February 3, 2026 · Ken Armstrong
If you have been asked for evidence of information access management, the requirement behind the question is 45 CFR 164.308(a)(4). What follows is what it says, what satisfies it, and where organizations usually come up short.
45 CFR 164.308(a)(4) governs information access management. The operative text is not reproduced here: read it at the source linked below, because the conditions in it are the requirement and a summary of a conditional rule is not a safe substitute for the rule.
This is a standard, and standards are required in full. 45 CFR 164.306(d)(1) applies to every covered entity and business associate regardless of size.
In an assessment, 45 CFR 164.308(a)(4) is not one question. It resolves into several, and each one is really asking for a different artifact:
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.
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.
The sequence below is the order that produces evidence as a by-product rather than as a separate documentation exercise:
The same evidence answers more than one framework. The questions behind 45 CFR 164.308(a)(4) also map to NIST CSF PR.AA-05; ISO 27001 A.5.15, A.5.18; SOC 2 CC6.1, CC6.2, CC6.3; NIST 800-53 AC-1, AC-2, AC-6; CIS v8 3.3, 5.1, 6.1; HITRUST 01.a, 01.b. That matters for scoping: if you are working toward SOC 2 or an ISO certification alongside HIPAA, this control is one piece of work and several answers, provided the artifact is written once and referenced rather than rewritten per framework.
For this requirement the artifact types that satisfy it are policy and procedure. 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Date every artifact and keep the superseded versions. 45 CFR 164.316(b)(2)(i) requires documentation be retained for six years from the date of its creation or the date when it last was in effect,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.
The usual gap is a control that exists in practice and nowhere in writing. Someone does the work, reliably, and it has never been written down, so the organization cannot demonstrate it and cannot notice when it stops. The fix is not more control, it is a dated record and a named owner.
None of this makes information access management harder than it is. The requirement asks for a decision, an implementation, and a record. Organizations that struggle at assessment time are rarely the ones without controls; they are the ones that cannot show when a control started or who owns it now.