Cybersecurity for Connected Medical Devices

Cybersecurity for Connected Medical Devices offers comprehensive coverage on all aspects of medical device cybersecurity, with a focus on technologies and processes. Sections explain why medical device cybersecurity is important and how it’s different from traditional IT security, introduce medical device and cybersecurity concepts, review regulations, survey different standards that impact cybersecurity for medical devices, and introduce a method for integrating the elements of a cybersecurity program into a traditional medical device quality organization. Finally, the book demonstrates how a cybersecurity development lifecycle can be integrated with the classical ‘product development lifecycle management’ process typically used in medical device companies.

In conclusion, the author reviews the larger implications of insecure devices, healthcare data breaches, and why securing medical devices is a necessary condition for the security of health IT.

• Lays out clear guidelines on to how to build a medical device cybersecurity program and assess its maturity
• Explores the interplay between device safety and security and the creation of a cybersecurity assurance argument for regulatory submissions
• Includes an overview of incident-response, vulnerability intake, and customer outreach processes for medical device cybersecurity
• Presents an overview of design-time cybersecurity controls and a candidate secure development lifecycle process that is integrated with a CFR 21 820.30 Design Controls based development process

Systems, software, and biomedical engineers working at medical device manufacturers and managers/leaders at medical device manufacturers, systems engineers and clinical/biomedical engineers working in clinical settings with medical devices

1. The challenges of medical device cybersecurity
2. Basic cybersecuirty concepts
3. Regulatory landscape for medical device cybersecurity
4. The product cybersecurity
5. Threat modeling
6. Cybersecurity Risk Management for Medical Devices (Safety and Privacy)
7. Capability Development for the Product Cybersecurity Organization for Medical Devices - Part 1
8. Capability Development for the Product Cybersecurity Organization for Medical Devices - Part 2
9. Closing thoughts