“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.