Cybersecurity for Connected Medical Devices

The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program.

1. Introduction to Medical Device Cybersecurity 2. Basic cybersecurity concepts 3. Regulatory Overview 4. The Product Cybersecurity Organization 5. Cybersecurity Risk Management-I 6. Cybersecurity Risk Management-II 7. Cybersecurity Design Engineering 8. Supply Chain Cybersecurity Risk Management, Secure Product Development, Secure Manufacture, Vulnerability Management, and Cybersecurity Training 9. Product Security Governance and Regulatory Compliance

• Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities
• Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System
• Provides a candidate method for system and software threat modelling
• Provides an overview of cybersecurity risk management for medical devices
• Presents technical cybersecurity controls for secure design of medical devices
• Provides an overview of cybersecurity verification and validation for medical devices
• Presents an approach to logically structure cybersecurity regulatory submissions