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Policies and Procedures: Policies and procedures that reflect what you do

April 6, 2026 · Ken Armstrong

Auditors ask about policies and procedures early, because the answer tells them how the rest of the program is likely to look. The requirement is 45 CFR 164.316(a).

What the rule says

Standard: Policies and procedures. Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in § 164.306(b)(2)(i), (ii), (iii), and (iv). This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart. A covered entity or business associate may change its policies and procedures at any time, provided that the changes are documented and are implemented in accordance with this subpart.

That is the text of 45 CFR 164.316(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 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 164.316(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 document its policies and procedures for audit controls (§ 164.312(b)) and review them periodically and update them as needed in response to environmental or operational changes affecting the security of ePHI?
  • Does the organization document its security awareness and training policies and procedures (§ 164.308(a)(5)) and review them periodically and update them as needed in response to environmental or operational changes affecting the security of ePHI?
  • 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?

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 audit controls: what activity in systems holding ePHI is recorded and examined, who is responsible, and how the records are protected and retained.
  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. Document security awareness and training policies and procedures: who must be trained, on what, and how often.
  6. Document policies and procedures for how each user is uniquely identified and how a person or entity seeking access to ePHI is authenticated.

Where else this maps

The questions behind 45 CFR 164.316(a) also map to HHS 405(d) HICP (2023 Edition) CSP 10 and NIST SP 800-66 Rev. 2 5.1.1, 5.1.3, 5.1.4, 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 type that satisfies it is a 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 164.316(a) that means 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. 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.

The practical test for 45 CFR 164.316(a) is whether someone unfamiliar with your organization could read your documentation and tell what you do, who does it, and when it last happened. If they can, the documentation will hold up; whether the requirement is met is a judgment about what it shows, and your counsel owns that conclusion. If they need you in the room to explain it, it will not.

Related requirements

References

  • 45 CFR 164.316(a), in 45 CFR 164.316 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).