FDA representatives said the agency would not respond to the report because the Department of Health and Human Services was taking the lead on the issue. The Institute of Medicine also declined to comment because the report has not yet been made public. ONC, which is part of HHS, did not respond to repeated requests for comment.

To adequately oversee health IT safety, the committee recommends that the secretary of health and human services create and fund a new independent watchdog agency, along the lines of the National Transportation Safety Board. Like NTSB, the new agency would conduct investigations and make recommendations for all stakeholders, including the secretary of the health and human services, vendors and health care organizations. Vendors of the technology would be required to report adverse events, while reporting would be voluntary for clinicians. Like NTSB, though, the new agency would also have no enforcement power.

The panel also recommends that the HHS secretary publically report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.

Creating a new independent agency would, of course, require resources; the current budget for NTSB is set at $559 million over the 2010 to 2014 period. In the current climate of fiscal restraint, convincing Congress to appropriate that sort of cash for a new government body might be a tall order.

Michael Ettlinger, vice president for economic policy at the Center for American Progress, a left-leaning research organization, said he couldn’t see that happening before the next election. “If the administration is for it then the Republicans are going to be against it,” he said.

But that doesn’t mean it won’t happen at all, he said, if there is a compelling case for it. “Having another agency doesn’t mean it’s going to cost a lot more if there is a reason that relates to efficiency,” he said. The biggest obstacles, he said, might be those who favor less government regulation.

Robert Wears, MD, a professor in the department of emergency medicine at the University of Florida in Jacksonville, expressed support for the idea of a new, independent agency. “FDA is nominally the logical place,” he said, “but their procedures are so convoluted and slow that I don’t think they would be suited to do it.”

Republican Sen. Chuck Grassley of Iowa, senior member of the Senate Finance Committee, said the new report “adds more to the list of unresolved questions, including which government agency, if any, should regulate health care information technology.” Grassley, who wrote HHS and health IT vendors two years ago asking what was being done to ensure the safety of the devices, said “the approach seemed to be, write checks first, solve the problems later, instead of the other way around.”

The Institute of Medicine committee does have one dissenter. Richard Cook, MD, from the University of Chicago, feels the FDA is indeed the proper agency to oversee health IT safety. Cook writes that health IT is considered a “Class III medical device,” that is to say, a device that performs integral medical functions, which the FDA already has the jurisdiction to regulate.

The committee ruled out other agencies – including the Office of the National Coordinator, the Centers for Medicare & Medicaid Services and the Agency for Healthcare Research and Quality – as possible contenders for the position.

In its report, the IOM panel also recommended that another study be done to quantify health IT-related deaths, serious injuries or unsafe conditions so that the safety concerns can be properly addressed. “You can only improve what you measure,” says the report.

Other recommendations in the report: establishing and enforcing criteria for the safety of electronic health records, funding a new Health IT Safety Council to set standards for safety, and requiring all health IT vendors to publicly register and list their products with the Office of the National Coordinator.