Meanwhile, 141 systems in the healthcare sector have successfully completed the evaluation process for the medication list of the electronic patient record (ePA). This is according to Gematik’s conformity assessment (KOB). For practice management systems, this corresponds to 98 percent of the market, according to Gematik. If doctor’s offices do not have the current software from January 2026, they must expect sanctions – a billing exclusion could also await them.

With the ePA for all, the KOB was introduced as mandatory – initially for the medication list. The medication plan is to be added in 2026. The goal is to only use systems that meet predefined requirements and provide medication information in a structured, secure, and continuous manner across system boundaries. This is intended to reduce media breaks and ensure clear requirements for manufacturers. Hospital information systems from major providers are also listed for clinics, although hospitals will only have to expect sanctions from April 2026 if their software does not have a certified ePA module.

"With the KOB, we ensure that the systems are interoperable and that standards are consistently implemented. These are important prerequisites for the interaction of the many different systems on the market and are crucial for the interoperability of care processes such as the digitally supported medication process," says Steffi Neumann, head of the Competence Center for Interoperability (KIG) at Gematik. For easier switching between practice management systems, the legally stipulated archive and switching interface is being developed together with a subsidiary of the National Association of Statutory Health Insurance Physicians, mio42. While the industry has criticized in the past for not being involved in time, this time all stakeholders are "involved early and comprehensively to develop a practical and future-proof solution."

"The KOB [...] will ensure greater dynamism in competition and is an important lever for interoperability. With the KOB, we promote the quality of interoperability that we need for modern care. We are creating clarity for service providers and manufacturers," adds Dr. Florian Fuhrmann, Chairman of the Gematik Executive Board.

Around 5,000 connectors still need to be replaced

However, not all doctors and pharmacists will be able to use the software listed in the KOB at the beginning of the year; others will likely have problems due to connectors that have not yet been replaced. Gematik states on request that "across manufacturers [...] approximately 5,300 RSA-only connectors still need to be converted or replaced by a TI gateway solution."

Postponement of sanctions demanded

Doctors have repeatedly criticized the sanctions: "We have been intensively involved with the ePA from the beginning and have exchanged ideas with numerous experts. To date, neither practicality nor security are sufficiently guaranteed. In our opinion, medical confidentiality also needs to be redefined due to the increased transparency of patient data and diagnoses. Therefore, we demand that the planned sanctions be postponed," emphasizes Dr. Norbert Smetak, Chairman of MEDI GENO Deutschland and a practicing cardiologist. Smetak finds it unfair that hospitals will only be sanctioned at a later date: As long as the ePA does not function smoothly in practices and leads to massive failures as last week, there should be no sanctions. Here, politics is in debt, not the practicing medical profession.

(mack)

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This article was originally published in German. It was translated with technical assistance and editorially reviewed before publication.