What types of AI tools used in healthcare will be regulated by the upcoming Medical Products Bill, if any?

Answer

The Medical Products Bill (the Bill) will regulate AI tools that are intended for a therapeutic purpose, rather than regulating AI more broadly. Specifically, the Bill will apply to software and AI that meet the internationally accepted definition of a medical device, ‘Software as a Medical Device’. Examples include AI systems used to screen for conditions, deliver therapy, or provide AI-driven diagnostics. AI tools used for administrative and operational purposes (such as AI-scribes and patient management systems), or for research or general informational purposes will not be regulated under the Bill.