 |
164.526 |
|
 |
|
|
|
Amendment of PHI:
|
|
Right to
amend and denial of amendment: |
|
|
| 164.526(a)(1) |
|
|
|
| |
| |
8.3.1.1.
|
Individual has
the right to have CE amend PHI or other information in the designated
record set for as long as CE maintains the record sets. |
|
|
| 164.526(a)(2) |
|
|
|
| |
8.3.1.2. |
CE may deny amendment
request if it determines that the PHI or other record:
8.3.1.2.1. |
Was not created
by the CE, unless the individual provides reasonable basis to
believe that originator of PHI is no longer available to act
on request; |
8.3.1.2.2. |
Is not part
of the designated record set; |
8.3.1.2.3. |
Would not be available for inspection
under ¶ 8.1.; or
|
8.3.1.2.4. |
Is accurate
and complete. |
|
|
164.526(b) |
|
|
|
| |
|
Request for amendment
and timely action:
8.3.2.1. |
CE must permit
an individual to request that the CE amend PHI maintained in
the designated record set. CE may require request to be in writing
and to provide reason/support for request, provided there is
advance notice of these requirements. |
8.3.2.2. |
CE must act
on request within 60 days of receipt, as follows:
8.3.2.2.1.
|
If CE
grants the request, in whole or in part, it must follow
the requirements of ¶ 8.3.3.1. and ¶ 8.3.3.2.
If it denies the request, in whole or in part, it must
follow the requirements of ¶ 8.3.4. |
8.3.2.2.2.
|
If CE
needs more time to comply, it may obtain one extension
for up to thirty days, provided that the CE notifies the
individual in writing within the first 60 days of the
reasons for delay and of the date by which action will
be taken. |
|
|
|
164.526(c) |
|
|
|
| |
|
Accepting the amendment:
If the CE accepts the requested amendment, in whole or part, it must:
8.3.3.1. |
Make the amendment
by, at a minimum, identifying the affected records and appending
or otherwise providing a link to the location of the amendment; |
8.3.3.2. |
Timely inform the individual that the
amendment is accepted and obtain his/her identification of
and agreement to have the CE notify relevant persons with
which amendment needs to be shared pursuant to ¶ 8.3.3.3;
|
8.3.3.3. |
Make reasonable
efforts to inform and timely provide amendment to:
8.3.3.3.1.
|
Persons identified by the individual
as having received PHI and needing the amendment; and
|
8.3.3.3.2.
|
Persons,
including business associates, that the CE knows to have
PHI that is the subject of the amendment and that may
have relied, or could foreseeably rely on such information
to the detriment of the individual. |
|
|
|
164.526(d) |
|
|
|
| |
|
Denying the amendment:
If the CE denies the requested amendment, in whole or part, it must:
8.3.4.1. |
Provide the
individual with a timely, written denial in plain language and
containing: |
| |
8.3.4.1.1.
|
The basis for the denial;, in accordance
with ¶ 8.3.1.2;
|
8.3.4.1.2.
|
Notice
of individual's right to submit a written statement disagreeing
with the denial, and information on how to file such statement; |
8.3.4.1.3.
|
Statement that, if individual does
not submit a statement of disagreement, individual may
request that CE provide individual's request and the
denial with any future disclosures of the PHI that is
subject of the request; and
|
8.3.4.1.4.
|
Description
of how individual may complain to CE pursuant to procedures
described in ¶ 11.3.4. (including name or title,
and telephone number of contact person or office), or
to the Secretary of HHS. |
|
8.3.4.2. |
Statement of
disagreement: CE must permit the individual to submit to the
CE a written statement disagreeing with the denial and the basis
for disagreement. CE may reasonably limit the length of the
statement. |
8.3.4.3. |
Rebuttal statement:
CE may prepare a written rebuttal to the statement of disagreement.
Whenever a rebuttal is prepared, CE must provide a copy to the
individual. |
8.3.4.4. |
Record keeping:
CE must, as appropriate, identify the record or PHI that is
subject to the disputed amendment and append or otherwise link
the request for amendment, the denial, any statement of disagreement,
and any rebuttal to the designated record set. |
8.3.4.5. |
Future disclosures:
8.3.4.5.1.
|
If
a statement of disagreement has been submitted, the CE
must include the material appended in accordance with
¶ 8.3.4.4. or, at the election of the CE, an accurate
summary of such information, with any subsequent disclosure
of the PHI to which the disagreement relates. |
8.3.4.5.2.
|
If
a statement of disagreement has not been submitted, the
CE must include the request for amendment and the denial,
or an accurate summary of such information, with any subsequent
disclosure of PHI only if the individual has requested
such action in accordance with ¶ 8.3.4.1.3. |
8.3.4.5.3.
|
When
a subsequent disclosure is being made using a standard
transaction under Part 162 of the regulations that does
not permit additional material to be included, the CE
must separately transmit the material required by ¶
8.3.4.5.1. or ¶ 8.3.4.5.2., as applicable, to the
recipient of the standard transaction. |
|
|
| |
|
A CE that
is informed by another CE of an amendment to an individual's PHI pursuant
to ¶ 8.3.3.3. must amend the PHI in designated record sets as
provided in ¶ 8.3.3.1. |
| |
|
Documentation:
CE must document the titles of the persons or offices responsible
for receiving and processing requests for amendments and maintain
documentation as required by ¶ 11.3.10. |
|
| |
|
|
|
|
| |
|
|
|
|
