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The Digital Act (DigiG) and the Health Data Utilization Act (GDNG)

Opportunity for digitization in the healthcare sector or excessive demands on the healthcare landscape – a critical contribution to the legal innovations

The Digital Act (DigiG) and the Health Data Utilization Act (GDNG)

Opportunity for digitization in the healthcare sector or excessive demands on the healthcare landscape – a critical contribution to the legal innovations

The Federal Minister of Health Karl Lauterbach (SPD) aims to accelerate the expansion of digitalization in the healthcare sector and make digital applications more widely available with the law “to accelerate the digitalization of the healthcare system”, which was passed on 14.12.2023; in the context of the inadequate level of digitalization in German healthcare facilities, this goal is very welcome. However, service providers will have to contend with more organizational and bureaucratic work, so that the pressure is likely to increase in addition to the current challenges such as energy cost increases or the shortage of skilled workers.

The challenges of the ePA

Filling the electronic patient file (ePA) is at the heart of the new law and is aimed at a faster, nationwide distribution of the ePA. From 2025, the implementation of the ePA for all patients should therefore begin, provided that this is not contradicted by the so-called opt-out solution.

Among other things, patients receive a largely automatically generated medication overview, which increases patient safety by avoiding interactions. At the same time, the duties of cooperation for service providers will be significantly expanded. This concerns, for example, the filling of the ePA with data from doctor’s letters, findings or diagnostic reports as well as the digitization of old findings at the request of patients or the transfer of paper-based medical records to an electronic treatment record. In addition, a number of new information obligations are being created, combined with bureaucracy.

While the most structured, complete and automated possible filling of the ePA should be viewed positively (e.g. digital medication overview), the “simple” provision of data should not jeopardize the protection of patient-related data. In the context of the “Health Data Utilization Act” (GDNG), which was passed at the same time, the easier access to patient data for research and industry is to be welcomed in principle, but its design is to be viewed critically in places. For example, the orientation towards the common good is mentioned right at the beginning of the law in Section 1 GDNG, although the vagueness of this term was emphasized in several statements and in the Health Committee. The possibility of use by health insurance companies is also seen as a softening of the previous separation between care management and cost-bearing. In addition, the option for patients to delete data from the ePA poses a risk to patient safety if, for example, relevant medical data is not visible during treatment.

Mandatory introduction of the electronic prescription (e-prescription)

The digital prescription of medicines has been in the process of being introduced since mid-2021 and has so far functioned on a voluntary basis. In order to further expand the use of e-prescriptions, the digital prescription of medicines is now mandatory for patients with statutory health insurance from January 2024. In the following years, the e-prescription will then be extended to other areas of application such as digital health applications (DiGAs), anaesthetic prescriptions, nursing care and therapeutic products.

On the one hand, the introduction of e-prescriptions can help to simplify processes and improve accessibility for patients. On the other hand, complicated registration processes for the eHC with payers and technical problems with the telematics infrastructure are still hindering wider acceptance.

Cloud computing and data security

The new Section 393 of Book V of the German Social Code (SGB V) regulates the use of cloud computing services by hospitals for the first time. The focus here is on the security aspects of cloud service providers. The regulations make sense as part of a series of legislative projects to increase the cyber resilience of various critical industries against the backdrop of increasing cyber threats. The expansion of cloud computing in the healthcare sector is being promoted. Clearer framework conditions are being created for hospitals for the growing range of cloud-based services in terms of data protection and data security.

Opportunities of digital health applications (DiGAs)

Since the Digital Healthcare Act (DVG) 2019, patients have been able to make use of DiGAs in principle. According to TK’s DiGA Report 2022, around 19,000 DIGAs were used by 12.1 million TK policyholders in 2021 (2023)[1]. Similar to the ePA and e-prescription, the use of DiGAs is therefore to be expanded for new areas of application and spread more quickly. The medical device classification will be extended to the higher risk classes (IIb) in future in order to create more care options (e.g. telemonitoring). It is also positive for patient care that the design of the DiGA awards will be even more closely aligned with success criteria and that the proof of benefit for patients will be further developed and thus strengthened.

[1] Techniker Krankenkasse: DiGA Report 2022 (March 2022)
(Status: 10.01.2024)

Other key aspects of the draft law
Video consultations and teleconsultations:

The provision of telemedical services to insured persons is also to be expanded. The current volume limits of 30% for panel doctors will be lifted. Pharmacies are to be more closely involved via “assisted telemedicine”, such as providing advice and guidance on outpatient telemedicine services, as well as supporting medical telemedicine by taking over simple routine medical tasks.

The fact that pharmacies can relieve the burden on outpatient service providers is to be welcomed. At the same time, the benefits of the rising costs of “assisted telemedicine” must be guaranteed by pharmacies. University outpatient clinics, psychiatric institute outpatient clinics, socio-pediatric centers and medical treatment centers can now also provide telemedical services.

In addition to personal contact with doctors, video consultations and teleconsultations also offer the potential to mitigate the consequences of the shortage of specialists by enabling more patients to be cared for. However, the quality of treatment may be reduced by fewer personal contacts with doctors and less lucrative patient groups may be disadvantaged.


The topic of interoperability is also to be given greater focus through a “Competence Center for Interoperability” in order to drive forward the digital transformation. Interoperability standards for interfaces in hospitals, data in the electronic patient file and other areas are to be defined with the relevant professional associations such as the National Association of Statutory Health Insurance Physicians or the German Hospital Association. Greater interoperability is certainly desirable and urgently needed, but the legislator could have provided clearer framework conditions, as it has already done in an exemplary manner, for example, in the case of communication between service providers and service providers in accordance with Section 301 SGB V.

Instead, there is now the unlikely option of manufacturers issuing warnings to each other for “non-compliance” with interoperability standards. Overall, working on the topic of “interoperability” is of course a step in the right direction. It remains to be seen whether the legislator can realize its ideas of interoperability through such a construct.

Digital Advisory Board:

The original plan was to establish a “digital agency” instead of gematik, in which the Federal Ministry of Health would have become a 100% shareholder. The reason for this was criticism of the sometimes lengthy coordination processes and delays caused by the different interests of the self-governing partners. The Digital Act now provides for gematik to be retained and advised by a “Digital Advisory Board” on the topics of data security and protection, user-friendliness and data usage. This “Digital Advisory Board” consists of the Federal Office for Information Security (BSI), representatives of the Federal Commissioner for Data Protection and Freedom of Information (BfDI) and members from the fields of medicine and ethics.

Here, too, it will be necessary to observe whether the creation of additional organizational interfaces can meet the legislator’s objective.

Further changes to the law:

Other relevant legislative changes in addition to the Digi-G should be taken into account when planning changes in the day-to-day operation of healthcare facilities. Increased hacking attacks on hospitals, for example, have recently increased the importance of the security of sensitive healthcare data enormously and show a need for optimization. The NIS2 Implementation Act and the KRITIS Umbrella Act are intended to increase data protection and security and should be urgently taken into account in order to limit corporate risk.

Critical appraisal for service providers

The Digital Act and the Health Data Utilization Act are a significant step in the right direction. Relevant topics that are currently hampering the digital transformation, such as the expansion of ePA, interoperability and the cloud, are addressed.

However, the way the laws are drafted also means an increase in the already considerable amount of bureaucracy for service providers.

Talk to our experts!

Do you want to prepare for the new challenges at an early stage or do you already want to implement larger IT projects? Oberender AG already has many years of experience in the implementation of digital transformation processes such as cloud migrations and IT management and will be happy to advise you! Find out more about our digitalization competence team here.

Sources: Bundestag; Federal Ministry of Health; National Association of Statutory Health Insurance Physicians

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