European Health Data Space: Treating rare diseases better?

Can the creation of a common data space ensure better care for people with rare diseases? This and more was discussed at the Tagesspiegel Expert Forum.

Real World Evidence Data: unerlässlich bei Seltenen Erkrankungen

Can a common data space harmonise the handling of health data across the EU? What data do different actors in the medical care of patients with orphan diseases need? And how can a transnational, data protection-compliant linking of different data sets in the area of rare diseases be implemented in concrete terms, from which those affected can benefit to the maximum? These are complex questions that were addressed at the Tagesspiegel Health Forum under the title "Rare Diseases: Setting the National Course for a European Health Data Space". Speakers from medicine, politics, science, industry and patient representation came together in search of answers under the moderation of Mr. Gunnar Göpel, in Berlin, Germany.

Introducing the event, Mr. Thomas Renner, Head of the Digitalisation and Innovation Sub-Department at the German Federal Ministry of Health, explained: "A learning health system needs high-quality data. Patients with rare diseases in particular benefit massively from real-world evidence data - but the availability of high-quality data is always a problem. Renner listed the biggest barriers to data availability as:

Now the European Health Data Space comes into play: The "common data space's" politically defined goals are described by Mr. Renner as hoping to improve the exchange of electronic health data, which will not only support health care, but also health-related research, innovation and personalised medicine. A perfectly thought-out concept, then? To a large extent, this space has been very well thought out.

On the plus side, with regard to primary data and "record systems", the approaches of the EHDS are suitable for strengthening data exchange in Europe, e.g. with regard to data categories, exchange formats or platforms. However, data access to all primary systems was too extensive - questions of technical implementation had to be the responsibility of individual member states. With regard to secondary data, the EHDS provides suitable approaches to improve data availability; in addition, national access points could facilitate the location of and access to data. On the other hand, the categories of data to be provided still need to be specified. In addition, the European Commission must participate in the development of infrastructures, according to Mr. Renner.

All in all, Mr. Renner is convinced of the concept of the EHDS: it will not only strengthen the rights of patients in dealing with their data, but could also reduce existing uncertainties and different interpretations of the General Data Protection Regulation (GDPR) in dealing with health data. However, Mr. Renner considers the goal of establishing a European Data Space by 2025 to be very ambitious. In his view, a step-by-step approach should be taken here first and relevant health data should be made accessible gradually.

Health Data Space: without patient participation and "good data" it won't work

Prof. Stefan Mundlos (Director of the Institute of Medical Genetics and Human Genetics, Charité Berlin & Deputy Director, Berlin Centre for Rare Diseases), Ursula Gaedigk (Patient Representative of the State of Berlin, Senate Department for Science, Health, Care and Equality) and Jean-Luc Delay (Managing Director, Takeda Pharma Vertrieb GmbH & Co. KG) exchanged views on the question: "What data do we need in the future so that patients can benefit? Some key statements were:

There's great willingness to "donate data" - but little knowledge about digitalisation in the health sector

Judith Klose, Vice President Media & Marketing at CIVEY, provided exciting insights into the topic of data and health, presenting survey results on the topic of digitalisation/health research/data protection in her talk. The results showed that the topic of digitalisation in the healthcare sector currently only plays a role for a few people. The respondents perceived the topic of digitalisation in everyday life most strongly in the areas of leisure (25.9 %) and work (19.6 %) - in the area of health care it was only 3.1 %. But according to the survey results, there are high hopes for the topic of health data: The question "Would you be willing to make your health data available to health research anonymously and in compliance with data protection regulations?" was answered with "Yes" by 64 % of the respondents - a broad consensus of all age groups, from 16 to 65+.

What is still lacking in the digitisation of the German healthcare sector? Employees from the sector see the biggest problems in data protection (48%), a lack of infrastructure (41%) and a shortage of skilled workers (34%). A lack of resources, on the other hand, is only a problem for about one fifth of the respondents. Specifically with regard to rare diseases and what is needed to develop the data base for research, doctors, healthcare workers and industry workers agree: the absolute priority is the creation of a digital network/database (48%, 45.7% and 41.8% respectively). Only a few of the respondents, on the other hand, can do something with the European Health Data Space: More than 45 % of those working in the healthcare sector do not know about the EHDS, in the pharmaceutical industry it is even 66.8 %. Doctors, on the other hand, are in a better position here: Only 29 % of the respondents are not familiar with the European Health Data Space.

Judith Klose summed up:

Conclusion: Making the value of patient data better known

Finally, Gunnar Göpel summarised some of the most important findings of the event:

Rare Disease Day

230124-Rare-Disease-Day-Bann..Since 2008, the worldwide Rare Disease Day has taken place every year on February 28. esanum joins this awareness day and reports not only on current topics, but also on possible symptom complexes, diagnostics, therapy approaches and orphan drugs for the treatment of rare diseases. You can find more information on our dedicated Rare Disease Database.