims to create the conditions for a common European Health Data Space (EHDS) and to digitally connect the health systems of all Member States. The purpose of pooling health data is to improve healthcare delivery in the EU and to provide important information for research. Researchers hope to gain valuable insights into the prevention of diseases that could save lives in the future.

In Germany, an important step has already been taken in the right direction with the Telematics Infrastructure. This data highway for the health system enables doctors in Germany to exchange information digitally and to process applications, such as the electronic medication plan. The European Health Data Space builds on this and aims to make health data usable across borders.

The most important advantages of the European Health Data Space at a glance

1. Advantages for patients: Data sovereignty always and everywhere

For patients, the benefits of the Health Data Space are obvious. First of all, it enables patients to access autonomously manage their data, no matter where they were last treated in the EU. In addition, findings or X-ray images, for instance, can be made available faster than before. This makes communication between patients and practitioners less complicated and more effective. Diagnoses could be made faster and therapies initiated more quickly. One very practical advantage of the Common Health Data Space would also be the harmonization of different applications within the EU. A prescription issued by a German doctor could also be filled at a pharmacy in another EU country. What was once inconceivable is now actually no longer a problem thanks to the European Health Data Space. Last but not least, patients can benefit from an overall increase in the quality of treatment and care when health data used in research leads to promising results, for instance, for new therapies.

2. Advantages for medical professionals: less red tape and better treatment

Analog or non-optimized digital processes consume vast amounts of time in the healthcare sector. Time that doctors, physiotherapists, nurses or pharmacists would prefer to invest in the care of their patients. Simple exchange of data relating to medical treatment – even across national borders – significantly lessens the burden on medical staff.

3. Advantages for research: using data to help patients

For stakeholders from academia, research and the e-health sector, the European Health Data Space would provide a true treasure trove of data, offering huge possibilities for use. The data could help provide new insights into rare diseases, for instance, and shed light on prevention and treatment. The data could also be a powerful tool in dealing with pandemics. A European Health Data Space can therefore actively contribute to medical progress. If the transmitted data remains anonymous and secure, patients too will benefit.

Until this happens, there are still some fundamental issues that have yet to be clarified among the EU Member States. One major challenge seems to be the harmonization of the still different technical requirements. After all, when it comes to a European Health Data Space, the Member States need to establish a uniform system for collecting health data and standardize how the system is managed in order to ensure interoperability. And the legal basis is not the same in every EU country either: Although the General Data Protection Regulation (GDPR) applies in all Member States, protecting health data calls for more far-reaching measures which too must then be standardized throughout the EU.

What we can learn from Finland

Finland is one of the great models for the European Health Data Space where the digitalization of the healthcare system is being strongly promoted by the country’s government. The ‘Kanta’, Finland’s electronic health card, has been around for more than ten years together with ‘Kanta Services’: A website is provided where patients can at all times view all their collected health data and medical records. Electronic prescriptions, for instance, are also stored here, which patients can access and request via the platform. Paper prescriptions are the absolute exception in Finland. Doctors, pharmacists and other medical staff can also access the Kanta data. Laboratory findings, X-rays, examination results – all of this is digital form in Finland. Even researchers or start-ups from the e-health sector have access, because the data is first anonymized for this purpose.

With Findata, the country has also created its own agency for digital health and social data. This agency is responsible for collecting patient data from primary care together with data from national medical registers as well as social data of all kinds and, if necessary, for passing this data on in anonymized and processed form. Finland has regulated the release of its health data according to the principle of contradiction (Widerspruchsprinizip). However, only a tiny proportion of the Finnish population makes use this option. To create the legal basis for the health data space, Finland even passed the so-called ‘Act on the Secondary Use of Health and Social Data’ in 2019. This act permits stored health data to be generally used for purposes other than those envisaged at the time the data was actually collected. These purposes include, for example, scientific research and teaching or the compilation of statistics.

A data trustee can alleviate security concerns

In Germany, skepticism about data sharing is more pronounced than in Finland. Many in this country fear that personal health data could end up in the wrong hands, for instance, employers, insurance companies or even cybercriminals. Nevertheless, there is generally a basic willingness among Germans to provide health data. Seventy-nine percent of the population, for instance, would be willing to donate this data digitally to medical research, both anonymously and free of charge. This is the result of a representative forsa survey commissioned by Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V. (Technology and Methods Platform for Connected Medical Research) (TMF) from 2019. For many, reliable data protection is a prerequisite. According to a YouGov consumer survey commissioned by Bundesdruckerei in June 2020, health and data protection are of equal importance to half of all respondents.

In a European Health Data Space, the fear of data misuse could also be alleviated by a so-called data trustee. As a neutral body, the latter would have no commercial interest in utilizing the collected data and would guarantee secure, pseudonymized transmission of information. The trustee would also ensure that the data is disclosed only to recipients approved by the data donor. In this way, patients always retain control over their data. This is a concept that could pave the way for the European Health Data Space.