NRPM: Standards for Privacy of Individually Identifiable Health Information. i. What is a “provision” of State law?


The initial question that arises in the preemption analysis is, what does one compare? The statute directs this analysis by requiring the comparison of a “provision of State law [that] imposes requirements, standards, or implementations specifications” with “the requirements, standards, or implementation specifications imposed under” the federal regulation. The statute thus appears to contemplate that what will be compared are the State and federal requirements that are analogous, i.e., that address the same subject matter. Accordingly, a dictionary-type definition of the term “provision” does not seem appropriate, as the contours of a given “provision” will be largely defined by the contours of the specific “requirement[], standard[], or implementation specification” at issue.

What does one do when there is a State provision and no comparable or analogous federal provision, or the converse is the case? The short answer would seem to be that, since there is nothing to compare, there cannot be an issue of a “contrary” requirement, and so the preemption issue is not presented. Rather, the stand-alone requirement – be it State or federal -- is effective. There may, however, be situations in which there is a federal requirement with no directly analogous State requirement, but where several State requirements in combination would seem to be contrary in effect to the federal requirement. This situation usually will be addressed through the tests for “contrary,” discussed below.

At this juncture, it is difficult to frame options for dealing with this issue, because it is not clear that more of a structure is needed than the statute already provides. Rather, we solicit comment on how the term “provision” might be best defined for the purpose of the preemption analysis under the statute, along with examples of possible problems in making the comparison between a provision of State law and the federal regulations.