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March 07, 2016

FDA Recommends Medical Device Manufacturers Implement a Comprehensive Cybersecurity Risk Management Program in Accordance with NIST Standards

  • March 07, 2016
  • Shilpa Prem , Epstein Becker & Green PC , New York, NY
  • Kim Tyrrell-Knott , Epstein Becker & Green PC , San Diego, CA

The U.S. Food and Drug Administration is emphasizing the need for medical device manufacturers to proactively manage cybersecurity risks throughout the product life cycle. Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. Manufacturers need to create a comprehensive risk management program specifically designed to address the unique and evolving aspects of cybersecurity threats to mitigate the potential danger cybersecurity vulnerabilities may have on patient safety.

Read this briefing.

We would like to thank the authors for sharing their expertise with their colleagues. We also would like to thank the Life Sciences Practice Group leadership for sharing this Executive Summary with the Health Information and Technology Practice Group.

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