As the U.S. Food and Drug Administration updates its rules regarding software, will it choose to regulate electronic health records as medical devices?
Speaking at the first annual PharmEHR Summit in Philadelphia on April 7, Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health at the FDA, said his agency could change its traditional hands-off approach to EHRs, but he acknowledged that the potential of FDA regulation raises serious clinical issues and is a “political hot potato.” “As of right now we’re not regulating EHRs, and it may turn out that we won’t,” he said.
The FDA will issue new rules about software either later in 2011 or in 2012, Shuren said, adding that the agency already regulates certain types of software and is also developing rules for the development of medical mobile apps. FDA regulation could mean that EHR vendors would face review of their manufacturing processes and design controls, as well as FDA testing to show a system does what it claims to do.
The Office of the National Coordinator for Health IT (ONC) is leading an assessment of the role the federal government should play in addressing EHR safety, and the Institute of Medicine is conducting a study on the topic. But whether or not the FDA decides to regulate EHRs, interoperability issues must be addressed and device integration standards developed, Shuren said. “EHRs touch all kinds of medical devices that we have been regulating for a long time, and they impact the functioning of those technologies,” he said.
EHRs are becoming increasingly complex and interconnected, he said. In a vacuum they may work well, but interoperability can present problems. “We have cases where a PACS [picture archiving and communication system] interfaces with the EHR and the wrong image is conveyed or it is flipped. These things happen,” he said.
Software also requires frequent upgrades, he added, and small changes such as a security patch may have serious unintended consequences.
The EHR also has great potential to become a data source for medical devices, but so far the potential for the EHR to uniquely identify the device has been unrealized. “We can’t yet link the device with a patient’s experience with that device,” Shuren said. The FDA is working on rules for Unique Device Identifiers, which would likely use bar coding to feed specific information about a device into a patient’s electronic record. He said it is expected to improve adverse event reporting, document medical device use, bolster anti-counterfeiting efforts, support hospital IT systems and provide better claims data for third-party payers.
PDR Network, publisher of the Physician’s Desk Reference, hosted the two-day PharmEHR Summit. It brought together executives from the FDA, EHR vendors, and pharmaceutical and device companies to discuss the impact of EHR adoption on drugs and devices from a regulatory, liability and marketing perspective. Panels dealt with the role of the EHR in clinical trials and delivering drug safety alerts to physicians.
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