Healthcare's regulatory AI conundrum

It was the last question of the night and it hushed the entire room. An entrepreneur expressed his aggravation about the FDA's antiquated regulatory environment for AI-enabled devices to Dr. Joel Stein of Columbia University. Stein a leader in rehabilitative robotic medicine, sympathized with the startup knowing full well that tomorrow's exoskeletons will rely heavily on machine intelligence. Nodding her head in agreement, Kate Merton of JLabs shared the sentiment. Her employer, Johnson & Johnson, is partnered with Google to revolutionize the operating room through embedded deep learning systems. To better understand the frustration expressed at RobotLab, a review of the policies of the Food & Drug Administration (FDA) relative to medical devices and software is required.