[Federal Register Volume 66, Number 40 (Wednesday, February 28, 2001)]
[Rules and Regulations]
[Pages 12738-12739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4811]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Parts 160 and 164

RIN 0991-AB08


Standards for Privacy of Individually Identifiable Health 
Information

AGENCY: Office for Civil Rights, HHS.

ACTION: Final rule; request for comments.

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SUMMARY: This action provides for the submission of comments on a 
technical amendment to the final rule adopting standards for privacy of 
individually identifiable health information published on December 28, 
2000, in the Federal Register (65 FR 82462), to convert it to a final 
rule with request for comments. The purpose of this action is to permit 
public comment on the final rule for a limited period before the rule 
becomes effective.

DATES: 1. Comments will be considered if received as provided below, no 
later than 5 p.m. on March 30, 2001.
    2. The effective date of the final rule with request for comments 
published December 28, 2000 (65 FR 82462) was corrected to be April 14, 
2001. See 66 FR 12434 (February 26, 2001).

ADDRESSES: Comments will be considered only if provided through any of 
the following means:
    1. Mail written comments (1 original and, if possible, a floppy 
disk) to the following address: U.S. Department of Health and Human 
Services, Attention: Privacy I, Room 801, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201.
    2. Deliver written comments (1 original and, if possible, a floppy 
disk) to Room 801, 200 Independence Avenue, SW., Washington, DC 20201.
    3. Submit electronic comments at the following website: http://aspe.hhs.gov/admnsimp/.

FOR FURTHER INFORMATION CONTACT: Kimberly Coleman, 1-866-OCR-PRIV (1-
866-627-7748) or TTY 1-866-788-4989.

SUPPLEMENTARY INFORMATION:

Comment Procedures, Availability of Copies, and Electronic Access

    Comment procedures: All comments should include the full name, 
address, and telephone number of the sender or a knowledgeable point of 
contact. Each specific comment should specify the section of the final 
rule to which the specific comment pertains. If possible, please send 
an electronic version of the

[[Page 12739]]

comments on a 3\1/2\ inch DOS format floppy disk in Adobe Acrobat 
Portable Document Format (PDF), HTML, ASCII text, or popular word 
processor format (Microsoft Word, Corel WordPerfect). All comments and 
content must be limited to the 8.5 wide by 11.0 high vertical (also 
referred to as ``portrait'') page orientation. If identical/duplicate 
comment submissions are submitted both electronically and in paper 
form, each submission should clearly indicate that it is a duplicate 
submission.
    Because of staffing and resource limitations, we will not accept 
comments by electronic mail or facsimile (FAX) transmission. Any 
comments received through such media will be deleted or destroyed, as 
appropriate. They will not be considered as public comments.
    Comments that are timely received in proper form and at one of the 
addresses specified above will be available for public inspection by 
appointment as they are received, generally beginning approximately 
three weeks after this publication in Room 801 of the Department's 
offices at 200 Independence Avenue, SW, Washington, DC on Monday 
through Friday of each week from 8:30 a.m. to 5 p.m. Appointments may 
be made by telephoning 202-260-3392.
    After the close of the comment period, comments that we are 
technically able to convert will be posted on the Administrative 
Simplification website specified above.
    Copies: To order copies of the Federal Register containing this 
document, send your request to New Orders, Superintendent of Documents, 
PO Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue 
requested and enclose a check or money order payable to the 
Superintendent of Documents or enclose your Visa or Master Card number 
and expiration date. Credit card orders can also be placed by calling 
the order desk at 202-512-1800 or by fax to 202-512-2250. The cost for 
each copy is $9. Alternatively, the Federal Register may be viewed and 
photocopied at most libraries designated as Federal Depository 
Libraries and at many other public and academic libraries throughout 
the country that receive the Federal Register.
    Electronic Access: This document is available electronically at the 
above website as well as at the web site of the Government Printing 
Office at http://www.access.gpo.gov/su_docs/aces/140.html.

Discussion

    On December 28, 2000, we published in the Federal Register a final 
rule adopting standards for the privacy of individually identifiable 
health information (Privacy Rule). The Privacy Rule is the second in a 
series of rules mandated by sections 261-264 of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191. 
In general, the Privacy Rule establishes in 45 CFR part 160 a set of 
definitions applicable to the entire set of HIPAA rules, requirements 
for requesting that a state law be excepted from preemption by the 
statute, and compliance and enforcement requirements. The Privacy Rule 
also establishes a new subpart E of part 164. Subpart E establishes 
standards which entities covered by the statute--health plans, health 
care clearinghouses, and certain health care providers--are required to 
comply with to protect the privacy of certain individually identifiable 
health information (``protected health information''). The standards 
are requirements relating to the uses and disclosures of protected 
health information, the rights of individuals with respect to their 
protected health information, and the procedures for exercising those 
rights.
    The Privacy Rule affects over 600,000 entities and virtually every 
American. It is estimated to cost in excess of $17.6 billion over ten 
years. The Department received over 52,000 public comments in the 
public comment period on the proposed rule; in the period following 
publication of the final rule, HHS has received approximately a 
thousand inquiries about the impact and operation of the Privacy Rule 
on numerous sectors of the economy. Many comments exhibit substantial 
confusion over how the Rule will operate; others express great concern 
over the complexity and workability of the Rule. The significance of 
the Privacy Rule for the health care industry and for society as a 
whole, and the substantial nature of some concerns that have been 
raised have led us to conclude that an additional comment period on the 
Privacy Rule is warranted. Accordingly, we hereby solicit public 
comment for 30 days on the Privacy Rule, as published in the Federal 
Register on December 28, 2000 at 65 FR 82462.
    Based on telephone calls, e-mails, letters, and other contacts with 
HHS, we are aware that the Privacy Rule has been the subject of 
widespread debate in the health care industry and the public at large 
in the almost two months since its publication. Thus, we believe that 
many of the public's concerns about the Privacy Rule have already 
crystallized. We accordingly are of the view that 30 days should be 
sufficient for the public to state its views fully to HHS.
    We determined that the report to Congress required by 5 U.S.C. 
801(a)(1) was not received by the Congress concurrent with the 
transmission of the Privacy Rule to the Federal Register, as previously 
thought. We have published elsewhere in this section of the Federal 
Register a final rule correcting the effective date of the Privacy Rule 
to April 14, 2001 to comply with 5 U.S.C. 801(a)(3)(A). This action 
does not alter the corrected effective date. The public comment period 
provided for above accordingly will close before the Privacy Rule 
becomes effective.

    Dated: February 22, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 01-4811 Filed 2-26-01; 11:13 am]
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