Permitted and Required Uses and Disclosures: The default rule and its exceptions

45 CFR 164.502(a) covers permitted and required uses and 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 164.502(a) governs permitted and required uses and 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.

A covered entity or business associate may not use or disclose PHI except as the Privacy Rule permits or requires (164.502(a)); disclosure is required only to the individual under 164.524 or 164.528 and to the Secretary (164.502(a)(2)).

What this looks like in practice

In an assessment, 45 CFR 164.502(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 prohibit the sale of protected information and obtain a valid authorization, disclosing any remuneration involved, before any use or disclosure that constitutes a sale?
• If the organization is a business associate, does it recognize the obligations for which it is DIRECTLY liable to HHS, independent of its business associate agreement?
• Does the organization limit access to genetic information to workforce members who need it for their roles, as part of its minimum necessary policies?

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. Adopt a policy prohibiting the sale of protected information except where a valid authorization that states the disclosure involves remuneration has been obtained.
2. Define what constitutes a sale, including direct or indirect remuneration, and the limited statutory exceptions.
3. Implement controls that block disclosures meeting the definition of a sale until an appropriate authorization is on file.
4. Train workforce members who handle disclosures on the prohibition and the authorization requirement.
5. If the organization acts as a business associate for any customer, assess itself against the directly-liable set rather than only against what its agreements promise, and keep that assessment separate from its covered-entity posture, the two roles carry different obligations and an organization is often both. Confirm subcontractor agreements exist and flow the obligations down, since that is itself a direct-liability item. Where a customer's agreement assigns access or accounting duties, build the operational capability to meet them rather than treating the clause as boilerplate.
6. Configure system access controls to limit access to genetic test results and genetic family-history data to workforce members who need it.

Evidence an assessor asks for

For this requirement the evidence types that satisfy it are configuration, 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

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 164.502(a) that means a configuration export or screenshot showing the setting live, dated, 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.
• 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.

The practical test for 45 CFR 164.502(a) 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

• Minimum Necessary: Applying minimum necessary to real workflows
• Personal Representatives: Who may act for a patient, and when
• Business Associate Contracts: The privacy-side contract requirements

References

• 45 CFR 164.502(a), in 45 CFR 164.502 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).