FDA's Dr. Scott Gottlieb: EHRs need stricter regulations

FDA Commissioner Scott Gottlieb, MD, said the government should apply stronger regulations on EHRs to ensure patient safety, Kaiser Health News reports.

For the government to be granted EHR oversight, Congress would have to enact legislation to define when an EHR requires regulation, Dr. Gottlieb told KHN. EHR systems currently do not fall under the FDA's existing legislation to regulate items like medical devices and drugs. Under the 21st Century Cures Act of 2016, the FDA is prohibited from regulating EHRs as a medical device.

To introduce regulations, Dr. Gottlieb said the EHRs should be considered as medical devices once they hit certain abilities, according to the report. Patient risks, such as injuries and death, resulting from EHR software glitches or user errors are not the same as traditional medical devices implanted in a patient, Dr. Gottlieb told KHN.

"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.

Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, testified in a 2010 public hearing that the agency had determined six patient deaths and more than 200 patient injuries had occurred due to health IT causes. The findings were pulled from reports submitted to the FDA that suggested "significant clinical implications and public safety issues," according to KHN. Since 2010, numerous government and private repositories have associated EHRs with thousands of injuries, near misses and deaths, KHN reports.

Earlier this month, Dr. Gottlieb submitted his letter of resignation from the FDA. His last day at the agency will be April 5, according to the report.

To access the full report, click here.

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