In this Thought Leaders in Health Law® video, Neil Di Spirito, Alaap Shah, Jessika Tuazon, and Patricia Wagner, attorneys in the Health Care and Life Sciences practice, look at the Food and Drug Administration’s (FDA’s) guidance on the cybersecurity of medical devices and how the FDA’s approach is impacting innovation and product development in the medical device industry.

This video discusses the following:

  • The FDA’s guidance and playbook for medical device manufacturers regarding cybersecurity vulnerabilities when designing and developing medical devices
  • The importance of designing devices that are enabled to be updated in order to maintain cybersecurity throughout the lifetime of the device
  • How to analyze the cybersecurity risk associated with a device and take the appropriate risk mitigation steps
  • Best practices, such as proactively monitoring for vulnerabilities, implementing updates, and balancing security with the function of the device

Epstein Becker Green’s Privacy, Cybersecurity, and Data Asset Management attorneys help device manufacturers and companies across the health care industry tackle complex cybersecurity compliance and risk mitigation challenges.

About Thought Leaders in Health Law

The Thought Leaders in Health Law® video series tracks the latest trends in multiple areas of the health care and life sciences industries, featuring attorneys and advisors from Epstein Becker Green and EBG Advisors.

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THOUGHT LEADERS IN HEALTH LAW® is a registered trademark of Epstein Becker & Green, P.C.

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