Agency information collection activities; proposals, submissions, and approvals,

[Federal Register: April 21, 2003 (Volume 68, Number 76)]

[Notices]

[Page 19551-19553]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21ap03-87]

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).

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

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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

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.

\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,

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comments, and return address to: cingersoll@hqe.ihs.gov. 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]

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