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Challenges in Post-Market Surveillance of AI Medical Devices
The chapter focuses on the difficulties encountered in tracking and monitoring patients in dermatology pathways, stressing the importance of digitization for streamlined patient follow-ups. It discusses the significance of real-world evidence, collaboration with dermatologists and AI experts, and setting a sensitivity benchmark of 95% for AI performance. Furthermore, it explores the complexities of data sharing between NHS organizations and the speaker's organization for post-market clinical follow-up of AI medical devices, emphasizing joint data control and transparency.