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Risk Analysis: What a defensible analysis has to contain

January 22, 2026 · Ken Armstrong

45 CFR 164.308(a)(1)(ii)(A) is the requirement on risk analysis. It is short to read and easy to underestimate, because satisfying it means producing evidence rather than holding an intention.

What the rule says

Risk analysis (Required). Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.

That is the text of 45 CFR 164.308(a)(1)(ii)(A). Read it closely: it describes an outcome to achieve, not a product to buy, which is why two practices of the same size can satisfy it in different ways and both be right.

This is a required implementation specification. 45 CFR 164.306(d)(2) gives no documented-alternative route: you implement it, or you have a finding.

Read that way, the text sets four tests for a defensible analysis: it is accurate and thorough; it assesses potential risks and vulnerabilities, not only incidents that have happened; it covers all three of confidentiality, integrity and availability; and it reaches all of the ePHI the organization holds. The rule names no method, no tool and no interval, so everything else in this post is practice, not the text.

What this looks like in practice

In an assessment, 45 CFR 164.308(a)(1)(ii)(A) is not one question. It resolves into several, and each one is really asking for different evidence. These are among the questions asked about it:

Does the organization conduct a documented, periodic risk analysis that identifies threats and vulnerabilities to sensitive information and rates their likelihood and impact?
Does the organization conduct penetration testing of Internet-facing and internal systems that handle ePHI at a frequency its risk analysis supports?
Does the organization document its risk analysis policies and procedures (§ 164.308(a)(1)(ii)(A)) and review them periodically and update them as needed in response to environmental or operational changes affecting the security of ePHI?

Ownership usually sits with the security official, though the evidence is often produced by someone else, which is where the trail breaks. A control that works but has no owner tends to stop working the month the person who quietly maintained it changes roles.

Who this applies to

Every covered entity and every business associate, at any size. 45 CFR 164.306(b) allows flexibility of approach, so a two-provider practice and a hospital system may implement this differently and both comply. What flexibility does not allow is skipping the decision: the smaller the organization, the more the written reasoning carries the weight, because there is no scale of operation to make the control self-evident.

Building it, in order

These steps are one way to meet it, drawn from our question bank. Unless a step names a provision, the Security Rule does not require that particular measure: 45 CFR 164.306(b)(1) lets you use any security measures that allow you to reasonably and appropriately implement the standards and implementation specifications, chosen with the factors in 45 CFR 164.306(b)(2).

The sequence below is the order that produces evidence as a by-product rather than as a separate documentation exercise:

Define a repeatable risk analysis methodology covering asset identification, threat and vulnerability identification, and likelihood/impact rating.
Inventory the systems, locations, and data flows that hold or process sensitive information.
Perform the analysis at least annually and after significant changes, recording each identified risk and its rating. (HIPAA sets no interval; this is common practice, not a rule.)
Have leadership review and approve the results.
Establish a policy setting a penetration-testing frequency the organization's risk analysis supports for Internet-facing and internal systems that store, process, or transmit ePHI. (HIPAA does not require penetration testing by name or set an interval.)
Engage a qualified internal team or third party to perform the testing.

Where else this maps

The questions behind 45 CFR 164.308(a)(1)(ii)(A) also map to HHS 405(d) HICP (2023 Edition) CSP 10, CSP 5, CSP 6 and NIST SP 800-66 Rev. 2 5.1.1, 5.5.1, 5.5.2, which are voluntary guidance rather than law; following them does not by itself establish compliance with any law. That matters for scoping: the same evidence can be written once and referenced from each, rather than rewritten per framework.

Evidence an assessor asks for

For this requirement the evidence types that satisfy it are inventory, policy, procedure, record, report, and risk assessment. The distinction matters more than it looks: a policy states what you intend to do, a procedure states how, and a record proves it happened on a date. Auditors ask for all three, and a practice that has written the first two often has nothing for the third.

Date every document and keep the superseded versions. 45 CFR 164.316(b)(2)(i) requires the documentation 164.316(b)(1) calls for (the Security Rule policies and procedures, and the written record of any action, activity or assessment the Security Rule requires to be documented) to be retained for six years from the date of its creation or the date when it last was in effect, whichever is later, so a policy you replaced two years ago is still part of the record.

Where this usually goes wrong

In our question bank this is weighted Critical: a gap here is raised as a critical finding (a partial answer as high). The usual cause of a gap is drift: the control was implemented once, the environment changed, and nothing re-checked it. A dated review on a fixed cadence is cheaper than the remediation.

What to do about it

Produce the evidence, not the intention. For 45 CFR 164.308(a)(1)(ii)(A) that means an inventory with an owner and a last-reviewed date on every row, a signed, dated policy with a named owner and a review date, a step-by-step procedure someone unfamiliar with the task could follow, dated records of each occurrence, not a description of the process, a dated report with the period it covers and who reviewed it, and a completed assessment showing the method, the findings and the date. If the only evidence is that someone knows how this works, you have a practice and not a record.
Put a name on it. Your security official should be recorded as the owner. Where the work is done by someone else, say so in the document: the split between who owns it and who performs it is where the trail usually breaks. A control with no owner stops working the month the person who quietly maintained it changes roles, and nobody notices.
Review it on a fixed date, not when you remember. In our question bank this is weighted Critical: a gap here is raised as a critical finding (a partial answer as high). Put the review on the calendar with an owner, and keep the dated output of each one.
There is no documented-alternative route for the requirement itself. It is required (45 CFR 164.306(d)(2) for a specification, 164.306(c) for a standard), so a risk-based decision not to meet it is not available. How you meet it is yours to choose under 45 CFR 164.306(b); the measures in this post are examples, not the rule's text.

The recurring lesson with risk analysis is that documentation is not the paperwork after the control. It is the part an assessor can read, and therefore the part that has to exist.

Related requirements

References

45 CFR 164.308(a)(1)(ii)(A), in 45 CFR 164.308 on eCFR. Quoted text verified against the eCFR text current as of 2026-10-06.
The Required and Addressable designations are defined at 45 CFR 164.306(d).
Crosswalk references in this post are the mappings in our question bank, and are not verified against the published text of those standards.
This post describes what a requirement asks for and what evidence documents it. It is not legal advice, and your counsel owns the conclusion. State law may impose additional obligations; HIPAA preempts a State law only where it is contrary to HIPAA (45 CFR 160.202, 160.203).