Only $35.99/year

Terms in this set (35)

• If the subject of the PHI has granted specific written
permission through an Authorization (that satisfies
section 164.508)
• For reviews preparatory to research with
representations obtained from the researcher that
satisfy section 164.512(i)(1)(ii) of the Privacy Rule
• For research solely on decedents' information with
certain representations and, if requested,
documentation obtained from the researcher that
satisfies sctn164.512(i)(1)(iii) of the Privacy Rule\• If the covered entity receives appropriate
docum entation that an IRB or a Privacy Board has
granted a waiver of the Authorization requirement that
satisfies section 164.512(i)
• If the covered entity obtains documentation of an IRB
or Privacy Board's alteration of the Authorization
requirement as well as the altered Authorization from
the individual
• If the PHI has been de-identified in accordance with
the standards set by the Privacy Rule at section
164.514(a)-(c) (in which case, the health information is
no longer PHI)
• If the information is released in the form of a limited
data set, with certain identifiers removed and with a
data use agreement between the researcher and the
covered entity, as specified under section 164.514(e)
• Under a "grandfathered" informed consent of the
individual to participate in the research, an IRB waiver
of such informed consent, or Authorization or other
express legal permission to use or disclose the
information for research as specified under the
transition provisions of the Privacy Rule at section
164.532(c)