The FDA’s New Guidance on Cybersecurity Risks for Medical Devices [Corporate Counsel]

Jillian Thornton Flax and Abby Sacunas, both members of Cozen O'Connor's Products Liability practice, discuss the FDA's new guidance on cybersecurity risks for medical devices in Corporate Counsel. On January 15, the Food and Drug Administration issued draft guidance outlining key steps medical device manufacturers should take to address and proactively manage post-market cybersecurity vulnerabilities. The draft guidance follows increasing reports of medical device hijacking at hospitals and health care institutions that could result in theft of sensitive data, risk to the effectiveness of the device and, most alarmingly, harm to patients.

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