45 CFR 160.401 HIPAA · Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS · Subpart D: Imposition of Civil Money Penalties
45 CFR 160.401 HIPAA: Definitions
eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026.
Official text
As used in this subpart, the following terms have the following meanings:
Reasonable cause means an act or omission in which a covered entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.
Reasonable diligence means the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances.
Willful neglect means conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated.
Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR.
Source credit: [74 FR 56130, Oct. 30, 2009, as amended at 78 FR 5691, Jan. 25, 2013]
eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026.
This is reference material, not legal advice.