Should EHRs be regulated like medical devices?

Will the Food and Drug Administration (FDA) decide to regulate electronic health records (EHRs) as medical devices--or will it decline? That's an interesting question that came up this past week at the first annual PharmEHR Summit in Philadelphia.

Jeffrey Shuren, MD, JD, the director of the FDA's Center for Devices and Radiological Health, told the audience that the FDA may reconsider its earlier hands-off approach toward EHRs. Or again, maybe it won't, he said. But either way, the issue remains "a political hot potato."

The EHR concerns are not new. Last year, for instance, the FDA's voluntary notification system logged in over a two-year period a total of 260 related reports of "malfunctions with the potential for patient harm," which resulted in 44 injuries and six deaths. Among the problems encountered were mixing up patients, putting test results in the wrong person's file, or losing critical medical information.

At a congressional hearing last year, Shuren suggested several approaches under consideration that would promote tighter oversight. This included the FDA requiring manufacturers to register their products with the government and to report safety issues. Another approach was that EHR systems could be subject to regulatory actions under the FDA that medical devices must meet before they go on the market.

Shuren did not indicate at the meeting what direction the FDA would take at this point. However, a great deal of information still needs to be evaluated. For instance, the Office of the National Coordinator for Health IT--along with the Institute of Medicine--currently are reviewing what role the federal government should take in addressing EHR safety.

But no matter which way the FDA turns, another critical issue remains: interoperability, Shuren said. Basically, since EHRs interface with many medical devices themselves, this relationship needs to be closely evaluated.

In a vacuum, EHRs and medical devices may work well by themselves, but interoperability can present problems, Shuren said. He noted, for instance, cases where a PACS [picture archiving and communication system] incorrectly interfaced with the EHR and the wrong image was created or flipped over. "These things happen, he said.

In addition, EHR software also requires frequent upgrades--and small changes, such as the addition of a security patch, could leave unintentional consequences.

So is increased government regulation in the future of EHRs? Shuren wasn't saying anything just yet. But it's likely to remain an evolving issue--both from a safety and a quality perspective--that we must closely monitor. - Janice