Accounting of Disclosures: The six-year accounting and its exclusions

45 CFR 164.528 covers accounting of disclosures. In most assessments the control itself is present and the record proving it is not, which is why this requirement produces findings at organizations that are, in practice, doing the work.

What the rule says

45 CFR 164.528 governs accounting of disclosures. 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.

The accounting excludes disclosures for treatment, payment and health care operations; to the individual; incident to a permitted use or disclosure; under an authorization; for the facility directory or to persons involved in the individual's care; for national security or intelligence purposes; to correctional institutions or law enforcement officials about an inmate or person in custody; as part of a limited data set; and those made before the compliance date (164.528(a)(1)(i) through (ix)). It includes disclosures to or by business associates (164.528(b)(1)). A health oversight agency or law enforcement official may have the right temporarily suspended, for the time a written statement specifies, or for no longer than 30 days on an oral statement unless a written one follows (164.528(a)(2)).

What this looks like in practice

In an assessment, 45 CFR 164.528 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 maintain the records and process needed to provide individuals an accounting of certain disclosures of their protected information on request?
• Does the organization have a process for disclosures to health oversight agencies under §164.512(d) that verifies the agency and the oversight activity authorized by law, applies the exception where the individual rather than the health care system is the subject of the investigation, and records each disclosure for the accounting?

Ownership usually sits with the privacy 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

Covered entities. A business associate is bound directly by the provisions that name it (for example 45 CFR 164.502(a)(3), the minimum necessary standard at 164.502(b), and 164.410) and otherwise through its business associate agreement, so read the provision for whom it names. The Privacy Rule has no counterpart to the Security Rule's flexibility-of-approach clause (164.306(b)). Instead, 45 CFR 164.530(i)(1) requires policies and procedures reasonably designed for the size and type of your activities, and any deadline a provision sets applies at every size.

Building it, in order

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

1. Maintain a log of accountable disclosures, capturing the date, recipient, a description of the information, and the purpose of each.
2. Establish a process to act on a request no later than 60 days after receipt, with at most one written extension of up to 30 days stating the reason and the new date, and provide the first accounting in any 12-month period without charge (a reasonable, cost-based fee for a later request in that period is allowed only with advance notice and a chance to withdraw or modify the request).
3. Provide an accounting covering the six years before the request, or a shorter period the individual asks for (§164.528(a)(1), (a)(3)), excluding the disclosures §164.528(a)(1) lists.
4. Train staff to record qualifying disclosures as they occur.
5. Maintain a list of the health oversight agencies the organization deals with (state licensing boards, Medicaid fraud control units, CMS and OIG auditors, civil rights enforcement) and the legal authority for each.
6. Route each oversight request through the Privacy Officer, who confirms the requester is a health oversight agency and the activity is one §164.512(d)(1) names.

Evidence an assessor asks for

For this requirement the evidence 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 document and keep the superseded versions. Under 45 CFR 164.530(j)(2) the documentation 164.530(j)(1) requires is kept six years from the date of its creation or the date when it last was in effect, whichever is later. It is the same period the Security Rule sets at 164.316(b)(2)(i), under a different provision, so cite the one that governs the document you are holding.

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 164.528 that means a signed, dated policy with a named owner and a review date and a step-by-step procedure someone unfamiliar with the task could follow. 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 privacy official should be recorded as the owner. A control with no owner stops working the month the person who quietly maintained it changes roles, and nobody notices.
• Re-read it when something changes. A new system, a new vendor or a departure is what makes a correct control stale. Tie the review to those events as well as to the calendar, and date the result.

The practical test for 45 CFR 164.528 is whether someone unfamiliar with your organization could read your documentation and tell what you do, who does it, and when it last happened. If they can, the documentation will hold up; whether the requirement is met is a judgment about what it shows, and your counsel owns that conclusion. If they need you in the room to explain it, it will not.

Related requirements

• Right to Amend: Handling an amendment request and a denial
• Privacy Official Designation: Naming a privacy official and a contact person
• Individual-Directed Transmission: Third-party directives after Ciox v. Azar

References

• 45 CFR 164.528, in 45 CFR 164.528 on eCFR.
• 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 stricter obligations (45 CFR 160.203).