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Plan for Cybersecurity Threats

The US Congress and the Food and Drug Administration are tackling the cybersecurity threats to which medical devices might be vulnerable, the Verge reports.

It notes that medical devices like infusion pumps that connect to the internet could be susceptible to hacking, which could not only reveal sensitive patient information but also affect patient safety.

According to the Verge, the FDA has issued a new draft guidance aimed at countering this problem by calling on device manufacturers to include a Software Bill of Materials (SBOM) with their products that would enable patients to more easily check if a vulnerability or bug has been uncovered related to their device.

Additionally, the Protecting and Transforming Cyber Health Care (PATCH) Act was introduced into Congress last week that would change the Federal Food, Drug, and Cosmetic Act so that premarket submissions to FDA must include a SBOM and a plan for addressing cybersecurity issues, it adds.

"This would give us extra teeth," Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation at FDA, tells the Verge. "This really, for the first time, would establish, very explicitly, authority in the area of cybersecurity and tie that directly to the safety of medical devices."