>> In information technology, there is the concept of the "Single Point of Truth" (SPOT) or "Single Source of Truth" (SSOT). Wikipedia aptly describes the underlying principle: "It states that a universally valid data set is to be available, which claims to be correct and can be relied upon. A data model in which a universally valid data set is to be made available, with the necessary data quality and reliability, is particularly important when data is kept redundant" (entry accessed on March 7, 2022). Indeed, many phenomena and, above all, problems surrounding the electronic health record (ePA) can be understood by drawing on the SPOT concept, not least the derivation of the necessity of the ePA itself.

In traditional, "analog" care, such a SPOT does not exist. Data points on individual patients are available in a wide variety of locations, e.g., in the documentation of the general practitioner or specialist, in the pharmacy, in radiology, laboratory or dental practices, with all kinds of therapists, health insurance companies, hospitals, rehabilitation and nursing facilities, and many more. They all have the reference point of the respective person being treated, but do not belong to them and are largely unknown to them and inaccessible in everyday situations. No person or institution involved has even a remotely complete picture – and the timeliness of the respective data also varies greatly. Naturally, this data chaos poses significant threats to patient safety! It was precisely for this reason that the telematics project, and in particular the electronic patient record, was launched in 2001: so that whether important medical history information is included, drug interactions are checked, and emergency data is used in a timely manner no longer depends on the individual patient's level of information, assertiveness, memory, and coordination skills. People die or suffer lasting damage when relevant information is not available or not linked. The lack of a complete, up-to-date, and accurate patient record is no trivial offense!

The EHR is intended to relieve patients' burdens, not to disempower them—quite the opposite: Immediate access to a patient record that's understandable, structured, up-to-date, and linked to evidence-based information is an important step in increasing the health literacy of those affected. Missing this opportunity is by no means a small matter!

Therefore, in 2021, the Patient Safety Action Alliance established a working group to define minimum requirements for the ePA from a patient safety perspective. At its core, these minimum requirements must be to ensure that the ePA, for the first time, creates a "source of truth" in the healthcare system, one that reliably, up-to-date, understandable, and easy to use, summarizes all relevant medical data about a person. Then—and only then!—is this project attractive. One cannot expect any relevant benefit from an ePA—or from any digital application, such as an eMedication Plan—if these tools cannot be established in such a mandatory and comprehensive manner that they truly become "sources of truth."

Unfortunately, we in Germany are still not on this path when it comes to ePAs. Individual, small pieces are still being experimented with under the name "Medical Information Objects" (MIO). Significantly, gematik, which is central to the implementation of the ePA, offers an online "MIO toolkit" instead of an overarching structure for the ePA into which all elements fit, support, and complement each other. In fact, the individual subprojects currently being developed by the National Association of Statutory Health Insurance Physicians are, at best, small snippets of a complete patient record.

The closest thing to the idea of a structured, comprehensive view of a person's health situation is probably the "patient summary," which is intended to summarize the existing emergency data set and personal statements. With a lot of goodwill, one could view this as the starting point and crystallization point of a truly structured electronic health record—if it were created with the needs of those affected in mind and developed further accordingly. A look at the procedural rules of the National Association of Statutory Health Insurance Physicians, however, is sobering: 26 associations and institutions from the healthcare sector are involved in the design of the patient summary—but not a single one represents patient interests or has an explicit focus on patient safety. The "patient summary" also appears to be an isolated project in a vast field of other, equally isolated digital islands.

What are the reasons behind the disastrous performance in this core area of digitization in healthcare? Let's take a look at the key players and the unpleasant truths they face.

The first truth that must be stated here is that gematik is not (fully) doing the job it should be doing. Even if the current work program is already a Herculean task, the ePA is not just about overcoming technical and data protection hurdles, establishing interoperability standards, and building the necessary infrastructure. Representatives of gematik describe this package as providing an arena in which medical applications can thrive. Whether this arena will result in an orderly team game that serves a meaningful goal, or a wild coexistence, perhaps even competition, will ultimately determine whether digitalization will achieve more than the creation of a digital plastic bag in which data of dubious timeliness, accuracy, and completeness is thrown together more or less randomly without any overarching structuring – often bypassing those affected. gematik, and with it first and foremost the Federal Government and the responsible Ministry, will therefore have to face the truth that they cannot abandon the task of technical and content-related design.

But the unpleasant truths for the Federal Ministry of Health, as the regulatory authority, don't end there. For the ePA to truly fulfill its role as a "single source of truth," a series of organizational requirements are necessary, requiring a significant change of course from the established players. These obligations can only be defined and enforced at a higher level by the state. Experience over the past two decades shows that otherwise, self-administration remains stuck in its entrenched stereotypes. No one can or will take away this creative achievement from the BMG, but above all the substantive and political responsibility – unless we get a purely commercial offering like Amazon.care, which would mean a complete break with the statutory health insurance system.

The most unpleasant truth facing service providers is that a reliable, complete, and up-to-date patient record can only be used for daily work if every single service provider and every organization is strictly obliged to document current, complete, and structured information in the ePA. Whether a particular lab result or diagnosis appears in the ePA cannot be left to the individual decision and active intervention of, for example, the individual general practitioner or specialist. This must be automated via the practice management or hospital information systems used. And there must be a clear requirement that only services included in the ePA can be billed to health insurance companies. (This, of course, entails special requirements for the design of the record, so that cold treatments from recent years do not appear more comprehensively than cancer.) This ends the exclusive ownership of patient records, especially by doctors, which naturally also promotes quality assurance and the hoped-for reduction in unnecessary services.

In any case, the health insurance landscape will have to face the truth that the service providers' efforts to provide structured documentation in the ePA cannot be compensated with €1.67 per quarter per patient (see Ärzteblatt 2021). The amount of this compensation agreement speaks volumes that both partners have agreed on the lowest possible quality level for patient record maintenance—which is by no means sufficient.
to create a functional ePA. Health insurance companies should also abandon the idea of making the ePA, of all things, a central competitive tool. It certainly doesn't matter whether the app that insured persons use to access the data is green, blue, orange, or yellow—but the functionality and data structure must be the same. Not to mention the portability of the file when changing insurers.

Another truth concerns data protection. A high level of protection for health data is undoubtedly essential. But the ePA definitively demonstrates that the old data protection instruments, especially data minimization and detailed consent from data subjects, not only fail to prevent misuse of the ePA, but also block the potential benefits of these digital solutions for the lives and well-being of those affected. It is time to rethink data protection methods entirely, for example, placing greater emphasis on access logging and consistent abuse control and punishment.

In any case, the dogma of the patient-led health record must be abandoned. While this construct may have significance in traditional data protection as a justification for data collection, in practice it represents the safest route to a digital plastic bag. Hardly any patient or insured person will be able and willing to maintain their own health record, i.e., determine its composition and enforce documentation with service providers. At the same time, the fiction of the patient-led health record would relieve service providers, health insurance companies, and gematik or the Federal Ministry of Health (BMG) themselves of their responsibility to ensure the necessary professional structure and quality of the record. The ePA must be assigned to the patient or insured person and accessible to them at any time, but it must not be arbitrarily altered or even compiled.

Perhaps the fact that every stakeholder in the healthcare system has to face unpleasant truths and accept painful changes regarding ePAs is the main reason why, even after twenty years, the telematics initiative in Germany has yet to produce any significant results. Pain is avoided as long as possible. Perhaps, however, the severe strains facing the healthcare system with the (hopefully) waning pandemic, the staff shortages, and the financial burdens of global political developments are the initial spark that will finally overcome the pain of not having a functional ePA as a "source of truth" and the linchpin of efficient care. Things are currently happening in politics that were unthinkable just a few weeks ago. One can only hope that this will be the case with ePAs.