Report: Outgoing FDA head Gottlieb calls for better regulation of EHRs

Outgoing FDA commissioner Dr. Scott Gottlieb is calling for stricter oversight of electronic health records systems, according to a report from Kaiser Health News.

The call for heightened scrutiny comes in response to a investigative report, published by KHN and Fortune magazine, alleging a number of serious issues that have arisen over the past 10 years as the U.S. government has pushed to switch from paper to digital records systems.

In the report, investigators shed light on thousands of reported deaths, injuries and near misses tied to EHR system, as well as other concerns raised as more systems move towards digital health records keeping.

“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 told the KHN.

Gottlieb said that oversight of electronic health records would require Congress pass legislation defining when EHRs would need regulation, adding that currently digital records systems that store a patient’s medical history don’t fit under the FDA’s regulatory purview, according to the report.

Currently, the FDA is prohibited from having oversight of EHRs, as the 21st Century Cures Act of 2016 excluded the federal watchdog from having regulatory control over EHRs as a medical device, according to KHN.

Gottlieb suggested that a possible path towards regulation would be identifying that EHRs have the capability to become a medical device, calling the records a “unique tool” and noting that risks posed by their use are different than traditional devices, according to the report.

“You need a much different regulatory scheme,” Gottlieb told KHN.

Healthcare IT companies could add new functionality to EHRs that would improve their usefulness, Gottileb said, but companies have been reluctant to do so because it would put their products under FDA jurisdiction, according to the report.

Gottlieb, who’s last day as head of the FDA is slated for next Friday, clarified that he is not calling for the FDA to take over regulation of EHRs, and added that any new regulatory approach to the system could be years away, according to KHN.

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