What evidence do auditors commonly ask for on 164.308(a)(1)(ii)(A) Risk Analysis (Required)?

Documented risk analysis report; Risk analysis methodology aligned to NIST SP 800-30; Periodic refresh schedule; Evidence of ePHI scoping.

What is the most common gap auditors find on 164.308(a)(1)(ii)(A)?

Risk analysis is checklist-style, not threat-based

HIPAA Security Rule · Administrative

`164.308(a)(1)(ii)(A)` Risk Analysis (Required)

Conduct accurate and thorough assessment of potential risks and vulnerabilities to ePHI. NIST recommends the nine-step risk analysis methodology and integration with NIST SP 800-30 and the NIST RMF.

Source: HIPAA Security Rule, 164.308(a)(1)(ii)(A). The statement above is our statement of the clause, read from the published text and cited so you can check it against the official text, not the instrument verbatim. Open HIPAA Security Rule in the compliance library.

Applies to covered entities and business associates. An addressable specification can be met by a documented, reasonable alternative.

artefacts

held by a system

at each review

hard

to go live

Policy repository / GRC workspace

where the evidence lives

teal = a system already holds it · olive = produced at each review. To go live: easy when half or more of the artefacts are already held by a system, moderate from a quarter to a half, hard below a quarter.

These are the artefacts auditors commonly ask for on this requirement, our guidance rather than text from the standard. Your assessor decides what is sufficient in your context, and asks for samples across the period when a report covers one.

system holds itEvidence a system already holds

none for this control

periodic reviewEvidence produced at each review

Documented risk analysis report · Policy repository / GRC workspace
Evidence of ePHI scoping · Policy repository / GRC workspace

governing documentDocuments that govern the control

Risk analysis methodology aligned to NIST SP 800-30 · Policy repository / GRC workspace
Periodic refresh schedule · Policy repository / GRC workspace

First move

No system holds this evidence for you: it is people and documents. Reminders and routing to the owner still save time. Put the document under version control with an owner and review date, and log each review as a record with reviewer and date.

Common gaps auditors find

Risk analysis is checklist-style, not threat-based
Not refreshed after material changes
No integration with enterprise risk register

Do this for your whole sheet

Paste the rows you run your controls from and get this mapping for every control at once, with the periodic-review ones flagged and a first move per row. No account for the first run.

Build my evidence sheet

164.308(a)(1)(i) Security Management Process (Standard) · 164.308(a)(1)(ii)(B) Risk Management (Required)