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• Foreword 1. Why Secure Medical Devices?1.1. Why a 2nd Edition? 2. Establishing Cybersecurity Focus Within the MDM2.1. Security Governance2.2. Building a Security-Capable Organization2.3. Security and Lifecycle Management – High-level Overview2.4. Communicating Cybersecurity Needs, Costs, and Risks to Senior Leadership2.5. Organizational Roles and Responsibilities2.6. Regular Review of Security Maturity 3. Global Regulations and Standards3.1. Regulatory Expectations in Major Markets3.2. Consensus Standards3.3. Harmonization and Alignment 4. Use Environments4.1. Hospitals4.2. Clinics, Doctors’ Offices, and Labs4.3. Home Health Care4.4. Military4.5. Unregulated Environments 5. Supply Chain Management5.1. Upstream Supply Chain Management5.2 Security Criteria for Approved Supplier Lists5.3 SBOM5.4 Build Integrity and Attestation5.5 Downstream Supply Chain Management5.6 The Impact of Endemic Vulnerabilities 6. Secure Development and Production for Medical Device Manufacturers6.1. Introduction6.2. Secure Lifecycle Diagram Overview6.3. Threats vs. Vulnerabilities6.4. Securing Development Environments and Activities6.5. Concept Phase6.6. Planning Phase6.7. Requirements Phase6.8. Design Phase6.9. Implementation Phase6.10. Verification & Validation6.11. Release Phase / Transfer to Production6.12. Production 7. Documentation and Artifacts7.1. Overview of Secure Development Deliverables7.2 System Security Plan7.3 Design Vulnerability Assessments7.4 System Security Architecture7.5. Interface Control Documents7.6 Testing Reports7.7 Software Bill of Materials (SBOM)7.8 System Security Report7.9 Labeling7.10 Marketing and Sales Supporting Materials 8. Postmarket Vulnerability Management8.1. Understanding FDA Expectations8.2. Postmarket Surveillance8.3. Updating Devices in the Field8.4. Product Recalls8.5. Managing End of Support (EOS) and End of Life (EOL) 9. Incident Response & Communications9.1. Cybersecurity in Postmarket - Continuing Product Support9.2. Incident Response9.3. Communications9.4. Communicating Cybersecurity Risks to Patients 10. Device Security Lifecycle for Healthcare Delivery Organizations10.1 Pre-Procurement10.2 Procurement10.3 Deployment10.4 Operations10.5 Decommissioning10.6 Special Scenarios 11. Aspects of IT Security in Medical Device Systems11.1 Endpoint Security11.2 Securing Communication Mediums11.3 Hardware and Physical Interface Security11.4. Hardening Common Operating Systems and Other Commercial Software11.5. Utilizing Smart Phones and Other Off-the-Shelf or “Bring-Your-Own” Devices in Medical Device Systems11.6. Smartphone Security11.7. Software as a Medical Device (SaaMD)11.8. Multifunction Products11.9. Network Security11.10 Chapter Conclusion: How are MDMs Making Use of These Technologies? 12. Applying Cryptography to Medical Device Systems12.1 Overview of Cryptographic Concepts12.2 Practical Implications and Applications of Cryptography Concepts 13. Cybersecurity Failures 14. Common Myths & Excuses 15. Appendices15.1. Afterword to the 2nd Edition15.2. Resources15.3. Glossary15.4.Index15.5. Authors and Contributors

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• Foreword 1. Why Secure Medical Devices?1.1. Why a 2nd Edition? 2. Establishing Cybersecurity Focus Within the MDM2.1. Security Governance2.2. Building a Security-Capable Organization2.3. Security and Lifecycle Management – High-level Overview2.4. Communicating Cybersecurity Needs, Costs, and Risks to Senior Leadership2.5. Organizational Roles and Responsibilities2.6. Regular Review of Security Maturity 3. Global Regulations and Standards3.1. Regulatory Expectations in Major Markets3.2. Consensus Standards3.3. Harmonization and Alignment 4. Use Environments4.1. Hospitals4.2. Clinics, Doctors’ Offices, and Labs4.3. Home Health Care4.4. Military4.5. Unregulated Environments 5. Supply Chain Management5.1. Upstream Supply Chain Management5.2 Security Criteria for Approved Supplier Lists5.3 SBOM5.4 Build Integrity and Attestation5.5 Downstream Supply Chain Management5.6 The Impact of Endemic Vulnerabilities 6. Secure Development and Production for Medical Device Manufacturers6.1. Introduction6.2. Secure Lifecycle Diagram Overview6.3. Threats vs. Vulnerabilities6.4. Securing Development Environments and Activities6.5. Concept Phase6.6. Planning Phase6.7. Requirements Phase6.8. Design Phase6.9. Implementation Phase6.10. Verification & Validation6.11. Release Phase / Transfer to Production6.12. Production 7. Documentation and Artifacts7.1. Overview of Secure Development Deliverables7.2 System Security Plan7.3 Design Vulnerability Assessments7.4 System Security Architecture7.5. Interface Control Documents7.6 Testing Reports7.7 Software Bill of Materials (SBOM)7.8 System Security Report7.9 Labeling7.10 Marketing and Sales Supporting Materials 8. Postmarket Vulnerability Management8.1. Understanding FDA Expectations8.2. Postmarket Surveillance8.3. Updating Devices in the Field8.4. Product Recalls8.5. Managing End of Support (EOS) and End of Life (EOL) 9. Incident Response & Communications9.1. Cybersecurity in Postmarket - Continuing Product Support9.2. Incident Response9.3. Communications9.4. Communicating Cybersecurity Risks to Patients 10. Device Security Lifecycle for Healthcare Delivery Organizations10.1 Pre-Procurement10.2 Procurement10.3 Deployment10.4 Operations10.5 Decommissioning10.6 Special Scenarios 11. Aspects of IT Security in Medical Device Systems11.1 Endpoint Security11.2 Securing Communication Mediums11.3 Hardware and Physical Interface Security11.4. Hardening Common Operating Systems and Other Commercial Software11.5. Utilizing Smart Phones and Other Off-the-Shelf or “Bring-Your-Own” Devices in Medical Device Systems11.6. Smartphone Security11.7. Software as a Medical Device (SaaMD)11.8. Multifunction Products11.9. Network Security11.10 Chapter Conclusion: How are MDMs Making Use of These Technologies? 12. Applying Cryptography to Medical Device Systems12.1 Overview of Cryptographic Concepts12.2 Practical Implications and Applications of Cryptography Concepts 13. Cybersecurity Failures 14. Common Myths & Excuses 15. Appendices15.1. Afterword to the 2nd Edition15.2. Resources15.3. Glossary15.4.Index15.5. Authors and Contributors