Veterans Administration Adopts UL Security Certification Program For Medical Devices

The US Department of Veterans Affairs will use a new program and a set of standards developed by Underwriters Laboratories (UL) to ensure that network-connectable medical devices and systems the VA procures meet baseline requirements for security.

The VA and UL this week entered into a Cooperative Research and Development Agreement Program (CRADA) to facilitate the process. Under the agreement, the VA’s office of information technology will use UL’s Cybersecurity Assurance Program (CAP) to establish testable cybersecurity requirements for network-enabled medical devices, data systems, and associated technologies.

The program is scheduled for completion in December and is designed to support improvements in patient safety and security at the VA.

UL CAP, which Underwriters Laboratories announced earlier this year, which uses a newly created set of standards for IoT and critical infrastructure vendors to use for assessing security vulnerably and weaknesses in their products. features a set of standards, collectively referred to as UL 2900, that lets organizations asses network connected products for software vulnerabilities, known malware, and other security issues. The program combines input from multiple stakeholders from the federal government, academia, and industry.

The White House Cybersecurity National Action Plan (CNAP) officially recognizes UL’s CAP as a way to test and certify the security readiness of Internet connected products used in critical infrastructure sectors such as energy, healthcare, critical manufacturing, and utilities.

The VA’s plans to use UL CAP to refine its pre-procurement product vetting process are significant. Security vulnerabilities in network-enabled medical devices pose a significant risk to patient safety and security. Researchers in the past have demonstrated how security flaws in wireless enabled insulin pumps, pacemakers and heart monitors, and other medical devices can be exploited to deadly effect. 

In one demonstration five years ago, a security researcher at Black Hat USA showed how an attacker could shut down an insulin pump remotely by taking advantage of a security flaw in the device. In another demonstration, a security researcher showed how a flaw in a wireless-enabled pacemaker could be exploited to deliver a lethal shock to the wearer of the device. Malware in medical devices can also cause issues with reliability and availability of medical devices.

Concerns over the issue prompted the US Food and Drug Administration to issue draft cybersecurity guidelines and best practices for medical device makers earlier this year.

“Medical devices are susceptible to cybersecurity attacks, creating both patient safety risks and disclosure risks for protected health information,” the UL and VA said in a joint statement this week. The agreement “will seek to address an existing gap in the marketplace for cybersecurity standards and practical certification approaches for connected medical devices.”

Anura Fernando, global principal engineer at UL, says the CRADA project will accelerate the sharing of medical device cybersecurity information.

“Disclosure of potential cybersecurity concerns can be a sensitive topic when dealing with relationships across the supply chain,” Fernando says. “The UL CAP certification process provides mechanisms for having a blend of both public disclosures that can help the problems be effectively managed with minimal risk of public exposure or exploitation.”

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