| Description |
1 online resource (xv, 285 pages) illustrations |
| Series |
Artech House information security and privacy series
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Artech House information security and privacy series.
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| 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 |
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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 |
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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 |
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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 |
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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 |
| 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 |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Medical instruments and apparatus industry.
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Medical instruments and apparatus -- Safety regulations.
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Computer security.
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Computer security |
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Medical instruments and apparatus industry |
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Medical instruments and apparatus -- Safety regulations |
| Added Author |
Gates, Christopher, author.
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Smith, Jason (Jason L.), author.
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| Other Form: |
Print version: Wirth, Axel Medical device cybersecurity for engineers and manufacturers Norwood, MA : Artech House, [2020] 9781630818159 (OCoLC)1156197077 |
| ISBN |
9781630818166 electronic bk. |
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163081816X electronic bk. |
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9781630818159 |
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1630818151 |
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