← All posts

Individual Breach Notification: The 60-day deadline and required content

May 21, 2026 · Ken Armstrong

Auditors ask about individual breach notification early, because the answer tells them how the rest of the program is likely to look. The requirement is 45 CFR 164.404.

What the rule says

45 CFR 164.404 governs individual breach notification. 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.

Notify without unreasonable delay and in no case later than 60 calendar days after discovery (45 CFR 164.404(b)), treating the breach as discovered on the first day it is known, or would have been known with reasonable diligence, to any workforce member or agent other than the person committing it (164.404(a)(2)); the only extension is a law enforcement delay under 164.412.

If the covered entity knows the individual is deceased and has the address of the next of kin or personal representative, the written notice goes by first-class mail to either of them (164.404(d)(1)(ii)).

What this looks like in practice

In an assessment, 45 CFR 164.404 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 to notify affected individuals of a breach of their data without unreasonable delay and within the required time limit, using a notice that contains all required content?
Does the organization's breach notification template include every element §164.404(c) requires, a brief description of what happened and the date of the breach and of its discovery, the types of unsecured PHI involved, the steps individuals should take to protect themselves, what the organization is doing to investigate and mitigate the harm and prevent recurrence, and contact procedures including a toll-free number, e-mail address, Web site, or postal address?

Ownership usually sits with the privacy and security officials, 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:

Maintain a templated individual notification letter containing all required content: a description of what happened, the dates of the event and its discovery, the types of data involved, steps individuals should take to protect themselves, what the organization is doing, and contact information.
Define the process and timeline to issue notices without unreasonable delay and within the regulatory deadline.
Specify delivery methods and handling of insufficient contact information.
Document each notification issued.
Maintain a pre-approved individual breach-notice template that carries all five §164.404(c)(1)(A)-(E) elements as named fields, element (A) itself carries both the description of what happened and the two dates, so none can be omitted under time pressure, written in plain language per §164.404(c)(2). Pair it with a delivery decision tree covering first-class mail, agreed e-mail, the urgent telephone route, and both substitute-notice branches under §164.404(d)(2), an alternative written notice, telephone, or other means where fewer than 10 individuals have insufficient or out-of-date contact information, and a conspicuous posting for 90 days on the home page of the organization's Web site or notice in major print or broadcast media serving the relevant geographic area, together with a toll-free number active for at least 90 days, where 10 or more individuals do. Have counsel review the template before it is needed, not during an incident.

Evidence an assessor asks for

For this requirement the evidence type that satisfies it is a 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 (applied to a covered entity by 164.414(a)) 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 164.404 that means 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 and security officials should be recorded as the owners. 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.

If 45 CFR 164.404 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

References

45 CFR 164.404, in 45 CFR 164.404 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).