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HHS/OS

RIN: 0991-AB08

Publication ID: Fall 2000

Title: Standards for Privacy of Individually Indentifiable Health Information
Abstract: The final rule would implement part of the Administrative Simplification requirements of Public Law 104-191 by establishing standards for health plans, health care clearinghouses and certain health care providers to protect the privacy of individually identifiable health information.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: Yes	Unfunded Mandates: State, local, or tribal governments; Private Sector
CFR Citation: 45 CFR 160 45 CFR 164
Legal Authority: 42 USC 1320d-2 42 USC 1320d-4 PL 104-191, sec 264

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		02/21/2000

Statement of Need: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191) requires the Department to issue final standards for the privacy of individually identifiable health information by February 21, 2000. The confidentiality of such information varies significally. The standards will establish national protections applicable to individually identifiable health information created or maintained by health plans, health clearinghouses, and health providers that conduct transactions electronically.

Summary of the Legal Basis: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191) directed the Department to issue several standards to facilitate the electronic exchange of information with respect to financial and administrative transactions. It also directed the Department to develop and submit to Congress recommendations for privacy legislation. In addition, if Congress did not enact legislation governing privacy standards with respect to individually identifiable health information by August 21, 1999, HIPAA directed the Department to promulgate final regulations containing such standards by February 21, 2000. A proposed rule was published in the fall of 1999. A final regulation reflecting the public comments to the proposal will be issued to satisfy the statutory requirement.

Alternatives: The Department is required by statute to issue final regulations by February 21, 2000. Therefore, no alternatives to regulatory action have been considered.

Anticipated Costs and Benefits: The proposal was esimated to cost $3.8 billion. Estimates of the economic impact that will stem from this rule will be revised based on the public comments. A final anaylsis will be included with the final regulation.

Risks: The extensive comments on the proposed rule provided detailed information on a wide range of important and complex information. The final rule will reflect these insights. Publication of the final rule will enable the Department to meet its statutuary deadline.

Timetable:

Action	Date	FR Cite
NPRM	11/03/1999	64 FR 59967
Final Action	11/00/2000

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Federal, Local, State, Tribal
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations	Federalism: Yes
Included in the Regulatory Plan: Yes
Agency Contact: Roxanne Gibson Senior Administrative Assistant Department of Health and Human Services Office of the Secretary Room G-322A, Attention: Privacy-P, 200 Independence Avenue SW., Washington, DC 20201 Phone:202 260-5083