Ehds is ambitious but achievable, complex but manageable

10 January 2023
When working for the public health insurer, Wrosch realized that one of the most valuable resources – a renewable good that could be transformed into better medicine and prevention – is wasted. It's data. Prior to digitalization, medical files were closed on paper. When data finally got digitized, they were trapped within healthcare facilities or Electronic Medical Records. Paper has cemented a culture of working in silos that have proved stronger than the opportunities created by technology. It's easy to say that we have to rethink healthcare. But how to do it in Europe with its patchwork of 27 legislative systems, a different approach to ethics, diverse expectations, habits and systems' structures? In a 50-page master's thesis, Wrosch describes challenges and potential improvements to patient care and the healthcare system from the perspective of expert groups. What's in it? The conclusion of your master thesis is clear: Germany is not yet ready for EHDS, and many other EU countries aren't. Does this mean that the project is doomed to significant delays? The EHDS proposal is indeed very ambitious and, according to my interviews, could pose considerable challenges to member states and even overstretch them. However, it is important to note that the EHDS is, so far, only a proposal by the European Commission. After consultations with the Parliament and the Council, I assume the project will be implemented in a modified form, presumably with adjusted deadlines. I don't think the European Commission's aim will be to overburden any member states. So yes, I'm sure the implementation will take longer than foreseen in the proposal. Within the series of interviews, you found out that one of the obstacles is self-governing bodies. You quote one of the MDs: "we have self-governing bodies that do not actually work together at the top but deliberately set themselves up against each other." There is even an opinion that "group egoism has been considered more important than pursuing a common goal." Is there a way to break these "interest silos" in healthcare? After my interviews, I have the impression that the interests of several stakeholder groups are not necessarily opposed to each other but that dialogue, education, and understanding are often lacking. With a large project like the EHDS, it will be a matter of convincing the multitude of stakeholders and the public of the idea - of winning them over to it. So, much educational work has to be done, and no one should feel left out or left behind. How do we break down the silos of interest? I'd say educate, involve citizens and stakeholders comprehensively and remove fears of new approaches and solutions. Basically, do exactly what the Federal Ministry of Health has been doing and has been striving for since September 2022 as part of its digitalization strategy. I think its development is overdue; it can lay an important foundation for future progress and will contribute enormously to breaking down existing interest silos. We already have Gematik (an institution responsible for the digitalization of Germany's healthcare market) for implementation and an interoperability council striving for standardization. What we need is a clear and consensus-based governance strategy for digitalization in healthcare that contains long-term goals and realistic deadlines and is constantly monitored to adjust if necessary. Another factor hampering digitalization in healthcare is GDPR. You quote another stakeholder: "The real problem in the GDPR is the G, namely, it is not a data protection regulation, but a general regulation." It means that every country has its own regulations. Is EHDS in such a fragmented ecosystem possible?  Indeed, such a fragmented data protection ecosystem makes the implementation of a project like the EHDS much more difficult. But the EHDS could also be utilized as a great foundation to address the problem of fragmentation. For example, health data protection could be more standardized based on a European Health Data Space. This would facilitate the implementation of the EHDS itself and also release many more potentials for research and innovation. What is important to me here is: that standardization in no way stands for any "weakening" of data protection; actually, quite the opposite! I am convinced that standardized data protection – I mean sensitive health data – can even lead to more security, as uncertainties on the part of citizens and stakeholder groups could be reduced. In any case, even within the framework of the GDPR, it is clear that digitalization and innovation in healthcare are possible. There are numerous role models in the EU. So what must be done for the EHDS to be launched in 2025 as planned by the EC? First, of course, we need the further political process and the next steps at the European level. Apart from that, referring to Germany: The EHDS is already briefly mentioned in the current coalition agreement, which also contains important projects that fit in well with the EHDS, such as the planned Health Data Usage Act, the development of a research data infrastructure, and the digitalization strategy that is currently being developed. Therefore, it would be important that the EHDS is already being considered during these projects' elaboration and implementation, as far as possible. What did surprise you the most during your research? In fact, the experts interviewed were basically very much in agreement, even if framed from their different perspectives. On the one hand, about the existing problems regarding digitalization in the German healthcare system, combined with quite self-critical stances of some stakeholder groups. On the other hand, with regard to their desire for the functional, secure, patient- and user-oriented digitalization and health data use, with tangible and measurable added values for all. To summarize: could you please list the recommendations you share in the paper?  Based on my analysis and discussion, I was able to derive nine recommendations for action. One set is directed at the German healthcare system, the other one at the European Commission. The recommendations are partly in line with those of other studies, such as the Bertelsmann study from 2018, basically confirming them and also showing that there is still a need for action since back then. My recommendations are described in more detail in my thesis and are short as follows: Concerning the German healthcare system, I recommend the following:
  • Development of a holistic governance strategy for digitalization in healthcare;
  • Development of a common, consensual position on the EHDS proposal;
  • Step-by-step assurance of interoperability;
  • Standardization of health data protection legislation;
  • Increase stakeholder participation and citizens' involvement;
  • Increase digital health literacy among professional groups and citizens.
Concerning the European Commission, I suggest:
  • Raise awareness, education, and involvement regarding the EHDS;
  • Clarification of European infrastructure and providing European access bodies;
  • Review and adjustment of the deadlines and competencies provided for in the proposal.
After writing the paper, are you optimistic or pessimistic about implementing EHDS? I do not think the EHDS will be implemented exactly as it was proposed. However, I am very optimistic that the project will be a big push for care, research, and innovation in the EU and will strengthen our health systems. Especially in Germany, where we have had such a hard time with digitalization in the health sector, we must make good use of an opportunity like the EHDS. Download the Master Thesis by Lukas Wrosch.