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Subpart
B - Preemption of State Law
§160.201
Applicability. The
provisions of this subpart implement section 1178 of the Act, as added by
section 262 of Public Law 104-191.
§
160.202 Definitions. For purposes of this
subpart, the following terms have the following meanings:
Contrary ,
when used to compare a provision of State law to a standard, requirement, or
implementation specification adopted under this subchapter, means:
(1)
A covered entity would find it impossible to comply with both the
State and
federal requirements; or
(2)
The provision of State law stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of part C of title XI of the Act
or section 264 of Pub. L. 104-191, as applicable.
More
stringent means, in the context of a comparison of
a provision of State law and a standard, requirement, or implementation
specification adopted under subpart E of part 164 of this subchapter, a State
law that meets one or more of the following criteria:
(1)
With respect to a use or disclosure, the law prohibits or restricts a use or
disclosure in circumstances under which such use or disclosure otherwise would
be permitted under this subchapter, except if the disclosure is:
(i)
Required by the Secretary in connection with determining whether a covered
entity is in compliance with this subchapter; or
(ii)
To the individual who is the subject of the individually identifiable health
information.
(2)
With respect to the rights of an individual who is the subject of the
individually identifiable health information of access to or amendment of
individually identifiable health
information, permits greater rights of access
or amendment, as applicable; provided that, nothing in this subchapter may be
construed to preempt any State law to the extent that it authorizes or
prohibits disclosure of protected health information about a minor to a
parent, guardian, or person acting in loco parentis of such minor.
(3)
With respect to information to be provided to an individual who is the subject
of the individually identifiable health information about a use, a disclosure,
rights, and remedies, provides the greater amount of information.
(4)
With respect to the form or substance of an authorization or consent for use
or disclosure of individually identifiable health
information, provides
requirements that narrow the scope or duration, increase the privacy
protections afforded (such as by expanding the criteria for), or reduce the
coercive effect of the circumstances surrounding the authorization or consent,
as applicable.
(5)
With respect to recordkeeping or requirements relating to accounting of
disclosures, provides for the retention or reporting of more detailed
information or for a longer duration.
(6)
With respect to any other matter, provides greater privacy protection for the
individual who is the subject of the individually identifiable health
information.
Relates
to the privacy of individually identifiable health information
means, with respect to a State law, that the State law has the specific purpose
of protecting the privacy of health information or affects the privacy of
health
information in a direct, clear, and substantial way.
State
law means a constitution, statute, regulation,
rule, common law, or other State action having the force and effect of law.
§
160.203 General rule and exceptions.
A standard, requirement, or implementation specification adopted under this
subchapter that is contrary to a provision of State law preempts the provision
of State law. This general rule applies, except if one or more of the following
conditions is met:
(a)
A determination is made by the Secretary under § 160.204 that the provision
of State law:
(1)
Is necessary:
(i)
To prevent fraud and abuse related to the provision of or payment for
health care;
(ii)
To ensure appropriate State regulation of insurance and health plans to
the extent expressly authorized by statute or regulation;
(iii)
For State reporting on health care delivery or costs; or
(iv)
For purposes of serving a compelling need related to public health,
safety, or welfare, and, if a standard, requirement, or implementation
specification under part 164 of this subchapter is at issue, if the
Secretary determines that the intrusion into privacy is warranted when
balanced against the need to be served; or
(2)
Has as its principal purpose the regulation of the manufacture,
registration, distribution, dispensing, or other control of any controlled
substances (as defined in 21 U.S.C. 802), or that is deemed a controlled
substance by State law.
(b)
The provision of State law relates to the privacy of health information and is
more stringent than a standard, requirement, or implementation specification
adopted under subpart E of part 164 of this subchapter.
(c)
The provision of State law, including State procedures established under such
law, as applicable, provides for the reporting of disease or injury, child
abuse, birth, or death, or for the conduct of public health surveillance,
investigation, or intervention.
(d)
The provision of State law requires a health plan to report, or to provide
access to, information for the purpose of management audits, financial audits,
program monitoring and evaluation, or the licensure or certification of
facilities or individuals.
§
160.204 Process for requesting exception determinations.
(a)
A request to except a provision of State law from preemption under § 160.203(a)
may be submitted to the Secretary. A request by a
State must be submitted
through its chief elected official, or his or her designee. The request must be
in writing and include the following information:
(1)
The State law for which the exception is requested;
(2)
The particular standard, requirement, or implementation specification for
which the exception is requested;
(3)
The part of the standard or other provision that will not be implemented based
on the exception or the additional data to be collected based on the
exception, as appropriate;
(4)
How health care
providers, health plans, and other entities would be affected
by the exception;
(5)
The reasons why the State law should not be preempted by the federal
standard,
requirement, or implementation
specification, including how the State law
meets one or more of the criteria at § 160.203(a); and
(6)
Any other information the Secretary may request in order to make the
determination.
(b)
Requests for exception under this section must be submitted to the Secretary at
an address that will be published in the Federal Register. Until the
Secretary's determination is made, the standard, requirement, or implementation
specification under this subchapter remains in effect.
(c)
The Secretary's determination under this section will be made on the basis of
the extent to which the information provided and other factors demonstrate that
one or more of the criteria at § 160.203(a) has been met.
§
160.205 Duration of effectiveness of exception determinations.
An exception granted under this subpart remains in effect until:
(a)
Either the State law or the federal standard, requirement, or
implementation
specification that provided the basis for the exception is materially changed
such that the ground for the exception no longer exists; or
(b)
The Secretary revokes the exception, based on a determination that the ground
supporting the need for the exception no longer exists.
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