This episode features a conversation with Dr Hugh Harvey- Managing Director at Hardian Health exploring the regulatory, ethical and logistical challenges involved in developing Large Language Models (LLMs) as medical devices.

Discussion topics include:

- A step-by-step guide to the regulatory approval process for LLM medical devices

- Should users be allowed to ask general purpose LLMs (like chatGPT) medical questions?

- What needs to change in current regulation in order for it to keep pace with recent AI developments

Blog posts mentioned in podcast:

Hardian Health blog by Hugh Harvey: https://www.hardianhealth.com/blog/how-to-get-regulatory-approval-for-medical-large-language-models

MHRA LLM blog post: https://medregs.blog.gov.uk/2023/03/03/large-language-models-and-software-as-a-medical-device/

RSM Ethics and Regulation for AI in health event: https://www.rsm.ac.uk/events/digital-health/2022-23/ter04/

LLMs as medical devices with Dr Hugh Harvey- Managing Director at Hardian Health