What this control covers
Definitions: Breach - Risk Assessment. Breach means the acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E of this part which compromises the security or privacy of the PHI. (2) Except as provided in paragraph (1) of this definition, an acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment of at least the following factors: (i) The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification; (ii) The unauthorized person who used the PHI or to whom the disclosure was made; (iii) Whether the PHI was actually acquired or viewed; and (iv) The extent to which the risk to the PHI has been mitigated.
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: Definitions: Breach - Risk Assessment.
Quick checklist
- Security — Security / Management
- Business — Security / Management
- Person — Security / Management
- Policy — Security / Management
- Definitions: — Security / Management
- Notification — Security / Management