Autonomous Surgical Robots

Abstract

Autonomous surgical robots will soon operate on patients. Robots will use sensors to measure patients’ physiology and pathologies, use that information to plan how to complete the necessary surgical actions, and execute those plans by physically moving surgical tools, all without direct human control. These emerging surgical robots pose new questions for the legal and regulatory regimes surrounding medical devices and the practice of medicine. This paper builds on a growing body of legal scholarship about Robot Law to examine the legally-disruptive potential of robots in surgery. The United States Food and Drug Administration (FDA) will evaluate new robots before they reach market, most likely through its rigorous premarket approval process which is accompanied by a preemption of state tort law. FDA has experience dealing with uncertainty in inherently unpredictable new technologies, and should be able to eventually find a way to evaluate surgical robots. Eventually, FDA regulation will clash with state licensure of medical professionals as people begin to regard robots less as tools and more as anthropomorphized social actors who themselves practice medicine. Because of autonomous robots’ novel capabilities, surgical robots may push federal regulation into more direct conflict with the states’ traditional role in regulating the practice of medicine.