Notice of Privacy Practices: What the notice must say and where it must appear

If you have been asked for evidence of notice of privacy practices, the requirement behind the question is 45 CFR 164.520. What follows is what it says, what satisfies it, and where organizations usually come up short.

What the rule says

45 CFR 164.520 governs notice of privacy practices. 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 health care provider with a direct treatment relationship must, except in an emergency treatment situation, make a good faith effort to obtain a written acknowledgment that the individual received the notice, and document the effort and the reason if it is not obtained (164.520(c)(2)(ii)), keeping those acknowledgments with the notices it issued (164.520(e)). The notice must also state the individual's right to a paper copy, including after agreeing to receive it electronically (164.520(b)(1)(iv)(F)).

What this looks like in practice

In an assessment, 45 CFR 164.520 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:

• When the organization materially changes its privacy practices, does it promptly revise the Notice of Privacy Practices and redistribute it as §164.520 requires for its entity type?
• Does the organization maintain a current privacy notice that describes its uses and disclosures of protected information, individuals' privacy rights, and the organization's legal duties?
• Does the organization have a documented process to provide its privacy notice when §164.520(c) requires for its entity type (a health care provider with a direct treatment relationship no later than the first service delivery, a health plan at enrollment with a notice of availability at least every three years), post it where §164.520(c) requires, and provide copies on request?

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 owes no notice of privacy practices of its own. Two covered entities are carved out: a group health plan that provides benefits solely through an insurance contract and receives no PHI beyond summary health information and enrollment information is not required to maintain or provide a notice (164.520(a)(3)(iii)), and a correctional institution, whose inmates have no right to notice (164.520(a)(4)). The Privacy Rule has no counterpart to the Security Rule's flexibility-of-approach clause (164.306(b)); 45 CFR 164.530(i)(1) requires policies and procedures reasonably designed for the size and type of your activities.

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. Attach a notice-review step to the change-control process for anything that alters uses, disclosures, or individual rights, so the revision is triggered by the change rather than by an annual calendar. Record the effective date and the redistribution actions taken, because the evidence an auditor asks for is the redistribution, not the document. Health plans should establish which branch of §164.520(c)(1)(v) applies to them and diarize accordingly. Keep every superseded version for six years from the date of its creation or the date when it last was in effect, whichever is later (§164.530(j)(2)), the version in force at the time of a past disclosure is the one that matters.
2. Maintain a current privacy notice describing the types of uses and disclosures the organization may make without authorization.
3. Include a statement of individual rights, including access, amendment, accounting, restriction, and confidential communications.
4. Describe the organization's legal duties to protect the information, to abide by the notice, and to notify affected individuals following a breach of unsecured protected health information (§164.520(b)(1)(v)(A)).
5. If the organization receives or maintains records subject to 42 CFR Part 2, include the statement § 164.520(b)(1)(iii)(D) requires and, if it intends to use or disclose those records for fundraising, the statement (iii)(E) requires.
6. Include the contact for complaints and the effective date.

Evidence an assessor asks for

For this requirement the evidence 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 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 164.520 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 a common floor; what fails an assessment is a control implemented once and never re-checked against a changed environment.

If 45 CFR 164.520 is new to you, the useful first step is not a policy template. It is writing down what you already do, dating it, and naming an owner. That turns an undocumented practice into evidence, and it usually reveals the real gap.

Related requirements

• Verification Requirements: Verifying identity and authority before disclosing
• Requests for Restrictions: The self-pay restriction you cannot refuse
• Limited Data Set: When a limited data set is the right tool

References

• 45 CFR 164.520, in 45 CFR 164.520 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).