Stephen Gilbert

About

With over 15 years of experience in clinical research, computational biology, and regulatory science, I am passionate about advancing the field of digital health innovation and governance. I am a Professor in the Faculty of Medicine, Dresden University of Technology (Else Kröner Fresenius Center for Digital Health), where I lead a multidisciplinary team of researchers and collaborators on regulatory science themes relating to medical devices and in vitro diagnostic devices. I am also News and Views Editor at Nature Portfolio - Digital Health, where I curate and edit high-quality articles on the latest developments and challenges in medical software and AI applications in healthcare. Additionally, I serve as an Advisor for several projects, such as the EY-coordinated study for DG SANTE European Commission on regulatory governance and innovation in the field of medical devices. I leverage my analytical skills, clinical evaluation expertise, and publication record to contribute to the scientific and policy discourse on digital health.

Experience

• Expert Consultant (in addition to full time professor position) at Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH
  May 2026 - Present · 2 mos

  Consultation on AI in telemedicine and hospital partnerships.

• Member of the Faculty of Business and Economics - in Business Information Systems (co-opted) at Technische Universität Dresden
  Jan 2026 - Present · 6 mos

  https://tu-dresden.de/bu/wirtschaft/die-fakultaet/news/stephen-gilbert-becomes-a-second-member-of-the-faculty?set_language=en Stephen Gilbert's core research areas are the development and evaluation of responsible and trustworthy frameworks for the development, oversight, monitoring, control and evaluation of medical AI, with a particular focus on agent-based AI and large multimodal/language-based healthcare models, including medical decision support systems for doctors and patients. His research is highly interdisciplinary and, with interfaces between medicine, economics, regulatory science, policy and informatics, offers numerous points of contact with researchers at the Faculty.

• Expert Consultant (additional to core academic role) at Saudi Arabia Food and Drug Authority (SA FDA)
  Oct 2025 - Present · 9 mos

  Expert Advisor to the Saudi Arabia Food and Drug Authority (FDA) on AI-enabled and innovative medical device policy, funded through the United Nations Development Programme (UNDP).

• MBA Course Director (AI, Regulatory Affairs & Transformation in Medical Technology) at Dresden International University (DIU)
  Jun 2025 - Present · 1 yr 1 mo

  https://www.di-uni.de/master/ai-regulatory-affairs-transformation-medical-technology

• RAPS Euro Convergence Program Committee: AI/Software track at Regulatory Affairs Professionals Society (RAPS)
  Aug 2024 - Present · 1 yr 11 mos

  RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest topics and developments in healthcare products in Europe and beyond — with sessions in medical devices, IVDs, pharmaceuticals, combination products, regulatory business, AI, software, and cybersecurity. https://www.raps.org/europe-2025/home