C.F.R. » Title 45 » SUBCHAPTER C—ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS › PART 160—GENERAL ADMINISTRATIVE REQUIREMENTS › Subpart C—Compliance and Investigations

45 C.F.R. § 160.306

Complaints to the Secretary

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Right to file a complaint. A person who believes a covered entity or business associate is not complying with the administrative simplification provisions may file a complaint with the Secretary.

(b) Requirements for filing complaints. Complaints under this section must meet the following requirements:

(1) A complaint must be filed in writing, either on paper or electronically.

(2) A complaint must name the person that is the subject of the complaint and describe the acts or omissions believed to be in violation of the applicable administrative simplification provision(s).

(3) A complaint must be filed within 180 days of when the complainant knew or should have known that the act or omission complained of occurred, unless this time limit is waived by the Secretary for good cause shown.

(4) The Secretary may prescribe additional procedures for the filing of complaints, as well as the place and manner of filing, by notice in the Federal Register.

(c) Investigation. (1) The Secretary will investigate any complaint filed under this section when a preliminary review of the facts indicates a possible violation due to willful neglect.

(2) The Secretary may investigate any other complaint filed under this section.

(3) An investigation under this section may include a review of the pertinent policies, procedures, or practices of the covered entity or business associate and of the circumstances regarding any alleged violation.

(4) At the time of the initial written communication with the covered entity or business associate about the complaint, the Secretary will describe the acts and/or omissions that are the basis of the complaint.

[71 FR 8424, Feb. 16, 2006, as amended at 78 FR 5690, Jan. 25, 2013]
Notes of Decisions
Cited in 29 cases (12 in the last 5 years), 2005–2025 · leading case: Billy Overstreet v. TRW Commercial Steering Division
Sort: Relevance Newest Treatment
Billy Overstreet v. TRW Commercial Steering Division (2008) tenn · cites it 2× “45 CFR §§ 160.306 , 160.312 (2008). A violation of HIPAA results in a civil fine.”
Rickman v. Premera Blue Cross (2015) wash · cites it 2× “45 C.F.R. § 160.306 (a); see also id. at (b)(2) (complaint must “describe the acts or omissions believed to be in violation”).”
Menorah Park Ctr. for Senior Living v. Rolston (Slip Opinion) (2020) ohio “45 C.F.R. 160.306(a). HHS can impose a civil money penalty—ranging from $100 to $50,000 per violation, with maximum penalties of $25,000 or $1,500,000 per calendar year, 42 U.”
Spencer v. Roche (2010) mad “45 C.F.R. §§ 160.306 , 160.308 (2010). Therefore, any claim for invasion of privacy under HIPAA fails as a matter of law.”
Brown v. Hill (2016) dcd “26, 2012) (citing 45 C.F.R. § 160.306 ); see Royce v. Veterans Affairs Regional Office, No.”
State v. Eichhorst (2008) indctapp “See 45 C.F.R. § 160.306 . Eichhorst cites no authority for the proposition that evidence given in violation of HIPAA should be suppressed or excluded in a criminal setting.”
State v. Downs (2005) lactapp “See also 45 C.F.R. § 160.306 . This Court must now determine whether the State complied with La.”
Hector L. Rodriguez v. State (2015) texapp “45 C.F.R. § 160.306 ; see 42 U.S.C. §§ 1320d-5, 1320d-6 (providing for imposition of monetary fines on a covered entity in the event of a violation).”
Hopkins v. Balachandran (2013) connappct “8 45 C.F.R. § 160.306 ; see also Acara v. Banks, 470 F.”
Hill v. Wilson Smoot (2018) dcd “26, 2012) (citing 45 C.F.R. § 160.306 ) (other citations omitted)).”
Freier v. State of Colorado (2020) ca10 “45 C.F.R. § 160.306 . If HHS finds the complaint meritorious after an investigation, it may refer the case to the Department of Justice for prosecution under HIPAA’s criminal provisions; obtain voluntary compliance, corrective action, or a resolution agreement; or issue a formal…”
Jane Doe v. Ashland Hospital Corporation (2022) kyctapp “45 C.F.R. § 160.306 . Thus, once again, the HIPAA standards are the more “stringent” and state law claims such as those presented herein are preempted.”
Show all 29 citing cases →
— 45 C.F.R. § 160.306(a) — 1 case
Menorah Park Ctr. for Senior Living v. Rolston (Slip Opinion) (2020) ohio “45 C.F.R. 160.306(a). HHS can impose a civil money penalty—ranging from $100 to $50,000 per violation, with maximum penalties of $25,000 or $1,500,000 per calendar year, 42 U.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.