[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Notices]
[Pages 19551-19553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Proposed Information Collection; Request for Comments

AGENCY: Indian Health Service, HHS.

ACTION: Request for public comment: 30-day proposed information 
collection: ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 
and 164).

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SUMMARY: The Indian Health Service (IHS), as part of its continuing 
effort to reduce paperwork and respondent burden, conducts a pre-
clearance consultation program to provide the general public and 
Federal agencies with an opportunity to comment on proposed and/or 
continuing collections of information in accordance with the Paperwork 
Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program 
helps to ensure that requested data can be provided in the desired 
format, reporting burden (time and financial resources) is minimized, 
collection instruments are clearly understood, and the impact of 
collection requirements on respondents can be properly assessed. As 
required by section 3507(a)(1)(D) of the Act, the proposed information 
collection has been submitted to the Office of Management and Budget 
(OMB) for review and approval. The IHS received comments in response to 
the 60-day Federal Register notice (67 FR 67411) published on November 
5, 2002. The public comments received in response to the notice and the 
Agency responses are summarized and addressed below.
    Comment: One comment questioned the readability of the forms. The 
commentor suggested that the Flesch Reading Ease score be raised to 50-
75 percent from the 27.9 percent-47.3 percent readability score that 
the forms received. The commentor also noted that the Flesch-Kincaid 
Grade level for the forms required a reading level of 11\1/2\ to 12 
years of education. The commentor also suggested decreasing the 
required education level for the forms.
    Agency Response: The data collection instruments were field tested 
at the Fort Duchesne IHS Health Center, Fort Duchesne, Utah to 
determine whether the data collection instruments and instructions were 
clear and user friendly. They were found to be user friendly, clear and 
understandable. Changes suggested during the field testing were 
incorporated into the forms. Since the forms are generally filled in by 
the patient at an IHS facility, questions regarding understandability 
will be answered by IHS staff who will be trained on the correct and 
proper use of each form.
    Comment: The only other comment received concerned the proposed IHS 
Form 911 (renumbered 917), the Request for Correction/Amendment of 
Protected Health Information. The commentor requested that the IHS 
eliminate the word ``Correction'' from the title and the word 
``corrected'' in the body of the form. The commentor believed that the 
word ``correction'' implies a deletion of information. The commentor 
points out that the word ``correction'' was deleted from Sec.  164.526 
of the Privacy Rule for the same reason. In addition the commentor also 
states that the Privacy Act of 1974 (5 USC 552a) in section (d)(2) 
Access to Records does not reference ``correction/amendment.'' This 
last point is not correct. If one continues to read section (d)(2) 
further to subsection (d)(2)(B)(i) the Privacy Act states that the 
agency is required to ``make any correction of any portion thereof 
which the individual believes is not accurate, relevant, timely or 
complete; * * *'' The Privacy Act clearly uses the word ``correction'' 
regarding the corrective action that the Agency is required to take. 
Furthermore, the Department of Health and Human Services (DHHS) Privacy 
Regulations at 45 CFR 5 b.7 and 5 b.8 also use the terms ``correction 
or amendment'' in either the titles of the subsections or in the body 
of the subsection. Section 5 b.7 is titled ``Procedures for correction 
or amendment of records'' and Sec.  5 b.8 is titled ``Appeals of 
refusals to correct or amend records.'' Furthermore, the DHHS Privacy 
Regulation also clearly states in section 5 b.7 when an actual deletion 
would occur. Section 5 b.7 states that ``The record will be deleted 
without regard to its accuracy, if the record is not relevant or 
necessary to accomplish the Department functions for which the record 
was provided or is maintained.'' Therefore we believe that the Privacy 
Act and the DHHS regulations in this regard are quite clear. As an 
added note, the IHS Manual at Chapter 3-3.14(c)(6) describes the method 
for correcting entries in a medical record. The manual states that no 
erasure or other obliteration shall be made and also required that 
incorrect data shall be lined out with a single line.
    Therefore, the IHS has decided not to follow the suggestions 
submitted by the commentor.
    The purpose of this notice is to allow an additional 30 days for 
public comment to be submitted directly to OMB.
    Proposed Collection: Title: 09-17-NEW, ``IHS Forms to implement the 
Privacy Rule (45 CFR parts 160 and 164)''. Type of Information 
Collection Request: New collection. Form Number(s): IHS-810 
Authorization for Use or Disclosure of Health Information, IHS-917 
Request for Correction/Amendment of Protected Health Information, IHS-
912-I Request for Restriction(s), IHS 912-2 Terminating a Restriction, 
and IHS 913 Request For an Accounting of Disclosures. Need and Use of 
Information Collection: This collection of information is made 
necessary by the Department of Health

[[Page 19552]]

and Human Services Rule entitled ``Standards for Privacy of 
Individually Identifiable Health Information'' (``Privacy Rule'') (45 
CFR parts 160 and 164). The Privacy Rule implements the privacy 
requirements of the Administrative Simplification subtitle of the 
Health Information Portability and Accountability Act of 1996 and 
creates national standards to protect an individual's personal health 
information and gives patients increased access to their medical 
records. Sections, 45 CFR 164.508, 552, 526 and 528 of the Rule require 
the collection of information to implement these protection standards 
and access requirements. The IHS will use the following data collection 
instruments to implement the information collection requirements 
contained in the Rule.
    45 CFR 164.508: This provision requires covered entities to obtain 
or receive a valid authorization for its use or disclosure of protected 
health information for uses other than for treatment, payment and 
healthcare operations. Under the provision, individuals may initiate a 
written authorization permitting covered entites to release their 
protected health information to entities of their choosing. The ``IHS-
810 Authorization for Use or Disclosure of Health Information'' form 
will be used to document an individual's authorization to use or 
disclose their protected health information.
    45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to 
permit individuals to request that the covered entity restrict the use 
and disclosure of their protected health information. The covered 
entity may or may not agree to the restriction. The ``IHS-912-1 Request 
for Restriction(s)'' form will be used to document an individual's 
request for restriction of their protected health information and 
whether IHS agreed or disagreed with the restriction. Section 
164.522(a)(2)(1) permits a covered entity to terminate its agreement to 
a restriction if the individual agrees to or requests the termination 
in writing. The ``IHS-912-2 Request for Revocation of Restriction(s)'' 
form will be used to document the agency's or the individual's request 
to terminate a formerly agreed to restriction regarding the use and 
disclosure of protected health information.
    45 CFR 164.526: This provision requires covered entities to permit 
an individual to request that the covered entity amend protected health 
information. If the covered entity accepts the requested amendment, in 
whole or in part, the covered entity must inform the individual that 
the amendment is accepted and obtain the individual's identification of 
and agreement to have the covered entity notify the relevant persons 
with whom the amendment needs to be shared. If the covered entity 
denies the requested amendment, in whole or in part, the covered entity 
must provide the individual with a written denial. The ``IHS-917 
Request for Correction/Amendment of Protected Health Information'' form 
will be used to document an individual's request to amend their 
protected health information and the agency's decision to accept or 
deny the request.
    45 CFR 164.528: This provision requires covered entities to permit 
an individual to request that the covered entity provide an accounting 
of disclosures of protected health information made by the covered 
entity. The ``IHS 913 Request for an Accounting of Disclosures'' form 
will be used to document an individual's request for an accounting of 
disclosures of their protected health information and the agency's 
handling of the request. Completed forms used in this collection of 
information are filed in the medical record.
    Affected Public: Individuals and households. Type of Respondents: 
Individuals. Burden Hours: The table below provides the estimated 
burden hours for this information collection:

                                          Estimated Annual Burden Hours
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                                                                                    Burden per
             45 CFR section/IHS form                 Number of     Responses per   response \1\    Total annual
                                                    respondents     respondent       (minutes)        burden
----------------------------------------------------------------------------------------------------------------
164.508 IHS-810.................................         500,000               1              20        166,667.
164.522(a)(1) IHS-912-I.........................          15,000               1              10          2,500.
164.522(a)(2) IHS-912-2.........................           5,000               1              10            833.
164.526 IHS-917.................................           7,500               1              15           1,875
164.528 IHS-913.................................          15,000               1              10          2,500.
                                                 -----------------
      Total Annual Burden.......................  ..............               5  ..............       174,375.
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\1\ For ease of understanding, burden hours are provided in actual minutes.

    The total estimated burden for this collection of information is 
174,375 hours.
    There are no Capital Costs, Operating Costs and/or Maintenance 
Costs to respondents to report.

Request for Comments

    Your written comments and/or suggestions are invited on one or more 
of the following points: (a) Whether the information collection 
activity is necessary to carry out an agency function; (b) whether the 
agency processes the information collected in a useful and timely 
fashion; (c) the accuracy of public burden estimate (the estimated 
amount of time needed for individual respondents to provide the 
requested information); (d) whether the methodology and assumptions 
used to determine the estimate are logical; (e) ways to enhance the 
quality, utility, and clarity of the information being collected; and 
(f) ways to minimize the public burden through the use of automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Direct Comments to OMB: Send your written comments and suggestions 
regarding the proposed information collection contained in this notice, 
especially regarding the estimated public burden and associated 
response time, to: Office of Management and Budget, Office of 
Regulatory Affairs, New Executive Office Building, Room 10235, 
Washington, DC 20503, Attention: Allison Eydt, Desk Officer for IHS. 
Send request for more information on the proposed collection or to 
obtain a copy of the data collection instrument(s) and instructions to: 
Ms. Christine Ingersoll, IHS Reports Clearance Officer, 12300 Twinbrook 
Parkway, Suite 450, Rockville, MD 20852-1601, call non-toll free (301) 
443-1116, send via facsimile to (301) 443-2316, or send your E-mail 
requests,

[[Page 19553]]

comments, and return address to: [email protected].

FOR FURTHER INFORMATION CONTACT: For questions directly pertaining to 
the proposed data collection instruments and/or the process, please 
contact Godwin Odia, RHIA, The Reyes Building, 801 Thompson Avenue, 
Suite 322, Rockville, MD 20852-1627, telephone (301) 443-1479.
    Comment Due Date: Your comments regarding this information 
collection are best assured of having their full effect if received 
within 30-days of the date of this publication.

    Dated: February 3, 2003.
Charles W. Grim,
Assistant Surgeon General, Interim Director, Indian Health Service.
[FR Doc. 03-9436 Filed 4-18-03; 8:45 am]
BILLING CODE 4160-16-M