HIPAA (45 CFR Part 164)·§ 164.308(b)(1)·medium·Component: Security Rule

What this control requires

A covered entity may permit a business associate to create, receive, maintain, or transmit electronic protected health information on the covered entity's behalf only if the covered entity obtains satisfactory assurances, in accordance with 164.314(a) that the business associate will appropriately safeguard the information. A covered entity is not required to obtain such satisfactory assurances from a business associate that is a subcontractor. 164.308(b)(2): A business associate may permit a business associate that is a subcontractor to create, receive, maintain, or transmit electronic protected health information on its behalf only if the business associate obtains satisfactory assurances, in accordance with 164.314(a), that the subcontractor will appropriately safeguard the information.
— HIPAA (45 CFR Part 164), § 164.308(b)(1)

In plain English

A covered entity may permit a business associate to create, receive, maintain, or transmit electronic protected health information on the covered entity's behalf only if the covered entity obtains satisfactory assurances, in accordance with 164.314(a) that the business associate will appropriately safeguard the information. In practice, this means you can prove you security security-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 (§ 164.308(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.
  • Business. Document the trigger, the owner and the cadence.
  • Other. Document the trigger, the owner and the cadence.
  • Policy. Document the trigger, the owner and the cadence.
  • Scope: security, management, associate contracts, arrangements, business associate, policy, obtain, accordance.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Business Associate Contracts and 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.

Related controls in HIPAA (45 CFR Part 164)

References

Topics: governance riskpolicy management