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Digital Health Section Podcast- Royal Society of Medicine
Post-market Surveillance of AI medical devices. With Dr Dan Mullarkey- Medical Director at Skin Analytics
Mar 19, 2024
Exploring post-market surveillance of AI medical devices with Dr. Dan Mullarkey from Skin Analytics. Topics include setting sensitivity levels for AI devices, accessing outcome data from NHS, challenges of real-world data analysis, deployment of Skin Analytics' technology in NHS, adherence to regulations like ISO 3485, monitoring patient pathways in dermatology, collaboration with experts, and future expansion plans in healthcare industry.
34:35
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Quick takeaways
- Implementing appropriate sensitivity levels for AI medical devices is crucial for post-market surveillance.
- Accessing real-world outcome data from NHS organizations poses a challenge for monitoring AI device performance.
Deep dives
Postmarket Surveillance Challenges and Methods at Skin Analytics
Implementing postmarket surveillance for AI medical devices involves challenges such as ensuring appropriate sensitivity levels, accessing necessary outcome data from NHS organizations, and analyzing real-world data compared to traditional research studies. Skin Analytics uses its Derm product for skin cancer detection, focusing on identifying common skin cancers and benign conditions to support skin cancer pathways. Deployed in over 17 NHS sites, Skin Analytics conducts AI triage using Dermoscopic images in a secondary-care, post-referral model.
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