HIPAA (45 CFR Part 164) 164.306(b) — Flexibility of approach

What this control requires

Flexibility of approach. (1) Covered entities and business associates may use any security measures that allow the covered entity or business associate to reasonably and appropriately implement the standards and implementation specifications as specified in this subpart. (2) In deciding which security measures to use, a covered entity or business associate must take into account the following factors: (i) The size, complexity, and capabilities of the covered entity or business associate. (ii) The covered entity's or the business associate's technical infrastructure, hardware, and software security capabilities. (iii) The costs of security measures. (iv) The probability and criticality of potential risks to electronic protected health information.

In plain English

Flexibility of approach. In practice, this means you can prove you flexibility approach-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 (§ 164.306(b)) 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

• Flexibility. Document the trigger, the owner and the cadence.
• 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.
• Policy. Document the trigger, the owner and the cadence.
• Scope: approach, security, management, business associate, policy, i, ii, iv.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Flexibility of approach.

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.

• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
• NIST SP 800-53 Rev. 5 PL-2(3) — Plan And Coordinate With Other Organizational Entities
• ISO/IEC 27001:2022 A.5.1 — Policies for information security
• NIST SP 800-171 Rev. 3 3.12.1 — Security Assessment

Related controls in HIPAA (45 CFR Part 164)

• § 164.316(a) — Policies and Procedures
• § 164.308(a)(8) — Evaluation
• § 164.314(a)(2)(i)(C) — Business associate contracts.
• § 164.306(a) — General Requirements
• § 164.308(a)(4)(ii)(C) — Information Access Management - Access Establishment and Modification
• § 164.308(a) — Security Management Process

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.306(b)

Topics: governance riskpolicy management