Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. A. Introduction


Pursuant to the Regulatory Flexibility Act 5 U.S.C. 601 et.seq., the Department must prepare a regulatory flexibility analysis if the Secretary certifies that a final rule would have a significant economic impact on a substantial number of small entities. 74

This analysis addresses four issues: (1) the need for, and objective of, the rule; (2) a summary of the public comments to the NPRM and the Department's response; (3) a description and estimate of the number of small entities affected by the rule; and (4) a description of the steps the agency has taken to minimize the economic impact on small entities, consistent with the law and the intent of the rule. The following sections provide details on each of these issues. A description of the projected reporting and record keeping requirements of the rule are included in Section IX, below.