Hasty digitization endangers the health system

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Digitalization in the healthcare system should actually relieve doctors, shorten waiting times and make patient treatment easier. Instead, doctors and developers of practice management systems (PVS) complain about massive problems and demand a change of course in politics.

The negotiators of the Ampel coalition have agreed on a joint “paper of the working group on health and care”. On six pages, the SPD, Greens and FDP outline how they want to expand the health system in Germany over the next four years. In the future, digitization will be promoted even faster than under Health Minister Jens Spahn (CDU). In addition to the upgrade of the electronic patient record and the start of the electronic certificate of incapacity for work (eAU), this includes, above all, the accelerated expansion of the telematic infrastructure (TI), which networks practices and clinics in Germany.

More from c't magazine

More from c't magazine

More from c't magazine

More from c't magazine

But while other industries welcome digitization to make work easier and increase efficiency, large parts of the doctors and their software suppliers are not enthusiastic. The Ministry of Health and the health insurance companies force them to do so and deduct 2.5 percent from the fee for those who do not join the TI.

The skepticism of the doctors and software developers is based on many problems and conceptual errors of the TI, which were exacerbated by the enormous deadline pressure that the former Minister of Health Jens Spahn exerted on the digitization project. Then there was the corona pandemic, which increased the pressure on everyone involved. Doctors, installation technicians and software developers are now exhausted and exhausted. This raises the question of whether the upcoming government should actually increase the pace of digitization even further, or should it be better to shift down a gear.

The Gematik project company is responsible for expanding the TI. Among other things, it determines the standards and certifications of individual components. The Federal Ministry of Health (BMG) is in charge of the Gematik administrative board. It holds 51 percent of the votes and drafts the laws in which the deadlines are stipulated, when which parties have to complete which components.

The software manufacturers of the hospital and practice management systems (PVS) must implement the requirements of the BMG and Gematik on time. You have to implement new components such as the eAU and test them in the TI test and simulation environment (TITuS) provided by Gematik. Updates will only be sent to customers when everything works. This only works if the PVS manufacturers can work undisturbed and have enough time to check the complex systems for errors. If something slips through them, it will affect hundreds or even thousands of medical practices and hospitals, which may then no longer be able to treat their patients.

The problem children are primarily the hardware connectors – special routers through which the practices connect to the TI. Every time a new function of the TI is to be put into operation, it needs an update. At the end of June, for example, there was also the option of creating and reading out electronic patient files (ePA). However, the associated connector update ensured that in some practices the communication in the medical field (KIM), which doctors use to exchange information, no longer worked.

In fact, such mistakes shouldn’t happen. The connectors – currently available in the CoCoBox flavors from CGM, Secunet and RISE – are only partially certified, but fully approved by Gematik. Gematik’s legal mandate also includes ensuring interoperability. However, the approval procedures are apparently incomplete, so that software problems and incompatibilities occur again and again.

Heiko Rügen and Uwe Streit, managing directors of Indamed, with 5000 installations of one of the larger PVS software providers, explained the problems in detail in an open letter to the National Association of Statutory Health Insurance Physicians (KBV): “It is very time-consuming for us and partly due to the time lag Availability of the new functions in the connectors impossible to test against each of the three currently available connectors. ” However, this is exactly what is necessary, as the various models require individual adjustments – despite the approval of Gematik.

For example, Indamed customers with the Cocobox only received cryptic error messages when attempting to sign emergency data. “It took several months before we could isolate the problem and solve it with more or less support from the connector manufacturer,” explained Streit. But after the bug for the Cocobox was fixed, customers with the Rise connector suddenly complained that they could no longer read electronic health cards. Because Cocobox and Rise-Konnektor react differently to certain soap header entries during data transmission, which makes the tests of the PVS providers so difficult. Certification and approval should actually prevent such differences, but in practice this is not the case.

The Indamed bosses see the illusory deadlines according to which new functions are to be integrated into the PVS systems as the main reason why the IT in medical practices and hospitals keeps on strike. As examples, they cite the electronic medication plan (eMP), emergency data management (NFDM), the electronic patient file (ePA) and the electronic certificate of incapacity for work (eAU), but also new software interfaces such as the prescription interface (VOSS) and the archive and exchange interface (AWS) . “What all of the above-mentioned specialist applications have in common is that they are conceptually not fully developed and not ready for the market simply because of the specification,” judge Rügen and Streit in their letter.

In between, the developers had to insert the support of the vaccination certificate at short notice from May to July 2021 and pause at other construction sites. In their letter, the two managing directors describe in detail the time pressure under which work was carried out. According to this, the manufacturer did not receive the stylesheet required to implement the eAU until December 2020 – one month before the originally legally prescribed start date by which the eAU was supposed to be ready. In the course of the year, the introduction dates of the ePA and the e-prescription were pushed back further and further. “Because of these postponements and reworking for non-functioning specialist applications, reliable development planning is not possible,” Rügen and Streit clarify.

The former health minister Jens Spahn (CDU) did not take his foot off the gas with the digitization despite persistent problems and put developers under tight deadlines.

(Image: Michael Kappeler / dpa)

Indamed makes the Gematik responsible for the bad planning. It provides the software manufacturers with the TITuS test environment, which the manufacturers can use to check new functions and updates. “TITuS is not prepared for the specialist applications e-prescription and ePA”, states Streit. “The environment cannot be reached reliably and has not given any reliable feedback.” Rügen and Streit describe the technical support provided by Gematik as “poor”. A ticket with “highest urgency” to problems of the eAU had eleven days without a reaction.

When asked, Gematik confirmed to c’t: “A specification-compliant implementation of individual systems does not guarantee 100 percent interoperability.” Over the past two years, Gematik has developed measures that “contribute to a reduction in quality defects”. These included “Connectathons organized by Gematik” and “end-to-end interoperability tests” with the manufacturers. In the TITuS test environment, Gematik granted unplanned maintenance windows and updates that were not successful. Manufacturers should therefore definitely carry out “tests against real components”.

Although Gematik and BMG were aware that manufacturers had to develop with an unfinished test environment, they did not move away from the TI constraints and deadline pressure. This raises the question of whether the Gematik fulfills its statutory tasks (§ 311 SGB V) in full. Next, the introduction of the e-prescription threatens to fail on January 3rd, the nationwide test run of which the Gematik will not start until December 1st.

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