Congress Must Update FDA Regulations for Medical AI
Ref: Congress Must Update FDA Regulations for Medical AI
The use of mobile devices for the measurement or detection of medical variables is rapidly expanding and is practically available to anyone who has access to a device. This necessarily implies a specific regulatory definition. It is interesting to read the guidance, ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’, published by the FDA, which although referring to something more specific, makes reference to regulatory aspects.
In this context, I find it appropriate to share the paper by Scott Gottlieb, ‘Congress Must Update FDA Regulations for Medical AI’ published in JAMA Health Forum, where he concludes by emphasizing that Congress should update the laws governing FDA oversight to foster innovation in medical AI while ensuring it is safe for public use. This includes supporting transparency, ethical guidelines, and robust post-market surveillance.