National Coordinator Looks to Vendors for Improving Patient Safety

Regulation of Digital (EHR) RecordsHHS Stops Short Of Calling For Safety Regulations

By Jay Hancock
Kaiser Health News

The Obama administration last Friday urged cooperation 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.

“We are saying to the vendors: Step up and prove your ability to create a code of conduct that would be enforceable, that would bind you voluntarily to reporting safety events,” Dr. Farzad Mostashari, the administration’s coordinator for health information technology, said about the report. “And what we’re saying is: If you don’t step up, we can always look at more classic regulatory approaches.”

That doesn’t go far enough, said Arthur Levin, director of the Center for Medical Consumers, which promotes safety and effectiveness in health care.

“These are very baby steps,” he said. “They’re all voluntary. They rely on the goodwill of everybody involved, including the vendor industry, which really hasn’t been willing to admit there may be real problems here.”

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 records (EHRs), the Department of Health and Human Services said in June.

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) raised questions about the safety of computerized records, finding reports of patient harm and “gaps in knowledge” about the risks they pose. It also criticized hospitals for limiting transparency by shielding software vendors from potential lawsuits.

Today’s report from Mostashari’s Office of the National Coordinator for Health Information Technology was a response to the IOM findings. The Obama administration says it’s trying to promote innovation and jobs in electronic medical record development, while monitoring patient safety at the same time.

“We don’t really know right now what portion of patient safety events are directly or indirectly caused by health IT,” Mostashari said. “It’s probably pretty small right now.” However, he added: “There’s probably a lot of under-reporting.”

Health care providers have voluntarily reported adverse health events to the Food and Drug administration that researchers say 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’s 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’s 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 requiring hospitals to sign contracts shielding them from potential liability.

“We’re taking realistic steps toward using existing authorities to move patient safety forward in partnership with others in the federal government and the private sector,” Mostashari said.

But that’s 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.

“It sort of strikes one as saying, ‘Because we don’t have any evidence, we don’t think there’s a problem,’” he said. “If that’s so, wouldn’t you feel compelled in a fairly short timeline to learn more?”

This article was reprinted from and is used here with permission. Kaiser Health News is an editorially independent news service program that is part of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.