“We’re taking realistic steps toward using existing authorities to move patient safety forward in partnership with others in the federal government and the private sector,” Mostashari said.

But that’s unlikely to satisfy critics who believe the FDA should regulate EHRs as medical devices, or those such as Levin, who sat on the IOM commitee and believes voluntary reporting of patient harm caused by digital records may not be enough.

“It sort of strikes one as saying, ‘Because we don’t have any evidence, we don’t think there’s a problem,’” he said. “If that’s so, wouldn’t you feel compelled in a fairly short timeline to learn more?”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.