Generating Evidence for Artificial Intelligence Based Medical Devices: A Framework for Training Validation and Evaluation
Including a use-case study for Cervical Cancer Screening
Overview
This first-of-its-kind publication from the WHO is a framework targeted at developers and researchers of AI-based software as a medical device, as well as policy-makers and implementers. It is intended to guide those seeking to understand the evidence generation requirements from development to post-market surveillance of these devices.
The publication uses cervical cancer screening as a use-case to support the goals of the WHO strategy on cervical cancer elimination and set the foundations for WHO to be able to usher in new and emerging technologies in cancer screening and beyond.
To allow acceleration in the global effort in cancer screening and clinical decision support, WHO will begin to facilitate building the enabling environments so that the benefits of innovative technologies reaches all populations and use-cases of high disease burden globally.
