Artificial Intelligence

If the promise of adaptive artificial intelligence (sometimes called “Machine Learning”) is to be achieved in the medical area, FDA’s regulation of medical devices is going to have to graduate from geometry to calculus.  By its nature, machine learning changes the details of its output constantly.  The rigid regulatory model requiring FDA pre-approval of all

The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence (“AI”) in the medical field. The Act added this provision to the FDCA:

(o) Regulation of medical and certain decisions support software: (1) The term device . . . shall not include a software function that is intended


In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in surgery.  Surgeonless surgery would “allow[] work around the clock with higher productivity, accuracy, and efficiency as well as shorter