Industries & Practices

Health Care Industry


    HIPAA Regulations: General Provisions - Modifications - § 160.104

    As Contained in the HHS HIPAA Rules


    HHS Regulations
    General Provisions: Modifications - § 160.104


    (a) Except as provided in paragraph (b) of this section, the Secretary may adopt a modification to a standard or implementation specification adopted under this subchapter no more frequently than once every 12 months.

    (b) The Secretary may adopt a modification at any time during the first year after the standard or implementation specification is initially adopted, if the Secretary determines that the modification is necessary to permit compliance with the standard or implementation specification.

    (c) The Secretary will establish the compliance date for any standard or implementation specification modified under this section.

    (1) The compliance date for a modification is no earlier than 180 days after the effective date of the final rule in which the Secretary adopts the modification.

    (2) The Secretary may consider the extent of the modification and the time needed to comply with the modification in determining the compliance date for the modification.

    (3) The Secretary may extend the compliance date for small health plans, as the Secretary determines is appropriate.


    HHS Description
    General Provisions: Modifications


    Note: The HHS Description is the same as for § 160.101

    Part 160 applies to all the administrative simplification regulations. We include the entire regulation text in this rule, not just those provisions relevant to this Privacy regulation. For example, the term “trading partner” is defined here, for use in the Health Insurance Reform: Standards for Electronic Transactions regulation, published at 65 FR 50312, August 17, 2000 (the “Transactions Rule”). It does not appear in the remainder of this Privacy rule.

    Sections 160.101 and 160.104 of Subpart A of part 160 were promulgated in the Transactions Rule, and we do not change them here. We do, however, make changes and additions to § 160.103, the definitions section of Subpart A. The definitions that were promulgated in the Transactions Rule and that remain unchanged here are: Act, ANSI, covered entity, compliance date, group health plan, HCFA, HHS, health care provider, health information, health insurance issuer, health maintenance organization, modify or modification, Secretary, small health plan, standard setting organization, and trading partner agreement. Of these terms, we discuss further in this preamble only covered entity and health care provider.