دانلود کتاب Cybersecurity for Connected Medical Devices

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Front Cover
CYBERSECURITY FOR CONNECTED MEDICAL DEVICES
CYBERSECURITY FOR CONNECTED MEDICAL DEVICES
Copyright
Dedication
Contents
Preface
Acknowledgment
One - Introduction to medical device cybersecurity
Medical device cybersecurity: a brief history
Code complexity
Connectivity
Patient safety and usability
Long device lifetimes
Cybersecurity being a shared responsibility
Cybersecurity patch delivery
Cybersecurity risk management
Lack of information sharing
Shortage of cybersecurity talent
Cybersecurity culture
The Product Cybersecurity Organization
References
Two - Basic cybersecurity concepts
A bag full of diamonds
Understanding cybersecurity risk
Asset
System level assets/system assets
Subsystem level assets/subsystem assets
Vulnerability
System level vulnerabilities/system vulnerabilities
Design vulnerabilities
Unremediated subsystem vulnerabilities
Process vulnerabilities
Subsystem level vulnerabilities/subsystem vulnerabilities
Threat
System level threats/system threats
Likelihood
Severity
Subsystem level threats/subsystem threats
Cybersecurity risk for patient safety and patient privacy
Cybersecurity controls
Technical cybersecurity controls
Technical control category: cryptography
Confidentiality
Cryptographic integrity
Threats to cryptography
Technical cybersecurity control category: authentication
Technical control category: authorization
Technical control category: access control
Technical control category: logging
What to observe?
When to react?
How to prevent the logging system being attacked?
Procedural controls
Legal controls
Summary and key takeaways
References
Three - Regulatory overview
Introduction
Regulations, quality, and the medical device quality management system
Structure of a medical device quality management system
Summary of regulatory requirements for cybersecurity
Shared responsibility
Secure design principles for safety
Security management
Security requirements
Secure by design
Secure implementation
Security verification and validation testing
Management of security-related issues
Secure design principles for privacy
Cybersecurity labeling
Premarket and postmarket cybersecurity risk management
Premarket
Postmarket
Information sharing
Coordinated vulnerability disclosure
Proactive vulnerability monitoring
Patching and communication
Standards
Healthcare delivery organization–specific cybersecurity standards
Medical device manufacturer–specific cybersecurity standards
Supporting medical device manufacturer–specific standards
Integrating regulatory requirements into a medical device quality management system
Step 1: scope the cyber-QMS
Step 2: determine regulations, guidance, and standards
Step 3: create a set of technical and procedural controls based on the identified regulations, guidance, and standards
Step 4: align with existing process architecture
Step 5: create a quality plan
Summary and key takeaways
References
Four - The Product Cybersecurity Organization
Introduction
The NIST cybersecurity framework
People: building up a Product Cybersecurity Organization
Global shortage of cybersecurity professionals
Specializations needed for medical device cybersecurity
Culture
Develop proper organizational structure within business units
Know what you are looking for
Be flexible
Process and tools: building up a Product Cybersecurity Organization
Summary and key takeaways
References
Five - Cybersecurity risk management-I
Introduction
Threat modeling
There are two threat models
Running example: the Zeus infusion pump
Identifying the system
Subsystem (software and hardware) cybersecurity risk modeling
Subsystem threat modeling
Identify subsystem assets (Cybersecurity Bill of Materials or CBOM)
Identify subsystem vulnerabilities and threats
Subsystem cybersecurity risk assessment
Defining risk acceptability at subsystem level
Defining risk response at subsystem level
System cybersecurity risk modeling
System threat modeling
Identify system assets
Identify system vulnerabilities
Identify system threats
System cybersecurity risk assessment
Severity of a system threat
Likelihood of a system threat
Timely observability
Summary and key takeaways
References
Six - Cybersecurity risk management-II
Introduction
Defining risk acceptability at system level
Defining risk response for system threats
Primary controls
Secondary controls
Defining risk response for subsystem–level threats that pose “unacceptable” risk at the subsystem level
Risk–benefit analysis
A method for assessing system risk of risk responses
A process for continually evaluating risk throughout the product lifecycle
Summary and key takeaways
References
Seven - Cybersecurity design engineering
Introduction
Secure requirements
Master set of technical controls
System authentication
User authentication
Requirements for exact mechanism used for establishing user identity
Requirements for provisioning/restoring user credentials
Secure updates
Session integrity and confidentiality
Session management
Data integrity and confidentiality in motion
Data integrity at rest
Data confidentiality at rest
Code and data authenticity during execution
Key and credentials management
Key and credentials strength
Keys and credentials secure storage
Requirements for securing private/shared symmetric keys
Requirements for securing public keys
Role-based authorization and access control
Emergency access
Restrict access
Denial-of-service protection
Code updateability
Secure configuration
Cybersecurity logging and monitoring
Cybersecurity alerting
Secure system specification and implementation
Secure system verification and validation
Secure system verification
Positive coverage
Negative coverage
Secure system validation
Static analysis
Dynamic analysis
Malware detection and analysis tools
Penetration testing
Labeling for security
Summary and key takeaways
References
Eight - Supply chain cybersecurity risk management, secure product development, secure manufacture, vulnerability m ...
Introduction
Product supply chain risk management
Product supply chain cybersecurity risk modeling (Fig. 8.1)
Create inventory of assets
Model cybersecurity risk from third-party components
Formulate risk responses
Secure product development
Secure manufacture
Secure manufacture
Vulnerability management
Vulnerability monitoring
Product monitoring
Internal product verification and validation
Product returns and servicing
Customer complaints
Supplier notifications
Public sources of product-specific vulnerabilities
Coordinated vulnerability disclosure
Threat intelligence feeds
Cybersecurity patch management
External communication
Corrective and preventive action
Cybersecurity training
Summary and key takeaways
References
Nine - Product security governance and regulatory compliance
Introduction
Product security governance
Cybersecurity strategy
Criteria for identifying regulations, standards, and guidance that drive cybersecurity strategy
Method for defining and maintaining mapping from regulations, standards, and guidance to set of technical and procedural co ...
Method for gap and noncompliance assessment
Method for gap and noncompliance remediation
Defining and maintaining roles and responsibilities
Cybersecurity management review
Operational metrics
Design metrics
Standards and regulatory compliance
Regulatory submissions
Summary and key takeaways
References
Afterword
Index
A
B
C
D
E
F
G
H
I
J
K
L
M
N
P
Q
R
S
T
U
V
W
Z
Back Cover