Vulnerability Assessment and Response

Assess every new vulnerability in four steps: triage whether it affects your device at all, analyze exploitability in your actual deployment, analyze the patient safety and security impact, then score the risk to set a response deadline. A CVSS 9+ finding gets a 24 to 48 hour response, while low scores can wait for the next release.

5.4.1 The Assessment Process

When a vulnerability is discovered, you need a systematic assessment process:

flowchart TD
    A[Vulnerability Discovered] --> B[Initial Triage]
    B --> C{Affects Our Device?}
    C -->|No| D[Document and Close]
    C -->|Yes| E[Detailed Assessment]
    E --> F[Exploitability Analysis]
    F --> G[Impact Analysis]
    G --> H[Risk Scoring]
    H --> I{Risk Level?}
    I -->|Critical| J[Emergency Response]
    I -->|High| K[Expedited Response]
    I -->|Medium| L[Standard Response]
    I -->|Low| M[Scheduled Response]

5.4.2 Exploitability Analysis

Not all vulnerabilities are equal. Assess exploitability by examining:

Attack Vector:

• Network accessible?
• Requires physical access?
• Needs authentication?
• User interaction required?

Attack Complexity:

• Easy to exploit?
• Requires special conditions?
• Timing dependent?
• Needs insider knowledge?

Required Privileges:

• No authentication needed?
• Basic user sufficient?
• Admin rights required?
• Physical access needed?

Example Assessment:

Factor	Assessment	Notes
Component	OpenSSL 1.1.1k	Network library
Vulnerability	CVE-2021-3711	Buffer overflow
Attack Vector	Network	But device air-gapped
Complexity	Low	If network accessible
Privileges	None	Anonymous attack
Exploitable?	No	No network path exists

5.4.3 Impact Analysis

If exploitable, what's the impact?

Patient Safety Impact:

• Could therapy be affected?
• Might monitoring fail?
• Could data be corrupted?
• Would device availability suffer?

Security Impact:

• Data confidentiality loss?
• System integrity compromise?
• Availability disruption?
• Authentication bypass?

Business Impact:

• Regulatory action risk?
• Reputation damage?
• Liability exposure?
• Operational disruption?

5.4.4 Risk Scoring and Prioritization

Use the MITRE Medical Device CVSS Rubric:

Base Score Calculation:

• Start with standard CVSS
• Apply healthcare context
• Consider safety impacts
• Factor in mitigations

Temporal Factors:

• Exploit code availability
• Patch availability
• Confidence level

Environmental Factors:

• Your specific deployment
• Existing controls
• Patient population
• Clinical context

Priority Matrix:

CVSS Score	Safety Impact	Response Time
9.0-10.0	Any	24-48 hours
7.0-8.9	High	7 days
7.0-8.9	Low	30 days
4.0-6.9	Any	60 days
0.0-3.9	Any	Next release

For a deeper look at adapting CVSS scoring to medical devices, see Medical device risk assessment using CVSS.