Medical device cybersecurity for engineers and manufacturers

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 de...

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Bibliographic Details
Main Authors: Wirth, Axel (Security strategist), (Author), Gates, Christopher, (Author), Smith, Jason (Author)
Format: eBook
Language: English
Published: Norwood, MA Artech House [2020]
Series: Artech House information security and privacy series.
Subjects:
Medical instruments and apparatus industry.
Medical instruments and apparatus > Safety regulations.
Computer security.
elektronické knihy
electronic books
ISBN: 9781630818166
163081816X
9781630818159
1630818151
Physical Description: 1 online resource (xv, 285 pages) illustrations

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Table of contents

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035 |a (OCoLC)1203946802  |z (OCoLC)1199584532  |z (OCoLC)1224365431  |z (OCoLC)1388675433 
100 1 |a Wirth, Axel  |c (Security strategist),  |e author.  |1 https://id.oclc.org/worldcat/entity/E39PCjDMPr6Kxb4FVV93hTJRXb 
245 1 0 |a Medical device cybersecurity for engineers and manufacturers  |c Axel Wirth, Christopher Gates, Jason Smith 
264 1 |a Norwood, MA  |b Artech House  |c [2020] 
264 4 |c ©2020 
300 |a 1 online resource (xv, 285 pages)  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Artech House information security and privacy series 
504 |a Includes bibliographical references and index 
505 0 |a 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 
505 8 |a 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 
505 8 |a 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 
505 8 |a 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 
505 8 |a 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 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a 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 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Medical instruments and apparatus industry. 
650 0 |a Medical instruments and apparatus  |x Safety regulations. 
650 0 |a Computer security. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
700 1 |a Gates, Christopher,  |e author. 
700 1 |a Smith, Jason  |q (Jason L.),  |e author. 
776 0 8 |i Print version:  |a Wirth, Axel  |t Medical device cybersecurity for engineers and manufacturers  |d Norwood, MA : Artech House, [2020]  |z 9781630818159  |w (OCoLC)1156197077 
830 0 |a Artech House information security and privacy series. 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpMDCEM00O/medical-device-cybersecurity?kpromoter=marc  |y Full text 

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