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 promote the adoption of digital applications and to improve the use of available health data for both care and research purposes. The Digital Act is intended to accelerate the introduction of binding standards and foster the use of digital solutions in the healthcare sector. Starting in 2025, the electronic health record (ePA) will be introduced for all statutorily insured persons using an opt-out model, meaning individuals must actively object if they do not wish to participate. The electronic prescription (e-prescription) is set to become mandatory in 2024. The Digital Networking in Health Care Act (GDNG) aims to simplify the use of health data for public purposes by establishing a decentralized health data infrastructure. This allows statutory health and care insurance providers to use their data securely, particularly for improving medication safety and disease detection. An opt-out procedure is also being introduced for the release of data from the ePA to facilitate its use in research.

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 distributed across multiple institutions, leading to redundancies, misdiagnoses, and overall suboptimal treatment. The introduction of electronic health records aims to improve these conditions—for the benefit of patients and the medical professionals treating them. The primary goal is to promote improved and more efficient healthcare services. Telemedicine is cited as an example, with its expansion being actively pursued. This eases the burden on medical practices and ensures optimized care delivery. The Digital Networking in Health Care Act enables the targeted use of data originating from various sources such as electronic health records, billing data from health insurance providers, and registries—all brought together in a protected framework. This consolidated information can be used for research purposes and the application of artificial intelligence (AI), contributing to improved and personalized patient care—particularly in the field 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 will also be offered to privately insured individuals on an appeal basis by private health insurance companies.

Digital Medication Overview: The introduction of the ePA provides insured persons with a comprehensive digital medication overview, generated automatically. This supports physicians in avoiding adverse drug interactions and optimizes treatment processes.

E-Prescription: The e-prescription is standardized and established as an integral part of medication supply. Additional access is available via the ePA app.

Digital Health Application (DiGA): Digital health applications (DiGA) are increasingly being integrated into care processes, with greater transparency in their use. The expansion of DiGA to include digital medical devices in risk class IIb enables their use in more advanced treatments, such as telemonitoring.

Telemedicine: To establish telemedicine more firmly in the healthcare system, quantity restrictions are being removed. Assisted telemedicine will also enable easier access to care. University outpatient clinics, psychiatric outpatient clinics, and psychotherapeutic consultations can now offer telemedical services.‍

Digital Advisory Board: A Digital Advisory Board is being established, which includes representatives from the Federal Commissioner for Data Protection and Freedom of Information (BfDI) and the Federal Office for Information Security (BSI). Ethical and medical perspectives are specifically considered in its composition. The board will provide ongoing support by offering balanced recommendations on issues such as data protection, data security, data use, and usability.

The debate about the use of health data for research is becoming increasingly important. While some emphasize its potential benefits, others warn of associated risks, particularly concerning the use of data in the name of the common good. Critics argue that this term is vague and open to politically motivated interpretation, creating uncertainty around the true intentions behind data processing. Some voices have gone as far as to make serious allegations regarding the handling of health data to date. It is claimed that data—originally intended to protect people—is often obscured, withheld, or even not collected at all. Additionally, there are concerns that health data is used to support multi-billion-dollar business interests in the pharmaceutical industry, while the actual goal of serving the public interest remains unclear. These concerns highlight the need for clear, ethically responsible guidelines for the use of health data. The security and protection of sensitive information must remain a top priority in order to preserve public trust in how their data is handled.