Health Insurance Reform Security Standards - Final Rule

Forms and Documents

Document Name	Status
0945-0004 Supporting Statement Security Rule ver2.docx Supporting Statement A	2016-05-26

IC Document Collections

IC ID	Document Title	Status
8803	Health Insurance Reform Security Standards - Final Rule	Modified

ICR Details

OMB Control No: 0945-0004	ICR Reference No: 201604-0945-001
Status: Historical Active	Previous ICR Reference No: 201305-0945-001
Agency/Subagency: HHS/OCR	Agency Tracking No: 19000
Title: Health Insurance Reform Security Standards - Final Rule
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/21/2016
	Date Received in OIRA: 05/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	09/30/2016
Responses	135,560	0	4,000,000
Time Burden (Hours)	536,746	0	64,539,263
Cost Burden (Dollars)	0	0	0

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Abstract: This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and other Federal health programs, and private health programs, and the effectiveness and efficiency of the health care industry in general by establihsing a level of protection for certain electronic health information.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 13806	03/15/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 31645	05/19/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Health Insurance Reform Security Standards - Final Rule

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	135,560	4,000,000	0	-3,864,440	0	0
Annual Time Burden (Hours)	536,746	64,539,263	0	-64,002,517	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Cutting Redundancy

Short Statement: Changes have been made to the total burden hour estimates in this supporting statement; due to an error in the previously approved ICR (for reinstatement and transfer of the ICR from CMS/OESS to OCR), the ROCIS table and supporting statement for this ICR did not match. As noted above, to better reflect our experience, we make adjustments to the estimated burden of compliance with the Security Rule in the new, consolidated ICR (0945-0003), which we will submit shortly for review.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/27/2016

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