● Talk to a security engineer: +92 323 8295031info@protonyte.com  ·  PCSF batch enrolling now

HIPAA penetration testing: what the Security Rule asks for today

The HIPAA Security Rule does not require a penetration test. It requires a risk analysis under §164.308(a)(1)(ii)(A) and periodic technical and non-technical evaluation under §164.308(a)(8), and testing is how most covered entities and business associates satisfy the second. A proposed rule published in January 2025 would change that to an explicit annual requirement, but it is still a proposal, and we are not going to sell you work on the strength of a rule that has not been made.

the clause your report

ENGAGEMENT SCOPEtypical 1 - 2 week test

Systems that create or hold ePHIIN SCOPE
Patient and provider portalsIN SCOPE
APIs and integrationsIN SCOPE
Access control between rolesIN SCOPE
Audit logging coverageIN SCOPE
Live patient dataOPTIONAL
// the basics

Read this before you engage any offshore firm

We are a Pakistani company, and that matters here more than in any other engagement we offer. HIPAA itself does not prohibit protected health information being accessed from outside the United States. Several states and many state contracts do: Wisconsin restricts contractors and subcontractors from performing work abroad involving access to patient health information, Texas requires certain managed care services and data to be kept within the United States, Florida ties certified electronic health record data to the continental US, its territories or Canada, and Medicare Advantage organizations must obtain signed offshore vendor attestations.

So here is how we work, and it is not a negotiating position. We test against sanitised or staging environments containing no live patient data, and that is written into the scope document before anything begins. If your contract or your state requires the work to be performed on US soil or by a US-based entity, we are the wrong firm and we would rather say so now than three weeks into procurement.

  • 01No live ePHI, in writingSanitised or staging environments only, stated in the scope document.
  • 02Honest about the ruleThe Security Rule does not require a penetration test today. We will not pretend otherwise to close a sale.
  • 03Mapped to the safeguardsFindings tied to the technical safeguards in §164.312 so your risk analysis can absorb them.
  • 04Business associates tooThe same obligations reach you, and your covered-entity customers will ask for the report.
// coverage

What we test

Scoped to the systems that create, receive, maintain or transmit electronic protected health information, and mapped to the technical safeguards at §164.312.

// 164.312(a)(1)

Access control

The safeguard most often failed, and the one that leaks records.

  • Access between patients and between providers
  • Role separation in practice
  • Emergency access procedure
  • Unique user identification
// 164.312(d)

Authentication

Proving the person is who they claim.

  • Login, reset and recovery flows
  • Multi-factor coverage
  • Session timeout and automatic logoff
  • Integration and SSO paths
// 164.312(e)(1)

Transmission security

What travels, and whether it is protected on the way.

  • Transport security configuration
  • Data sent to third parties
  • Integration and interface security
  • Mobile and remote access paths
// the integrations

APIs and interfaces

Where health systems usually connect to each other badly.

  • Object-level authorisation between records
  • Interface authentication
  • Data exposed beyond what is needed
  • Older endpoints still answering
// 164.312(b)

Audit controls

Whether you could reconstruct who looked at what.

  • Logging of access to records
  • Coverage across systems
  • Retention and protection of logs
  • Whether anybody reviews them
// 164.308(a)(8)

The evaluation record

What the periodic evaluation standard asks you to be able to show.

  • Scope, dates and who performed it
  • Findings against the safeguards
  • Remediation and retest evidence
  • Input for your risk analysis
// methodology

How the work runs

  1. 1

    The data question first

    Before scope, before price. Whether we can lawfully and contractually do this work for you.

    • Your state and contractual restrictions
    • Whether a staging environment exists
    • Business associate agreement, if needed
    • Who signs it off on your side
  2. 2

    Scope

    The systems that touch ePHI, and the roles that reach it.

    • Applications, portals and APIs
    • Two accounts at each role
    • Sanitised data loaded
    • Written authorisation
  3. 3

    Test

    Access control first, because that is where the records leak.

    • Record access between accounts
    • Authentication and session handling
    • Transmission and integration security
    • Audit logging coverage checked
  4. 4

    Report

    Mapped to the safeguards so it feeds your risk analysis.

    • Findings with evidence and severity
    • Mapped to §164.312 safeguards
    • Remediation your team can action
    • Written for the evaluation record
  5. 5

    Retest and record

    Dated evidence you can show if asked.

    • Findings re-attacked after you fix
    • Closure summary retained
    • Input for the next risk analysis
    • A note on what was out of scope and why
// the deliverable

What you are left holding

Two documents and a conversation. Written so the person who signs the invoice and the person who writes the fix can both use them.

  • Executive summary in plain language, with the business risk first
  • Technical findings with the evidence that proves each one
  • CVSS score and a risk rating that reflects your business, not a template
  • Remediation written for the stack you actually run
  • A free retest, and a closure summary you can hand to a customer
  • A debrief call with the tester who did the work, not an account manager
Ask for a sample report
// the standards

Measured against something

The work follows HIPAA Security Rule 45 CFR Part 164 Subpart C, NIST SP 800-66, OWASP Web Security Testing Guide and NIST SP 800-115, so the coverage can be checked rather than taken on trust, and the report maps to what your auditor or your enterprise customer already recognises.

This page is one part of our compliance and audit service. Where a finding needs a different kind of engagement to answer properly, we say so in the report rather than selling you the test we happen to be running.

// faq

Common questions

Does HIPAA require penetration testing?

Not today. The Security Rule requires a risk analysis under §164.308(a)(1)(ii)(A) and periodic evaluation under §164.308(a)(8); neither names a penetration test. A notice of proposed rulemaking published in January 2025 would add an explicit annual requirement, with vulnerability scanning every six months. It has not been finalised, and the regulatory agenda has pushed projected final action well beyond its original date. We will update this page when it changes.

Can a Pakistani firm test a US healthcare system at all?

Sometimes, and not always. HIPAA itself does not bar offshore access to protected health information, but several states and many state contracts do. We test against sanitised or staging environments with no live patient data and put that in the scope document. If your obligations require the work to be done on US soil, we will tell you we are the wrong firm.

What is a sanitised environment, exactly?

A copy of your system with synthetic or de-identified records in place of real ones. It has to be configured like production to be worth testing - same roles, same integrations, same settings - and we will review that with you before starting rather than discover the difference in the findings.

We are a business associate, not a covered entity. Does this apply?

Yes. The Security Rule reaches business associates directly, and in practice your covered-entity customers will ask for a penetration test report during vendor review whatever the rule says. That second pressure usually arrives first.

Will this satisfy an OCR investigation?

Nothing we produce can guarantee that, and anybody promising it is overselling. What a dated, scoped, independent evaluation with documented remediation does is evidence that you performed the periodic evaluation the rule asks for. That is worth having and it is not a guarantee.

// start here

Let's protect your business together.

Tell us what you need tested. Our team will reply with a clear scope and quote.

By submitting, you agree to our Terms of Use and Privacy Statement.