AI-SC 20 - The regulatory landscape: navigating regulatory clearance, reimbursement, and liability
Lectures
1
Panel discussion
45:00Catherine Mary Jones, Brisbane / AU, Sergey Morozov, Brussels / BE, Luis Marti-Bonmati, València / ES, Shahriar Islam, London / UK
5 min
Chairperson's introduction
Elmar Kotter, Freiburg Im Breisgau / Germany
45 min
Panel discussion
Shahriar Islam, London / United Kingdom Sergey Morozov, Brussels / Belgium Catherine Mary Jones, Brisbane / Australia Luis Marti-Bonmati, Valencia / Spain
To clarify current FDA regulatory pathways for AI/ML-based medical devices.
To discuss evolving reimbursement models for AI-augmented radiology services.
To address medicolegal considerations and liability distribution between radiologists, institutions, and AI vendors.
To explore international regulatory harmonization efforts.
To examine the role of continuous learning algorithms and post-market surveillance.
10 min
Q&A: Untangling regulation, payment and risk in AI radiology