sitem-insel AG

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.

Main learning objectives

• 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

• Understand privacy and data protection topics

• Can describe and evaluate anonymization technologies of patient data

• Know how to protect IP in AI software

• Understand regulatory demands on digital health technologies

• 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

• 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

• Introduction to legal and ethical challenges
• Prerequisites
• Data protection and IP for software
• Regulatory aspects of AI in medical imaging
• Anonymisation, cryptographic protocols, and security
• Is AI software for medical imaging a medical device?
• IP and RA issues of AI software