Data Backup Plan: Backups you have actually restored from

If you have been asked for evidence of data backup plan, the requirement behind the question is 45 CFR 164.308(a)(7)(ii)(A). What follows is what it says, what satisfies it, and where organizations usually come up short.

What the rule says

Data backup plan (Required). Establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information.

That is the text of 45 CFR 164.308(a)(7)(ii)(A). 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)(A) 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 data backup plan that creates and retains retrievable copies of sensitive data?
• Does the organization keep its retrievable exact copies of ePHI (its data backups) where a single event at the primary site cannot destroy them as well, for example at an off-site facility or in a separate cloud region?
• Does the organization test a restore from backup on a defined schedule and confirm the recovered data is complete and usable?

Ownership usually sits with the IT or security team, 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. Define which systems and data sets must be backed up and how frequently.
2. Configure backups to run on a regular schedule with secure, retained copies.
3. Periodically restore from backups to confirm the data is recoverable.
4. Protect backup copies against unauthorized access and loss.
5. Identify the backups of ePHI that must survive loss of the primary site.
6. Store backup copies at an alternate location that is geographically separated so a single event cannot destroy both, for example a cloud backup region or an off-site facility.

Where else this maps

The questions behind 45 CFR 164.308(a)(7)(ii)(A) also map to HHS 405(d) HICP (2023 Edition) CSP 4 and NIST SP 800-66 Rev. 2 5.1.7, which are voluntary guidance rather than law; following them 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 configuration, plan, record, and report. 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)(A) that means a configuration export or screenshot showing the setting live, dated, a written plan naming who does what, and evidence it was tested, dated records of each occurrence, not a description of the process, and a dated report with the period it covers and who reviewed it. If the only evidence is that someone knows how this works, you have a practice and not a record.
• Put a name on it. Whoever administers the systems 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.
• 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.

None of this makes data backup plan 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

• Response and Reporting: Response and reporting, and where breach analysis begins
• Disaster Recovery Plan: A disaster recovery plan sized to your practice
• Security Incident Procedures: Incident procedures before you need them

References

• 45 CFR 164.308(a)(7)(ii)(A), 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).