Global application of AI-based Medical Devices

Artificial intelligence (AI) has potential to optimize healthcare and improve outcomes for all. For countries which have yet to achieve universal health coverage, data-driven technology will play a vital role in the next decade. Current AI, machine learning and deep learning applications include the use of clinical decision support tools, diagnostics, and workflow optimisation solutions. AI is also being used to enhance health research and drug development, and in assisting with the deployment of different public health interventions, such as disease surveillance, outbreak response, and health systems management.

Together with the World Health Organization we defined a first-of-its-kind 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.