Overview
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Explore the critical safety implications of medical device cybersecurity in this 51-minute RSA Conference talk. Delve into the FDA's initiatives, including the development of a Cyber Med Safety Analysis Board, to assess and validate high-risk device vulnerabilities. Gain insights into pre-market and post-market guidance, cybersecurity risk assessment, and the FDA's safety action plan. Examine case studies like WannaCry's impact on healthcare, and learn about stakeholder feedback, the We Heart Hackers Challenge, and key takeaways for improving medical device security. Understand the shared responsibility in maintaining cybersecurity, the importance of medical device sandboxes, and the role of recertification and remote support in ensuring patient safety.
Syllabus
Introduction
Medical Device Cybersecurity
Shared Responsibility
FDAs Response
PreMarket Guidance
PostMarket Guidance
Cybersecurity Risk Assessment
FDAs Thinking
Safety Action Plan
FDA Public Workshop
Stakeholder Study
CMS in Healthcare
Wannacry
Medical Device Sandbox
Analysis Boards
Stakeholder Feedback
We Heart Hackers Challenge
FDA
Key takeaways
Application
FDA Contacts
Recertification
Remote support
Taught by
RSA Conference