HIPAA Penetration Testing
HIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.
The short answer
Does HIPAA require penetration testing?
The HIPAA Security Rule doesn't name penetration testing, but it requires regular risk analysis and technical evaluation of safeguards protecting electronic patient data. A penetration test is one of the clearest ways to show those safeguards work. We scope testing to the systems that create, store or send ePHI and map findings to the Security Rule so they feed your risk analysis.
275+ FDA submissions supported, zero cybersecurity 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
Fixed-fee engagement
HIPAA penetration testing: deliverables, inputs, and exclusions
Included work is defined in the signed proposal. These scope options are not automatic inclusions in every engagement.
Fixed-fee deliverables
- Agreed ePHI attack-path testing and findings mapped to relevant HIPAA technical safeguards to support the organization's risk analysis.
- A Penetration Test Plan, Test Cases, and Test Report for the agreed attack surface and product versions.
- Documented findings, reproduction evidence, and remediation recommendations. Clean test cases and agreed retest evidence. Device tests trace to documented threats. They distinguish security impact from manufacturer-supplied patient-harm context.
Required inputs
- ePHI system boundary and data flows, network/cloud/application inventory, existing risk analysis, authorized test accounts, and safeguards in scope.
- Written authorization, rules of engagement, in-scope targets and versions, test windows, and an escalation contact.
- Test accounts, environment access, architecture and data-flow information, and known access restrictions. Device work also needs intended use, available threat model, and ISO 14971 hazard context.
Exclusions and separate work
- Unlisted targets, production disruption, destructive hardware work, and third-party systems without authorization are excluded. Additional interfaces require agreement.
- SBOM generation, SAST, threat-model creation, and architecture views are separate unless explicitly bundled. A targeted test is not whole-device coverage.
- General software verification and validation, clinical performance testing, and full QMS implementation or certification are outside Blue Goat's product cybersecurity scope.
- The manufacturer retains engineering changes, clinical-risk evaluation, risk acceptance, release approval, and regulatory submission decisions. No regulatory outcome is promised.
Pricing and scope changes
A written fixed-fee quote after scoping. The proposal names deliverables, versions, assumptions, required inputs, exclusions, and agreed dates. Additional work requires a separately agreed scope change. Missing inputs, access restrictions, manufacturer fixes, and review feedback can affect delivery.
Reviewer-ready deliverables in one engagement
Every engagement ships with documented artifacts, traceable, complete, and aligned with current guidance.
- ePHI data-flow mapping
- Administrative, physical, and technical safeguards
- Risk analysis support
- Documentation for OCR audits
Testing for a hospital, health system, or connected health product? See our healthcare penetration testing overview for how scope differs for healthcare organizations and medical device makers. For what FDA guidance recommends for testing, read FDA cybersecurity requirements for medical devices.
HIPAA Penetration Testing FAQs
Cybersecurity alerts and guides
Goat's Weekly alerts
Medical device advisories and safety communications, with links to original sources. An alert is a reason to assess applicability, not proof that your device is affected.
Threat modeling, eSTAR 7.1, and SBOM evidence
Connect threats to controls and test evidence. Compare the CISA 2026 SBOM fields with the NTIA 2021 baseline the FDA still cites, plus its support fields. Guidance recommendations remain separate from statutory duties.
HIPAA penetration testing scoped to your ePHI perimeter.
HIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.