NRPM: Standards for Privacy of Individually Identifiable Health Information. § 160.204 Process for requesting exception determinations or advisory opinions.

11/03/1999

(a) Determinations.

(1) A State may submit a written request to the Secretary to except a provision of State law from preemption under § 160.203(a). The request must include the following information:

(i) The State law for which the exception is requested;

(ii) The particular standard(s), requirement(s), or implementation specification(s) for which the exception is requested;

(iii) 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;

(iv) How health care providers, health plans, and other entities would be affected by the exception;

(v) The length of time for which the exception would be in effect, if less than three years;

(vi) 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

(vii) Any other information the Secretary may request in order to make the determination.

(2) Requests for exception under this section must be submitted to the Secretary at an address which 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.

(3) The Secretary’s determination under this paragraph 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. If it is determined that the federal standard, requirement, or implementation specification accomplishes the purposes of the criterion or criteria at § 160.203(a) as well as or better than the State law for which the request is made, the request will be denied.

(4) An exception granted under this paragraph is effective for three years or for such lesser time as is specified in the determination granting the request.

(5) If an exception is granted under this paragraph, the exception has effect only with respect to transactions taking place wholly within the State for which the exception was requested.

(6) Any change to the standard, requirement, or implementation specification or provision of State law upon which an exception was granted requires a new request for an exception. Absent such a request and a favorable determination thereon, the standard, requirement, or implementation specification remains in effect. The responsibility for recognizing the need for and making the request lies with the original requestor.

(7) The Secretary may seek changes to a standard, requirement, or implementation specification based on requested exceptions or may urge the requesting State or other organizations or persons to do so.

(8) Determinations made by the Secretary pursuant to this paragraph will be published annually in the Federal Register.

(b) Advisory opinions.

(1) The Secretary may issue advisory opinions as to whether a provision of State law constitutes an exception under § 160.203(b) to the general rule of preemption under that section. The Secretary may issue such opinions at the request of a State or at the Secretary’s own initiative.

(2) A State may submit a written request to the Secretary for an advisory opinion under this paragraph. The request must include the following information:

(i) The State law for which the exception is requested;

(ii) The particular standard(s), requirement(s), or implementation specification(s) for which the exception is requested;

(iii) How health care providers, health plans, and other entities would be affected by the exception;

(iv) The reasons why the State law should not be preempted by the federal standard, requirement, or implementation specification, including how the State law meets the criteria at § 160.203(b); and

(v) Any other information the Secretary may request in order to issue the advisory opinion.

(3) The requirements of paragraphs (a)(2), (a)(5)-(a)(7) of this section apply to requests for advisory opinions under this paragraph.

(4) The Secretary’s decision under this paragraph will be made on the basis of the extent to which the information provided and other factors demonstrate that the criteria at § 160.203(b) are met.

(5) Advisory opinions made by the Secretary pursuant to this paragraph will be published annually in the Federal Register.