Person or Entity Authentication: Person or entity authentication beyond a password

If you have been asked for evidence of person or entity authentication, the requirement behind the question is 45 CFR 164.312(d). What follows is what it says, what satisfies it, and where organizations usually come up short.

What the rule says

Standard: Person or entity authentication. Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed.

That is the text of 45 CFR 164.312(d). 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.

What this looks like in practice

In an assessment, 45 CFR 164.312(d) 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 policies and procedures for unique user identification (§ 164.312(a)(2)(i)) and person or entity authentication (§ 164.312(d)) and review them periodically and update them as needed in response to environmental or operational changes affecting the security of ePHI?
• Does the organization require multi-factor authentication for remote access, external-facing systems, and all administrative and privileged accounts, extending it to additional users based on risk?
• Does the organization proof the identity of users and bind them to credentials appropriately when accounts are established?

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 policies and procedures for how each user is uniquely identified and how a person or entity seeking access to ePHI is authenticated.
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. 45 CFR 164.312(d) requires procedures to verify that a person or entity seeking access to ePHI is the one claimed, and does not name MFA. Requiring it for remote access, external-facing systems and privileged accounts is common security practice beyond the rule's text, so record the risk-based reasoning where you scope it differently.
6. Enable multi-factor authentication for each of these accounts.

Where else this maps

The questions behind 45 CFR 164.312(d) also map to HHS 405(d) HICP (2023 Edition) CSP 3, CSP 6 and NIST SP 800-66 Rev. 2 5.1.4, 5.3.1, 5.3.2, 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, inventory, log, policy, procedure, 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

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 164.312(d) that means a configuration export or screenshot showing the setting live, dated, an inventory with an owner and a last-reviewed date on every row, retained logs plus evidence somebody actually reviewed them, 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 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. 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.
• 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 person or entity authentication 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

• Mechanism to Authenticate Electronic Protected Health Information: Authenticating that ePHI was not altered
• Transmission Security: Transmission security for email, fax and portals
• Integrity: Integrity controls for the record itself

References

• 45 CFR 164.312(d), in 45 CFR 164.312 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).