The Regulatory Review: Improving Federal Regulation of Medical Algorithms

The Regulatory Review: Improving Federal Regulation of Medical Algorithms. “In emergency situations, doctors have little time to save the lives of trauma patients. Gunshot wounds, car crashes, and other life-threatening harms often cause severe blood loss, which is the leading cause of preventable death when trauma puts patients’ lives on the line. To manage the demands of these emergency cases, physicians today complement their medical skill-set with a new tool: algorithms. But in a recent paper, a legal scholar argues that federal regulatory reforms must occur to unleash the full lifesaving potential of algorithms in health care. Nicholson Price, a professor at University of Michigan Law School, claims that the U.S. Food and Drug Administration (FDA) lacks the necessary expertise in computer science to apply its current regulations to medical algorithms and, as a result, could discourage much-needed innovation.”