Facility Access Controls: Facility access controls in a leased clinical suite

If you have been asked for evidence of facility access controls, the requirement behind the question is 45 CFR 164.310(a)(1). What follows is what it says, what satisfies it, and where organizations usually come up short.

What the rule says

Standard: Facility access controls. Implement policies and procedures to limit physical access to its electronic information systems and the facility or facilities in which they are housed, while ensuring that properly authorized access is allowed.

That is the text of 45 CFR 164.310(a)(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(a)(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 document its facility access controls policies and procedures (§ 164.310(a)(1)) for the facilities that house systems holding ePHI and review them periodically and update them as needed in response to environmental or operational changes affecting the security of ePHI?
• Does the organization restrict physical access to facilities and areas housing servers, network equipment, and systems that store or process sensitive data to authorized personnel only?
• Does the organization design and apply physical security for offices, rooms, and facilities that house sensitive information or systems?

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. Document facility access controls policies and procedures for the facilities that house systems holding ePHI, covering access, visitors and equipment.
2. Document the supporting procedures that put them into practice.
3. Assign an owner, review the documents periodically, and update them as needed in response to environmental or operational changes affecting the security of ePHI.
4. Communicate the documents to the workforce members they apply to, for example with management's approval recorded.
5. Define which facilities, rooms, and zones house systems that store or process sensitive data.
6. Establish a policy granting physical access only to authorized personnel based on documented need.

Where else this maps

The questions behind 45 CFR 164.310(a)(1) also map to NIST SP 800-66 Rev. 2 5.2.1, 5.5.1, 5.5.2, 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 plan and policy. 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(a)(1) that means a written plan naming who does what, and evidence it was tested and a signed, dated policy with a named owner and a review date. 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.
• Re-read it when something changes. A new system, a new vendor or a departure is what makes a correct control stale. Tie the review to those events as well as to the calendar, and date the result.
• 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)).

None of this makes facility access controls 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

• Business Associate Contracts and Other Arrangements: What the contract must require of a vendor
• Contingency Operations: Contingency operations for physical access
• Evaluation: The periodic evaluation most practices skip

References

• 45 CFR 164.310(a)(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).