Solutions · Compliance · HIPAA
HIPAA compliance asks you to know where ePHI is exposed. ioSENTRIX tests your patient portals, APIs, cloud and networks the way an attacker would, maps each finding to the Security Rule, and includes a retest of your fixes so your risk analysis and evaluation rest on proof, not assumptions.
01The requirement
Not by name. The current HIPAA Security Rule does not use the term penetration testing. It requires an accurate and thorough risk analysis (45 CFR 164.308(a)(1)(ii)(A), Required) and a periodic technical and nontechnical evaluation (164.308(a)(8)). A penetration test is direct evidence for both.
Risk analysis and evaluation are required; how you evidence them is up to you.
The January 2025 proposed rule would add it. It has not been finalized.
A pentest shows whether your safeguards protect ePHI against a real attacker.
HIPAA penetration testing is a penetration test scoped to the systems that create, receive, maintain or transmit ePHI. It is documented so that findings, remediation and the retest can feed your risk analysis, risk management and periodic evaluation under the Security Rule.
The Security Rule requires administrative, physical and technical safeguards for ePHI, for covered entities and business associates alike. Read the rule on eCFR, or our HIPAA penetration testing guide. The proposed update is on the Federal Register.
02See it in action
How one access control on a patient portal is tested like an attacker would, fixed, retested and recorded in your HIPAA evaluation.
We start from the safeguard you rely on, such as patients seeing only their own records, and test whether it holds against a real attacker.
Each finding carries evidence, likelihood and impact on ePHI, and the Security Rule standard it relates to, so it drops straight into your risk analysis.
A retest of your fixes is included, so your evaluation records the risk as found, fixed and confirmed.
Illustrative example. The portal, endpoint and statuses are a composite for explanation only and do not describe any client. Testing uses test accounts and data agreed in the rules of engagement.
03Requirement to evidence
One test can support several standards at once. This is the mapping we put in your report, so your compliance team can trace each piece of evidence back to the rule.
| Standard | What it asks | What ioSENTRIX tests | Evidence for your file |
|---|---|---|---|
| 164.308(a)(1)(ii)(A)Risk analysis | An accurate and thorough assessment of potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI. | Threat modeling and penetration testing of systems holding ePHI. | Proven vulnerabilities with likelihood and impact |
| 164.308(a)(1)(ii)(B)Risk management | Security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level. | Prioritized fix guidance, then a retest of your fixes. | Remediation plan and retest results |
| 164.308(a)(8)Evaluation | Periodic technical and nontechnical evaluation, and again after environmental or operational changes affecting ePHI security. | An independent penetration test of apps, APIs, cloud and network in scope. | Report with scope, dates, method and testers |
| 164.312(a)(1)Access control | Allow access to ePHI only to persons or software programs granted access rights. | Authorization, IDOR, role and tenant checks in portals and APIs. | Access-control findings with proof |
| 164.312(b)Audit controls | Mechanisms that record and examine activity in systems that contain or use ePHI. | Whether our test activity was logged, and optional red team detection checks. | What was logged and what was missed |
| 164.312(d)Authentication | Verify that a person or entity seeking access to ePHI is the one claimed. | Login, MFA, password reset and session handling on web and mobile. | Authentication findings and fixes |
| 164.312(e)(1)Transmission security | Guard against unauthorized access to ePHI transmitted over an electronic communications network. | TLS configuration, API transport and mobile app traffic. | Transport findings by endpoint |
Standard wording summarized from 45 CFR 164.308 and 164.312 (eCFR, current text). The Security Rule does not name penetration testing; it is one way to evidence these standards. Orientation, not legal advice.
04Timing
Before you finalize your risk analysis, and again whenever your environment or operations change.
Identify where ePHI lives and which systems matter most.
Scope inputPortals, apps, APIs, EHR integrations, cloud and networks.
Written scopeManual testing by certified engineers. A web application test typically takes 1–2 weeks.
Manual testingFix guidance for each finding, then a retest of your fixes.
Retest includedResults recorded as part of your periodic evaluation.
Evidence packNew systems, integrations or operational changes affecting ePHI security.
Next cycleProviders, health plans and clearinghouses test the systems they run, and use the results in their risk analysis and evaluation.
Vendors that handle ePHI follow the same Security Rule standards, and covered entities may ask for a recent report.
05Evidence pack
What your compliance team, auditors and covered-entity customers ask for, in one place.
Scope, method and results in plain language for leadership and compliance.
Systems holding ePHI, dates, testers and the standards followed.
Each finding with evidence, likelihood, impact on ePHI and steps to reproduce.
Specific remediation for your engineers, prioritized for your risk management plan.
Fixes retested and recorded, so risks are tracked to closure.
Each result mapped to the standard it supports.
Share it with confidence. The report comes from a CREST-accredited firm that is itself ISO/IEC 27001 certified and SOC 2 Type 2 attested. See our trust center.
06Independently verified
“The team at ioSENTRIX is professional and highly skilled at their craft.”
“We were impressed with ioSENTRIX's ability to independently validate the security of our customer-facing product.”
07How we help
From the first risk analysis to retests after every significant change.
08Insights
09FAQ
Short answers to what healthcare security and compliance teams ask us most.
Ask us something elseNot by name. The current HIPAA Security Rule (45 CFR Part 164, Subpart C) does not use the term penetration testing. It requires an accurate and thorough risk analysis (164.308(a)(1)(ii)(A)) and a periodic technical and nontechnical evaluation (164.308(a)(8)). A penetration test is direct evidence for both, which is why many covered entities and business associates commission one.
It would, but it is not final. HHS published a proposed rule on January 6, 2025 (90 FR 898) that would require penetration testing by a qualified person at least once every 12 months, or more often if your risk analysis calls for it. As of November 2026 the proposal has not been finalized, and the Security Rule text in force does not include it.
The Security Rule does not set a frequency. It asks for a periodic evaluation, and another one in response to environmental or operational changes affecting the security of ePHI. Many organizations test at least annually and after significant changes, such as a new patient portal, EHR integration or cloud migration.
The Security Rule standards, including risk analysis and evaluation, apply to business associates as well as covered entities. A recent penetration test report is practical evidence for both, and covered entities may ask their vendors for one during due diligence.
The systems that create, receive, maintain or transmit electronic protected health information (ePHI): patient portals and mobile apps, APIs and EHR integrations, cloud infrastructure, internal and external networks, and the access controls around them. Scope follows your risk analysis.
Usually not on its own. A vulnerability scan lists known weaknesses automatically. A penetration test is carried out by people who exploit and chain weaknesses, including access control and business logic flaws, and prove whether ePHI can be reached. Both can feed your risk analysis.
No. ioSENTRIX provides testing, evidence and compliance support that feed your risk analysis, risk management and evaluation. Decisions about your HIPAA compliance remain with your organization and its advisors.
Ready when you are
Tell us whether you are a covered entity or business associate, and which systems handle ePHI. We will help you scope the right test.
Takes about a minute.
