What this control covers

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.

Why it matters

Risk is the language an executive team understands; this control connects technical reality to board-level decisions and budget allocation.

How to implement

AWS

Codify the policy intent as SCPs, AWS Config conformance packs, and Security Hub standards so the cloud enforces what the document says.

Azure

Codify in Azure Policy initiatives (built-in regulatory compliance for CIS, ISO 27001, SOC 2, HIPAA) and assign at management-group level.

On-premises

Maintain a policy library with a documented review cadence (annual minimum); store in your GRC tool with attestation tracking. Map each policy to controls so an audit pull cites the exact policy clause.

Evidence to collect

  • policy_document — A signed, version-controlled policy stating leadership intent and the named owner.

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

Quick checklist

  • Flexibility — Approach / Security
  • Security — Approach / Security
  • Information — Approach / Security
  • Business — Approach / Security
  • Policy — Approach / Security

Related articles on this site