Health companies will improve digital records, but safety concerns linger
Federal health officials announced a deal Monday that should make digital health records easier for consumers and regulators to access and address safety issues linked with the data.
Nearly all of the companies that provide digital health records and 16 of the largest hospitals and health systems agreed to stop the practice of “information blocking," to adopt a universal language and to improve the systems so patients can easily monitor their health information.
"It’s great to have an electronic record, but if that record can’t be easily accessed by doctors and patients because of clunky technology, then we aren’t consistently seeing the benefit," Health and Human Services Secretary Sylvia Burwell said in remarks prepared for delivery Monday night.
The information in these records, also called electronic health records (EHRs), is also often blocked either on purpose or because there are misunderstandings about how the main health privacy law works, Burwell says.
"The problem is more in the system than in the evil that some people may be doing," says Ross Koppel, a sociology professor and electronic health records expert at the University of Pennsylvania.
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Koppel worries that by saying companies will be required to meet new and emerging standards, regulators have allowed "enough wiggle room to drive a fleet of Mack trucks through." And without talk of testing, monitoring or enforcement, there may not be enough teeth for the plan to make a difference, he says.
About 75% of doctors and nearly every hospital now uses EHRs, which means "there is now a digital care footprint for almost everyone in this country," Burwell says.
The promise of EHRs can be realized only if there is the kind of "seamless flow of data," envisioned in the HHS plan, says Robert Wachter, a physician and professor at the University of California-San Francisco. Wachter's 2015 book, The Digital Doctor, described safety issues with the records, including a massive prescription overdose given to a teenage patient at his hospital.
"There are many patient safety problems that occur when information is siloed in one part of the system — a blood test, an X-ray result, an allergy," says Wachter. "Just as importantly, the promise of using big data to improve care for individual patients and to improve the system can only be realized if data flow freely."
Despite potential problems, these digital records hold great promise, federal officials say.
"We're seeing an accumulation of data that safety does improve in hospital systems" that use EHRs, Karen DeSalvo, a physician who is the Department of Health and Human Services' national coordinator for health IT, told reporters Monday.
A new study funded by HHS' Agency for Healthcare Research and Quality found that cardiovascular, surgery and pneumonia patients whose complete treatment was captured in a fully electronic EHR were between 17% and 30% less likely to experience safety problems in the hospital.
Alerting doctors to possible drug interactions are "one of the greatest advancements that having a digital health record can bring," says DeSalvo.
And it was digital health records that helped pediatrician Mona Hanna-Attisha quickly determine lead levels in the blood of children in some Flint, Mich., neighborhoods were double or triple those in other areas, Burwell noted in her prepared remarks.
When in comes to safety problems caused or worsened by EHRs, some companies already choose to report them to the Food and Drug Administration, but the practice is far from widespread, DeSalvo said. Some companies include gag clauses in contracts with providers that prohibit the release of information about system issues.
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That's a key reason HHS is excited about the commitment to be "more transparent about business practices," DeSalvo says, as it will enable everyone to learn from safety mishaps.
"It's not so much about name, blame, shame," says DeSalvo, but rather trying to "get to the root cause" of why something went wrong.
DeSalvo declined to give a firm deadline other than to say some of the changes are expected this fall, while they should all be implemented in 2018. "We’re leaning in as far as we can,” she says.
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