Health Breach Notification Rule

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Not Applicable Notice of Breach of Health Information	Form and Instruction	Modified	Available
Form Not Applicable Notice for Health Applications (Non-Labor Costs for Breaches without Forensic Services)	Form and Instruction	Modified	Repair queued
Form Not Applicable Notice of Breach of Health Information	Form and Instruction	Modified	Available
Form Not Applicable Notice for Health Applications (Non-Labor Costs for Breaches that include Forensic Services)	Form and Instruction	Modified	Repair queued
Form Not Applicable Notice of Breach of Health Information	Form and Instruction	Modified	Available
Form Not Applicable Major Breaches	Form and Instruction	Modified	Repair queued
Form Not Applicable Notice of Breach of Health Information	Form and Instruction	Modified	Available
Form Not Applicable Single-person Breaches	Form and Instruction	Modified	Repair queued
HBNR_2024_Supporting Statement_Final .pdf	Supporting Statement A	Uploaded 2024-05-22	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
260390	Notice for Health Applications (Non-Labor Costs for Breaches without Forensic Services)	Form and Instruction	Modified	Notice of Breach of Health Information
260390	Notice for Health Applications (Non-Labor Costs for Breaches without Forensic Services)	Form and Instruction	Modified
260389	Notice for Health Applications (Non-Labor Costs for Breaches that include Forensic Services)	Form and Instruction	Modified	Notice of Breach of Health Information
260389	Notice for Health Applications (Non-Labor Costs for Breaches that include Forensic Services)	Form and Instruction	Modified
235941	Major Breaches	Form and Instruction	Modified	Notice of Breach of Health Information
235941	Major Breaches	Form and Instruction	Modified
188848	Single-person Breaches	Form and Instruction	Modified	Notice of Breach of Health Information
188848	Single-person Breaches	Form and Instruction	Modified

ICR Details

OMB Control No: 3084-0150	ICR Reference No: 202403-3084-001
Status: Active	Previous ICR Reference No: 202305-3084-001
Agency/Subagency: FTC	Agency Tracking No:
Title: Health Breach Notification 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: 06/27/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/30/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	07/31/2025
Responses	2,583	0	2,501
Time Burden (Hours)	16,954	0	4,654
Cost Burden (Dollars)	92,016,002	0	31,632

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Abstract: The Health Breach Notification Rule ("Rule"), 16 C.F.R. Part 318, requires vendors of personal health records ("PHR") 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 (PHR) 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. The proposed amendments pertain to, among others: (1) the coverage of the rule—specifically, the rule’s coverage of developers of many health applications (“apps”) and PHR identifiable health information that is drawn from multiple sources; (2) methods of notice; and (3) the content of notice.

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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:
3084-AB56	Final or interim final rulemaking	89 FR 47028	05/30/2024

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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
Major Breaches	Not Applicable	Notice of Breach of Health Information
Notice for Health Applications (Non-Labor Costs for Breaches that include Forensic Services)	Not Applicable	Notice of Breach of Health Information
Notice for Health Applications (Non-Labor Costs for Breaches without Forensic Services)	Not Applicable	Notice of Breach of Health Information
Single-person Breaches	Not Applicable	Notice of Breach of Health Information

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ICR Summary of Burden

table that charts list 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	2,583	2,501	0	82	0	0
Annual Time Burden (Hours)	16,954	4,654	0	12,300	0	0
Annual Cost Burden (Dollars)	92,016,002	31,632	0	91,984,370	0	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The Federal Trade Commission (“FTC” or “Commission”) is finalizing amendments to the Health Breach Notification Rule (“Rule”), 16 C.F.R. Part 318. The Rule currently requires vendors of personal health records (“PHR”) and PHR related entities that are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) to comply with certain notice requirements in the event of a breach of unsecured personally identifiable health information. Among others, the amendments pertain to (1) the scope of the Rule, (2) the methods of notice, and (3) the content of notice.

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Annual Cost to Federal Government: $150,000

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? No

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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: 05/30/2024

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