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
- Sign up to the LEAP Digital Health Hub mailing list - http://eepurl.com/iDxjL2
Produced by Karen Louise Dawe PhD and Emily Nielsen PhD