Respond to Unauthorized Changes
High Risk
Complex
High Cost
CM-6(2) (Respond to Unauthorized Changes) enhances base CM-6 within the NIST Configuration Management family. Base CM-6 sets the foundational expectation; this enhancement adds specificity: Take the following actions in response to unauthorized changes to [organization-defined]: [organization-defined]. Responses to unauthorized changes to configuration settings include alerting designated organizational personnel, restoring established configuration settings, or—in . Covered entities and business associates apply it to configuration baselines, change control, and inventory for EHR, PACS, interfaces, and clinical devices.
Control Objective
Implement Respond to Unauthorized Changes so organization-defined configuration management safeguards operate consistently on systems and networks that handle ePHI, with measurable evidence for HIPAA and NIST assessments.
Implementation Guidance
- Map CM-6(2) to systems in scope (EHR, imaging, lab, pharmacy, billing, identity, backups, and BA connections).\n2. Translate “Respond to Unauthorized Changes” into technical settings, procedures, or architecture patterns owned by named roles.\n3. Prefer enforceable controls (config, automation, mediation) over awareness-only measures where feasible.\n4. Integrate with change, incident, and downtime processes so clinical operations are not surprised.\n5. Log and retain evidence of operation (tickets, configs, test results) aligned to audit needs.\n6. Include vendors/BAs in contracts and connection standards when they touch the control surface.\n7. Test after major EHR, network, or cloud changes — upgrades often reset protections.\n8. Review exceptions at least quarterly; expire “temporary” holes that expose ePHI paths.
Real-World Use Cases
How this control shows up in healthcare and HIPAA-covered environments.
Best Practices
- Name an owner for CM-6(2) in the SSP control matrix.\n- Favor system enforcement on ePHI paths over informal email approval.\n- Measure coverage: percent of in-scope clinical systems where the enhancement operates.\n- Review exceptions quarterly with security and clinical informatics.\n- Feed relevant events to SIEM with a named use case.\n- Keep a one-page evidence pack (config + sample log + last test) ready for assessors.
Common Gaps & Violations
- Policy cites CM-6(2) but production EHR/network paths show no enforcement of respond to unauthorized changes.\n- Permanent exceptions with no expiry for vendors or “special” clinics.\n- Control implemented only on corporate IT — clinical devices and interfaces omitted.\n- No logs or test records; reliance on tribal knowledge.\n- Major upgrade silently disabled the enhancement.
Required Documentation
- Procedure/standard for Respond to Unauthorized Changes (CM-6(2))\n- Architecture or configuration baselines showing enforcement points\n- Exception register with owners and expiry\n- Sample logs, alerts, or test results\n- Training or runbook references for clinical/IT operators
How to Test & Validate
- Attempt a prohibited or out-of-policy action related to respond to unauthorized changes; confirm block, alert, or required workflow.\n2. Complete an authorized clinical/IT path; confirm success and logging.\n3. Sample open exceptions for approval and expiry.\n4. Verify at least one EHR-adjacent and one BA/vendor path are in scope.\n5. Confirm evidence retained for the last 90 days (or per policy).
Audit Considerations
Assessors look for operating evidence of Respond to Unauthorized Changes on systems touching ePHI — configs, logs, restore/DR artifacts, or failed-test results — not only a policy paragraph referencing CM-6(2).
HIPAA Mapping
How this NIST control supports HIPAA Security Rule expectations.
- 164.308(a)(1)(ii)(B) Risk Management — configuration drift creates residual ePHI risk.\n- 164.312(a)(1) Access Control — hardened baselines limit who can alter systems holding ePHI.\n- 164.308(a)(5)(ii)(B) Protection from Malicious Software — least-function configs reduce malware footholds.\n- 164.316(b)(1) Documentation — retain configuration and change evidence for six years where required.
Compliance Tips
- List CM-6(2) explicitly in the system security plan with system inventory references.\n- Prioritize emergency department, inpatient EHR, and remote access paths first.\n- Bundle evidence with related HIPAA contingency or transmission-security narratives where they overlap.
References & Resources
- NIST SP 800-53 Rev. 5 — CM-6(2)\n- Related controls: CM-6, IR-4, IR-6, SI-7
Related Guidelines
Related controls that commonly accompany CM-6(2).
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