Feature

FDA chief calls for stricter scrutiny of electronic health records


 

Food and Drug Administration Commissioner Scott Gottlieb, MD, on March 20, 2019, called for tighter scrutiny of EHR 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,” Dr. Gottlieb said in an interview with Kaiser Health News.

Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 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.

Dr. Gottlieb said Congress would need to enact legislation to define when an EHR 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.

Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.

The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.

Pages

Recommended Reading

Disruptive behavior on the job linked to depression, burnout
The Hospitalist
Influenza activity continues to increase
The Hospitalist
Final ‘Vision’ report addresses MOC woes
The Hospitalist
Malpractice suits are less frequent – but more costly
The Hospitalist
AAP: Treating patients during disasters raises liability risks
The Hospitalist
Groups of physicians produce more accurate diagnoses than individuals
The Hospitalist
Scott Gottlieb to step down as FDA commissioner
The Hospitalist
What’s the price of rude behavior in the hospital?
The Hospitalist
Prior authorization an increasing burden
The Hospitalist
Advance care planning codes not being used
The Hospitalist
   Comments ()