Request for Public Comment: 30-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 notice announces the IHS intent to submit the collection, which expires September 30, 2023, to OMB for approval of an extension with modifications, and to solicit comments on specific aspects of the information collection.

DATES:

Comment Due Date: October 20, 2023. Your comments regarding this information collection are best assured of having full effect if received within 30 days of the date of this publication.

ADDRESSES:

Send your 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: Desk Officer for IHS.

FOR FURTHER INFORMATION CONTACT:

To request additional information, please contact Evonne Bennett, Information Collection Clearance Officer, by email: Evonne.Bennett@ihs.gov or (240) 472–1996.

SUPPLEMENTARY INFORMATION:

The IHS published a notice on this previously approved information collection in the Federal Register (88 FR 42726) on July 3, 2023, and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).

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, with modifications 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, IHS–917, IHS–982, and IHS–963. 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 an individual's personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.520, 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 use the following data collection instruments to meet the information collection requirements contained in the Rule.

(a) 45 CFR 164.508—Authorization for Use or Disclosure of Protected Health Information (IHS–810)

45 CFR 164.508 requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information for purposes that are not otherwise authorized or required by HIPAA ( e.g., treatment, payment and healthcare operations). Under this provision, 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 by patients at IHS facilities to document and authorize the use, disclosure or release of their protected health information from their medical record to anyone they specify.

(b) 45 CFR 164.522(a)(1)—Request For Restriction(s) (IHS–912–1)

Under the Privacy Rule, an individual can request to restrict the use of their information with some exceptions. Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict certain uses and disclosures of their protected health information. The covered entity may or may not agree to the restriction, and it is only required to agree in certain limited situations. 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 IHS agreed or disagreed with the requested restriction.

(c) 45 CFR 164.522(a)(2)—Request For Revocation of Restriction(s) (IHS–912–2)

Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction when the individual agrees to or requests the termination in writing. The form IHS–912–2 “Request for Revocation of Restriction(s)” is used to document the agency or individual request to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. A previous request to restrict information may be revoked by the individual or IHS, subject to the limitations set forth in 164.522(a)(2).

(d) 45 CFR 164.528 and HHS Privacy Act Regulations, 45 CFR 5b.9(c)—Request for an Accounting of Disclosures (IHS–913)

These provisions require the IHS, as a covered entity and an agency within HHS, to permit individuals to request that the IHS provide an accounting of disclosures of the individual's protected health information and/or record. The form IHS–913 “Request for an Accounting of Disclosures” is used for the collection of information for the purpose of processing an accounting of disclosures requested by the patient and/or personal representative, and to document that request.

(e) 45 CFR 164.526—Request for Correction/Amendment of Protected Health Information (IHS–917)

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 request for an amendment is accepted. 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 developed the form (IHS–917) to permit individuals to submit their request and to document IHS's acceptance or denial of a patient's request to correct or amend their protected health information.

(f) 45 CFR 164.520—Acknowledgement of Receipt of the IHS Notice of Privacy Practices (IHS–982)

This provision requires covered entities to provide a Notice of Privacy Practices to patients and to document compliance with the notice requirements by retaining copies of written acknowledgments of the receipt of the notice or documentation of good faith efforts to obtain written acknowledgment. The IHS developed the form (IHS–982) to obtain the written acknowledgment of the receipt of the IHS Notice of Privacy Practices.

(g) 45 CFR 164.522—Request for Confidential Communication by Alternative Means or Alternate Location (IHS–963)

This provision requires covered entities to permit individuals to request and must accommodate reasonable requests by individuals to receive communications of protected health information from the covered health care provider by alternative means or at alterative locations. The IHS developed the form (IHS–963) to permit individuals to request communications by alternative means or locations.

Completed forms used in this collection of information are filed in the IHS “Medical, Health and Billing Records,” a Privacy Act System of Records. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides the following details for this information collection: types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response.

The total estimated burden for this collection of information is 35,253.5 hours.

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

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.