Keynote by Prof. Dr. Gilbert on The regulation and implementation of LLMs in health: past, current and future paradigms (and controversies) from around the world … and what happens when these meet JITAI, March 5, 2026
Thursday, 5 March 2026, 4:15 pm CET, University of St. Gallen (HSG Square, Arena) & ZOOM
About Stephen Gilbert
Prof. Dr. Gilbert worked in senior MedTech and Digital Heath roles in industry for 5 years, before returning to academia in 2022 in Dresden, Germany as Europe’s first full Professor of Medical Device Regulatory Science for AI and Digital Health, where he teaches and conducts research. His research goals are the advancement of regulatory science in digital medicine and AI-enabled medical devices. Innovative digital approaches in healthcare must be accompanied by innovative regulatory and oversight approaches to ensure speed to market, to maximise the access of patients to life saving treatments while at the same time ensuring safety on market. His projects involve the evaluation of existing methods and regulatory frameworks, data science approaches, the development of new solutions for the monitoring and oversight of AI and digital health solutions, including AI-enabled in point-of-care patient support, adaptive dosing and monitoring of personalised drug therapy. He has recently completed expert projects for the European Commission and the Saudi Arabia FDA on these themes”
About the Lecture
Almost since their inception, LLMs have been applied in health and medicine use cases. Since their inception potential and risks have been clear. Presciently, early after OpenAI launched its GPT API researchers simulated conversations with suicidal users and showed the LLM could make dangerous suggestions to such users promoting them to kill themselves. I will present a timeline of different LLMs alongside a timeline of their use in health, medicine and wellness. These timelines will be added to, with an international comparative timeline of regulatory approaches and a discussion of differing regulatory attitudes, which vary in their degree of regulatory ‘stringency’ , and also on their degree of proactivity versus passivity. I will present and review the degree to which regulators take a ‘nothing new here’ approach, versus a questioning and experimentation approach, and discuss the pros and cons of each. I will present detailed takes from my own work on how we need to consider the regulation of LLMs, their properties of being like ‘simulated AGI’, which mean that they are unlike ‘devices’ considered by traditional regulatory frameworks. I will discuss the use of airlocks/sandboxes to develop LLM regulation. I will also address new challenges in regulating agentic systems in medicine and the critical role of collecting open built-in’ feedback through interfaces in the safety oversight of LLMs. I will do a deep dove into test benches and how test benches challenge the existing regulatory paradigm. I will describe my teams recent work on independent ‘Good Samaritan’ / ‘Guardian Angel’ AI chaperones for chaperoning the young and vulnerable in their interactions with LLM-characters/chatbots, both 1<>1 chats and in social media. Finally, I will describe the opportunities of LLM-driven JITAI: its regulatory status, how could we ever know if it works, how could it be overseen and how is it likely to develop.
We are pleased to invite you to join this guest lecture, which is part of our CDHI Lecture Series Digital Health Forum. Registration is not required. Please be aware that we will be recording this guest lecture and will be making it available in our teaching library. If you have any questions, please contact Victoria Brügger (victoria.bruegger@unisg.ch) prior to the start of the guest lecture.
Prof. Dr. Tobias Kowatsch, Associate Professor for Digital Health Interventions, Institute for Implementation Science in Health Care, University of Zurich; Director, School of Medicine, University of St.Gallen (HSG); Scientific Director, Centre for Digital Health Interventions (CDHI), ETH Zurich & HSG; Principal Investigator, Future Health Technologies programme, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore
Prof. Dr. Elgar Fleisch, Professor of Information Management, ETH Zürich; Professor of Technology Management, University of St.Gallen; Advisory Board Member, CDHI, ETH Zürich & University of St.Gallen; Principal Investigator, Future Health Technologies programme, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore
Prof. Dr. Florian von Wangenheim, Professor of Technology Marketing, ETH Zurich & Advisory Board Member, CDHI; Principal Investigator, Future Health Technologies programme, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore
