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Device and Media Controls: Tracking devices and media that hold ePHI

March 9, 2026 · Ken Armstrong

45 CFR 164.310(d)(1) covers device and media controls. In most assessments the control itself is present and the record proving it is not, which is why this requirement produces findings at organizations that are, in practice, doing the work.

What the rule says

Standard: Device and media controls. Implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain electronic protected health information into and out of a facility, and the movement of these items within the facility.

That is the text of 45 CFR 164.310(d)(1). 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 standard, and a standard is met in full: 45 CFR 164.306(c) requires a covered entity or business associate to comply with the applicable standards.

Some of the implementation specifications beneath it are addressable, and each of those carries its own decision under 45 CFR 164.306(d)(3): implement it or, if implementing it is not reasonable and appropriate, document why and implement an equivalent alternative measure if that is reasonable and appropriate. The standard itself is not optional either way.

What this looks like in practice

In an assessment, 45 CFR 164.310(d)(1) 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 provide rules to workforce members governing the removal, download, or storage of sensitive data on hard drives or removable media such as USB drives, optical discs, and smartphones?
Does the organization protect physical media containing sensitive data while it is transported outside controlled facilities?
Does the organization protect assets that are used or stored off-premises against the risks of operating outside its facilities?

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:

Establish a written policy governing when and how sensitive data may be removed, downloaded, or stored on portable and removable media.
Require encryption of sensitive data placed on portable or removable media or, where the organization determines encryption is not reasonable and appropriate, record that determination and the equivalent alternative measure implemented instead (45 CFR 164.312(a)(2)(iv) is Addressable, 45 CFR 164.306(d)(3)).
Define approval and tracking requirements for media that leaves controlled facilities.
Communicate the rules to the workforce and obtain acknowledgment.
Establish a procedure governing the transport of physical media containing sensitive data outside controlled facilities.
Require authorization and a record (chain of custody) for each transport, capturing sender, recipient, and contents.

Where else this maps

The questions behind 45 CFR 164.310(d)(1) also map to HHS 405(d) HICP (2023 Edition) CSP 4 and NIST SP 800-66 Rev. 2 5.2.4, 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 policy, procedure, and record. 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

The usual gap is a control that exists in practice and nowhere in writing. Someone does the work, reliably, and it has never been written down, so the organization cannot demonstrate it and cannot notice when it stops. The fix is not more control, it is a dated record and a named owner.

What to do about it

Produce the evidence, not the intention. For 45 CFR 164.310(d)(1) that means a signed, dated policy with a named owner and a review date, a step-by-step procedure someone unfamiliar with the task could follow, and dated records of each occurrence, not a description of the process. 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.
Set a review cadence and keep the evidence of each review. An annual date with a dated output is a common floor; what fails an assessment is a control implemented once and never re-checked against a changed environment.
Meet the standard, and decide each addressable specification on paper. The standard is required. The documented-alternative route belongs to the addressable specifications beneath it, one at a time, and only with the reasoning written down (45 CFR 164.306(d)(3)).

If 45 CFR 164.310(d)(1) 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 164.310(d)(1), in 45 CFR 164.310 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).