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164.508(d) |
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Additional elements
required if CE seeks authorization for its own use or disclosure:
If the authorization is sought by CE for its own uses/disclosures
of PHI that it maintains, authorization must include following elements
in addition to those specified in ¶ 7.3:
7.4.1. |
For any authorization to
which the prohibition of ¶ 7.2.5. applies, a statement
that treatment, payment, enrollment in health plan, or eligibility
for benefits will not be conditioned by the CE on the individual's
grant of authorization; |
7.4.2. |
Description of each purpose
of the requested use or disclosure; |
7.4.3. |
State that the individual
may inspect or copy the PHI to be used or disclosed as provided
in 164.524 [see ¶ 8.1.]; |
7.4.4. |
State that the individual
may refuse to sign the authorization; |
7.4.5. |
State any remuneration to
CE resulting from use or disclosure, if applicable. |
7.4.6. |
CE must provide individual
with copy of the signed authorization. |
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164.508(e) |
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Additional
elements required if CE seeks authorization for disclosures to it
by another CE: If authorization is sought by CE for another CE
to disclose PHI for TPO, the CE requesting the authorization must
include the following elements in addition to those specified in ¶
7.3:
7.5.1. |
Description of each purpose
of the requested disclosure; |
7.5.2. |
For any authorization to
which the prohibition of ¶ 7.2.5. applies, a statement
that treatment, payment, enrollment in health plan, or eligibility
for benefits will not be conditioned on the individual's grant
of authorization; |
7.5.3. |
Statement that
individual may refuse to sign the authorization. |
7.5.4. |
CE must provide individual
with copy of the signed authorization. |
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| 164.508(f) |
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Authorizations
for Use or Disclosure of PHI Created for Research that Includes Treatment
of the Individual: |
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7.6.1. |
Required Elements:
Except as permitted under 164.512(i) [¶ 9.8.], CE that creates
PHI for purpose, in whole or part, of research that includes treatment
of individual must obtain authorization for use/disclosure of the
PHI. Such authorization must meet requirements of ¶ 7.3. and
¶ 7.4., and contain:
7.6.1.1. |
Description of extent to
which PHI will be used or disclosed for TPO; |
7.6.1.2. |
Description of any PHI that
will not be used or disclosed for purposes permitted under 164.510
and 164.512 [¶ 6. and ¶ 9.], though CE may not limit
its use/disclosures required by law or as necessary to avert
serious, imminent threat to health and safety; |
7.6.1.3. |
If consent obtained or to
be obtained, or privacy notice given or to be given, the authorization
must refer to the consent [164.506/¶ 5.] or privacy notice
[(164.520/¶ 4.], and state that statements made pursuant
to ¶ 7 are binding. |
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7.6.2. |
Optional Procedure: Authorization
under ¶ 7.6. may be included in the same document as:
7.6.2.1. |
Consent to participate
in research; |
7.6.2.2. |
Consent
to use/disclose PHI for TPO [164.506/¶ 5.]; |
7.6.2.3. |
Notice of privacy
practices. [164.520/¶ 4.] |
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