2019-09041. Request for Public Comment: 60 Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule

AGENCY:

Indian Health Service, HHS.

ACTION:

Notice and request for comments. Request for extension of approval.

SUMMARY:

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, “IHS Forms to Implement the Privacy Rule” Office of Management and Budget (OMB) Control Number 0917-0030.

This previously approved information collection project was last published in the Federal Register (81 FR 15347) on March 22, 2016, and allowed 30 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit the collection, which expires August 31, 2019, to OMB for approval of an extension, and to solicit comments on specific aspects of the information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2016-1).

Title of Collection: 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164). Type of Information Collection Request: Extension of the currently approved information collection, 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164). Form(s): IHS-810, IHS-912-1, IHS-912-2, IHS-913, and IHS-917. Need and Use of Information Collection: This collection of information is made necessary by the Department of Health 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 Insurance Portability and Accountability Act of 1996, creates national standards to protect individual's personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.522, 164.526 and 164.528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will continue to use the following data collection instruments to meet the information collection requirements contained in the Rule.

45 CFR 164.508: This provision generally requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information, unless otherwise permitted or required by the Privacy Rule. (See, e.g., 45 CFR 164.506 for a common exception to this general rule, which involves uses and disclosure for treatment, payment, or healthcare operations.) Individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The form IHS-810 “Authorization for Use or Disclosure of Protected Health Information” is 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, and with a limited exception, a covered entity is not required to agree to a requested restriction. 45 CFR 164.522(a)(1)(vi). The form IHS-912-1 “Request for Restrictions(s)” is used to document an individual's request for restriction of their protected health information, and whether the IHS agreed or disagreed with the restriction. Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction under certain conditions. For example, termination may occur if the individual agrees to or requests the termination in writing. 45 CFR 164.522(a)(2)(i). The form IHS-912-2 “Request for Revocation of Restriction(s)” is used to document the individual's request, the individual's agreement, and/or the agency's decision to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information.

45 CFR 164.528: This provision requires covered entities to provide an accounting of certain disclosures of protected health information made by the covered entity. See also, 45 CFR 5b.9(c). The form IHS-913 “Request for an Accounting of Disclosures” is 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.

45 CFR 164.526: Under this provision, individuals have a right to amend protected health information or a record about the individual in a designated record set, under certain conditions. 45 CFR 164.526(a). This provision further requires covered entities to permit an individual to request that the covered entity amend protected health information. 45 CFR 164.526(b). The covered entity must inform the individual if the covered entity accepts the requested amendment, in whole or in part. The covered entity must provide the individual with a written denial containing certain information if the covered entity denies the requested amendment, in whole or in part. 45 CFR 164.526(d)(1). The form IHS-917 “Request for Correction/Amendment of Protected Health Information” will be used to document an individual's request to amend his/her protected health information and the agency's decision to accept or deny the request.

Completed forms used in this collection of information are filed in the IHS medical, health and billing record, a Privacy Act System of Records Notice. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides for this information collection: types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hour(s).

Data collection instrument	Number of respondents	Number of responses per respondent	Average burden hour per response *	Total annual burden hours
Authorization for Use or Disclosure of Protected Health Information (OMB Form No. 0917-0030, IHS-810)	210,954	1	10/60	35,159
Request for Restriction(s) (OMB Form No. 0917-0030, IHS-912-1)	214	1	10/60	36
Request for Revocation of Restriction(s) (OMB Form No. 0917-0030, IHS-912-2)	3	1	10/60	.5
Request for Accounting of Disclosures (OMB Form No. 0917-0030, IHS-913)	39	1	10/60	6.5
Request for Correction/Amendment of Protected Health Information (OMB Form No. 0917-0030, IHS-917)	54	1	10/60	9
Total Annual Burden	211,264			35,211
* For ease of understanding, burden hours are provided in actual minutes.

The total estimated burden for this collection of information is 35,211 hours.

There are no capital costs, operating costs and/or maintenance costs to respondents.

Requests 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 the 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 estimates 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.

ADDRESSES:

Send your written comments, requests for more information on the collection, or requests to obtain a copy of the data collection instrument and instructions to Evonne Bennett-Barnes by one of the following methods:

• Mail: Evonne Bennett-Barnes, Information Collection Clearance Officer, Indian Health Service, Office of Management Services, Division of Regulatory and Policy Coordination, 5600 Fishers Lane, Mail Stop 09E70, Rockville, MD 20857.
• Phone: [phone].
• Email: [e-mail].

Comment Due Date: July 2, 2019. Your comments regarding this information collection are best assured of having full effect if received within 60 days of the date of this publication.

Michael D. Weahkee,

Assistant Surgeon General, U.S. Public Health Service, Principal Deputy Director, Indian Health Service.