Section § 164.414Administrative requirements and burden of proof

(a) Administrative requirements. A covered entity is required to comply with the administrative requirements of § 164.530(b), (d), (e), (g), (h), (i), and (j) with respect to the requirements of this subpart.

(b) Burden of proof. In the event of a use or disclosure in violation of subpart E, the covered entity or business associate, as applicable, shall have the burden of demonstrating that all notifications were made as required by this subpart or that the use or disclosure did not constitute a breach, as defined at § 164.402.

HIPAA, the United States rules protecting health information, § 164.414

Text: 45 CFR Part 164, from the Electronic Code of Federal Regulations (eCFR) as it stood on 6 October 2026.