164.314(b)(1)·medium·Component: Security RuleWhat this control requires
Except when the only electronic protected health information disclosed to a plan sponsor is disclosed pursuant to 164.504(f)(1)(ii) or (iii), or as authorized under 164.508, a group health plan must ensure that its plan documents provide that the plan sponsor will reasonably and appropriately safeguard electronic protected health information created, received, maintained, or transmitted to or by the plan sponsor on behalf of the group health plan.
In plain English
Except when the only electronic protected health information disclosed to a plan sponsor is disclosed pursuant to 164.504(f)(1)(ii) or (iii), or as authorized under 164.508, a group health plan must ensure that its plan documents provide that the plan sponsor will reasonably and appropriately safeguard electronic protected health information created, received, maintained, or transmitted to or by the plan sponsor on behalf of the group health plan. 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(b)(1)) 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.
- Information. Document the trigger, the owner and the cadence.
- Requirements. Document the trigger, the owner and the cadence.
- Group. Document the trigger, the owner and the cadence.
- Policy. Document the trigger, the owner and the cadence.
- Scope: requirements, security, management, group health plans, policy, ii, iii.
Evidence to collect
- Policy Document. A signed and version-controlled policy / standard / procedure document.
Signed policy or standard documents the safeguard. Focus: Requirements for Group Health Plans.
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)
- § 164.308(a)(5)(i) — Security Awareness and Training
- § 164.308(a)(7)(ii)(E) — Contingency Plan -Application and Data Criticality Analysis
- § 164.310(c) — Workstation Security
- § 164.312(a)(2)(iv) — Access Control - Encryption and Decryption
- § 164.312(c)(2) — Integrity - Mechanism to Authenticate ePHI
- § 164.314(a)(2)(ii) — Other Arrangements
References
- U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
- Catalogue identifier:
§ 164.314(b)(1)
Topics: governance riskpolicy management