Algorithm-fueled software isn’t reliable if the people who design it or use it let their unconscious biases seep into the process, and the FDA is considering how to regulate medical software that constantly learns and adapts.

Software as a medical device, or SaMD, is intended to be used for medical purposes without being part of a hardware medical device. The benefits of technology powered by artificial intelligence and machine learning include earlier disease detection, more accurate diagnoses, and development of...