On December 14, 2023, the Bundestag adopted a draft law “to accelerate the digitization of healthcare” (Digital-Gesetz-DigiG 20/9048). The law aims to disseminate digital applications and to improve the use of available health data for care purposes and research purposes.

The Digital Act aims to accelerate the introduction of binding standards and to promote the use of digital applications in healthcare. From 2025, the electronic health record (ePA) will be introduced for all legally insured persons, using the opposition procedure (opt-out) if the use would not be desired. The electronic prescription (e-prescription) is to be made mandatory this year. The Digital Networking in Health Care Act (GDNG) aims to facilitate the use of health data for public purposes by creating a decentralized health data infrastructure. This enables statutory health and care insurance funds to securely use their data, particularly in the area of drug therapy safety and the detection of diseases. An objection procedure is also being introduced for the release of data from the EPA in order to make it easier to use the data for research purposes.

Federal Minister of Health Karl Lauterbach (SPD) announces a significant increase in the quality of care through the new digital options and an increased level of safety for patients. Diagnoses and laboratory results are currently spread across a number of institutions, leading to redundancies, incorrect diagnoses and, overall, sub-optimal treatment. The introduction of electronic health records will change these circumstances, for the benefit of patients and the treating medical profession.

The primary aim is to promote improved and more efficient medical services. Telemedicine, whose expansion is being sought, is mentioned as an example. This relieves medical practices and ensures optimized care. The Digital Networking in Health Care Act (GDNG) enables the targeted use of data that comes from various sources such as electronic health records, billing data from health insurance companies and registries and is brought together in a protected framework. This information can be used for research purposes and the application of artificial intelligence (AI) and thus contribute to improved and personalized treatment of patients in the area of personalized medicine.

Electronic health records (ePA): From January 2025, the electronic health record (ePA) will be introduced for all legally insured persons, with an opt-out option. A corresponding ePA is also provided for privately insured persons on an appeal basis by private health insurance companies: The introduction of the ePA provides insured persons with a comprehensive digital medication overview, which is generated automatically. This helps doctors avoid adverse drug interactions and optimizes the treatment process.

E-prescription: The e-prescription is standardized and established as an integral part of the drug supply. Additional access is also provided via the EPA app.

Digital Health Application (DiGA): Digital health applications (DiGA) are increasingly being integrated into care processes and their use is made more transparent. By expanding DiGA to include digital medical devices in risk class IIb, they can now also be used for more sophisticated treatment processes such as telemonitoring.

telemedicine: In order to firmly establish telemedicine in healthcare, quantity restrictions are being lifted. In addition, assisted telemedicine provides easier access to care. Institutions such as university outpatient clinics, psychiatric outpatient clinics and psychotherapeutic consultations can now provide telemedicine services.

Digital Advisory Board: A digital advisory board is being set up on the subject, which includes representatives of the Federal Commissioner for Data Protection and Freedom of Information (BfDI) and the Federal Office for Information Security (BSI). Ethical and medical perspectives are particularly taken into account in the further composition of the Digital Advisory Board. The task of the Digital Advisory Board is to support the issue on an ongoing basis in its decisions on topics such as data protection, data security, data use and usability with balanced recommendations.

The debate about the use of health data for research is an issue of growing importance. While some stress the potential benefits, others warn of the risks, particularly with regard to the use of data for the common good. Critics argue that this term allows a politically motivated interpretation and thus creates uncertainty about the actual intentions of data processing.

Some voices are even making serious allegations against the previous handling of health data. It is claimed that data, which was actually intended to protect people, is often obscured, suppressed or not even collected in the first place. It is also stated that health data is often used to enable the pharmaceutical industry to do business worth billions of dollars, while the actual purpose of using it for the common good remains obscure.

These considerations stress the importance of establishing clear and ethically responsible guidelines for the use of health data. The security and protection of sensitive information should remain a priority to ensure public confidence in the use of their data.