If the Corona-Warn-App had been rolled out across Europe more quickly and comprehensively, could this contact tracing app have mitigated the spread of the pandemic? Maybe. Would uniform, Europe-wide e-health applications based on the General Data Protection Regulation (GDPR) or the EU Medical Device Regulation have served as a powerful alternative to solutions from China or the US? Presumably yes. As long as Europe has no uniform e-health strategy, we won’t have reliable answers to questions like these. But how can a European-made e-health system succeed when individual countries have already had a difficult time implementing a uniform strategy? A new discussion paper from the Bertelsmann Foundation outlines one approach to the problem.
“Proposals for an Integrated e-Health Strategy” is the title of a 64-page paper from a group of authors led by Dr. Thomas Kostera of the Bertelsmann Foundation. The paper does more than simply provide a clear, comprehensive introduction to the guidelines, recommendations, initiatives and strategies that deal with the issue of e-health at the EU level (there are a lot of them!)—it also explains why these have produced too few tangible results (too fragmented). The focus of the paper, however, is on concrete recommendations for how a European e-health system could arise and be successful. And the authors have good news: the GDPR and EU Medical Device Regulation already provide a solid legal framework. Nevertheless, the Bloc still has some catching up to do, as the following areas illustrate.
Making e-health applications relevant to our lives
Those needing medical care in European countries outside of their own no longer need to fear being denied treatment or having to pay out of pocket, and a number of regulations ensure that the process is smooth. Filling (e-)prescriptions across national borders or having an electronic file accessible throughout Europe would also be ways of offering citizens direct added value. That projects like these can work has been demonstrated by a pilot project between Finland and Estonia allowing patients to fill e-prescriptions across their borders.
Creating a European e-health market
With estimated sales volumes of €226 billion and €126 billion respectively, China and the US will account for nearly 60 percent of the global e-health market by 2025 according to one Roland Berger study. If European countries hope to play an independent role in the e-health market of the future and offer their citizens solutions that meet European data privacy standards, then there will have to be a multinational strategy capable of creating sufficient economies of scale in terms of data and markets. According to the paper, a European market would have “an estimated sales volume of €155 billion by 2025, along with over 500 million potential users. That would make Europe the second largest market in the world. A uniform market offers more opportunities for successful companies to develop, as a large home market would put them in a better position to enter a global market.”
European data governance
The e-health strategies of individual countries are always geared toward exchanging, using and analyzing health data for utilitarian purposes. In other words, the data are not an end unto themselves, but instead serve as a foundation for the work and decisions of physicians and scientists. This is the mechanism by which they provide a benefit to the patient. But: a purely technical exchange of data delivers little added value, which is why technical interoperability on its own is only half the battle. The discussion paper illustrates this with the following example: “Over the course of 15 years, the Netherlands learned, for instance, that developing technical interoperability and sharing electronic documents that were identical to their paper counterparts did not deliver the success the country was hoping to achieve. It was not until the past two years that they refocused their national digital health efforts on developing clinical data models (structure, formats, standardized measured values, semantic coding). In terms of optimum healthcare delivery, the full benefits of this kind of fully interoperable infrastructure are not going to be obvious or even recognizable until the data model specifications and requirements of all software systems can be mapped out or until the data to be exchanged can be fed into these models automatically.”
The use of artificial intelligence
Even now, e-health applications based on artificial intelligence (AI) are already making more efficient use of resources. And the same discussions arise, regardless of country: When does it make sense to use AI and when is it ethically justifiable? What do we know about the quality of the data underlying the algorithms? If we are to answer these questions, we need to create structures and processes that steer the focus toward ethical requirements such as privacy protection and anti-discrimination efforts. This doesn’t necessarily require new legal foundations and institutions—we can supplement existing standards and strengthen institutions so that they can fulfill their new roles. All of these and other ethical considerations need to be discussed within the framework of developing a European e-health strategy—particularly when it comes to a possible European governance structure, but also in terms of the interface with a European data infrastructure, with a code of conduct for data usage and with supranational use of e-health solutions.
The ideas and suggestions of the Bertelsmann Foundation authors are presented here in a highly abridged form. If you would like to learn more about a uniform e-health strategy for Europe, you may download the full discussion paper here for free.