This week, Bloomberg News published a special report examining the shift of US healthcare to electronic health records, and in particular, the questions hospitals, doctors and patients are asking about the “problems and potential harm arising from these new computerized systems.” One story in particular provides an overview of a number of the safety issues being encountered, which include everything from medical data seemingly disappearing from EHRs to user interface issues. Not surprisingly, the Bloomberg article reports that the “most dangerous time for patients appears to be immediately after a facility installs” a new EHR system because of staff learning curve issues as well as the myriad of operational system fixes that always need to be made to get the EHR system to work reliably and correctly.
Jodi Daniel, director of policy and planning for the Office of the National Coordinator for Health Information Technology, which coordinates the U.S. effort to implement and use EHR systems, seemed to downplay the patient safety concerns the article raised. Daniel told Bloomberg News that, “So far, the evidence we have doesn’t suggest that health information technology is a significant factor in safety events.”
That’s a very interesting statement for Daniel to make considering that a 2011 Institute of Medicine report, and another report published this week by the American College of Emergency Physicians, state there isn't sufficient evidence for anyone to reach such a conclusion!
The Institute of Medicine report, titled “Health IT and Patient Safety: Building Safer Systems for Better Care,” and which I wrote about, investigated the use of health IT and its affects on improving patient safety. The report's conclusion was that there was insufficient evidence to make informed judgments about how health IT either improves—or importantly, harms—patient safety.
Part of the reason for the lack of safety-related information is that, unlike medical devices, reporting of problems with electronic health record systems to the US Federal Drug Administration is not mandatory. In addition, it is often difficult to identify whether an “EHR problem” is due to a simple human error, a design flaw that encourages human errors to occur, or some specific software or other type of system-related error. Further, even if there was a reliable means to identify and classify these issues, EHR vendors frequently include “hold harmless clauses” in their contracts that help them escape responsibility for errors or defects in their software, as well as nondisclosure or confidentiality clauses that can prevent EHR users from disclosing the problems they encountered with a vendor’s software.
To gain better insight into EHR safety issues, a coalition of medical societies and liability carriers called the iHealth Alliance announced with great fanfare in November 2010 that it was going to set up a voluntary EHR safety reporting system called EHRevent.org. The press release at the time stated that EHRevent.org was to be “modeled after other national reporting systems, including the system used in the aviation industry, and its reports include issues related to software problems, inadequate user training, security breaches and near-misses. Reports will be confidential but used to better understand challenges associated with the adoption and implementation of EHRs and to improve patient safety.”
However, while seemingly a good idea that at least publicly was strongly supported by EHR vendors, EHRevent.org never seemed to gain any traction once put into place. Last November, EHRevent.org was unceremoniously and quietly shut down without apparently providing any additional evidence-based insights into EHR use and their possible impacts to patient safety.
The continued lack of health information technology risk data has become a deeply vexing issue for the American College of Emergency Physicians, according to a story published this week in Modern Healthcare. According to the story, two study groups from the American College of Emergency Physicians “have recommended a program of systemic vigilance over electronic health-record systems used in emergency departments to improve patient safety and enhance quality of care.”
The reason for the recommendation is that the American College of Emergency Physicians has found that poorly designed EHR systems in use at hospital emergency departments are leading to “communication failure, wrong order–wrong patient errors, poor data display, and alert fatigue.” What worries the emergency physicians group is as more emergency room departments across the U.S. implement EHRs, there is still little to no concrete data in regard to “how commonly these errors occur.” In addition, there are “few studies [that] are actually focused on collecting evidence of these errors,” the group says.
Furthermore, the American College of Emergency Physicians stated that “there is currently no mechanism in place to systematically allow, let alone encourage, users to provide feedback about ongoing safety issues or concerns.” On top of a call to begin collect such feedback, another main recommendation—or better stated, demand— is for vendors to get rid of hold harmless and gag clauses from EHR vendor contracts which the emergency physicians says is impeding the flow of EHR-related safety information. By coincidence, some forty or so EHR vendors belonging to the Electronic Health Record Associationpromised earlier this month that they would begin to remove those clauses.
The American College of Emergency Physicians recommendation to collect data on EHR patient safety concerns follows the one made by the Institute of Medicine in its report that called upon the US Department of Health and Human Services to “fund a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT and the use of health IT to enhance safety.”
Don’t hold your breath about any systematic monitoring of EHRs happening anytime soon, however. The first thing that needs to happen is for the Institute of Medicine, the American College of Emergency Physicians and the Office of the National Coordinator for Health Information Technology to first agree on the definition of the word "evidence."
Robert N. Charette is a Contributing Editor to IEEE Spectrum and an acknowledged international authority on information technology and systems risk management. A self-described “risk ecologist,” he is interested in the intersections of business, political, technological, and societal risks. Charette is an award-winning author of multiple books and numerous articles on the subjects of risk management, project and program management, innovation, and entrepreneurship. A Life Senior Member of the IEEE, Charette was a recipient of the IEEE Computer Society’s Golden Core Award in 2008.