Federal Cabinet passes digital laws for better care and research in the healthcare system

31.08.2023 14:25

On August 30, the cabinet approved the drafts of a “Law to Accelerate the Digitalization of the Health Care System” (Digital Law - DigiG) and a “Law for the Improved Use of Health Data” (Health Data Usage Act – GDNG). The aim is to use digital solutions to improve everyday care and research opportunities in Germany.

The core element of the digital law is the ePA from 2025 onwards for all legally insured people who do not object to this (opt-out). It will promote the exchange and use of health data and provide targeted support for care - in the first step by introducing digital medication management. In addition, the e-prescription will be set up as a binding standard in the supply of medicines.

The GDNG creates the basis for better availability of health data in order to be able to offer optimal medical care and bring Germany into the world's leading health, research and business location. The central component is the easier use of health data for public welfare purposes. To this end, a decentralized health data infrastructure with a central data access and coordination point for the use of health data is being set up. The law also promotes the development of an internationally competitive health data infrastructure.

Health Minister Prof. Karl Lauterbach said: “The digital laws are the foundation of digital care and research in our health system. In this way, we are starting to catch up both in everyday care and in research and are building one of the most modern medical digital infrastructures in Europe in Germany. Patients should be able to rely on the fact that their health data is used securely everywhere in order to provide them with better care. And scientists should be sure that they have the best conditions for their research in Germany. Following these two laws, which are now going to the cabinet, we will present a medical research law this year to comprehensively accelerate clinical studies. With these reforms, we are launching a fast track to conduct cancer research studies, dementia studies and answer other important research questions in medicine. My wish is that we use AI – ideally “Made in Germany” – to become top again in the development of drugs and medical devices.”

The content of the law in detail

Digital law

• The electronic patient file (ePA) will be set up for all legally insured people at the beginning of 2025. who the ePA If you do not want to use this, you can object to this (opt-out). For privately insured people, the companies can PKV also a contradiction-based one ePA offer.
• With the ePA the insured receive a complete, largely automatically created, digital medication overview. In close connection with the e-prescription, unwanted drug interactions are better avoided and doctors are supported in the treatment process.
• The E-prescription will be further developed and established as a binding standard in drug supply from January 1, 2024, and use for insured persons via electronic health card and ePA-App greatly simplified.
• Digital Health Applications (DiGA) are integrated more deeply into the supply processes and their use is made transparent. With the expansion of the DiGA to digital medical devices in risk class IIb, they will also be used for more complex treatment processes - e.g for telemonitoring – can be used.
• So that Telemedicine becomes an integral part of health care, the quantity limits will be lifted. With the assisted telemedicine Low-threshold access to care is also created.
• A Digital Advisory Board at the gematik, which includes representatives of the Federal Commissioner for Data Protection and Freedom of Information (BfDI), the Federal Office for Information Security (BSI), which will be occupied by medicine and ethics, will be the future gematik advise you on all of your determinations with carefully considered recommendations on issues of data protection, data security, data use and user-friendliness.

Health Data Use Act

• One central data access and coordination point for the use of health data will reduce bureaucratic hurdles and facilitate access to research data. Here, for the first time, data from different data sources can be linked together. The access point is intended to act as a central contact point for data users.
• The Lead data protection supervisory authority for transnational research projects should open all health data be expanded. Data protection supervision for cross-state research projects in the healthcare sector is coordinated by a state data protection officer.
• The Health Research Data Center (FDZ) at the BfArM is being further developed. Eligibility to apply is no longer determined by who applies, but for what. The decision is based on the purposes of use that are in the common good.
• For the Data sharing from the ePA becomes a Opt-out procedure introduced to ensure the use of data from the ePA for the permissible purposes of the FDZ. A simple management of objections will be set up so that patients can decide whether to release their data to the FDZ for research or other purposes.
• Health and nursing care insurance companies are allowed to process dataif this demonstrably serves to protect the individual health of the insured, for example the safety of drug therapy or the detection of cancer or rare diseases.