C.F.R. » Title 45 » SUBCHAPTER C—ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS › PART 164—SECURITY AND PRIVACY › Subpart A—General Provisions

45 C.F.R. § 164.103

Definitions

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As used in this part, the following terms have the following meanings:

Common control exists if an entity has the power, directly or indirectly, significantly to influence or direct the actions or policies of another entity.

Common ownership exists if an entity or entities possess an ownership or equity interest of 5 percent or more in another entity.

Covered functions means those functions of a covered entity the performance of which makes the entity a health plan, health care provider, or health care clearinghouse.

Health care component means a component or combination of components of a hybrid entity designated by the hybrid entity in accordance with § 164.105(a)(2)(iii)(D).

Hybrid entity means a single legal entity:

(1) That is a covered entity;

(2) Whose business activities include both covered and non-covered functions; and

(3) That designates health care components in accordance with paragraph § 164.105(a)(2)(iii)(D).

Law enforcement official means an officer or employee of any agency or authority of the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, who is empowered by law to:

(1) Investigate or conduct an official inquiry into a potential violation of law; or

(2) Prosecute or otherwise conduct a criminal, civil, or administrative proceeding arising from an alleged violation of law.

Plan sponsor is defined as defined at section 3(16)(B) of ERISA, 29 U.S.C. 1002(16)(B).

Required by law means a mandate contained in law that compels an entity to make a use or disclosure of protected health information and that is enforceable in a court of law. Required by law includes, but is not limited to, court orders and court-ordered warrants; subpoenas or summons issued by a court, grand jury, a governmental or tribal inspector general, or an administrative body authorized to require the production of information; a civil or an authorized investigative demand; Medicare conditions of participation with respect to health care providers participating in the program; and statutes or regulations that require the production of information, including statutes or regulations that require such information if payment is sought under a government program providing public benefits.

[68 FR 8374, Feb. 20, 2003, as amended at 74 FR 42767, Aug. 24, 2009; 78 FR 34266, June 7, 2013]
Notes of Decisions
Cited in 20 cases (6 in the last 5 years), 2004–2026 · leading case: Commonwealth v. Williams
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Commonwealth v. Williams (2017) pasuperct “45 C.F.R. § 164.103 (“Law enforcement official means an officer or employee of any agency or authority of .”
Law v. Zuckerman (2004) mdd “statutes or regulations that require such information^]” 45 C.F.R. § 164.103 .”
Montgomery v. Cuomo (2018) nywd “28, 2000) ; see also , 45 C.F.R. § 164.103 ("Required by law means a mandate contained in law that compels and entity to make a use or disclosure of protected health information that is enforceable in a court of law.”
Harrold-Jones v. Drury (2018) alaska “35 See 45 C.F.R. § 164.103 . For instance, it would violate HIPAA if, under Alaska law, a trial court's order constituted an abuse of discretion by being overly broad.”
State v. Carter (2009) fladistctapp “” 45 C.F.R. § 164.103 . Statutes requiring the production of information are included in the definition of “required by law.”
United States v. Zamora (2006) txsd “” 45 C.F.R. § 164.103 . “Required by law includes, but is not limited to, court orders and court-ordered warrants; subpoenas or summons issued by a court, grand jury, a governmental or tribal inspector general, or an administrative body authorized to require the production of…”
Loparo v. Univ. Hosps. Health Sys., Inc. (2024) ohioctapp “Planned Parenthood, 122 Ohio St. 399 , to support their claim that the requested records are privileged.”
New York City Health & Hospitals Corp. v. New York State Commission of Correction (2012) ny “an administrative body authorized to require the production of information” (45 CFR 164.103). The subpoena at bar, the validity of which we now uphold as against petitioner’s claim of privilege, falls comfortably within this description.”
State Ex Rel. Adams County Historical Society v. Kinyoun (2009) neb “"Required by law" is defined under 45 C.F.R. § 164.103 (2008) as "a mandate contained in law that compels an entity to make a use or disclosure of protected health information and that is enforceable in a court of law.”
Oregon Health & Science University v. Oregonian Publishing Co. (2016) orccmultnomah · cites it 3× “OHSU also contends that the definition of “required by law” at 45 CFR section 164.103 does not contemplate the disclosure of protected health information under a public records law.”
Disability Rights Texas v. Hollis (2024) ca5 “” See 45 C.F.R. § 164.103 . The United States further argues that DRTx is required by law to keep the video footage confidential to the same extent that Houston Behavioral itself is required to do.”
Leslie, A. v. Public Health Mngmt. Corp. (2023) pasuperct · cites it 2× “45 C.F.R. § 164.103 , 164.500(a). In addition, HIPAA permits disclosure of medical information in litigation in response to a subpoena or discovery request where notice has been given to the patient, as long as a protective order is in place that prohibits the parties from using…”
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