§ 3.20 Definitions.

As used in this part, the terms listed alphabetically below have the meanings set forth as follows:

Affiliated provider means, with respect to a provider, a legally separate provider that is the parent organization of the provider, is under common ownership, management, or control with the provider, or is owned, managed, or controlled by the provider.

AHRQ stands for the Agency for Healthcare Research and Quality in HHS.

ALJ stands for an Administrative Law Judge of HHS.

Board means the members of the HHS Departmental Appeals Board, in the Office of the Secretary, which issues decisions in panels of three.

Bona fide contract means:

(1) A written contract between a provider and a PSO that is executed in good faith by officials authorized to execute such contract; or

(2) A written agreement (such as a memorandum of understanding or equivalent recording of mutual commitments) between a Federal, State, local, or Tribal provider and a Federal, State, local, or Tribal PSO that is executed in good faith by officials authorized to execute such agreement.

Complainant means a person who files a complaint with the Secretary pursuant to § 3.306.

Component organization means an entity that:

(1) Is a unit or division of a legal entity (including a corporation, partnership, or a Federal, State, local or Tribal agency or organization); or

(2) Is owned, managed, or controlled by one or more legally separate parent organizations.

Component PSO means a PSO listed by the Secretary that is a component organization.

Confidentiality provisions means for purposes of subparts C and D, any requirement or prohibition concerning confidentiality established by sections 921 and 922(b)-(d), (g) and (i) of the Public Health Service Act, 42 U.S.C. 299b-21, 299b-22(b)-(d), (g) and (i) and the provisions, at §§ 3.206 and 3.208, that implement the statutory prohibition on disclosure of identifiable patient safety work product.

Disclosure means the release, transfer, provision of access to, or divulging in any other manner of patient safety work product by:

(1) An entity or natural person holding the patient safety work product to another legally separate entity or natural person, other than a workforce member of, or a health care provider holding privileges with, the entity holding the patient safety work product; or

(2) A component PSO to another entity or natural person outside the component PSO and within the legal entity of which the component PSO is a part.