Blue Goat CyberSMMedical Device Cybersecurity
    K
    Network & Infrastructure Testing

    HIPAA Penetration Testing

    HIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.

    250+ FDA submissions. Zero rejections.

    • Senior team
    • Fixed-fee
    • Reviewer-ready
    • Re-test included
    • Free 30-min call
    • No obligation
    • Senior expert, not a sales rep
    • Fixed-fee quote in 24 hours
    • NDA available on request

    Trusted by leading MedTech companies

    Intuitive Surgical logo, Blue Goat Cyber client
    bioMérieux logo, Blue Goat Cyber client
    Inogen logo, Blue Goat Cyber client
    Natera logo, Blue Goat Cyber client
    Velico Medical logo, Blue Goat Cyber client
    Medivis logo, Blue Goat Cyber client
    Spiro Robotics logo, Blue Goat Cyber client
    Nova Biomedical logo, Blue Goat Cyber client
    VitalConnect logo, Blue Goat Cyber client
    Intuitive Surgical logo, Blue Goat Cyber client
    bioMérieux logo, Blue Goat Cyber client
    Inogen logo, Blue Goat Cyber client
    Natera logo, Blue Goat Cyber client
    Velico Medical logo, Blue Goat Cyber client
    Medivis logo, Blue Goat Cyber client
    Spiro Robotics logo, Blue Goat Cyber client
    Nova Biomedical logo, Blue Goat Cyber client
    VitalConnect logo, Blue Goat Cyber client
    Trevor Slattery, COO

    Reviewed by Trevor Slattery · COO

    Last reviewed May 2026

    What's included

    Reviewer-ready deliverables in one engagement

    Every hipaa penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.

    • ePHI data-flow mapping
    • Administrative, physical, and technical safeguards
    • Risk analysis support
    • Documentation for OCR audits
    Relevant standards

    Standards this service maps to

    Every hipaa penetration testing engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.

    Featured site-wide
    HIPAA Security Rule

    Protected Health Information Safeguards

    Administrative, physical, and technical safeguards for ePHI handled by covered entities and business associates.

    NIST SP 800-115

    Technical Guide to Information Security Testing

    Reference methodology for planning, executing, and reporting security testing.

    NIST CSF 2.0

    Cybersecurity Framework

    Govern, Identify, Protect, Detect, Respond, Recover - the lingua franca for cybersecurity program maturity.

    Related services mapped to the same standards

    FAQ

    HIPAA Penetration Testing FAQs

    In their words

    Backed by MedTech leaders.

    Tim Sandberg, VP of IT Operations at Matrix One
    "The timeliness of this project exceeded my expectations - this was not my experience with other vendors. Blue Goat Cyber delivered a thorough, detailed report and complete testing faster than I anticipated, without compromising quality."
    Tim Sandberg
    VP of IT Operations · Matrix One
    Ready to start HIPAA Penetration Testing?

    HIPAA Penetration Testing - scoped, fixed-fee, FDA-ready.

    HIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.