May 15, 2003

Mr. Richard Campanelli
Director Office for Civil Rights
U.S. Department of Health
  and Human Services
200 Independence Avenue, S.W.
Room 515F, HHH Building
Washington, DC 20201

Re: Health Insurance Portability and Accountability Act of
1996 (HIPAA) - Standards for Privacy of Individually
Identifiable Health Information (hereinafter the Privacy
Rule)

Dear Mr. Campanelli:

The Office of Advocacy of the U.S. Small Business
Administration was created in 1976 to represent the views
and interests of small businesses in Federal policy making
activities.(1) The Chief Counsel for Advocacy participates
in rulemakings and other agency actions when he deems it
necessary to ensure proper representation of small business
interests. In addition to these responsibilities, the Chief
Counsel monitors agencies' compliance with the Regulatory
Flexibility Act (RFA), and works with Federal agencies to
ensure that their rulemakings demonstrate an analysis of the
impacts that their decisions will have on small
businesses.(2) Because the Office of Advocacy is an
independent entity within the U.S. Small Business
Administration (SBA), the views expressed by the Chief
Counsel do not necessarily reflect the views of the SBA, or
the Administration.

Based on U.S. Small Business Administration size standards,
the vast majority of health care professionals that practice
under the requirements of the Privacy Rule are small
entities.  Recently my office heard from many health care
providers, and their representatives, who voiced anxiety
about how to comply with the Privacy Rule's provisions.  I
am writing you at this time to encourage the Office of Civil
Rights (OCR) to immediately provide those small entities
covered by the rule with a small business compliance guide.

As OCR is responsible for implementing and enforcing the
Privacy Rule, Advocacy believes it is required to publish
the compliance guide pursuant to Section 212 of the Small
Business Regulatory Enforcement Fairness Act (SBREFA).
Section 212 provides that compliance guides be published by
the agency when it determines that the rulemaking will have
a significant impact on a substantial number of small
entities and prepares a final flexibility analysis pursuant
to the RFA.

This is not the first time that Advocacy has requested that
the U.S. Department of Health and Human Services provide
small business compliance guides in connection with the
Privacy Rule.  Advocacy was intimately involved in the
Privacy Rule during interagency review and during the public
comment periods provided in the proposed and final rules.
Advocacy filed public comments on the rule on February 25,
2000.(3) The comment letter specifically addressed
Advocacy's belief that under SBREFA, HHS had the obligation
to publish compliance guides for small businesses.  To
Advocacy's knowledge, no such compliance guides have been
issued to date.

Advocacy is also aware that on April 11, 2003, Chairman
Donald Manzullo and Ranking Member Nydia Velazquez, along
with various other members of the House Small Business
Committee, wrote Secretary Thompson asking that HHS
supplement its current guidance pursuant to SBREFA and allow
for a year delay in the enforcement provisions provided for
in the Privacy Rule for small providers.  Advocacy supports
the request made by the House Small Business Committee since
guidance would be most helpful prior to having to comply
with the rule.

It is my hope that you will agree to provide small health
care providers with the requested compliance guide.  Once
completed, you have my commitment to make it broadly
available to the small business community.  If you have any
questions about the content of this letter, please do not
hesitate to contact my associate, Linwood Rayford at (202)
205-6880.

Sincerely,
Thomas M. Sullivan
Chief Counsel for Advocacy

CC:  Secretary Tommy Thompson, U.S. Department of Health and
Human Services
     Chairman Donald Manzullo, Committee on Small Business,
     U.S. House of Representatives
     Representative Nydia Velazquez, Ranking Member,
     Committee on Small Business, U.S. House of
     Representatives
     Chairwoman Olympia Snowe, Committee on Small Business &
     Entrepreneurship, U.S. Senate
     Senator John Kerry, Ranking Member, Committee on Small
     Business & Entrepreneurship, U.S. Senate
     Dr. John D. Graham, Administrator, Office of
Information and Regulatory Affairs

ENDNOTES

1.  Pub. L. No. 94-305 (1976)(codified as amended at 15
U.S.C.  634a-g, 637).
2.  Pub. L. No. 96-354, 94 Stat. 1164 (1981) (to be codified
as amended at 5 U.S.C.  601-612).
3.  The February 25, 2000, comment letter can be found on
Advocacy's web site at
www.sba.gov/advo/laws/comments/hhs00_0225.html.