FDA finalizes guidance on medical device interoperability

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The FDA's new guidelines emphasize the use of existing consensus standards to ensure uniform data exchange.

The Food and Drug Administration has finalized new guidance for medical device manufacturers that focuses on transparency, risk management and the use of consensus standards to ensure safe and effective interoperability with connected devices.

The new recommendations (PDF), released on Tuesday, maintain the FDA’s steady stream of digital health guidance that has emerged as a priority under Commissioner Scott Gottlieb. Medical device interoperability is one of several policies the agency outlined in its Digital Health Innovation Plan released in July, and it comes on the heels of finalized guidelines on the use of real-world data to regulate innovative medical devices.

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Highlighting the value of data generated by medical devices across the healthcare ecosystem, Bakul Patel, the FDA’s associate director for digital health at the Center for Devices and Radiological Health (CDRH), said safety is the agency’s foremost concern. Consistent data formatting and greater transparency from manufacturers regarding their products interface can limit the possibility of inadvertent medical errors.

“It’s not likely that medical device interoperability is a part of the everyday vocabulary of American consumers—and frankly, we hope it stays that way,” Patel wrote in a post on FDA’s blog. “At CDRH, we want patients and consumers to have confidence that medical devices work as intended without concern over how these devices operate together.”

The FDA references several existing consensus standards that focus on the development and design of interoperable devices. But the guideline provides leeway for device manufacturers by allowing the use of customized design standards as long as it's openly available to all users.  

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With more medical devices connected to the network, manufacturers are toeing a fine line between increasing interoperability—which can provide providers with valuable real-time data on their patients—and combating cybersecurity threats.

Last week, the FDA announced a firmware update for Abbott-manufactured pacemakers to resolve cybersecurity vulnerabilities that would have allowed unauthorized users to access the implanted devices. Industry leaders have called on medical device manufacturers to take the lead on developing cybersecurity standards amid a growing number of threats against healthcare.