The FBI today released recommendations to help protect medical devices from cyberattacks that can threaten health care operations, patient safety, and data privacy and integrity, citing a growing number of unpatched medical device vulnerabilities.

“This past June, the AHA issued a letter of support to Congress for pending legislation known as the PATCH Act,” said John Riggi, AHA’s national advisor for cybersecurity and risk. “The letter echoed the need for medical device manufacturers to implement increased cybersecurity requirements for medical devices. Cyber vulnerabilities in medical devices, often containing outdated legacy technology, have posed a significant cyber risk to hospitals. In 2017, the FBI reported that the North Korean WannaCry global health care ransomware attack was fueled by vulnerabilities in medical devices.  

“The pending legislation would require medical device manufacturers to monitor and identify post-market vulnerabilities in a timely manner, develop a plan for coordinated vulnerability disclosure, provide lifetime cybersecurity support of the device and provide an accounting of all software contained in the device, including third party software. 

“In the interim, it is good practice to increase cybersecurity requirements in medical device and medical technology business associate agreements. An excellent resource for medical technology model contract language can be found here.”

For more information on this or other cyber and risk issues, contact Riggi at jriggi@aha.org.

Headline
A joint advisory released Aug. 19 by the FBI, Cybersecurity and Infrastructure Security Agency, and the Department of Health and Human Services provides…
Headline
The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial…
Headline
The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed…
Perspective
Public
Every day, hospitals and health systems perform a remarkable balancing act. They invest in talented caregivers, advanced technologies, innovative partnerships…
Headline
U.S. and international agencies released a joint cybersecurity advisory Aug. 10 warning of actions by Gunra ransomware. Gunra is a ransomware-as-a-service…
Headline
The Cybersecurity and Infrastructure Security Agency and other U.S. and international agencies July 29 released joint guidance outlining minimum elements for a…