AAIH Statement in Response to FDA Announcement of Proposed Regulatory Framework for Artificial Intelligence-based Medical Devices

April 5, 2019 — We believe that patients’ lives will continue to be improved through investment, innovation and the thoughtful and responsible application of AI in the discovery and development of medical technologies. The steps being undertaken by the FDA to research and outline proper guidelines for the medical device community will help ensure patient safety while demonstrating the power of AI in healthcare. The Alliance for Artificial Intelligence in Healthcare (AAIH) looks forward to working with the FDA to evolve the regulatory framework through collaboration with experts from all aspects of the healthcare industry.

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices