How will these new privacy regulations impact existing research projects?
The HIPAA privacy regulations contain explicit provisions that address how the new regulations will be phased into effect. The regulations provide that, notwithstanding the new authorization requirements and the new HIPAA research provisions, a covered entity may to the extent allowed by one of the following permissions continue to use or disclose for research PHI that it created or received either before or after the applicable compliance date subject to the following conditions: • That there is no agreed-to restriction between the covered entity and the subject; • The covered entity has obtained, prior to April 14, 2003, either: • An authorization or other express legal permission from an individual to use or disclose protected health information for the research; • The informed consent of the individual to participate in the research; or • waiver, by an IRB, of informed consent for the research; and, • Provided, that a covered entity must obtain authorization in accordance with § 16
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