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Chapter 5: Post-Market Security Management · Section 5.6
Coordinated Vulnerability Disclosure
5.6.1 Understanding CVD
Coordinated Vulnerability Disclosure (CVD) is the process of working with security researchers who find vulnerabilities. FDA references ISO 29147:2018 and ISO 30111:2013 as standards for CVD.
Why CVD Matters
Benefits:
- Find vulnerabilities before attackers
- Build researcher relationships
- Demonstrate security maturity
- Improve products
Without CVD:
- Researchers go public immediately
- No time to develop patches
- Surprised by disclosures
- Reputation damage
5.6.2 Setting Up Your CVD Program
Essential Elements
Clear Reporting Channel:
security@manufacturer.com
https://manufacturer.com/security
PGP key for encrypted reports
Published Policy:
- Scope (what products)
- Process (what happens)
- Timeline (response times)
- Recognition (acknowledgments)
Example CVD Policy Structure:
# Coordinated Vulnerability Disclosure Policy
## Scope
This policy applies to all [Manufacturer] medical devices
and associated software.
## Reporting
Email: security@manufacturer.com
PGP: [Key fingerprint]
Web: https://manufacturer.com/report-vulnerability
## Our Commitment
- Acknowledge receipt within 5 business days
- Provide severity assessment within 10 days
- Regular updates on progress
- Coordinate disclosure timing
## Recognition
- Public acknowledgment (with permission)
- Inclusion in security advisories
- Good faith commitment
## Out of Scope
- Physical attacks requiring device modification
- Social engineering of our staff
- Denial of service attacks
5.6.3 Managing Researcher Relationships
Initial Response Template:
Subject: Re: Vulnerability Report - [Device Name]
Thank you for your vulnerability report dated [date].
We confirm receipt and are beginning our assessment.
Tracking number: VULN-2024-001
Expected initial assessment: [date + 10 days]
We'll provide regular updates on our progress.
Best regards,
[Product Security Team]
Relationship Best Practices:
- Respond promptly
- Be professional
- Show appreciation
- Keep promises
- Give credit
5.6.4 Disclosure Timeline Negotiation
Work with researchers on disclosure timing:
Standard Timeline:
- 0 days: Report received
- 5 days: Acknowledgment
- 10 days: Initial assessment
- 30-120 days: Patch development
- X days: Coordinated disclosure
Factors Affecting Timeline:
- Vulnerability severity
- Exploit complexity
- Patch difficulty
- Deployment challenges
- Patient risk
See how your device measures up
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