Information System Activity Review: Reviewing system activity without drowning in logs

45 CFR 164.308(a)(1)(ii)(D) sets the expectation for information system activity review. The text is brief; the evidence it implies is not, and the difference between the two is where most remediation time goes.

What the rule says

Information system activity review (Required). Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.

That is the text of 45 CFR 164.308(a)(1)(ii)(D). 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.

What this looks like in practice

In an assessment, 45 CFR 164.308(a)(1)(ii)(D) 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 review audit records from its different systems together, so activity that spans more than one system can be seen, and report what the review finds to a named role?
• Does the organization regularly review access to patient records in its electronic health record and other applications that hold ePHI for access by its own workforce without a job need, such as staff viewing the records of coworkers, family members, neighbors or public figures, and act on what the review finds?
• Does the organization regularly review activity logs to identify inappropriate access or security events?

Ownership usually sits with the IT or security team, 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:

1. List the places audit records are held, such as the clinical system, the firewall, the identity provider, and any cloud service.
2. Bring those records together, or review them side by side, so a sequence of events that crosses systems can be followed.
3. Set how often the review happens and who carries it out.
4. Report what the review finds to a named role, and record the actions taken.
5. Confirm that each application holding ePHI records who opened which patient record and when.
6. Define what the review looks for, such as access to records of workforce members, people sharing a workforce member's surname or address, VIP patients, and records with no treatment relationship to the user.

Where else this maps

The questions behind 45 CFR 164.308(a)(1)(ii)(D) also map to HHS 405(d) HICP (2023 Edition) CSP 8 and NIST SP 800-66 Rev. 2 5.1.1, 5.3.2, 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 log, record, and report. 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

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.

What to do about it

• Produce the evidence, not the intention. For 45 CFR 164.308(a)(1)(ii)(D) that means retained logs plus evidence somebody actually reviewed them, dated records of each occurrence, not a description of the process, and a dated report with the period it covers and who reviewed it. If the only evidence is that someone knows how this works, you have a practice and not a record.
• Put a name on it. Whoever administers the systems 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.
• Set a review cadence and keep the evidence of each review. An annual date with a dated output is a common floor; what fails an assessment is a control implemented once and never re-checked against a changed environment.
• 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.

Work backward from the evidence. Decide what evidence would prove information system activity review to someone who does not already trust you, then build the control that produces it. Programs built in that order tend to stay current, because the evidence goes stale visibly.

Related requirements

• Sanction Policy: Writing a sanction policy you will actually apply
• Assigned Security Responsibility: Naming a security official and giving the role real authority
• Risk Management: Turning risk findings into tracked remediation

References

• 45 CFR 164.308(a)(1)(ii)(D), 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).