Short Takes On News & Events

HHS Stops Short Of Calling For Safety Regulation Of Digital Records

By Jay Hancock

December 21st, 2012, 5:50 PM

The Obama administration 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?”

One Response to “HHS Stops Short Of Calling For Safety Regulation Of Digital Records”

  1. larry says:

    Does anyone remember walking into your doctors office and seeing shelves upon shelves of paper folders containing medical records? Whenever I would visit my doctor, as I stood at the desk to sign in and pay my copay, I could literally reach over and grab any number of folders while the secretary wasn’t looking. Security? Is that all we have to complain about when it comes to electronic record keeping? In just the short time since they enacted the Affordable Care Act (ACA), virtually every paper medical record has been digitized and password protected. Millions of once easily accessible paper folders, folders that sat on open shelves where anyone had access without any kind of security whatsoever, those paper records that were filled with our personal and private medical details, are off those unprotected shelves are protected in a database that only certain people are authorized to access. Does anyone else get tired of the Republican whining and crying since the ACA has been enacted? In less than three years, electronic records is now the industry standard. Obamacare did that! If it were up to Republicans, we’d still be seeing endless shelves of paper records! Stop whining you morons! The ACA is the law of the land, it’s working, it’s saving lots of money and people are seeing huge benefits. Get over it you right-wing wackos!