Risk Management: Turning risk findings into tracked remediation

If you have been asked for evidence of risk management, the requirement behind the question is 45 CFR 164.308(a)(1)(ii)(B). What follows is what it says, what satisfies it, and where organizations usually come up short.

What the rule says

Risk management (Required). Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with § 164.306(a).

That is the text of 45 CFR 164.308(a)(1)(ii)(B). 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)(1)(ii)(B) 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 apply security patches and updates to the operating systems and applications of systems that create, receive, maintain or transmit ePHI, tracking each to installation or a documented exception, as part of its risk management?
• For cloud environments that store or process ePHI, does the organization define infrastructure as code with peer-reviewed changes and run cloud security posture monitoring that detects misconfigurations, such as public storage, open security groups, and disabled logging, and remediates them?
• Does the organization assess and manage risks from legacy and end-of-life systems running unsupported software, implementing and documenting compensating controls where they cannot be upgraded or replaced?

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. Inventory the operating systems and applications on systems that create, receive, maintain or transmit ePHI, and the source of patches and updates for each.
2. Apply security patches and updates on a schedule the risk analysis sets, sooner for vulnerabilities known to be exploited, with automated tooling where it fits.
3. Track each patch to installation, or record a documented exception with its compensating measure and review date.
4. Record how the measure chosen meets the cited provision. 45 CFR 164.306(b)(1) lets the organization use any security measures that allow it to reasonably and appropriately implement the standards and implementation specifications, and the Security Rule does not name this practice. The cited standard and any Required implementation specification must be met. An Addressable one must be implemented, or the organization documents why it is not reasonable and appropriate and implements an equivalent alternative measure if that is reasonable and appropriate (45 CFR 164.306(d)(3)). Choose the measure with the factors in 45 CFR 164.306(b)(2) and document it with the risk analysis.
5. Define the cloud accounts and services in the ePHI environment and the secure configuration baseline each must meet.
6. Manage that infrastructure as code in version control, with peer review and automated policy checks before changes are applied.

Where else this maps

The questions behind 45 CFR 164.308(a)(1)(ii)(B) also map to HHS 405(d) HICP (2023 Edition) CSP 10, CSP 2, CSP 5 and NIST SP 800-66 Rev. 2 5.1.1, 5.1.8, 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, procedure, record, report, and risk assessment. 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 164.308(a)(1)(ii)(B) 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, a step-by-step procedure someone unfamiliar with the task could follow, dated records of each occurrence, not a description of the process, a dated report with the period it covers and who reviewed it, and a completed assessment showing the method, the findings and the 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. Whoever administers the systems 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.
• 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 risk management 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

• Risk Analysis: What a defensible analysis has to contain
• Sanction Policy: Writing a sanction policy you will actually apply
• Information System Activity Review: Reviewing system activity without drowning in logs

References

• 45 CFR 164.308(a)(1)(ii)(B), 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).