Health Information Technology for Economic and Clinical Health Act (HITECH) -Breach Notification

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
KP_Comments_OCR_Information_Collection_090908.DOC	Supplementary Document	Uploaded 2009-09-23	Repair queued
0990-BreachPRA Supplementary Statement.doc	Supplementary Document	Uploaded 2009-09-23	Repair queued
0990-Breach_Supporting_Statement FINAL (4).doc	Supporting Statement A	Uploaded 2009-09-23	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
190772	Notice to Secretary		New
190771	Meia Notice		New
190770	Individual Notice Substitute Notice		New
190769	Individual Notice Written and E-mail Notice		New

ICR Details

OMB Control No:	ICR Reference No: 200909-0990-004
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Health Information Technology for Economic and Clinical Health Act (HITECH) -Breach Notification
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 09/24/2009
OIRA Conclusion Action: Withdrawn	Conclusion Date: 09/25/2009
	Date Received in OIRA: 09/23/2009
Terms of Clearance: This ICR is withdrawn per agency request.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The final rule implements statutory provisions that require covered entities and business associates to provide appropriate notifications following the discovery of a breach of unsecured protected health information. Pursuant to ? 164.404 of the final rule, covered entities must provide notification of a breach to affected individuals to alert them that their protected health information has been compromised and to encourage them to take the necessary steps to prevent any resulting harm.

Emergency Justfication: This regulation goes into effect September 23, 2009. Due to the short length of time between the publication date and the effective date of the regulation, the Office for Civil Rights used an emergency process to approve the information collection associated with the regulation. In the interim final rule, we published our PRA burden table and invited public comments for 14 days. We received one comment during that time period, and we plan to consider the comment as we develop the final regulation.

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Authorizing Statute(s): US Code: 13 USC 13402 Name of Law: Health Information Technology for Economic and Clinical Health Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0991-AB56	Final or interim final rulemaking	74 FR 42740	08/24/2009

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Individual Notice Written and E-mail Notice
Individual Notice Substitute Notice
Meia Notice
Notice to Secretary

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new data collection

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Annual Cost to Federal Government: $500,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Yes

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: 09/23/2009

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