sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 6 - Legal and Ethical Challenges



New and emerging medical technologies and devices are regulated for safety and efficacy by competent authorities such as Swissmedics in Switzerland. In module 6, participants will be able to identify and solve legal ethical, and regulatory challenges related to the whole life cycle of AI technologies in the medical sector.

Learning objectives

After participants have successfully finished this module, they can identify legal and ethical issues and know about the necessary steps and efforts to resolve them, know ethical principles that need to be considered when AI algorithms are used and have an understanding of privacy and data protection topics. They also can describe and evaluate anonymization technologies of patient data, know how to protect IP in AI software and understand regulatory demands on digital health technologies.

And last but not least, they can evaluate the use of clinical trials for AI software algorithms, know about the importance pf post-market surveillance (PMS) of AI algorithms to enter into clinical care and know when and how AI software needs competent authorities’ approval and the consecutive need for SW validation according to ISO standards and safety and efficacy standards.

Learning content

In this module, a variety of legal aspects are covered, such as introduction to legal and ethical challenges, prerequisites, data protection and IP for software, regulatory aspects of AI in medical imaging.
It also contains anonymisation, cryptographic protocols, and security and IP and RA issues of AI software. And it further debates the open question, whether AI software for medical imaging a medical device is.

Start & Duration

2020: 15 May 2021
2021: TBC

The completion of this module takes approximately 6 weeks.




The cost of this standalone module is 1'600.– SFr.




Module Leader

Professor for Translational Medicine and Entrepreneurship, University of Bern

Prof. Dr. Jürgen Burger

Jürgen Burger is Professor of Translational Medicine and Entrepreneurship at the Medical Faculty of the University of Bern. He is also director of the Swiss School in Translation and Entrepreneurship in Medicine at sitem-insel AG. The focus of Jürgen Burger's research lies in bringing innovative treatment methods and therapeutic / diagnostic systems into clinical use. Special focus is on intelligent implants and surgical instruments in combination with pharmaceutical products.