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IOM report to influence future of EHR safety

An Institute of Medicine report on health IT due in early fall could rewrite the book on EHR safety and trip off FDA rulemaking. A new, free newsletter keeps tabs on the issue.

An upcoming Institute of Medicine (IOM) report could set policy wheels in motion that lead to the regulation of electronic health record (EHR) safety, observers believe.

The IOM promises that the report, commissioned by a $989,000 grant from the Office of the National Coordinator for Health IT (ONC), will be "comprehensive and specific," and contain recommendations for public and private entities to improve the safety of patient care. The report is due in September.

That could give the Food and Drug Administration (FDA) the impetus to move forward with plans to regulate EHR safety, said Dr. Edward Fotsch, the CEO at PDR Network LLC, who does not have specific details of the pending report's contents.

Whatever comes out of the report, this would not be the first time that IOM findings have led to significant shake-ups in the health care industry. Its 1999 "To Err Is Human," report regarding caregiver mistakes that harmed patients, brought on a flood of federal health-care delivery safety initiatives. Patient safety advocates continue to point to the 12-year-old report and the need for better communication among providers and patients.

Regardless, Fotsch thinks it's a pretty sure thing that the IOM report will include substantive ideas for improving safety, as well as for reporting adverse events -- something the institute has recommended in past publications. That's one of his interests, as well: He is the head of EHRevent, a site that collects adverse event reports from the field and delivers them to vendors and other health IT stakeholders. In addition, the PDR Network recently debuted a free EHR safety newsletter for physicians.

Adverse event reports on the radar

Adverse event reports -- most likely issued through the FDA or the Centers for Medicare & Medicaid Services -- potentially could be hardwired into federal EHR safety regulations, Fotsch said. ONC-commissioned EHR certification bodies eventually could have a say in the matter too, if some systems don't pass the safety standards the IOM might recommend and write into regulatory law.

"Without a crystal ball, there are a few things you can see," said Fotsch, who keeps in contact with the FDA and IOM. He has some ideas about where officials might come down on the matter, although he has no specific inside information about the contents of the forthcoming IOM health IT safety report.

I believe that the recom-
mendations from the IOM and the path forward have a whole lot more to do with monitoring safety signals than regulating usability.

Dr. Edward Fotsch, CEO, PDR Network LLC

"First, it would be unlikely the IOM comes out and says, 'EHR and [health IT] are just fine, no need to do anything, thanks for the million bucks,'" Fotsch said. "Second, I can't imagine them saying, 'EHRs are incredibly dangerous; they should be withdrawn from the market.' In between, [EHRs] either get regulated, monitored, or something -- and with the IOM being a government-sponsored group, it would be safe to assume that they would lean toward a government-sponsored role of oversight or regulation."

Making usability a piece of EHR safety

At the Health Information and Management Systems Society's 2011 annual conference last month, ONC Chief Scientific Officer Charles Friedman announced that EHR usability will be a part of Stage 2 of meaningful use. Meanwhile, ONC, in partnership with the National Institute for Standards and Technology, developed EHR usability standards, which were published late last year.

Safety and usability might go hand in hand, however. The Leapfrog Group asks participants in its hospital safety initiatives to monitor how well they catch errors made in IT systems, such as computer physician order entry (CPOE) systems, where mistakes can lead to patient harm. Vigilance and better technology designs could help reduce errors, according to the group.

Usability is a component of EHR safety, Fotsch concedes. In fact, the first article in the first issue of the EHRevent newsletter deals with the topic, outlining the difficulties some physicians have using a stylus to navigate EHR systems with tablet computers. Pull-down menus are the specific problem, he noted, because "letting up" on the stylus sometimes can lead to wrong drug choices and other errors.

That's not likely to be the focus of IOM's findings, however. "I believe that the recommendations from the IOM and the path forward have a whole lot more to do with monitoring safety signals than regulating usability," Fotsch said. "It's doable; there's a tradition behind it. If it's like drugs and devices, it's something you can mandate and put the burden on the vendor community, and you don't have to create a massive staff."

Eventually, EHR safety regulations will run along the lines of FDA regulations for drugs and medical devices, Fotsch believes. Regulating software usability would be mostly uncharted waters for whichever agency took on the task, and would require more manpower than monitoring alone, as well as the creation of a new system of standards.

Let us know what you think about the story; email Don Fluckinger, Features Writer.

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