IOM Recommends Independent Safety Agency For Health IT

The federal government is spending billions to encourage hospitals and doctors to use electronic medical records.

But a report out yesterday from the Institute of Medicine finds that digitized records and other health IT products are expected to improve patient safety — but only when the products are well-designed and correctly used.

“Designed and applied inappropriately, health IT can add an additional layer of complexity to the already complex delivery of health care, which can lead to unintended adverse consequences, for example dosing errors, failing to detect fatal illnesses and delaying treatment due to poor human-computer interactions or loss of data,” the report finds.

We wrote about one study, for example, that found that the transition to a newer electronic prescribing system led to an overall drop in prescribing errors, but that certain types of errors actually increased in the couple of months following the switch.

The magnitude of the health IT safety problem, or how the harms of the products stack up against their benefits, isn’t known, the report says.

The IOM recommends setting up an independent federal entity akin to the National Transportation Safety Board to investigate deaths, serious injuries or unsafe conditions associated with health IT. The organization wouldn’t regulate or approve those products, however. Nor does the report recommend immediately giving the FDA the power to do so.

“Our feeling was that if the FDA got too involved, that could inhibit innovation,” says David Bates, a member of the committee that produced the report and chief of the general medicine division at Brigham and Women’s Hospital. He tells the Health Blog that software is different from the medical devices that fall under the FDA’s purview in that it needs to be continuously updated, and those iterative changes need to be made “expeditiously.”

But the committee holds out the possibility of FDA regulation “if progress toward safety and reliability is not sufficient.” It wants health IT vendors to permit “the free exchange of information about health IT experiences and issues and not prohibit sharing of such information, including details (e.g. screenshots) relating to patient safety.” That means axing nondisclosure agreements built into vendor contracts that might prohibit sharing that kind of info.

The report also calls for a mechanism for vendors and users to report safety problems with health IT products — reporting should be mandatory for vendors, and “voluntary, confidential and nonpunitive” for users.

Allscripts Healthcare Solutions, a health IT company, tells us via email that it supports the IOM’s conclusion that the FDA shouldn’t regulate electronic medical records. It also suggests that patient safety organizations be used to collect data on adverse events rather than creating any new structure to do so.

“Physicians and consumers could greatly benefit from the idea of sharing vendor details of safety risks and publicly available comparative user data” called for in the report, says Lou Ann Wiedemann, director of professional practice resources at American Health Information Management Association, via email.

Bates said much of the research on electronic medical records has been done in institutions that developed their own custom systems.? “It would be helpful to do more large studies of the vendor systems that are being implemented today,” he says.

Bonus: Web-Based Electronic Health Record Safety Registry Launches

Update: Adds comment from Allscripts, the American health Information Management Association.