FDA, ONC clash over EMR safety issues

The CMS regulations for "meaningful use" of EMRs are 864 pages long. The companion rule on EMR certification, from the Office of the National Coordinator for Health Information Technology, is another 228 pages. Yet there's not a word about reporting and tracking of errors in EMR software and related systems, according to the Huffington Post Investigative Fund. (National coordinator Dr. David Blumenthal was unaware of a serious glitch with the Cerner system at Michigan-based Trinity Health in late June until a reporter brought it to his attention. We hadn't heard of it, either.)

"That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows," the article says.

The Huffington Post Investigative Fund story also discusses long-running tension between ONC and the Food and Drug Administration over whether EMRs should be regulated for safety. Neither Blumenthal nor the FDA would comment about the status of negotiations between the two HHS agencies. An unnamed ONC spokesperson said EMR safety is a "continual process," and said that Blumenthal and his team are "working with a number of organizations throughout the healthcare industry" to improve safety, the HuffPo fund reports. "FDA is one agency that we are working with," the spokesperson said.

Some critics are not satisfied by such vague statements. "The industry is glossing over these problems," Dr. Robert B. Elson, a former vice president of medical affairs in McKesson's IT division and now a Cleveland-based consultant, is quoted as saying. "It's mind-boggling how little innovation there has been over the last 10 to 15 years."

Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology, references some recent studies showing the downside of poorly implemented EMRs. "While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards," Leveson says. "People just assume that computers will make things safer."

Both former national coordinator Dr. Robert Kolodner and AMIA President Dr. Edward Shortliffe say that safety issues weren't really on people's minds in 2004, when President George W. Bush first called for most Americans to have interoperable EMRs within a decade. This year, AMIA for the first time formed a workgroup to study EMR safety, but any findings haven't been made public yet. While it's not likely AMIA will take a stand on EMR regulation, Shortliffe says, "We recognize that there are significant challenges that the field as a whole is facing."

The HuffPo investigation revealed that FDA Commissioner Dr. Margaret Hamburg told senior staff on Sept. 22, 2009, that "the FDA needs to be involved in the White House [EMR] initiative," according to minutes of the meeting. In February 2010, the FDA's Dr. Jeffrey Shuren publicly blamed poorly implemented CPOE for at least six documented deaths and 200 injuries, while an FDA report noted "significant clinical implications and public safety issues surrounding health information technology."

Blumenthal reportedly called the findings "anecdotal and fragmentary."

To learn more:
- check out this Huffington Post Investigative Fund story

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