Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp45.2.160.b&rgn=div6
Timestamp: 2020-04-05 10:58:15
Document Index: 242930363

Matched Legal Cases: ['art 160', '§160', '§160', '§160', '§160', 'art 164', '§160', '§160', '§160']

Title 45 → Subtitle A → Subchapter C → Part 160 → Subpart B
§160.201 Statutory basis.
§160.202 Definitions.
§160.204 Process for requesting exception determinations.
§160.205 Duration of effectiveness of exception determinations.
The provisions of this subpart implement section 1178 of the Act, section 262 of Public Law 104-191, section 264(c) of Public Law 104-191, and section 13421(a) of Public Law 111-5.
For purposes of this subpart, the following terms have the following meanings:
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:
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.
[65 FR 82798, Dec. 28, 2000, as amended at 67 FR 53266, Aug. 14, 2002; 74 FR 42767, Aug. 24, 2009; 78 FR 5689, Jan. 25, 2013]
(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.
(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.