After the publication of the draft bill for the law on the improved use of health data (Health Data Usage Act - GDNG) on August 4th and the specialist hearing on August 8th, the cabinet draft was published on August 30th, 2023 and - as well as the "law to accelerate the digitalization of the healthcare system (Digital Law - DigiG) passed by the Federal Cabinet on August 30th. The time frame was tight, as the amendments to the law are scheduled to come into force on January 1, 2024. In advance, many actors contributed numerous statements, suggestions, recommendations and information to the political decision-making process.

>> “The digital laws are the foundation of digital care and research in our health system,” explained Federal Health Minister Prof. Karl Lauterbach on the occasion of the adoption of the two laws – the Health Data Usage Act, or GDNG for short) and the “Law to Accelerate the Digitalization of the Health Care System” ( Digital Law, DigiG for short) - by the Federal Cabinet: “We are now 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 everywhere can be used safely to provide them with better care. And scientists, Lauterbach continued, “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, Lauterbach says a medical research law to comprehensively accelerate clinical studies will be presented this year. “With these reforms, we are starting a fast track to carry out cancer research and dementia studies and to answer other important research questions in medicine,” said the Federal Minister of Health. His wish is that we “use AI – ideally “Made in Germany” – to become top again in the development of medicines and medical devices.”
As a core element of the Digital Act, the ePA will be made available from 2025 to all legally insured people who do not object to it (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, on the other hand, creates the basis for better availability of health data in order, according to the politicians' intention, to be able to "offer optimal medical care and bring Germany as a health, research and business location to the top in the world". 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.
This is exactly what several people had voted for in advance
stakeholders empowered; Here are some excerpts from the original quote:
AOK Federal Association
Positive “The intention of the draft bill for a health data usage law to use health data to improve care, public health, research, innovation and the further development of the health system is expressly welcomed and supported by the AOK community. This draft bill provides a good basis for using existing health data even more systematically and effectively in the future to improve care and further develop our health system. Some measures, such as the linking of data from the research data center and those from the cancer registries as well as the intended possibility of enabling health insurance companies to use data from their insured persons to promote health, should be highlighted positively.
“The aim of combining the health insurance data from the research data center with the data from the regional cancer registries is welcomed by the AOK community, as this allows valuable insights to be gained for care. Studies prove the knowledge gained by linking secondary and cancer registry data, as recently shown by the AOK-supported study on the effectiveness of care in oncology centers (WiZen).”
Barmer
Positive: “So far, federal and state supervisory authorities have interpreted the data protection regulations for health data differently. This not only makes it more difficult to use the data for care, but also creates unequal competitive conditions for statutory health insurance companies when it comes to digital offerings. The GDNG is now intended to realign data protection supervision: This would give the Federal Data Protection Commissioner uniform data protection supervision for all health and nursing care insurance companies, the statutory (dental) medical associations and their umbrella organizations. In Barmer’s opinion, the planned harmonization is urgently necessary in order to ensure uniform action by the responsible data protection authorities in the future.”
Federal Joint Committee
Positive: “The full-time, impartial members of the Federal Joint Committee (G-BA) welcome the measures contained in the draft bill of the Federal Ministry of Health (BMG) for improved use of health data for research purposes as a basis for high-quality care for citizens. Long-standing discussions point to unused data resources in the German healthcare system that can be used to generate knowledge for better health and more individualized care. The establishment of the European Health Data Space is an important motivator for this development.”
“The regulation in Section 1 of the Act on the Use of Health Data (GDNG) creates a central institution for data users with the data access and coordination office for health data. The establishment's tasks include:
a public metadata catalog, advising data users when submitting applications and receiving and forwarding applications for secondary data use. The full-time, impartial members of the G-BA consider it correct that the data access and coordination office, in its role as an intermediary between data holders and data users, should forward applications for data use to the responsible authority and understand this to mean that the final decision on the application is made by the responsible authority position takes place.”
Negative: “However, the draft bill does not yet provide for any regulation through which the specific scope of application of the GDNG would be bindingly determined and limited with sufficient certainty. In particular, it is not clear from the regulatory text how the GDNG relates to Section 137a Paragraph 10 SGB V. Due to the constitutionally required clarity of standards, clear legal requirements should be sought, especially in connection with the processing of health data, which leave as little room as possible for questions of interpretation.”
Central Institute for Statutory Health Insurance (Zi)
Positive: “We expressly support the goal formulated in the draft bill of making the pseudonymized billing data from statutory health insurance companies available in the research data center more quickly usable. We also welcome the fact that pseudonymized health data will be linked more easily in the future and representative data from the electronic patient file will be made available for research.”
Negative: “However, we are very critical of the fact that health and nursing care insurance companies should be authorized in the future to automatically process personal data without the consent of the insured. The aim should be the early detection of rare diseases, cancer risks or other serious health risks. However, it is precisely this type of data evaluation that also opens the door to subtle possibilities of risk selection of undesirable, because supposedly 'expensive' insured persons.”
National Association of Statutory Health Insurance Physicians (KBV)
Positive: “The KBV fundamentally supports the approach of making more health data available for medical research if this further improves care for the population. This is also because it is the concern of the contracted doctors and contracted psychotherapists to be able to help patients through even more sophisticated methods of diagnostics and therapy.”
Negative: “The KBV considers it critical that the draft bill – in departure from known preliminary drafts – foregoes the protection of the transmitted data with criminal penalties. It would be desirable if – as in the handling of other sensitive data – the particular sensitivity of the data sets was also reflected in their punishment.”
Federal Association of Medical Technology (BVMed)
Positive: “In his statement on the draft bill of the Health Data Use Act (GDNG), he welcomes the planned establishment of a data access and coordination point for health data and the connection to the regulation on the European area for health data (EHDS). “What remains crucial is an equal treatment of all stakeholders when using data.” <<

The contents of the law in brief
Digital law
• The electronic patient record (ePA) will be set up for all those with statutory health insurance at the beginning of 2025. If you do not want to use the ePA, you can object to this (opt-out). For privately insured people, PKV companies can also offer an objection-based ePA.
• With the ePA, insured persons 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 medication supply from January 1, 2024, and its use will be greatly simplified for insured persons via an electronic health card and ePA app.
• Digital health applications (DiGA) are integrated more deeply into the care 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 able to be used for more complex treatment processes - for example for telemonitoring.
• In order for telemedicine to become an integral part of healthcare, the quantity limits will be lifted. Assisted telemedicine also creates low-threshold access to care.
• A digital advisory board at gematik, which will include representatives from the Federal Commissioner for Data Protection and Freedom of Information (BfDI), the Federal Office for Information Security (BSI), medicine and ethics, will be present at all of gematik's in the future We advise on specifications with balanced recommendations on issues of data protection, data security, data use and user-friendliness.

Health Data Use Act
• A 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 supervision for transnational research projects should be expanded to include all health data. 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.
• An opt-out procedure will be introduced for the release of data from the ePA in order to improve the use of data from the ePA for the permissible purposes of the FDZ. 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 may process data if 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.