ONC acknowledges gaps in health IT safety reporting but says it is largely powerless to act. “We don't have the authority, we believe, to mandate reporting,” said Jodi Daniel, director of ONC's Office of Policy Planning.

The ONC already requires vendors to list the EHRs that it certifies for purchase under the government's incentive program. But that leaves out parts of health IT, like mobile applications and large swaths of clinical decision support software.

That lack of a comprehensive listing is critical, said Dr. Julian Goldman, the medical director of biomedical engineering for Partners HealthCare in Boston. Listing “allows consumers of a device to report a problem.” Without such reports in a centralized place where they can be indexed, it is almost impossible for authorities to analyze safety-related problems, he said.

The failure to create a centralized registry is the result of a watering-down process that took place after the Food & Drug Administration, the ONC and the Federal Communications Commission convened a work group to formulate regulations in the wake of the IOM report. In August 2013, one of its final drafts stated that “vendors should be required to list products which are considered to represent at least some risk.” It said the requirement should be established “if a nonburdensome approach can be identified for doing so.”

Goldman, who was a member of the work group, criticized that language, saying listing must be required and it must be made nonburdensome. Dr. David Bates, chief innovation officer at Brigham and Women's Hospital, Boston, and chair of the work group, supported Goldman's position, as did all present members of the work group. Yet the original “nonburdensome” language still made it to the final draft.

Bates, who sits on boards or holds equity stakes in a number of health IT software firms, told Modern Healthcare that while he supports listing, such reporting could be quite burdensome for vendors. “There's a clear challenge in terms of managing something like that,” he said, noting any minor change in a software program could entail making a new filing with the government.

But Goldman rejected that argument. “It sounds like overstating the concern,” he said in an interview.

Months later, in April 2014, the federal agencies issued a draft report responding to the IOM and the summer 2013 work group. It cited the “nonburdensome” language and suggested a private entity could manage the list. Vendors, however, balked at any listing or reporting requirements. “We do not believe that there is a clear rationale for formalized listing,” GE Healthcare wrote in a July 2014 comment letter. Siemens, the Healthcare Information and Management Systems Society, and the Electronic Health Record Association expressed similar views.