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CSA Medical Device Incident Response Playbook
CSA Medical Device Incident Response Playbook

CSA Medical Device Incident Response Playbook

Release Date: 11/08/2021

Working Group: Internet of Things

This document presents a best-practices medical device incident response playbook that incorporates clinical aspects of medical device IR. As such, this guidance should be reviewed and adapted by clinical leadership to ensure it is acceptable from a patient care standpoint. This document should be viewed as a starting point for medical device incident response and not a prescriptive end goal.


Key Takeaways:

  • Example use cases to aid understanding of the role clinical considerations will play in the context of incident response
  • Process for responding to incidents with medical devices including how to prepare, detect/analyze the threat, eradicate the threat, conduct a post-incident analysis, and revise the process

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