Medical devices offer benefits to patients and physicians alike, but they also come with inherent risks. That’s the basis of the Food and Drug Administration (FDA)’s new “Medical Device Safety Action Plan,” which aims to improve patient safety, explore regulatory solutions and advance medical device cybersecurity nationwide.
Cybercriminals are now targeting medical devices. Their goal is often to gather information related to configurations, networks shares and user groups, account policies, administrators and more. Motivated cybercriminals could even cause loss of life by breaching insecure medical devices, suggesting a pressing need for improved device control and oversight.
According to Help Net Security, the FDA aims to provide both owners and users with a “Software Bill of Materials” — a list of all software components used by a device. Ideally, this should allow end users to “better manage their networked assets and be aware of which devices in their inventory or use may be subject to vulnerabilities.”
FCW reported that the administration is also considering new rules around patching: Devices directly linked to patient safety, such as pacemakers and insulin pumps, would require the capacity for ongoing patches and upgrades to improve medical device cybersecurity.
In addition, the plan earmarked $70 million of the FDA’s requested 2019 budget to create a “go-team” for device attack investigations. As noted by Fierce Healthcare, the CyberMed Safety Expert Analysis Board (CYMSAB) would include both public and private experts. Manufacturers and the FDA could call on the CYMSAB to address high-risk vulnerabilities, evaluate potential device risks and adjudicate disputes.
According to the FDA’s plan, there’s currently a gap in medical device cybersecurity. The CYMSAB would be an “invaluable asset” to both the FDA and device manufacturers to help bridge the divide between device issues and effective investigations.
Improving Outcomes With Medical Device Cybersecurity
Seventy percent of healthcare organizations suffered a data breach in 2017, per the “2018 Thales Data Threat Report.” More than half (55 percent) reported feeling “very” or “extremely vulnerable” to attacks. Part of this vulnerability stems from the 190,000 different devices produced by 18,000 firms across 21,000 manufacturing facilities regulated by the FDA.
The administration’s new plan focuses on software transparency, mandatory patching and the creation of an investigative body to deliver a “universal view of device oversight” and improve medical device cybersecurity.