Cyber Templates
Cyber templates for cyber risk assessment of vulnerabilities
Cyber Incident Response Exercise
š Worksheet A: Cyber Risk Assessment of Medical Device Vulnerabilities
Participant Name: ____________________
Date: ______________
Device Name & Model: ______________
System Version: ______________
1ļøā£ Asset Identification & Classification
- Device Type: ____________________
- Critical Functionality: ____________________
- Impact Level (š“ High / š” Medium / š¢ Low): ____________________
2ļøā£ Threat & Vulnerability Identification
ā
Source of Vulnerabilities (CVE, CISA, threat intel, static/dynamic scanner, SBOM): ____________________
ā
Software Components at Risk: ____________________
ā
Supply Chain Risks: ____________________
ā
Safety Risks (Patient Harm Potential): ____________________
Processes Impacted by Vulnerabilities
ā
Threat Intelligence Feed Alerts (CISA, MITRE, ISAO, FDA Notifications): ____________________
ā
Vulnerability Disclosure & Reporting Mechanisms: ____________________
ā
Safety / Clinical Risk Assessment Impact: ____________________
ā
Sources of Vulnerabilities (Firmware, Open-Source Dependencies, Third-Party Components): ____________________
3ļøā£ Risk Evaluation (NIST RMF-Based)
- Likelihood of Exploitation: š“ High / š” Medium / š¢ Low
- Impact on Device Functionality: š“ High / š” Medium / š¢ Low
- Impact on Patient Safety: š“ High / š” Medium / š¢ Low
4ļøā£ Mitigation & Residual Risk Analysis
- Mitigation Actions: ____________________
- Risk Level After Mitigation: š“ High / š” Medium / š¢ Low
- Residual Risk Level: š“ High / š” Medium / š¢ Low
5ļøā£ Response Plan & Next Steps
- Required Patch Updates: ____________________
- Compliance Documentation (FDA, NIST, ISO 14971): ____________________
- Ongoing Monitoring Measures (contaiment): ____________________
- Communication - Vulnerabilties Disclosure
5ļøā£ Design Controls and Fix
- Design input, output, verification, validation, traceability
- software specifications
- Traceability
- verification and validation (test cases / penetration testing)
- Update security controls (threat modeling , gap analysis, architectural diagram)
šØ Worksheet B: Cyber Incident Response Exercise
Participant Name: ____________________
Date: ______________
Incident Scenario: ____________________
1ļøā£ Identification
- Source of Attack: (Network, Physical Access, Software Exploit, Insider Threat) ____________________
- Affected Systems: ____________________
- Detection Method: (SIEM Logs, IDS/IPS Alerts, User Reports) ____________________
- Threat Intelligence Feeds Used: (CISA, MITRE ATT&CK, ISAO, FDA Cyber Alerts) ____________________
- Vulnerability Disclosure & Reporting: ____________________
2ļøā£ Containment
- Immediate Action Taken: ____________________
- Devices Isolated: Yes / No
- Access Revoked: Yes / No
3ļøā£ Eradication & Recovery
- Root Cause Analysis Findings: ____________________
- Malware or Exploit Used: ____________________
- System Patching & Remediation: ____________________
- Restoration Procedure: ____________________
4ļøā£ Incident Review & Lessons Learned
- How Could This Have Been Prevented? ____________________
- Additional Security Measures Required: ____________________
- Policy Updates Needed? Yes / No
- Training Improvement Recommendations: ____________________