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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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Acknowledgements

Michael Roza
Michael Roza
Risk, Audit, Control and Compliance Professional

Michael Roza

Risk, Audit, Control and Compliance Professional

Since 2012 Michael has contributed to over 100 CSA projects completed by CSA's Internet of Things, Zero Trust/Software-Defined Perimeter, Top Threats, Cloud Control Matrix, Containers/Microservices, DevSecOps, and other working groups. He has also served as co-chair of CSA's Enterprise Architecture, Top Threats, and Security-as-a-Service working groups while also serving as the Standards Liaison Officer for IoT, ICS, EA, SECaaS, and Cloud K...

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Hillary Baron
Hillary Baron
Senior Technical Director - Research, CSA

Hillary Baron

Senior Technical Director - Research, CSA

Ashish Vashishtha
Ashish Vashishtha
Security Compliance Leader

Ashish Vashishtha

Security Compliance Leader

Analytical, results-oriented IS/IT Audit, Governance, Risk, and Compliance (GRC) leader over 19 years of experience managing enterprise-wide IT/IS security risk approach for large healthcare and IT services organizations. Passionate design thinker with an ability to harness innovation by facilitating collaboration to develop enterprise-wide security risk assessments (onsite as well as remote) for high-risk Third-Parties leveraging NIST 800-...

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Brian Russell
Brian Russell

Brian Russell

Brian Russell is co-author of the book “Practical Internet of Things Security” and is a Chief Engineer focused on Cyber Security Solutions for Leidos (www.leidos.com). He oversees the design and development of security solutions and the implementation of privacy and trust controls for customers. Brian leads efforts that include security engineering for Unmanned Aerial Systems (UAS) and Connected Cars, and the development of hig...

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​Aaron Guzman
​Aaron Guzman

​Aaron Guzman

Aaron is a passionate information security professional specializing in IoT, embedded, and automotive security. He is co-author of the “IoT Penetration Testing Cookbook” and a technical editor for the "Practical Internet of Things Security” Packt Publishing books. Aaron is co-chair of CSA’s IoT working group as well as a leader for OWASP’s IoT and Embedded Application Security projects; providing practical guidance to address the most commo...

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Christopher Frenz
Christopher Frenz

Christopher Frenz

Christopher Frenz is the AVP of IT Security for Mount Sinai South Nassau. Christopher is widely regarded as being one of the first healthcare security leaders to embrace a zero-trust model for network security and for taking an evidence-based approach to solving security challenges. Christopher has also played a role in pushing for the adoption of improved security standards within healthcare, led the development of the OWASP ...

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