NRPM: Standards for Privacy of Individually Identifiable Health Information. II. Provisions of the proposed rule.


We propose to establish a new subchapter C to title 45 of the Code of Federal Regulations. Although the rules proposed below would only establish two new parts (parts 160 and 164), we anticipate the new subchapter C will eventually contain three parts, part 160, 162, and 164, with parts 161 and 163 being reserved for future expansion, if needed. Part 160 will contain general requirements and provisions applicable to all of the regulations issued under sections 262 and 264 of Public Law 104-191 (the Administrative Simplification provisions of HIPAA). We anticipate that Part 162 will contain the Administrative Simplification regulations relating to transactions, code sets and identifiers. The new part 164 will encompass the rules relating to the security standards authorized by section 1173(d), the electronic signature standard authorized by section 1173(e), and the privacy rules proposed below.

The new part 164 will be composed of two subparts: subparts A and E, with B, C, and D being reserved. Subpart A will consist of general provisions and subpart E will consist of the final privacy rules. Because the new part 160 will apply to the privacy rules, as well as the other Administrative Simplification rules, it is set out below.