On Friday 29 November 2024, a workshop was held on the governance and liability of medical AI. This event, organised by the Centre for Law, Medicine and Life Sciences and the PHG Foundation, was part of the Inter-CeBIL Programme led by Professor Timo Minssen.
The workshop brought together experts in law, policy, clinical practice, and artificial intelligence to discuss critical aspects of the regulatory and governance framework for medical AI. Key topics included:
- AI as a Medical Device: Exploring medical device and in vitro diagnostic (IVD) regulation.
- AI-Specific Regulation: Examining the EU AI Act and its implications for medical devices.
- Liability and Medical AI: Addressing the legal responsibilities of developers, deployers, and healthcare professionals under negligence and product liability laws.
- Medical AI and Data Regulation: Discussing GDPR and the governance of personal data used in training and processing by medical AI.
The workshop provided a comprehensive overview of the regulatory landscape, identifying gaps, overlaps, and compliance challenges. The collaborative efforts of the participants generated valuable insights and raised important questions about the ethical and governance issues surrounding medical AI.
We thank all those involved, and look forward to discussing further!