From electronic health records to telemedicine, the digitization of healthcare in the countries of the European Union is progressing at different speeds and resembles a patchwork quilt. It is certainly true that there are a large number of promising European initiatives in the e-health sector. But a clear, pan-European vision is still lacking. In an impulse paper, we argue for an integrated e-health strategy. Such a strategy must include a European Health Data Space to promote innovation, economic growth, and optimal healthcare. 

Pursuing a common strategy should mean having a clear structure and a common data basis for it. “Just imagine what would have been possible if we had already had a fully functioning European Health Data Space by the beginning of 2020?” asked Thomas Steffen, State Secretary at the German Federal Ministry of Health, at the opening of the virtual conference “Digital Health 2020 – EU on the Move” at the end of 2020. “With high-quality and comparable health data. What difference would this have made for the surveillance of outbreaks, the development of vaccines and the treatment of COVID-19?” 

For Germany’s Presidency of the Council of the European Union, the German government had set out to advance the European Health Data Space (EHDS) proposed by the EU Commission, and had presented a roadmap for doing so. Meanwhile, the EU is also planning to present a legislative initiative on the EHDS by the end of 2021. It goes without saying that the joint fight against pandemics is only one example of an application for the meaningful use of health data across Europe. The overall potential of an EHDS is immense, from access to large pools of data for the development of innovative diagnostics and therapies to the promotion of economic growth – not at least within an EU-wide e-health market, which could compete with China and the U.S.A.

How health data can be used across the EU broadly falls into three categories or scenarios: 

  • for healthcare purposes (primary data use) 
  • for research (secondary data use) 
  • for public health and health policy (secondary data use)

However, a common data space needs clearly defined legal and policy instruments to ensure legal certainty for research, industry and citizens. An essential requirement for this is solid and reliable governance of health data that enjoys the trust of different stakeholders – most importantly, of the patients whose data are to be used and reused. Such European governance in turn requires a common understanding of governance and regulatory frameworks across member states, as well as a legally anchored processing of health data. 

EU-wide code of conduct as the foundation for a common data space 

The problem: Unlike in other areas, the European General Data Protection Regulation (GDPR) has so not yet brought more uniformity to the healthcare sector: it does provide a general framework with requirements and rules for the use and collection of healthcare data. But it allows EU countries to interpret it in different ways by enacting regulations at the national level, especially in the area of research. 

Therefore, it is necessary to create an EU-wide code of conduct for a European governance model. In other words, a “code of conduct” for the primary and secondary use of health data that strengthens the self-interest of citizens and informs them as well as public and industrial researchers about the legal principles that apply to them when handling health data. 

Most importantly, both the benefits and the added value of European governance for data use must be clearly identified for each of the three use cases. Europe must strengthen citizens’ trust in digital sovereignty. This also means that citizens who consent to the processing and use of their data must understand what advantages or benefits they can expect as a result – whether directly, for example, through the improvement of care services, or indirectly, for example, through long-term opportunities for the development of innovative diagnostic and therapeutic services. 

Citizens must also be convinced about data protection and the safety of data use. This is the only way to convince them to take on an active role as data donors of additional information, for example for research purposes. In principle, the willingness of the population to donate data is very high: according to surveys, 90 percent of Germans alone would be willing to make their health data available to research. 

An active role for EU citizens

So far, however, opportunities for meaningful data donation have been sparse. One of them is the EU’s Smart4Health project: the open-source data platform is working on a pan-European electronic health record to help EU citizens manage their health data. In turn, they can drive innovation with their data donations. However, the amount of data available on this in the healthcare sector to date is still comparatively small. 

Various measures can be useful to strengthen citizens’ willingness to cooperate: Data donors must be able to manage access rights autonomously via a secure infrastructure and have the option of objecting to the use of their data in a simple procedure. In addition, anonymization models can help to create more trust, as this prevents conclusions being drawn about personal information. In this way, data sets could also be obtained from the electronic health records of individual countries, for example. In Germany, the Patient Data Protection Act (PDSG) will allow citizens to voluntarily make data sets in their electronic health record available to research in a pseudonymized form from 2023. 

An example from Finland shows how trustworthy governance of health data coupled with a code of conduct can succeed and lead to an active role for citizens: Findata, a licensing authority and central point of contact for the reuse of health and social data, has existed there since 2019. Findata’s mission is to improve data security and privacy for individuals, accelerate and streamline the use of social care and health data resources, and develop data descriptions for the social care and health sector together with data processors. The basis for Findata’s work is the Finnish “Act on the Secondary Use of Health and Social Data.” 

This example also illustrates how a European strategy could be focused to realize a unified European governance model for data. The focus should be on common data strategies and models that draw on European values to protect privacy rights and, at the same time, contribute to the economic power of the Digital Single Market and a potential European data economy. 

The Bertelsmann Stiftung’s impulse paper* contains a total of seven recommendations for action for an integrated European e-health strategy. We will discuss a number of them in more detail  in a series of  blog posts:

  1. An integrated European e-health strategy must be tailored to the needs of citizens.
  2. An integrated European e-health strategy must create a single e-health market. 
  3. An integrated European e-health strategy must include the governance for a European health data space.

*Paper available in German with English recommendations for action.