FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records

Food and Drug Administration Commissioner Scott Gottlieb on Wednesday called for tighter scrutiny of electronic health records systems, which have prompted thousands of reports of patient injuries and other safety problems over the past decade.

“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 said in an interview with Kaiser Health News.

Gottlieb was responding to “Botched Operation,” a report published this week by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries and near misses linked to EHRs have piled up in databases — including at least one run by the FDA.

Gottlieb said Congress would need to enact legislation to define when an electronic health record would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.

Read the full article at Kaiser Health News.

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