Health Breach Notification Rule

Forms and Documents

Document Name	Status
Form Not Applicable Identifying breach, affected customers, notifying customers, etc. Form and Instruction	Modified
Health Breach Notif. Rule - SS - 2016 - FINAL .pdf Supporting Statement A	2016-01-29

IC Document Collections

IC ID	Document Title	Status
188848	Identifying breach, affected customers, notifying customers, etc. Form and Instruction	Modified

ICR Details

OMB Control No: 3084-0150	ICR Reference No: 201601-3084-001
Status: Historical Active	Previous ICR Reference No: 201208-3084-004
Agency/Subagency: FTC	Agency Tracking No:
Title: Health Breach Notification Rule
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/07/2016
	Date Received in OIRA: 02/03/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	03/31/2016
Responses	2	0	2
Time Burden (Hours)	3,267	0	200
Cost Burden (Dollars)	49,960	0	7,918

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Abstract: The Health Breach Notification Rule ("Rule"), 16 C.F.R. Part 318, requires vendors of personal health records and PHR related entities to provide: (1) notice to consumers whose unsecured personally identifiable health information has been breached; and (2) notice to the Commission. The Rule only applies to electronic health records and does not include recordkeeping requirements. The Rule requires third party service providers (i.e., those companies that provide services such as billing or data storage) to notify vendors of personal health records and PHR related entities following the discovery of a breach; those entities in turn must provide notification to consumers and the Commission. To notify the FTC of a breach, the Commission developed a form for entities subject to the Rule to complete and return to the agency.

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Authorizing Statute(s): PL: Pub.L. 111 - 5 13407 Name of Law: American Recovery and Reinvestment Act of 2009
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 5 13407 Name of Law: American Recovery and Reinvestment Act of 2009

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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:
	80 FR 6530	10/16/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 5750	02/03/2016
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
Identifying breach, affected customers, notifying customers, etc.	Not Applicable	Notice of Breach of Health Information

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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	2	2	0	0	0	0
Annual Time Burden (Hours)	3,267	200	0	0	3,067	0
Annual Cost Burden (Dollars)	49,960	7,918	0	0	42,042	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: No

Burden Reduction Due to:

Short Statement: The annual time and cost burden have been adjusted upward because the FTC anticipates more consumers will receive breach notifications. Since the Rule has now been in effect for over five years, staff has more information relating to the actual notifications received from covered entities. This includes the number of consumers that the covered entities notified. In 2012, the FTC estimated that an average of 2,500 consumers per year received notifications over the years 2010 and 2011. In 2015-2016, the FTC estimates approximately 20,000 consumers will receive notices per year.

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Annual Cost to Federal Government: $75,000

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]? 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)? 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: 02/03/2016

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