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

Standard. A covered entity or business associate may not use or disclose protected health information, except as permitted or required by this subpart or by subpart C of part 160 of this subchapter.

That is the operative language of 45 CFR 164.502(a). 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.

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 a different artifact:

• Identify and oversee third parties that process personal information on its behalf to ensure they apply equivalent privacy protections
• Monitor tracking and analytics technologies on its individual-facing digital properties to prevent protected information from being disclosed
• A policy ensuring that protected information is used or disclosed only as permitted and that any other use or disclosure requires individual

Ownership usually sits with the compliance owner, 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. Business associates are directly liable for only a defined subset of these obligations, so read your business associate agreement alongside the rule rather than assuming the duty transfers. There is no scalability defense here of the kind the Security Rule offers at 45 CFR 164.306(b): a deadline is a deadline at any size. What does scale is how you meet it, and 45 CFR 164.530(i) expects your policies to be designed for the size and activities of your organization.

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. Identify all third parties that process personal information on the organization's behalf.
2. Require privacy protections through agreements before sharing personal information.
3. Assess each third party's privacy practices proportionate to risk.
4. Monitor and document ongoing compliance.
5. Upload the third-party privacy oversight procedure and inventory.
6. Inventory all third-party scripts, pixels, and analytics tags loaded on authenticated and individual-facing pages.

What else this satisfies

The same evidence answers more than one framework. The questions behind 45 CFR 164.502(a) also map to SOC 2 C1.1; NIST 800-53 PT-2, PT-3, SA-9; HITRUST 13.e, 13.f; NIST Privacy CT.PO-P1, GV.MT-P4, GV.PO-P4; GDPR Art 28, Art 5, Art 6. 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.

Evidence an assessor asks for

For this requirement the artifact types that satisfy it are policy, procedure, 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 artifact and keep the superseded versions. The Privacy Rule carries its own retention rule at 45 CFR 164.530(j)(2): six years from the date of 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 artifact, not the intention. For 45 CFR 164.502(a) that means a signed, dated policy with a named owner and a review date, a step-by-step procedure someone unfamiliar with the task could follow, 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. 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.
• Set a review cadence and keep the evidence of each review. An annual date with a dated output is enough; what fails an assessment is a control implemented once and never re-checked against a changed environment.

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 requirement is met. If they need you in the room to explain it, it is not.

References

• 45 CFR 164.502(a), in 45 CFR 164.502 on eCFR. Quoted text verified against the eCFR snapshot of 2026-01-01.
• The Required and Addressable designations are defined at 45 CFR 164.306(d).
• Crosswalk references in this post are our own mapping 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 stricter obligations (45 CFR 160.203).