Notification to the Secretary: The two HHS deadlines and which applies

If you have been asked for evidence of notification to the secretary, the requirement behind the question is 45 CFR 164.408. What follows is what it says, what satisfies it, and where organizations usually come up short.

What the rule says

45 CFR 164.408 governs notification to the secretary. 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 164.408 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 the Secretary of HHS of a breach of unsecured PHI within the required timeframes, accounting for differing deadlines based on the number of individuals affected?

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:

1. Define the process to notify the Secretary of HHS of a breach.
2. For 500 or more individuals, notify the Secretary contemporaneously with the individual notices (164.408(b)); for fewer than 500, log each breach and submit them not later than 60 days after the end of the calendar year in which they were discovered (164.408(c)). Capture the required submission content and retain confirmation of each filing.

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 164.408 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.

Work backward from the evidence. Decide what evidence would prove notification to the secretary to someone who does not already trust you, then build the control that produces it. Programs built in that order tend to stay current, because the evidence goes stale visibly.

Related requirements

• Media Notification: The more-than-500-residents threshold
• Business Associate Breach Notification: What a business associate owes the covered entity
• Individual Breach Notification: The 60-day deadline and required content

References

• 45 CFR 164.408, in 45 CFR 164.408 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).