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Covered Entity: A health plan, a health care clearinghouse, or a health care provider who transmits health information in electronic form in connection with a transaction for which HHS has adopted a standard.

Covered Functions: Those functions of a covered entity the performance of which makes the entity a health care provider, health plan, or health care clearinghouse under the HIPAA Administrative Simplification Rules.

Data Use Agreement: An agreement into which the covered entity enters with the intended recipient of a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected.

Designated Record Set: A group of records maintained by or for a covered entity that is (1) the medical and billing records about individuals maintained by or for a covered health care provider; (2) the enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or (3) used, in whole or in part, by or for the covered entity to make decisions about individuals. A record is any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.

Disclosure: The release, transfer, access to, or divulging of information in any other manner outside the entity holding the information.

Food and Drug Administration (FDA) Protection of Human SubjectsRegulations: Regulations intended to protect the rights, safety, and welfare of participants involved in studies subject to FDA jurisdiction (Title 21 CFR, Parts 50 and 56).

Health Care Clearinghouse: A public or private entity, including a billing service, repricing company, community health management information system or community health information system, and “value-added” networks and switches that either process or facilitate the processing of health information received from another entity in a nonstandard format or containing nonstandard data content into standard data elements or a standard transaction, or receive a standard transaction from another entity and



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