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Medical device cybersecurity for engineers and manufacturers
Title
Medical device cybersecurity for engineers and manufacturers Axel Wirth, Christopher Gates, Jason Smith
ISBN
9781630818166
163081816X
9781630818159
1630818151
Publication
Norwood, MA Artech House [2020]
Copyright Notice Date
©2020
Physical Description
1 online resource (xv, 285 pages) illustrations
Local Notes
Access is available to the Yale community.
Access and use
Access restricted by licensing agreement.
Summary
Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem
Variant and related titles
Knovel. OCLC KB.
Other formats
Print version: Wirth, Axel Medical device cybersecurity for engineers and manufacturers Norwood, MA : Artech House, [2020]
Format
Books / Online
Language
English
Added to Catalog
August 31, 2022
Series
Artech House information security and privacy series
Bibliography
Includes bibliographical references and index
Contents
Intro
Foreword
Why Secure Medical Devices?
1.1 The Inspiration for This Book
1.2 The Evolution of Cybersecurity in Health Care
1.3 The Unique Role of Medical Devices
1.4 Regulatory Environment
1.5 Looking Ahead
References
Establishing a Cybersecurity Focus
2.1 Security Governance
2.1.1 Effective Oversight
2.2 Building a Security-Capable Organization
2.2.1 Strong Governance
2.2.2 Ongoing Testing
2.2.3 Coordinated Vulnerability Disclosure
2.2.4 BOM: Commercial and Open-Source Software Governance
2.2.5 Maturity Road Map
2.2.6 Security Designed In
2.2.7 Section Summary
2.3 Regulations and Standards
2.3.1 Regulatory Considerations
2.3.2 Standards
2.4 Security and Lifecycle Management: High-Level Overview
2.4.1 Coordination between the Four Lifecycles
2.5 Regular Review of Security Maturity
References
Supply Chain Management
3.1 Upstream Supply Chain Management
3.1.1 Counterfeit Electronic Components
3.1.2 Third-Party Software Components
3.2 Security Criteria for Approved Supplier Lists
3.3 Downstream Supply Chain Management
References
Medical Device Manufacturers' Development Cycle
4.1 Introduction
4.2 Secure Lifecycle Diagram Overview
4.3 Threats vs. Vulnerabilities
4.4 Development Lifecycle: Concept Phase
4.4.1 Incremental Improvements and Secure Development
4.5 Development Lifecycle: Planning Phase
4.5.1 Security Goals
4.6 Development Lifecycle: Requirements Phase
4.6.1 Safe Harbor vs Full Encryption
4.7 Development Lifecycle: Design Phase
4.7.1 Design Phase Activities
4.7.2 Introduction to Vulnerability Scoring
4.7.3 Mitigations
4.7.4 Vulnerability Scoring
4.7.5 Scoring Rubrics
4.7.6 Alternative Approaches to Scoring
4.7.7 Informal Approaches to Vulnerability Assessment
4.8 Development Lifecycle: Implementation Phase
4.9 Development Lifecycle: Verification and Validation Phase
4.10 Development Lifecycle: Release Phase/Transfer to Production
4.10.1 Three Different Transfer Models
4.11 Development Lifecycle: Sales Phase
4.12 Development Lifecycle: End of Life Phase
References
Secure Production and Sales for Medical Device Manufacturers
5.1 Production
5.1.1 Production Line Functionality Left Enabled in a Shipped Device
5.1.2 Factory Service and Rework
5.1.3 Securing Production Infrastructure
5.2 Security Considerations in the Sales Process
5.2.1 MDS2
5.3 Cybersecurity in Contracts
5.4 Managing End of Life
References
Medical Device Manufacturer Postmarket Lifecycle
6.1 Understanding FDA Expectations
6.2 Postmarket Surveillance and Related Activities
6.2.1 Monitoring TPSC Vulnerabilities
6.2.2 Coordinated Vulnerability Disclosures
6.2.3 Engagement with End-Users
6.2.4 ISAO
6.3 Updating Devices in the Field
6.4 Product Recalls
References
HDO Lifecycle
Subjects
Subjects (Medical)
Equipment and Supplies - standards
Genre/Form
Electronic books.
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