HIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.
The short answer
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+ devices supported. No cybersecurity-related rejections to date.
Every hipaa penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
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 the FDA expects around testing, read FDA cybersecurity requirements for medical devices.
HIPAA-aligned penetration testing for covered entities, business associates, and MedTech companies handling ePHI.