I conceptualised and led the development of the first WHO AI guideline — on generating evidence for artificial intelligence-based medical devices. The AI devices – evidence generation guideline builds on existing frameworks and presents a unified framework for training, validation and evaluation of AI-based medical devices, and applies it to the use case of cervical cancer computer vision devices.
It can be used as reference for device developers and for regulators in considerations for evidence requirements in licensing AI-based medical devices.