>> Germany once had a dream: a modern IT infrastructure for its healthcare system, making it an international pioneer in e-health. "Today, we must soberly acknowledge: This has not been achieved. At least not for the time being," state Dr. Brigitte Mohn (member of the board) and Uwe Schwenk (director of "Improving Care – Informing Patients") of the Bertelsmann Foundation in the foreword to the study. While other countries have been storing key patient data in electronic files and transmitting prescriptions digitally for several years, Germany is still working on the foundations of digital networking and exchanging information primarily on paper.
But the authors of the foreword also offer encouragement: digital transformation is nowhere a straightforward process. The Bertelsmann Foundation's comprehensive, 400-page analysis is titled "SmartHealthSystems – Digitalization Strategies in International Comparison." The first part of the study, titled "International Benchmarking and Digital Health Index," depicts the status quo of digitalization in the German healthcare systems and those of other countries (a total of 17 EU and OECD countries). The study is based on "34 indicators relating to strategy, technical readiness or digital maturity, and actual networked health data exchange." The first part also includes a benchmarking exercise that allows for a country comparison with regard to digitalization (see Figure 1).
For the “Digital Health” Index and benchmarking, the Bertelsmann Foundation collected data on three thematic blocks in the relevant countries:
• Policy activity and political strategy,
• Technical implementation and readiness,
• Actual use of data.

Germany ranks second to last in the overall country ranking (see Figure 1) with 30 points. With this score, the country belongs to the bottom group of Switzerland, France, Germany, and Poland.
The study authors conclude that attempts to advance digital health at the political level, which have been ongoing for several years, have met with only moderate success, pointing to the "Policy Activity" sub-index, in which Germany also ranks second to last with 44.2 points (see Figure 2). In addition to the strict data protection regulations typical for Germany, the Bertelsmann experts criticize the lack of overarching strategic guidance and financial incentives to comprehensively introduce the solutions manufactured by industry and certified by gematik. There is no central political coordination by a corresponding agency. Readiness in Germany is the second lowest in the overall ranking (with 30.1 points, ranking 16th). National digital applications are not yet in operation. Another problem is the fact that gematik is constantly publishing new standards and interoperability regulations that must be met before digital solutions can be connected to the telematics infrastructure (TI). At the same time, however, the TI is neither mandatory nor do suppliers in Germany have to comply with gematik – they can develop their own solutions.
This fact is reflected in the "actual data usage" – here, Germany ranks 15th with 15.8 points. In general, health data is mostly documented electronically, and insurers use doctors' billing data for health reporting, according to the study's findings.
The federal government's legislative authority for the healthcare system, combined with the principle of self-administration, is leading to a multitude of "sometimes incongruent" political activities and statements on the topic of "digital health" in Germany. An overall strategy and a common vision that coherently encompasses research aspects and the issue of mobile health applications (mHealth) are not yet in sight.
Since the E-Health Act came into force in 2016, a formal roadmap for establishing digital health has existed at the federal level in Germany, the study authors note. There is also a general awareness within self-governing bodies, political parties, and associations of the key role of digital health services and applications for the quality and efficiency of the healthcare system.
The will is there, but no
Overall strategy
Despite some useful measures (such as the ongoing introduction of the telematics infrastructure, video consultations, or the establishment of patient records for the nationwide exchange of patient data, as well as the planned development of a health information portal), there is a lack of a concrete strategy to support technical and semantic interoperability. "The activation of gematik's interoperability directory vesta can be seen as a step in this direction," the authors conclude. However, they are critical of gematik's approach and (shareholder) structure as a developer and operating company for the telematics infrastructure. This structure appears "legally and politically incapable of coordinating and managing a national central system with all relevant stakeholders."
According to the analysis, larger strategic gaps also exist in the contexts of telemedicine and mHealth. While numerous successful telemedicine projects have existed in Germany for many years, the vast majority are offered only regionally or under selective contracts, preventing patients from benefiting from them across the board. The question arises as to the means and ways to scale beneficial approaches. In the area of mHealth, the greatest need for clarification exists with regard to adequate mechanisms for transferring applications into standard care.
Further criticism from the study authors relates to time management: "There are no comprehensive, binding target formulations, guidelines, or deadlines for a digital health system as a whole." Only individual applications, such as the insured persons' entitlement to an electronic patient record (ePA) from January 1, 2021, are regulated in the E-Health Act.
Another point of criticism is the issue of financing. Currently, the digitization of the healthcare system in Germany is not secured by a special digital health budget or supported by a specially created digitization authority, the authors complain. However, they see initial reform approaches in this direction, as Federal Health Minister Jens Spahn (CDU) has now established a department for digitization, which is intended to eliminate interface problems and develop the necessary political foundations (e.g., for telemedicine services).
The "Digital Health in Germany" overview (Fig. 3) reveals a particular need to catch up in digital health infrastructure and the corresponding applications. A more detailed breakdown (see Fig. 4) of these areas shows that electronic health services (such as e-prescriptions or information portals) are under-promoted and under-utilized. A major critical issue is the use of data. The analysis identifies the greatest deficiencies in the areas of interoperability, linking and sharing of data sets, as well as structuring and coding (see Fig. 4).
Furthermore, it is striking that only one measure in the "Digitalization Profile Germany" (Fig. 4) is rated as "fully implemented" – data protection. Patient privacy is therefore evidently already protected by sufficient security measures. The second and final piece of good news from this overview is that the political will to support data transfer and exchange is "almost complete." Overall, however, the picture is negative: Only a small portion of the measures are considered "partially implemented," while the majority are considered "rather not" or "not" implemented (see Fig. 4).
Recommendations: digital short files
and E-Health Institute
The study authors' conclusion on the status quo: "Currently, the discourse on digital health in Germany is heavily dominated by liability and data protection issues." The actual opportunities for medical care offered by digitalization are being pushed into the background. They advocate for a debate on new approaches to renewing governance structures and the role of gematik in Germany.
The second part of the analysis, entitled "Success Criteria and Levels of Use of Digital Applications," focuses on five countries: Denmark, France, Israel, the Netherlands, and Switzerland. The study's experts examine the political actions and structures, as well as the framework conditions, that have proven to be success factors or barriers in the digitalization of healthcare systems.
Based on these examples, they derive recommendations for the German healthcare system:
• Focus on two central, relatively quickly implementable use cases: an electronic short file of particularly relevant general patient data (electronic patient summary) and, in addition to the planned e-medication plan, the introduction of an e-prescription. So-called electronic patient summaries are now part of everyday operations in most countries, making patient data relatively easy to exchange across the board and across sectors. In this regard, Germany, for example, has an approach in place with the emergency data set and emergency data management (NFDM) that, upon closer inspection, meets the international definition of a patient summaries. Accordingly, the emergency data set could become the basis for further use cases independent of the electronic health card. In order to take into account the strong role of self-administration actors, individual summaries systems could be developed at the health insurance fund level. At the national level, a master data set in the form of a patient summaries could then be defined with the involvement of all relevant stakeholders, so that core data is also available across health insurance funds in the event of an emergency. In view of the emerging "island solutions" of the respective health insurance funds, such an approach would be realistic and the corresponding framework conditions should be developed so that the ePA required by 2021 can be realized, according to the study authors.
• Adequate care in rural areas: Use of the emerging infrastructure through problem-appropriate telemedicine tools.
• Secondary use of collected data by other users (e.g., other providers or health care researchers). This requires an ethical framework and stringent laws and guidelines for data protection and IT security, particularly for the forwarding, access, analysis, and use of health data in secondary use contexts. This should not only be done at a general level, but also consider the underlying usage scenarios and users involved, the authors emphasize. In their view, general principles should tend to be regulated in laws, while details should be regulated in legal regulations that can be more quickly adapted to new circumstances.
• The financial framework should be reliable, adequate, and sustainably available. The continued funding of new pilot projects ("pilotitis"), however, leads to a waste of public funds. Furthermore, financial incentives could be used to promote the faster introduction or use of central or regional data exchange platforms and cross-utility data access or exchange services.
• Establishment of a new institution to implement the Digital Health Agenda: a fully empowered
E-Health Institute. Bertelsmann experts define this as an organizational unit that is responsible for the overall development, management, and maintenance of the digital health platform and its infrastructure services. This unit must work in close collaboration with specialized organizations, such as those from e-government regarding cybersecurity or with national or regional organizations for managing electronic identities for citizens, physicians, and other healthcare professionals.
• The study authors see the most important task of the e-health institute as building consensus and cooperation in implementing the digital health agenda among healthcare system stakeholders with sometimes conflicting interests. They recommend establishing a general body—or a separate body for each application—and equipping it with an appropriate governance framework, enforcement powers (including for binding decision-making within a reasonable timeframe), and the necessary resources.
• To accelerate the implementation of a newly designed e-health policy and broaden the use of e-health solutions in Germany, the digital skills of providers and citizens must be expanded. This will also require the planning of corresponding capacities in the proposed German Digital Health Institute. Comprehensive digital health-related implementation and change management – including the promotion of digital skills and staff development – must be established there.
• Access to or exchange of healthcare system data, as well as its further use, processing, and analysis. To avoid unnecessary misplanning and the costs of a pure technology push in the digital health sector, it is essential to realize that data access and exchange are not an end in themselves, but should always be oriented towards the benefit for the data recipient – whether physician, patient, or secondary evaluator. And if no benefit of any kind can be achieved for the provider, it will be necessary to compensate them for the costs incurred in providing and transmitting the data. If the benefit ultimately accrues not to individual actors, but rather to the "system as a whole," the system must also bear the associated costs.
• When data and information are exchanged between actors who use different IT systems, interoperability becomes crucial for the functionality of the overall system. It is not enough to simply exchange data between technical systems. Rather, the healthcare organizations and individuals involved must understand the data and be able to process it meaningfully for their intended use. Solving the associated interoperability issues lies at the heart of any successful national or regional digital health infrastructure and the applications based on it. Taken to its logical conclusion, this implies that interoperability issues cannot be resolved through general standards, dictionaries, or abstract regulations, but only through usage-related analyses of concrete scenarios (use cases) and, based on these, solutions and specifications of all relevant parameters. In each case, specific usage contexts must be identified, for which a multitude of questions and details must then be discussed and a consensual solution supported by all those involved must be found.
• At the technical level, the study authors provide the following strategy recommendations:
1. First, the priority usage cases (e.g. short or full files, prescriptions, laboratory
results, discharge letters) and described in a standardised manner in all their facets, since there can be no general solution to interoperability issues in the healthcare system for the reasons discussed.
2. For each generic use case, the required information and data must be defined in detail and precisely.
3. It must be determined whether these should be exchanged in the form of simple text or documents, as strictly structured documents, or in part or as a whole as fully standardized and coded data. Depending on the further use of the data and the costs involved, quite different solutions to interoperability issues are conceivable and sensible.
• It should be determined whether the data will be available centrally, decentrally, via links at any time, or only upon individual request. Purely regionally oriented platform solutions are also conceivable (given that healthcare is primarily a regionally—rather than nationally—oriented service), which can be easily linked together using the same information processing, preferably based on open requirements and data models.
• Based on the analysis of successfully digitized countries, Germany will need consistent political action and leadership in the future – based on a clear vision shared by stakeholders and a clear implementation strategy. Measures and necessary standards should not be imposed "from above," but rather developed with the involvement of experts and—above all—end users. Among other things, the establishment of a "powerful" organizational unit for such an involvement process, in the form of a Digital Health Institute, would be suitable.

"Successful countries are characterized by a triad of effective strategy, political leadership, and coordinating national institutions—that is, 'digital health agencies' with a steering function," Mohn and Schwenk summarize. In their view, German health policy should continue consistently down this path, act more decisively, and expand its leadership role in shaping digitalization. "And last but not least, we must pick up the pace."
Author:
Olga Gilbers