Improving Federal Regulation of Medical Algorithms The Regulatory Review

Scholar argues that FDA should reform its regulation of algorithm-based medicine. 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.