Traceability In Cyber Security:Lessons Learned From The Medical Sector
summary
Covers concrete FDA milestones (2005 premarket software rules, 2014 cyber guidance, latest SPD update) and real incidents (2008 pacemaker, 2011 and later insulin-pump exploits) and shows how typical devices run Windows 10 IoT with MySQL, tablets and networked hospital links. Describes building a traceability matrix with unique IDs linking threat model risk assessment SBOM and tests, and combining CVSS environmental metrics with a patient-harm score to mark risks above a chosen threshold as uncontrolled.
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chapters (6)
- 0:00Introduction
- 10:07Cyber security in medical devices
- 20:50FDA cyber security requirements
- 33:07Traceability in risk management
- 37:20Lessons from medical sector
- 39:08Q&A
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