Cybersecurity risk assessor

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/cybersecurity-risk-assessor

Medical device cybersecurity risk assessment skill per FDA premarket and postmarket guidanceFrom its SKILL.md

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npx -y skills add a5c-ai/babysitter --skill cybersecurity-risk-assessor

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SKILL.md

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Cybersecurity Risk Assessor Skill

Purpose

The Cybersecurity Risk Assessor Skill evaluates cybersecurity risks for medical devices per FDA guidance and IEC 81001-5-1, supporting threat modeling, vulnerability assessment, and security control implementation.

Capabilities

Threat modeling (STRIDE methodology)
Vulnerability assessment
SBOM (Software Bill of Materials) generation
Security control identification
Penetration testing planning
Cybersecurity documentation for FDA submissions
Attack surface analysis
Security architecture review
Coordinated vulnerability disclosure planning
Postmarket cybersecurity management
Patch management planning

Usage Guidelines

When to Use

Assessing device cybersecurity risks
Planning penetration testing
Preparing FDA cybersecurity submissions
Managing software dependencies

Prerequisites

Software architecture documented
Network connectivity defined
Data flows identified
Third-party components cataloged

Best Practices

Integrate cybersecurity from design inception
Maintain current SBOM
Plan for security updates throughout lifecycle
Establish vulnerability disclosure process

Process Integration

This skill integrates with the following processes:

Software Development Lifecycle (IEC 62304)
Medical Device Risk Management (ISO 14971)
510(k) Premarket Submission Preparation
Post-Market Surveillance System Implementation

Dependencies

FDA Cybersecurity guidance
IEC 81001-5-1 standard
SBOM tools (CycloneDX, SPDX)
Vulnerability databases (NVD, CVE)
Threat modeling frameworks

Configuration

cybersecurity-risk-assessor:
  threat-methodologies:
    - STRIDE
    - PASTA
    - attack-trees
  sbom-formats:
    - CycloneDX
    - SPDX
  security-tiers:
    - Tier-1-higher
    - Tier-2-standard
  control-frameworks:
    - NIST-CSF
    - IEC-62443

Output Artifacts

Threat models
Vulnerability assessments
SBOM documents
Security architecture documents
Penetration test plans
FDA cybersecurity submissions
Security control matrices
Patch management plans

Quality Criteria

All threat vectors identified
Vulnerabilities assessed with CVSS scores
SBOM is complete and current
Security controls address identified risks
Documentation meets FDA requirements
Postmarket security plan established

What ships with it

Read from the repository

Just SKILL.md. No reference files, no scripts.