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.

The Food and Drug Administration's rigorous guidance for an emergency use authorization of a Covid vaccine was met by resistance from the White House, since some of the terms would make it virtually impossible to issue a vaccine-related emergency authorization before Election Day. Understanding the ethical dimensions of issuing it for a vaccine can provide clarity on the necessity of the FDA’s stringent guidelines.