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What You Need to Know to Start Implementing the FDA’s New Medical Device Security Requirements

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Medical device security takes center stage with the passing of the Consolidated Appropriations Act of 2023 (Omnibus). The Act outlines new requirements of medical device manufacturers to submit a detailed plan for addressing cybersecurity as part of their software development lifecycle.

But you don’t have to navigate these changes alone. NetSPI Managing Director Ron Kuriscak and Abbott Senior Director of Cybersecurity Operations Steve Currie took an in-depth look at the new requirements and pulled together a clear and actionable summary of what you need to know to stay agile while preparing for compliance.

Attendees will leave this session with a better understanding of:

  • Key Omnibus milestones and a summary of updates in Section 3305 “Ensuring Cybersecurity of Medical Devices” — and how to prepare
  • The requirements of submitting a medical device security plan to the FDA 
  • An overview of how the U.S. Department of Health and Human Safety is assisting hospitals and healthcare systems with implementing the NIST Cybersecurity Framework
  • Details on enforcement and compliance, zooming in on post-market guidance, vulnerability management best practices, and breach notification guidelines

Gain support on your path to enhancing device security. Watch Ron and Steve’s talk now to get started on solid footing!

Discover how NetSPI ASM solution helps organizations identify, inventory, and reduce risk to both known and unknown assets.