Food and Drug Administration Commissioner Scott Gottlieb called for tighter scrutiny of electronic health records systems, which have prompted thousands of reports of patient injuries and other safety problems over the past decade.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Gottlieb said in an interview with Kaiser Health News.
Gottlieb was responding to “Botched Operation,” a report published this week by KHN and Fortune magazine.
The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, electronic health records have created a host of risks to patient safety.
Patient harm: Electronic health records have created a host of risks to patient safety. Alarming reports of deaths, serious injuries and near misses – thousands of them – tied to software glitches, user errors or other system flaws have piled up for years in government and private repositories. Yet no central database exists to compile and study these incidents to improve safety.
One example, an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports – Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country – suggesting the company’s technology didn’t work quite the way it said it did.
In May 2017, eCW paid a $155 million settlement to the government over alleged false claims and kickbacks – one physician made tens of thousands of dollars – to clients who promoted its product. Despite the record settlement, the company denied wrongdoing
Signs of fraud: Federal officials say the software can be misused to overcharge, a practice known as “upcoding.” Some doctors and health systems are alleged to have overstated their use of the new technology, a potentially enormous fraud against Medicare and Medicaid likely to take years to unravel. Two software makers have paid a total of more than $200 million to settle fraud allegations.
Gaps in interoperability: Proponents of electronic health records expected a seamless system so patients could share computerized medical histories in a flash with doctors and hospitals anywhere in the country. That has yet to materialize, largely because officials allowed hundreds of competing firms to sell medical records software unable to exchange information.
Doctor burnout: Many doctors say they spend half their day or more clicking pulldown menus and typing rather than interacting with patients. An emergency room doctor can be saddled with making up to 4,000 mouse clicks per shift. This has fueled concerns about doctor burnout, which in January the Harvard T.H. Chan School of Public Health and Massachusetts Medical Society called a “public health crisis.”
Web of secrets: Entrenched policies continue to keep software failures out of public view. Vendors of electronic health records have imposed contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations – and some hospitals fight to withhold records from injured patients or their families.
For an in-depth examination of electronic health records, read “Death By 1,000 Clicks: Where Electronic Health Records Went Wrong.”