Security and Privacy

Taking Medical Device Cybersecurity to the Next Level

Tuesday, August 10 at 1:00 PM - 2:00 PM PDT
Venetian, Marco Polo 701
The Food and Drug Administration (FDA) has proactively reached out to medical device cybersecurity stakeholders across the ecosystem to encourage the industry to adopt a “whole of community” approach to medical device cybersecurity. The FDA, in partnership with MITRE, MDIC, and other stakeholders, has championed initiatives to bring medical device cybersecurity to the next level, to include harmonizing international cybersecurity principles and practices, promoting the use of threat modeling in medical device design and development, improving medical device vulnerability assessment and communication, and addressing the challenges of legacy devices.

Learning Objectives

  • Describe FDA engagements with the health sector and international partners to improve the security of legacy devices and software bill of materials (SBOM)
  • Identify FDA activities on developing a framework for the clear and consistent communication of medical device vulnerabilities
  • Explain FDA efforts to encourage the adoption of threat modeling throughout the medical device lifecycle
ABPM 1.0, CAHIMS 1.0, CME 1.0, CNE 1.0, CPHIMS 1.0, IAPP 1.0
Clinical Engineering Professional, CISO/CSO, CIO/CTO/CTIO/Senior IT


Suzanne Schwartz, MD, MBA
Director, Office of Strategic Partnerships and Technology Innovation
Food and Drug Administration (FDA)
Margie Zuk
Senior Principal Cybersecurity Engineer