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COMPLIANCE AND ENFORCEMENT:
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160.304 |
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Principals for Achieving Compliance:
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12.1.1.
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Cooperation: Secretary of HHS will, to
the extent practicable, seek cooperation of CEs in obtaining
compliance with the regulations.
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12.1.2.
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Assistance: Secretary of HHS may provide
technical assistance to CEs to help them comply voluntarily
with the regulations.
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160.306 |
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Complaints to the Secretary of HHS:
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12.2.1.
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Right to file complaint: A person who believes
a CE is not complying with the regulations may file a complaint
with the Secretary of HHS.
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12.2.2.
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Requirements for filing complaint:
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12.2.2.1.
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Complaint must be filed in writing, either
on paper or electronically;
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12.2.2.2.
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Complaint must name entity that is the
subject of the complaint and describe acts or omissions believed
to be in violation of the regulations;
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12.2.2.3.
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Complaint must be filed within 180 days
of when complainant knew or should have known of the act or
omission, unless the time limit is waived by the Secretary
of HHS for good cause shown.
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12.2.3
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Investigation: Secretary of HHS may investigate
complaints, which may include review of policies, procedures, or
practices of the CE and of the circumstances regarding the alleged
acts or omissions.
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160.308 |
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Compliance Reviews: Secretary of HHS
may conduct compliance reviews to determine whether CEs are complying
with applicable requirements of the regulations.
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160.310 |
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Responsibilities of CE:
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12.4.1.
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Provide records and compliance reports:
CE must keep such records and submit such compliance reports,
in such time and manner and containing such information, as
the Secretary of HHS may determine to be necessary to enable
the Secretary to ascertain whether CE has complied and is
complying with the regulations.
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12.4.2.
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Cooperate with complaint investigations
and compliance reviews: CE must cooperate with the Secretary
of HHS if the Secretary undertakes an investigation or compliance
review of the policies, procedures or practices of a CE.
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12.4.3.
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Permit access to information:
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12.4.3.1.
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CE must permit access by the Secretary
of HHS during normal business hours to its facilities,
books, records, accounts, and other sources of information,
including PHI, that are pertinent to ascertaining compliance
with the regulations. If the Secretary determines that
exigent circumstances exist, a CE must permit access
at any time, without notice.
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12.4.3.2.
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If any of the information required
of a CE hereunder is in the exclusive possession of
another agency, institution, or person that fails or
refuses to furnish the information, the CE must so certify,
and set forth the efforts it undertook to obtain the
information.
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12.4.3.3.
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PHI obtained by the Secretary of
HHS in connection with an investigation or compliance
review will not be disclosed by the Secretary, except
if necessary for ascertaining or enforcing compliance
with the applicable requirements of the regulations.
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| 160.312 |
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Secretarial Action Regarding Complaints
and Compliance Reviews:
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12.5.1.
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Resolution where noncompliance is indicated:
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12.5.1.1.
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If an investigation or compliance
review indicates a failure to comply, the Secretary
of HHS will so inform the CE and, if the matter arose
from a complaint, the complainant, in writing and attempt
to resolve the matter by informal means whenever possible.
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12.5.1.2.
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If the Secretary of HHS finds the
CE is not in compliance and determines that the matter
cannot be resolved informally, the Secretary may issue
to the CE, and, if the matter arose from a complaint,
the complainant, written findings documenting the noncompliance.
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12.5.2.
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Resolution when no violation is found:
If, after an investigation or compliance review, the Secretary
of HHS determines that further action is not warranted, the
Secretary will so inform the CE and, if the matter arose from
a complaint, the complainant, in writing.
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NOT COVERED: Transition Provisions [ 164.532];
Compliance Dates [ 164.534]
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