Healthcare Experts Confront EHR-Related Medical Errors

Though questions about the efficacy of electronic health records (EHRs) seem to have increased recently, usability and safety of health IT systems have been on the minds of medical informaticists for a while.

The American Medical Informatics Association (AMIA), which convened an EHR usability task force in late 2011, this week released a position paper on EHR usability in which the group called on multiple stakeholders to act in order to lessen the chance of patient harm from poorly designed and implemented technology.

In a position paper published online in the Journal of the American Medical Informatics Association (JAMIA), Bethesda, Md.-based AMIA spelled out 10 recommendations in four areas: research into health IT-related human factors; health IT policy; vendors; and clinician end users.

"These AMIA recommendations are intended to stimulate informed debate, provide a plan to increase understanding of the impact of usability on the effective use of health IT, and lead to safer and higher quality care with the adoption of useful and usable EHR systems," the paper said.

[ Is government throwing our money away on health IT? See Healthcare IT: Savior Or Sinkhole? ]

"The fundamental approach to health IT needs to change," lead author Dr. Blackford Middleton, corporate director of clinical informatics research and development at Partners Healthcare System and 2013 AMIA chair-elect, told InformationWeek Healthcare. "We've been installing it and not measuring it like we would any other intervention."

It is time, Middleton said, to take a step back and assess the direction of health IT, EHRs and the federal Meaningful Use incentive program. "We were motivated by the mounting evidence that there were unintended and untoward consequences with using health IT," Middleton explained.

Middleton gave a preview of the report at the 2012 AMIA annual meeting in November, but AMIA would not allow the authors to grant interviews until the paper's publication. He noted that the U.S. government's Office of the National Coordinator for Health Information Technology (ONC) has since issued a draft national patient safety plan based on a 2011 Institute of Medicine (IOM) report about the role of health IT in delivering safer care. ONC is taking public comments on the plan through Feb. 4.

AMIA called on the academic community to accelerate research into usability and human factors by standardizing use cases, developing a core set of measures for health IT-related adverse events and defining best practices for safe EHR implementation and usage.

On the policy front, the AMIA panel said ONC's policy framework should consider usability in the context of standardization and interoperability. Federal officials also should establish a reporting system for adverse events related to health IT, as the IOM called for in 2011, and create an educational program about safe and effective EHR use, the paper said.

For vendors, AMIA recommended that an industry coalition develop a common style guide for certain EHR functions related to patient safety to streamline training, much like all automobiles have similar information sources such as odometers and fuel gauges. Vendors also should conduct formal usability assessments on key EHR functions, AMIA said.

End users have responsibilities, too, according to AMIA. They should adopt best practices for EHR implementation and management, as well as monitor how clinicians use health IT systems and report any adverse events, the informatics group said.

"Following best practices for EHR implementation is essential to safe and effective use," the AMIA task force wrote. "User error may result in untoward outcomes and unintended negative consequences. These may also occur as a result of poor usability, and may also be an emergent property only demonstrated after system implementation or widespread use. User errors may occur without adverse events, and some may not even be apparent to the user, analyzed by hospital or clinic review boards, or reported to the vendor."

The AMIA usability task force included a diverse group from vendor companies, healthcare provider organizations, and academia. One of the members was University of Pennsylvania sociologist Ross Koppel, a longtime critic of major health IT vendors, which he considers barriers to true interoperability of health information. "The idea was to have a balanced number of industry people and academics," Middleton explained.

The policy statement concentrates on EHR usability, without considering medical devices, mobile devices, personal health records and other forms of health IT. Nor does the AMIA paper address potential EHR regulation by the U.S. Food and Drug Administration (FDA), as had been discussed in the formative days of the Meaningful Use program.

Middleton said the FDA's interest in health IT would lie in clinical decision support for medical devices. But the FDA probably has not stepped in because there is a "learned intermediary" such as a physician or nurse, not devices, making actual clinical judgments.