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FDA’s Schwartz Says New Draft Cybersecurity Guidance Addresses Emerging Threats

Agency shifts focus to software, removes tiered risk assessments

 
• By Brian Bossetta

Suzanne Schwartz, director of the US FDA’s Office of Strategic Partnerships and Technology Innovation, tells Medtech Insight that recent cyberattacks have crippled hospitals networks, putting many patients at risk.

Suzanne Schwartz is director of the Office of Strategic Partnerships & Technology Innovation at the Center for Devices & Radiological Health.
SUZANNE SCHWARTZ • Source: FDA

The US Food and Drug Administration’s latest draft guidance on medical device cybersecurity has evolved since the agency’s last update in 2018 because so has the threat, says Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation within the agency’s device center.

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