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1
Introduction
2
Medical Device Cybersecurity
3
Shared Responsibility
4
FDAs Response
5
PreMarket Guidance
6
PostMarket Guidance
7
Cybersecurity Risk Assessment
8
FDAs Thinking
9
Safety Action Plan
10
FDA Public Workshop
11
Stakeholder Study
12
CMS in Healthcare
13
Wannacry
14
Medical Device Sandbox
15
Analysis Boards
16
Stakeholder Feedback
17
We Heart Hackers Challenge
18
FDA
19
Key takeaways
20
Application
21
FDA Contacts
22
Recertification
23
Remote support
Description:
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.

Safety Implications of Medical Device Cybersecurity

RSA Conference
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