FDA Mulls Regulating Electronic Health Records

Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health

In the wake of almost 260 reports of “malfunctions with the potential for patient harm,” healthITBuzz reports that the FDA is considering regulation of healthcare IT, specifically Electronic Health Records.

In his prepared remarks for Congress today, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, an operating room electronic health record management system frequently “locked up” during surgery.  He noted that lost data had to be re-entered manually “in some cases from a nurse’s recollection,” creating potential for human error.

Shuren said, “the FDA recognizes the tremendous importance of HIT and its potential to improve patient care. However, in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety.”  continued that the FDA has “largely refrained” from regulating health IT.

Director Shuren proposed three possible approaches to regulating healthcare IT.

First, the FDA could require health IT developers to submit reports to the FDA on safety issues and correct problems that surface, enabling the FDA to track this information “to help improve the design of future products.”

Second, the agency could set minimum quality standards for products on the market.

Finally, systems could be subject to regulations similar to the way the FDA regulates new medical products.

According to the Huffington Post, EHR manufacturers generally oppose regulation by the FDA, arguing that strict controls would slow down the government’s campaign to drive widespread adoption of the technology.

Carl Dvorak, executive vice president of Epic Systems Corporation, said in his prepared testimony that regulation will not necessarily create a “safer” electronic health record “and might actually limit innovation and responsiveness when it is needed most.”

The Office of the National Coordinator for Health IT adoption has recognized the need for better surveillance, issuing a contract to address “undesirable and potentially harmful unintended consequences” of EHRs.

Whatever approach the federal government takes, it seems clear that regulation is coming for EHRs, one way or another.