FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for…

Today, the U.S. Food and Drug Administration is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by a remote attacker—may introduce risks for medical devices and hospital networks. URGENT/11 affects several operating systems that may then impact certain medical devices connected to a communications network, such as wi-fi and public or home Internet, as well as other connected equipment such as routers, connected phones and other critical infrastructure equipment. These cybersecurity vulnerabilities may allow a remote user to take control of a medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent a device from functioning properly or at all.

To date, the FDA has not received any adverse event reports associated with these vulnerabilities. The public was first informed of these vulnerabilities in a July 2019 advisory sent by the Department of Homeland Security. Today, the FDA is providing additional information regarding the source of these vulnerabilities and recommendations for reducing or avoiding risks the vulnerabilities may pose to certain medical devices.

“While advanced devices can offer safer, more convenient and timely health care delivery, a medical device connected to a communications network could have cybersecurity vulnerabilities that could be exploited resulting in patient harm,” said Amy Abernethy, M.D., Ph.D., FDA’s principal deputy commissioner. “The FDA urges manufacturers everywhere to remain vigilant about their medical products—to monitor and assess cybersecurity vulnerability risks, and to be proactive about disclosing vulnerabilities and mitigations to address them. This is a cornerstone of the FDA’s efforts to work with manufacturers, health care delivery organizations, security researchers, other government agencies and patients to develop and implement solutions to address cybersecurity issues that affect medical devices in order to keep patients safe.”

The URGENT/11 vulnerabilities exist in a third-party software, called IPnet, that computers use to communicate with each other over a network. This software is part of several operating systems and may be incorporated into other software applications, equipment and systems. The software may be used in a wide range of medical and industrial devices. Though the IPnet software may no longer be supported by the original software vendor, some manufacturers have a license that allows them to continue to use it without support. Therefore, the software may be incorporated into a variety of medical and industrial devices that are still in use today.


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