HIPAA (45 CFR Part 164) 164.314(a)(2)(ii) — Other Arrangements

What this control requires

The covered entity is in compliance with paragraph (a)(1) of this section if it has another arrangement in place that meets the requirements of 164.504(e)(3).

In plain English

The covered entity is in compliance with paragraph (a)(1) of this section if it has another arrangement in place that meets the requirements of 164.504(e)(3). In practice, this means you can prove you security requirements-level controls on a defined cadence.

Why it matters

HIPAA non-compliance is a strict-liability matter: OCR civil monetary penalties are assessed per-record per-violation (up to USD 1.9 million per identical-violation calendar year as of 2024), and willful neglect can trigger criminal referral.

What an auditor looks for

HHS OCR investigators and SOC-2+HIPAA auditors look for the specific 45 CFR § citation, whether the safeguard is required vs addressable (and if addressable, the documented decision), the implementation specification, the workforce member responsible, and the records that show it runs.

Within Security Rule, the assessor will trace your implementation back to the catalogue reference (§ 164.314(a)(2)(ii)) and look for objective evidence on the latest two assessment cycles.

How to implement

Policy Management

Docs. Keep each policy in version-controlled Markdown alongside the code that implements it; ship a signed PDF snapshot at each annual review and link the SHA into the SoA.

Operational checklist

• Security. Document the trigger, the owner and the cadence.
• Other. Document the trigger, the owner and the cadence.
• Requirements. Document the trigger, the owner and the cadence.
• Policy. Document the trigger, the owner and the cadence.
• Scope: requirements, security, management, arrangements, policy, e, section.

Evidence to collect

• Policy Document. A signed and version-controlled policy / standard / procedure document.

Signed policy or standard documents the safeguard. Focus: Other Arrangements.

Common pitfalls

• Policies that no engineer has read; the version in Confluence drifts from the version that's actually being enforced.

How it maps to other frameworks

Computed from shared tags, control component and key-operation subjects — handy when you are reconciling controls across an audit.

• ISO/IEC 27001:2022 A.8.26 — Application security requirements
• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
• NIST SP 800-53 Rev. 5 PL-2(1) — Concept Of Operations
• NIST SP 800-171 Rev. 3 3.12.1 — Security Assessment
• SOC 2 (2017 TSC) CC2.3 — External Communication on Internal Control Matters

Related controls in HIPAA (45 CFR Part 164)

• § 164.314(a)(2)(iii) — Business associate contracts with subcontractors
• § 164.308(a)(3)(i) — Workforce Security
• § 164.308(b)(3) — Business Associate Contracts and Other Arrangements - Written Contract or Other Arrangement
• § 164.314(a)(1) — Business Associate Contracts or Other Arrangements
• § 164.308(a)(5)(i) — Security Awareness and Training
• § 164.308(a)(7)(ii)(E) — Contingency Plan -Application and Data Criticality Analysis

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.314(a)(2)(ii)

Topics: governance riskpolicy management