FDA Scoring Tool Update Adds Vulnerability Risk to Patient Safety

Health IT Security

Jessica Davis

The FDA recently unveiled a new scoring system for assessing medical device vulnerabilities, an update from its previous system that was initially designed for commercial devices and didn’t account for patient safety, a move Elad Luz, head of research for CyberMDX, explained will better reflect the severity and characteristics of security flaws.

Awareness around medical device security has grown rapidly in recent years, given the FDA’s efforts to bridge the gap between device manufacturers and providers, which can bolster patient safety. Since the FDA unveiled its cybersecurity guidance for medical devices in 2016, vendors reported 400 percent more vulnerabilities per quarter: a sign of maturing security risk assessments and growing compliance.

However, many healthcare providers continue to...

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