Videos / The LEAPcast - Fundamentals of Medical Device Regulations for AI (37:45)

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The LEAPcast - Fundamentals of Medical Device Regulations for AI (37:45)

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Dr Paul Jewell (Assuric Ltd.) provides practical advice for developers looking to balance patient safety with cutting edge innovation. Join us as we delve into the evolving UK landscape of regulation for AI and LLMs, and what innovators should be doing to prepare.

Links to guidance and regulation mentioned in the show:

Definition of a medical device: https://www.england.nhs.uk/long-read/medical-devices-and-digital-tools/
How to determine whether your product is a medical device: https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device
Digital mental health technology: qualification and classification: https://www.gov.uk/government/publications/digital-mental-health-technology-qualification-and-classification
Medical Devices Regulations 2002: https://www.legislation.gov.uk/uksi/2002/618/contents
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Produced by Karen Louise Dawe PhD and Emily Nielsen PhD

Last Updated

1 January 2025

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LEAP Digital Health Hub
LEAP Digital Health Hub
LEAPcast is the podcast of the LEAP Digital Health Hub, exploring digital health through engaging conversations with innovators, clinicians, and researchers. Our aim is to demystify complex topics and share practical skills you can use in your work, all in an accessible, entertaining format.