Individual-Directed Transmission: Third-party directives after Ciox v. Azar

45 CFR 164.524(c)(3)(ii) sets the expectation for individual-directed transmission. The text is brief; the evidence it implies is not, and the difference between the two is where most remediation time goes.

What the rule says

If an individual's request for access directs the covered entity to transmit the copy of protected health information directly to another person designated by the individual, the covered entity must provide the copy to the person designated by the individual. The individual's request must be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of protected health information.

That is the text of 45 CFR 164.524(c)(3)(ii). Read each condition in it: it says what must be in place, and the method is yours only where the text leaves it open.

The eCFR prints this text, but it was challenged in Ciox Health, LLC v. Azar (D.D.C. 2020), which is reported to have vacated it in part; confirm its current scope with counsel before relying on it.

What this looks like in practice

In an assessment, 45 CFR 164.524(c)(3)(ii) 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 support an individual's right to direct that a copy of their electronic information be transmitted to a third party or application of their choice?

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. Establish a process to honor individual requests to transmit a copy of their electronic information to a designated third party or application.
2. Confirm systems support electronic transmission, including via standardized programmatic interfaces where available.
3. Verify the individual's identity and the validity of the direction before transmitting.
4. Apply the applicable response timeframe; note that a federal court (Ciox Health, LLC v. Azar, D.D.C. 2020) vacated HHS guidance that had applied the access fee limits to individual-directed transmissions to third parties, so have counsel confirm which fee rules, including state law, govern such a transmission. The §164.524(c)(4) cap continues to govern copies provided to the individual themselves.

Evidence an assessor asks for

For this requirement the evidence type that satisfies it is a policy. 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 164.524(c)(3)(ii) that means a signed, dated policy with a named owner and a review date. 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.

None of this makes individual-directed transmission harder than it is. The requirement asks for a decision, an implementation, and a record. Organizations that struggle at assessment time are rarely the ones without controls; they are the ones that cannot show when a control started or who owns it now.

Related requirements

• Right of Access: The 30-day clock, the fee cap and the format rules
• Right to Amend: Handling an amendment request and a denial
• Requests for Restrictions: The self-pay restriction you cannot refuse

References

• 45 CFR 164.524(c)(3)(ii), in 45 CFR 164.524 on eCFR. Quoted text verified against the eCFR text current as of 2026-10-06.
• 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).