Regulation of Artificial Intelligence in Health Care and Biomedicine—Reply
In Reply The US Food and Drug Administration (FDA) is committed to including patient perspectives in the development and evaluation of all medical products, and AI- and machine learning–enabled products are no different. We thank Mr Jaiswal and colleagues for highlighting the importance of patient and caregiver perspectives in response to our Special Communication investigating the FDA’s regulation of AI. While truly achieving a patient-centric approach to AI will take concerted effort from all involved entities, the FDA has taken several actions focused on priority issues to place patients at the center of the health AI life cycle.
In Reply The US Food and Drug Administration (FDA) is committed to including patient perspectives in the development and evaluation of all medical products, and AI- and machine learning–enabled products are no different. We thank Mr Jaiswal and colleagues for highlighting the importance of patient and caregiver perspectives in response to our Special Communication investigating the FDA’s regulation of AI. While truly achieving a patient-centric approach to AI will take concerted effort from all involved entities, the FDA has taken several actions focused on priority issues to place patients at the center of the health AI life cycle.
