As healthcare providers make the transition to electronic health records in response to the Affordable Care Act and general industry demands, many are questioning the integrity of such systems even as they look to them to streamline care, cut costs and reduce errors. In many cases, poor software design and system errors are creating unnecessary risks for patients, according to several recent reports. Experts have urged greater oversight of EHR glitches, as well as more robust, customized development processes.
Among the concerns leveled against EHR systems are that they can lead to the mysterious disappearance of medication information, that there are no regulatory standards in place that require error reporting and that they can lead to delays that place patients at risk. Additionally, some physicians have criticized the increasingly common practice of hospitals adopting comprehensive enterprise EHR solutions rather than selecting best-of-breed systems from multiple developers for different departments.
The issue is becoming more pressing as adoption increases before a 2015 government deadline, Bloomberg News noted. Early adopters can receive bonuses, while late adopters will be penalized. Approximately 69 percent of U.S. physicians used EHRs in 2012, according to a study by Health Affairs.
Tracking the errors
Bloomberg News recently highlighted some of the challenges with EHRs, noting that while they decrease errors such as those caused by illegible handwriting, they have introduced new errors in other cases. Confusing drop-down menus, incorrect or disappearing patient information and network delays have all led to injuries and deaths, particularly with regard to dangerous drug doses, according to one 2011 study of reports submitted to the U.S. Food and Drug Administration. Another recent study from the Pennsylvania Patient Safety Authority noted that the number of medical errors due to electronic health records is growing, with more than one-third of the 3,099 incidents reported in an eight year period occurring in 2011 alone.
At the same time, a study in the Journal of the American Medical Informatics Association found that more than 17 million medication mistakes are now avoided annually in the U.S. due to such systems. Leora Horwitz, a doctor and assistant professor of medicine at Yale University School of Medicine, told Bloomberg that there is no case for paper charts over electronic records.
“But while [electronic records] are good,” she added, “they’re so far from great it’s astonishing.”
One of the biggest issues facing EHR systems is that, unlike other medical device manufacturers, EHR software vendors are not required to report malfunctions or incidents resulting in serious injury or death to the FDA, Bloomberg noted. The current approach relies on voluntary reporting, which some experts have denounced as inadequate.
One of the areas for which EHR systems have been most intensely scrutinized is in emergency departments, according to a recent Modern Healthcare article. A study released by the American College of Emergency Physicians noted that the system functionality of different EHR systems used in emergency departments “varies greatly,” with effectiveness depending largely on whether the systems were designed explicitly for emergency departments or as more general enterprise systems. That study also expressed concerns over the lack of reporting mechanisms for errors that occur and the lack of accountability for vendors, who are often protected by “hold harmless” clauses in their contracts.
Improving system design
In addition to recommending better regulatory mechanisms for EHR systems and error reporting, some experts have also advocated for better design principles for these programs. The AECP study suggested that specialized systems targeted toward emergency department physicians would reduce the number of errors, especially if they were designed to streamline information entry for physicians. Similarly, a survey from IT market researcher KLAS Enterprises found that 75 percent of physicians using enterprise systems would prefer more streamlined workflows and tools. According to industry venture partner Todd Cozzens, better coding is needed both to eliminate flaws and reduce the likelihood of human error.
“These systems do have glitches, but it can be plain and simple bad design that can lead to clinical errors,” he told Modern Healthcare, adding that physicians are “having the enterprise systems forced upon them. To think you can take one system and adapt it to those different environments is totally wrong.”
As organizations seek to improve design and reduce errors, adopting secure, agile development processes that incorporate plenty of static analysis checks can be an essential approach. Additionally, as industry voices seek standards to ensure FDA compliance among EHR software, vendors will want to adopt tools that will help them follow evolving industry guidelines.
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