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HIPAA requires specific
authorization for well-defined information (usually not entire medical
record). Prior consent giving access
to entire record is still valid
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Allows access to information
in hand and information that will be obtained in course of study – even after
effective date.
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CE may use or disclose PHI
that was created or received for research, either before or after the
compliance date, if the CE obtained any one of the following prior to the
compliance date
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- Authorization or other legal permission to use or disclose PHI
information for research
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- Informed consent of the individual to participate in the
research
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- A waiver of informed consent by an IRB in accordance with the
Common Rule
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Must obtain authorization at
any point that individual is “re-consented”
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