Health Breach Notification Rule

Forms and Documents

Document Name	Status
Form Not Applicable Major Breaches Form and Instruction	New
Form Not Applicable Single-person Breaches Form and Instruction	Modified
Health Breach Notification Rule - SS - 2019 - FINAL.pdf Supporting Statement A	2019-05-02

IC Document Collections

IC ID	Document Title	Status
235941	Major Breaches Form and Instruction	New
188848	Single-person Breaches Form and Instruction	Modified

ICR Details

OMB Control No: 3084-0150	ICR Reference No: 201905-3084-001
Status: Active	Previous ICR Reference No: 201601-3084-001
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: 06/10/2019
	Date Received in OIRA: 05/02/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	06/30/2019
Responses	25,001	0	2
Time Burden (Hours)	4,779	0	3,267
Cost Burden (Dollars)	29,952	0	49,960

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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:
	84 FR 2868	02/08/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18845	05/02/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Single-person Breaches	Not Applicable	Notice of Breach of Health Information
Major Breaches	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	25,001	2	0	0	24,999	0
Annual Time Burden (Hours)	4,779	3,267	0	0	1,512	0
Annual Cost Burden (Dollars)	29,952	49,960	0	0	-20,008	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 from 3,267 annual hours in 2016 to 4,779 annual hours in 2019 and from $111,724 in annual labor and non-labor costs in 2016 to $126,608 annual labor and non-labor costs in 2019. For 2016, the FTC estimated two major breach incidents per year that, together, require the notification of approximately 40,000 consumers. There were no available estimates at that time for single breach responses. For 2019, the FTC has more comprehensive data on enforcing this rule which has been in effect since 2010. The FTC now estimates two primary categories of breaches reported: (1) single-person breaches, incidents in which a single individual’s information is potentially compromised; and (2) what are hereafter described as major breaches, in which multiple—and typically, many—individuals are affected. On average, staff now estimates 25,000 single-person breaches per year and that covered firms will require approximately 20 seconds of employee labor per single-person breach. Staff also estimates that 0.4 major breaches occur per year and the annual average hourly burden for major breaches is 4,640 hours. Taking the requirements relating to responding to single-person and major breaches, the reporting and third-party disclosure estimates have been adjusted upward since the most recent PRA submission.

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Annual Cost to Federal Government: $75,000

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 05/02/2019

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