Consideration of Cybersecurity vs Safety Risk Management
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1 Consideration of Cybersecurity vs Safety Risk Management Weiping Zhong, Ph.D. Global Director of Risk Management/Medical Devices GE Healthcare DISCLAIMER: The views and opinions expressed in this presentation are for academic discussions and are those of the authors and do not necessarily represent official policy or position of GEHC. IMDRF 2018
2 Agenda: Background and Purposes: Who & What? Regulatory Dynamics on Cybersecurity: How? Concepts: ISO14971 & Cybersecurity (AAMI TIR 57) Challenges and Forward Thinking: Summary
3 Who and What? Regulators Patient/User/Family HealthCare Provider Manufacturers /suppliers
4 Cybersecurity & Safety Risk Management Safety/Reducing Harms to Patients/Users Safety Clinical Performance Data Breach Traditional: Safety/Reducing Harms Availability Confidentiality Integrity
5 Applying similar concepts Safety Harm to Patients/Users Safety Clinical Performance Data Breach Premarket Postmarket Identify Risks Propose Requirements Implement Mitigations Verify and Validate Document & Submit Monitor Feedback/Complaints Report Injuries Determine Field Actions Determine Recalls
6 Examples of Regulations FDA: FDA Pre & Postmarket Guidance Mitigate from design/development Documentation - Hazard Analysis and Design Mitigations - Traceability Matrix between Risks & Controls - A Summary of Plan: validated updates, lifecycle, patches - Labeling Process: - Cybersecurity Risk Management system: leveraging ISO & Quality Management System - Recall decision CFDA Submission Guidance Life-cycle Risk-based approach: safety focused Establish traceability on validation Documentations (3 types) - Major changes affecting Safety/Effectiveness - Minor changes not affecting Safety - No changes European Union: Standards + Directive/Regulation Cybersecurity: design EN ISO 14971, EN and EN Data Protection Directive/General Data Protection Directive Data Protection: by design and by default Risk Assessment and Mitigations are required
7 How? Patients/Customers Regulators Manufacturers Patients /Customer s need Regulation Quality/Risk Management more Engineering: R&D, Production Post-production & Service
8 A Concept: ISO vs Cybersecurity Safety Harm to Patients/Users Safety Clinical Performance Data Breach ISO Top Management Responsibility Risk Management Plan Risk Analysis/Evaluation/Control Acceptability: Residual Risk Risk Management Report Production/Postproduction ISO 14971: Medical Device Risk Management AAMI TIR 57 Top Management Responsibility Security Risk Management Plan Security Risk Analysis/Evaluation/Control Acceptability: Security Residual Risk Security Risk Management Report Production/Postproduction AAMI TIR 57 Principles for medical device security Risk management
9 FDA: Post-market Guidance A Concept: ISO vs Cybersecurity ISO 14971: Risk Matrix FDA s Postmarket Guidance Severity of Harm = ISO Catastrophic: Death - Critical: Permanent impairment/life-threatening - Serious: Injury/imp. requiring professional medical intervention - Minor: temporary injury/impairment - Negligible: inconvenience or temporary discomfort Exploitability - High - Medium - Low
10 A Concept: Criteria for Acceptability FDA s Postmarket Guidance Controlled sufficiently low (acceptable) residual risk of patient harm ISO 14971: Overall residual risks acceptable Uncontrolled unacceptable residual risk of patient harm due to inadequate mitigations Login Login ID Login ID Password Login ID? Help Password: #%$!$@%#
11 Challenges and Forward Thinking Purpose: Intended Use vs Malicious Intend Technical: System is static, Cyberattacks are dynamic Regulatory vs Operational: existing system ---- New challenges Traditional lengthy processes vs speed Responsibility: shared responsibilities among key stakeholder Information Sharing vs Confidentiality Critical Infrastructure and National Security Large number of requirements vs Standardization
12 Summary Background: Why and What? Regulatory Dynamics on Cybersecurity: How? Concepts: ISO14971 Cybersecurity Challenges and Forward Thinking Questions
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