On November 18, 2025, another event in the lecture series “Automated Systems” took place in a hybrid format. The event was organized by the Chair of Civil Law, European and International Business Law (Prof. Dr. Buck-Heeb) in cooperation with the Interdisciplinary Institute for Automated Systems (RifaS).
This time, Professor Dr. Jan Eichelberger, LL.M.oec. was invited to speak. Professor Eichelberger holds the Chair of Civil Law, Intellectual Property Law and IT Law at Leibniz University Hannover. He studied, received his doctorate, and completed his habilitation at Friedrich Schiller University Jena. After his legal clerkship and professional activity as a lawyer in Berlin, he was appointed to the university in Hannover in 2016.
The lecture provided an overview of the legal framework for the use of artificial intelligence in medicine. The focus was on the regulatory environment arising from the interplay between medical device law and AI law, as well as on contract law and liability implications for medical treatment. It was demonstrated where the opportunities and risks of digitalization in medicine lie and how the “medicine of tomorrow” can be shaped to comply with legal requirements.
At the beginning, areas of application were outlined. AI can be used, for example, in diagnostics, such as in diagnostic imaging and dermatology. It can also be applied in therapy—where there have already been very positive experiences, for example, in (immediately available) psychotherapy—as well as for information provision, documentation (findings reports, medical letters, patient information), prevention, research and development, and practice management (e.g., appointment scheduling). From a legal perspective, the starting point was the definition of AI in Article 3, No. 1 of the AI Act. Practical cases involving AI systems were then presented.
The presentation then addressed questions from the perspective of medical contract law, professional law, and liability law. The focus was on the duties and limits for physicians: that is, what obligations a physician has when using AI, and what is permissible. It is crucial that AI is not yet considered a standard method, but rather a new and experimental method. This results in increased obligations regarding patient information and enhanced duties of care and supervision. At present, there is no legal requirement to use AI.
The lecture also discussed whether and under what circumstances the use of AI could be considered an impermissible delegation of tasks to non-physicians. As a possible solution to this issue, it was considered whether certification of AI could be introduced in the future as systems continue to develop. Furthermore, the question was raised whether AI could fulfill the duty to provide the information required under Section 630e (2) No. 1 of the German Civil Code (BGB). The speaker rejected this, at least based on the current wording of the provision. The issue of physician liability in the event of malfunctions of AI was also addressed, and again, certification was discussed as a possible solution for the future.
Finally, Professor Eichelberger spoke about the regulation of AI in medicine. He referred to the EU Medical Device Regulation (MDR) of 2017 and the new European AI Act of 2024. Both sets of European regulations interact and result in a significant amount of regulatory requirements. Regarding the MDR, for example, the question was addressed—ultimately answered in the negative—whether Chat-GPT could be considered a medical device within the meaning of the MDR.
Classification under the MDR is also decisive for the AI Act (see Article 6 (1) (b) AI Act). This means that such classified AI systems are regularly considered high-risk AI under the AI Act. The comprehensive requirements of the AI Act for high-risk AI systems therefore apply, both for manufacturers or providers and for users. Non-compliance can result not only in substantial fines, but also in claims for damages by those affected.
The lecture was followed by a lively discussion.
About the “Automated Systems” Lecture Series
You can find more information about the “Automated Systems” lecture series as well as further summaries of past events here.
About the Interdisciplinary Institute for Automated Systems (RifaS)
The institute was founded in autumn 2017 and stands for interdisciplinary, national, and international research in various areas of automated systems. The research areas are divided into mobility and transportation, manufacturing and economics, and medicine. The institute brings together both academics and practitioners and is active not only in research but also in teaching.
Information about current events can always be found at www.rifas.de.
