[Federal Register: February 28, 2001 (Volume 66, Number 40)]
[Rules and Regulations]
[Page 12738-12739]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe01-10]
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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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