A situation in which the data protection rule allows a covered company to use and disclose POs for research purposes, without obtaining the permission of each patient, is when an IRB or data protection committee (Box 4-3) reviews a research proposal relating to the use of the PHI and decides whether the researcher should be granted a “waiver” of the authorization of this specific research protocol.38 , functions that have nothing to do with health care. it can become a hybrid unit by referring to its “health components” in writing. 10 Only these health components are then bound by the data protection rule. For example, when a university includes a university medical center with a hospital, the entire university is classified as a covered entity, unless the university opts for a hybrid unit by designating only the hospital as a component of health. Only the hospital must comply with the data protection rule. The classification of researchers within a hybrid unit depends on the nature of the work done (for example. B whether researchers are in the health component, providing health care or conducting electronic transactions) (HHS, 2004c). A counterparty subcontractor is a person or entity to which a business partner delegates a function, activity or service.3 While a covered entity receives assistance from a trading partner, AAS terminate their own assistance. HIPAA designates these individuals and companies as business partners. Individuals may voluntarily authorize the use and disclosure of their POs for essential reasons, including for research purposes. To be valid under the data protection rule, an authorization must be “specific and meaningful”30, i.e.
it must contain a clear description of the information to be used or disclosed. The authorization must also be written in a simple language and contain essential elements (for example. B the person`s signature, description of the purpose of the use or disclosure requested) and statements that take into account the individual`s right to withdraw the authorization and the circumstances in which services or payments may be subject to the signing of the authorization.31 Response: no.
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