Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Federal Register, Volume 78 Issue 171 (Wednesday, September 4, 2013)
Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)
Notices
Pages 54467-54469
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-21398
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Document Identifier: HHS-OS-20296-30D
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0945-0003 scheduled to expire on 12/31/2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
DATES: Comments on the ICR must be received on or before October 4, 2013.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the OMB control number 0945-0003 and document identifier HHS-OS-20296-30D for reference.
Information Collection Request Title: Standards for Privacy of Individually Identifiable Health Information, Security Standards for the Protection of Electronic Protected Health Information, and Supporting Regulations Contained in 45 CFR Parts 160 and 164
OMB No.: 0945-0003.
Abstract: The Office for Civil Rights (OCR) is notifying the public of revisions to a previously approved OCR data collection. The revisions reflect certain regulatory modifications to the HIPAA Privacy and Security Rules, pursuant to the Health Information for Economic and Clinical Health (HITECH) Act and the Genetic Information Nondiscrimination Act (GINA), that were finalized in the Omnibus HIPAA Final Rule published on January 25, 2013 (78 FR 5566). These modifications strengthen privacy and security protections for individually identifiable health information used or disclosed by business associates and enhance the rights of individuals with respect to their identifiable health information.
Need and Proposed Use of the Information: The information collection addresses HIPAA requirements related to the use, disclosure, and safeguarding of individually identifiable health information by covered entities affected by the HIPAA Rules. The information is routinely used by covered entities and business associates for treatment, payment, and health care operations. In addition, the information is used for specified public policy purposes, including research, public health, and as required by other laws. The Privacy Rule also ensures that the individuals are able to exercise certain rights with respect to their information, including the rights to access and seek amendments to their health records and to receive a Notice of Privacy Practices (NPP) from their direct treatment providers and health plans.
Likely Respondents: Respondents include HIPAA covered entities and their business associates, as well as members of the public.
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the tables below.
Page 54468
Total Estimated Annualized Burden--Hours
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Average number Average burden
Section Type of Number of of responses hours per Total burden
respondent respondents per respondent response hours
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New Burdens Associated With the Final Rule
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164.316....................... Documentation of 300,000 1 70/60 350,000
Security Rule
Policies and
Procedures and
Administrative
Safeguards
(business
associates).
164.504....................... Business 375,000 1 20/60 125,000
Associates
Needing to
Establish or
Modify Business
Associate
Agreements with
Subcontractors.
164.520....................... Revision of 1,500 1 .111 167
Notice of
Privacy
Practices for
Protected
Health
Information
(drafting
revised
language)
(health plans).
164.520....................... Dissemination of 20,000,000 1 .00333335 66,667
Notice of
Privacy
Practices for
Protected
Health
Information
(health plans).
164.520....................... Revision of 697,000 1 .11111 77,444
Notice of
Privacy
Practices
(providers).
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Total..................... ................ .............. .............. .............. 619,278
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Ongoing Annual Burdens of Compliance with the Rules
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160.204....................... Process for 1 1 16 16
Requesting
Exception
Determinations
(states or
persons).
164.504....................... Uses and 700,000 1 5/60 58,333
Disclosures--Or
ganizational
Requirements.
164.508....................... Uses and 700,000 1 1 700,000
Disclosures for
Which
Individual
authorization
is required.
164.512....................... Uses and 113,524 1 5/60 9,460
Disclosures for
Research
Purposes.
164.520....................... Notice of 100,000,000 1 0.25 416,667
Privacy
Practices for
Protected
Health
Information
(health plans--
periodic
distribution of
NPPs by paper
mail).
164.520....................... Notice of 100,000,000 1 0.167 278,333
Privacy
Practices for
Protected
Health
Information
(health plans--
periodic
distribution of
NPPs by
electronic
mail).
164.520....................... Notice of 613,000,000 1 3/60 30,650,000
Privacy
Practices for
Protected
Health
Information
(health care
providers--diss
emination and
acknowledgement
).
164.522....................... Rights to 150,000 1 3/60 7,500
Request Privacy
Protection for
Protected
Health
Information.
164.524....................... Access of 150,000 1 3/60 7,500
Individuals to
Protected
Health
Information
(disclosures).
164.526....................... Amendment of 150,000 1 3/60 7,500
Protected
Health
Information
(requests).
164.526....................... Amendment of 50,000 1 3/60 2,500
Protected
Health
Information
(denials).
164.528....................... Accounting for 70,000 1 3/60 5,833
Disclosures of
Protected
Health
Information.
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Total..................... ................ .............. .............. .............. 32,143,642
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TOTAL HOURS
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32,762,920
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Page 54469
Keith A. Tucker,
Information Collection Clearance Officer.
FR Doc. 2013-21398 Filed 9-3-13; 8:45 am
BILLING CODE 4153-01-P
