The Obama administration Friday between software companies and caregivers to prevent patient harm caused by faulty electronic records. But it stopped short of calling for regulation or a federal requirement to report computer mistakes that pose a risk to patients.
That doesn鈥檛 go far enough, said Arthur Levin, director of the Center for Medical Consumers, which promotes safety and effectiveness in health care.
鈥淭hese are very baby steps,鈥� he said. 鈥淭hey鈥檙e all voluntary. They rely on the goodwill of everybody involved, including the vendor industry, which really hasn鈥檛 been willing to admit there may be real problems here.鈥�
Thanks to Medicare payment incentives, hospitals and doctors are swiftly installing computerized patient information systems. Nearly 100,000 health care providers are using electronic health聽records (EHRs),聽the Department of Health and Human Services.
Electronic records are often praised as more reliable than paper files and more efficient because they theoretically allow clinical information to follow the patient from one caregiver to another. But last year, a panel appointed by the prestigious Institute of Medicine (IOM) about the safety of computerized records, finding reports of patient harm and 鈥済aps in knowledge鈥� about the risks they pose.聽It also criticized hospitals for limiting transparency by shielding software vendors from potential lawsuits.
Today鈥檚 report from Mostashari鈥檚 Office of the National Coordinator for Health Information Technology was a response to the IOM findings. The Obama administration says it鈥檚 trying to promote innovation and jobs in electronic medical record development, while monitoring patient safety at the same time.
鈥淲e don鈥檛 really know right now what portion of patient safety events are directly or indirectly caused by health IT,鈥� Mostashari said. 鈥淚t鈥檚 probably pretty small right now.鈥� However, he added: 鈥淭here鈥檚 probably a lot of under-reporting.鈥�
Health care providers have voluntarily reported adverse health events to the Food and Drug administration that were linked to dozens of patient injuries and several deaths. Problems included small fonts causing caregivers to click on the wrong medication and lost or misdated test results that caused unnecessary surgery or delayed treatment.
Friday鈥檚 plan asks vendors to collect and analyze examples of harm or risks to patients from digital records, which critics say can be caused by bugs or poorly designed software that keeps important information from doctors. It calls on parties who certify EHR software to track its performance in the hospital or doctor鈥檚 office. It asks accrediting organizations such as the Joint Commission, which certifies hospitals, to develop standards for safe info-tech use. And it asks software companies to stop聽requiring hospitals to sign contracts shielding them from potential liability.
鈥淲e鈥檙e taking realistic steps toward using existing authorities to move patient safety forward in partnership with others in the federal government and the private sector,鈥� Mostashari said.
But that鈥檚 unlikely to satisfy critics who believe the FDA should regulate EHRs as medical devices, or those such as Levin, who sat on the IOM commitee and believes voluntary reporting of patient harm caused by digital records may not be enough.
鈥淚t sort of strikes one as saying, 鈥楤ecause we don鈥檛 have any evidence, we don鈥檛 think there鈥檚 a problem,鈥欌�� he said. 鈥淚f that鈥檚 so, wouldn鈥檛 you feel compelled in a fairly short timeline to learn more?鈥�