Demands on the Digital Health Agency Act: sanctions must be removed

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The draft Health Digital Agency Act (GDAG) is to be discussed in the Bundestag today, with which Gematik, which is responsible for digitalization in the healthcare sector, will become the digital agency of the Federal Ministry of Health. The BMG has high hopes that this will improve digitalization in the healthcare sector, and the SPD has also spoken of a "now-this-is-also-happening-in-Germany agency". However, the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) are critical of the draft, which was much discussed in advance.

The KBV is calling for significant improvements and the removal of threats of sanctions, as can be seen from a KBV statement. "Although there are certainly positive approaches, the draft bill still breathes the spirit of obvious mistrust towards colleagues in private practice. There are still threats of sanctions against doctors and psychotherapists. They must be abolished – without ifs and buts", according to the KBV board members. More and more fees are being deducted from doctors if they do not have a connection to the telematics infrastructure (TI) – the "data highway" of the healthcare system – and its components.

Gematik with its own products planned

However, the GDAG has also been criticized from other directions. In a statement from the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), its chairwoman Doris Pfeiffer criticized in particular the "conflict-prone constellation of the new digital agency as a market participant with its own products, which at the same time should continue to approve the products of its competitors from the industry". She warned that this could impair the necessary competition for the best solution. "Due to this conflict of interest, the planned option for the digital agency to operate its own TI components and services can and should only apply to central products that are only available or necessary once in the system," says Pfeiffer. Experts have no hope that the high availability of healthcare IT will improve as a result of more procurement processes; the plans are contrary to previous experience.

Financial burden on contributors

Pfeiffer also emphasized the financial challenges. She criticized the fact that the future digital agency is to be given more tasks and its powers are to be expanded without the corresponding cost increases being taken into account in the draft bill. She criticized the fact that 93% of the rising costs of the new digital agency would still have to be borne by those paying statutory health insurance contributions. Pfeiffer warned against an additional one-sided burden on contributors as a result of the Health Digital Agency Act.

Regulations on online appointments

Pfeiffer supported the proposal that the National Association of Statutory Health Insurance Funds and the National Association of Statutory Health Insurance Physicians should adopt guidelines for portals for digital appointment booking. She advocated further developing the existing portal of the National Association of Statutory Health Insurance Physicians and setting up an appointment directory that could also serve commercial platforms as a basis for arranging doctor's appointments. Another point of criticism from the KBV concerns the offer and use of appointment platforms. Although the KBV supports uniform requirements in principle, it sees problems in the implementation of the draft law.

Associations of statutory health insurance physicians not a federal data protection authority

The KBV still sees a need for clarification, particularly with regard to data protection for the various platform providers and financing. "We have neither the means nor the authority to monitor the data protection of the various platform providers. The KBV and the KVs are not a federal data protection authority. The question of financing is also completely unresolved," explains the KBV.

The Digital Agency for Health envisaged in the draft bill is intended to ensure user-friendliness. The KBV considers this to be one of its central demands. However, it is calling for clarification that the responsibility of the digital agency should also include the primary systems. "Digital processes can only be successful if the focus is on user orientation," says the KBV.

Electronic patient file: Industry calls for deadline postponement

The KBV also emphasizes the importance of interoperability, performance, stability and user-friendliness of information technology systems, especially with regard to the electronic patient file version 3.0 or higher, which was originally planned for January 2025. However, it now seems likely that the deadlines will be postponed further. The Federal Association of Health IT (Bvitg) has sent a letter to the Federal Ministry of Health (BMG), as reported by the Ärztezeitung.

In the letter, the Bvitg points out various problems and suggests that the timetable be adjusted. Originally, version 3.0 of the electronic patient file was to be launched in selected model regions from January 15, 2025, followed by a nationwide rollout by the end of the first quarter. A comprehensive update to the so-called ePA version 3.1 was planned for mid-2025.

Delays due to technical difficulties

However, the IT industry is clearly skeptical about these deadlines. One reason for this is that the so-called reference environment, which is required for testing the ePA modules, is not yet fully available according to the developers. This should actually have been the case by mid-October. In addition, an unscheduled change was made to the ePA specification at the end of October, which postponed the integration of image files into the ePA for the time being.

Proposal for a gradual roll-out

The industry proposes a gradual roll-out in selected practices and with a limited range of functions. A nationwide roll-out should therefore not take place until the second quarter, which in turn would postpone the planned ePA update 3.1, which is also intended to transfer data to the Health Research Data Center, for example.

Warning of impairment of the telematics infrastructure

Despite the problems outlined, the Federal Association emphasizes that it intends to stick to the timetable for the launch of the ePA. At the same time, however, it warns of a negative impact on the entire telematics infrastructure (TI) and potential problems in outpatient care if the launch of ePA 3.0 is rushed.

(mack)