7341 (2026). Hon Dr Ayesha Verrall to the Associate Minister of Health
Written Question
Published date: 19 Mar 2026
7341 (2026). Hon Dr Ayesha Verrall to the Associate Minister of Health: What types of AI tools used in healthcare will be regulated by the upcoming Medical Products Bill, if any?
Hon Casey Costello: 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.