In January, right before President Biden took office, the Food and Drug Administration proposed permanently exempting “software as a medical device” from regulatory review. The agency waived the approval process last year to streamline regulatory oversight during the Covid emergency. But the growing use of artificial intelligence programs and digital devices in health care raises safety and ethical concerns that require more attention. The Biden administration put the proposal on hold for now. Meanwhile, bioethicists should weigh in as the FDA reviews its action plan.

Telemedicine is becoming more widespread. This is care at a distance, where patient and clinician are connected by information technology that may include video, audio, and monitoring equipment linked by...