Emergency Mode Operation Plan: Emergency mode operation when systems are down

45 CFR 164.308(a)(7)(ii)(C) sets the expectation for emergency mode operation plan. 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

Emergency mode operation plan (Required). Establish (and implement as needed) procedures to enable continuation of critical business processes for protection of the security of electronic protected health information while operating in emergency mode.

That is the text of 45 CFR 164.308(a)(7)(ii)(C). Read it closely: it describes an outcome to achieve, not a product to buy, which is why two practices of the same size can satisfy it in different ways and both be right.

This is a required implementation specification. 45 CFR 164.306(d)(2) gives no documented-alternative route: you implement it, or you have a finding.

What this looks like in practice

In an assessment, 45 CFR 164.308(a)(7)(ii)(C) 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 maintain a business continuity plan to sustain critical operations during an emergency?
• Where its emergency mode operation plan relies on outside support, has the organization established mutual aid or reciprocal arrangements with peers or service providers to support emergency access to critical systems, data, or facilities during an extended outage?
• Does the organization maintain documented manual workaround procedures for critical workflows when systems are unavailable?

Ownership usually sits with the security 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

Every covered entity and every business associate, at any size. 45 CFR 164.306(b) allows flexibility of approach, so a two-provider practice and a hospital system may implement this differently and both comply. What flexibility does not allow is skipping the decision: the smaller the organization, the more the written reasoning carries the weight, because there is no scale of operation to make the control self-evident.

Building it, in order

These steps are one way to meet it, drawn from our question bank. Unless a step names a provision, the Security Rule does not require that particular measure: 45 CFR 164.306(b)(1) lets you use any security measures that allow you to reasonably and appropriately implement the standards and implementation specifications, chosen with the factors in 45 CFR 164.306(b)(2).

The sequence below is the order that produces evidence as a by-product rather than as a separate documentation exercise:

1. Develop a business continuity plan that identifies critical business operations and how they will continue during a disruption.
2. Address protection of sensitive data while operating in degraded conditions.
3. Define roles, responsibilities, and minimum service levels.
4. Review and update the plan on a defined schedule.
5. Assess the organization's ability to sustain operations in emergency mode and identify gaps that would require external support.
6. Where gaps exist, establish mutual aid agreements with peer organizations covering temporary use of systems, emergency access to records, or use of physical facilities.

Where else this maps

The questions behind 45 CFR 164.308(a)(7)(ii)(C) also map to NIST SP 800-66 Rev. 2 5.1.7, which is voluntary guidance rather than law; following it does not by itself establish compliance with any law. That matters for scoping: the same evidence can be written once and referenced from each, rather than rewritten per framework.

Evidence an assessor asks for

For this requirement the evidence types that satisfy it are agreement, plan, policy, and 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. 45 CFR 164.316(b)(2)(i) requires the documentation 164.316(b)(1) calls for (the Security Rule policies and procedures, and the written record of any action, activity or assessment the Security Rule requires to be documented) to be retained for six years from the date of its creation or the date when it last was in effect, whichever is later, so a policy you replaced two years ago is still part of the record.

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 164.308(a)(7)(ii)(C) that means the executed agreement, with the signature date on it, a written plan naming who does what, and evidence it was tested, a signed, dated policy with a named owner and a review date, and 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 security official should be recorded as the owner. Where the work is done by someone else, say so in the document: the split between who owns it and who performs it is where the trail usually breaks. 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.
• There is no documented-alternative route for the requirement itself. It is required (45 CFR 164.306(d)(2) for a specification, 164.306(c) for a standard), so a risk-based decision not to meet it is not available. How you meet it is yours to choose under 45 CFR 164.306(b); the measures in this post are examples, not the rule's text.

Work backward from the evidence. Decide what evidence would prove emergency mode operation plan 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

• Disaster Recovery Plan: A disaster recovery plan sized to your practice
• Testing and Revision Procedures: Testing the contingency plan and recording the result
• Data Backup Plan: Backups you have actually restored from

References

• 45 CFR 164.308(a)(7)(ii)(C), in 45 CFR 164.308 on eCFR. Quoted text verified against the eCFR text current as of 2026-10-06.
• The Required and Addressable designations are defined at 45 CFR 164.306(d).
• Crosswalk references in this post are the mappings in our question bank, and are not verified against the published text of those standards.
• 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 additional obligations; HIPAA preempts a State law only where it is contrary to HIPAA (45 CFR 160.202, 160.203).