Authorizations: When an authorization is required and what it must contain

Auditors ask about authorizations early, because the answer tells them how the rest of the program is likely to look. The requirement is 45 CFR 164.508.

What the rule says

45 CFR 164.508 governs authorizations. 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.

What this looks like in practice

In an assessment, 45 CFR 164.508 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 have a process for obtaining, managing, and revoking valid written authorizations for uses and disclosures that require them?
• Does the organization obtain a valid authorization before any use or disclosure of PHI that requires one, and honor an individual's written revocation of it?
• Does the organization obtain a valid §164.508(a)(3) authorization before using or disclosing PHI for marketing, and does that authorization state whether the organization receives financial remuneration from a third party for the communication?

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. Develop authorization forms containing all required elements, including a description of the information, the persons authorized to make and receive the disclosure, the purpose, an expiration, and the signature of the individual and date (164.508(c)(1)(vi)).
2. Require authorization for uses and disclosures not otherwise permitted, including psychotherapy notes (164.508(a)(2)), marketing, and any sale of information.
3. Establish a revocation process and honor revocations going forward.
4. Retain executed authorizations.
5. Identify the uses and disclosures that require an authorization under §164.508, for example most marketing and any sale of PHI.
6. Use an authorization form carrying the core elements and required statements of §164.508(c).

Evidence an assessor asks for

For this requirement the evidence types that satisfy it are policy, procedure, and record. 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 164.508 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 dated records of each occurrence, not a description of the process. 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.

The recurring lesson with authorizations is that documentation is not the paperwork after the control. It is the part an assessor can read, and therefore the part that has to exist.

Related requirements

• Business Associate Contracts: The privacy-side contract requirements
• Psychotherapy Notes: The separate authorization standard
• Personal Representatives: Who may act for a patient, and when

References

• 45 CFR 164.508, in 45 CFR 164.508 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).