View Information Collection Request (ICR) Package
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View ICR - Agency Submission
OMB Control No:
0945-0003
ICR Reference No:
202509-0945-001
Status:
Received in OIRA
Previous ICR Reference No:
202401-0945-002
Agency/Subagency:
HHS/OCR
Agency Tracking No:
20296
Title:
Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
11/13/2025
Requested
Previously Approved
Expiration Date
07/31/2027
07/31/2027
Responses
1,154,350,069
1,154,350,069
Time Burden (Hours)
953,982,239
953,982,239
Cost Burden (Dollars)
163,499,411
163,499,411
Abstract:
The individually identifiable health information collected is used by patients and by more than 700,000 covered entities affected by the HIPAA Privacy Rule. The information is routinely used by covered entities for treatment, payment, and health care operations. In addition, the information is used for specified public policy purposes, including research, public health, and as required by other laws.
Authorizing Statute(s):
PL:
Pub.L. 104 - 191 1
Name of Law: Health Insurance Portability and Accountability Act of 1996
PL:
Pub.L. 116 - 136 3221
Name of Law: Coronavirus Aid, Relief, and Economic Security Act
Citations for New Statutory Requirements:
PL: Pub.L. 116 - 136 3221 Name of Law: Coronavirus Aid, Relief, and Economic Security Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0945-AA20
Final or interim final rulemaking
89 FR 32976
04/26/2024
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
44
IC Title
Form No.
Form Name
164.504 Revising Business Associate Agreements
164.509 Disclosures for which attestation is required
164.520 Notice of Privacy Practices for Protected Health Information― Post updated notice online
164.520 Notice of Privacy Practices for Protected Health Information―Updating
164.530 Administrative Requirements-Policies & Procedures (new and updated)
164.530 Administrative Requirements―Training― 164.525 Update training content
500 or More Affected Individuals (investigating and documenting breach)
Access of Individuals to Protected Health Information (copies of PHI)
Accounting for Disclosures of Protected Health Information
Amendment of Protected Health Information (denials)
Amendment of Protected Health Information (requests)
Attestations requiring additional action
Attestations requiring investigation review
Business Associate Notice to Covered Entity – 500 or more affected individuals
Business Associate Notice to Covered Entity – Less than 500 affected individuals
Contingency Plan- Criticality Analysis
Contingency Plan- Testing and Revision
Documentation - Review and Update
Individual Notice- Substitute Notice (posting or publishing)
Individual Notice- Written and E-mail Notice (drafting)
Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information)
Individual Notice-Substitute Notice (staffing toll-free number)
Individual Notice-Written and E-mail Notice (preparing and documenting notification)
Individual Notice-Written and E-mail Notice(processing and sending)
Information System Activity Review- Documentation
Less than 500 Affected Individuals (investigating and documenting breach)
Less than 500 Affected Individuals (investigating and documenting breach) breaches affecting <10 individuals
Maintenance Records
Media Notice
Notice of Privacy Practice for Protected Health Information (Health plans- periodic distribution of NPPs by electronic mail)
Notice of Privacy Practices for Protected Health Information (health care providers - dissemination/acknowledgement
Notice of Privacy Practices for Protected Health Information/health plan distribution paper mail
Notice of Privacy Practices for Protected Health Information―Mailing notice to 10% of subscribers at a rate of 240 notices/hour
Notice to Secretary (notice for breaches affecting 500 or more individuals)
Notice to Secretary (notice for breaches affecting fewer than 500 individuals)
Process for Requesting Exception Determinations (states or persons)
Rights to request privacy protection for protected health information
Risk Analysis-Documentation
Security Incidents (other than breaches)- Documentation
Security Incidents- Business Associate reporting of incidents (other than breach) to Covered Entities
Security Reminders- Periodic Updates
Uses and Disclosures for Research Purposes
Uses and Disclosures for which Individual authorization is required
Uses and Disclosures-Organizational Requirement
ICR Summary of Burden
Total Request
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
1,154,350,069
1,154,350,069
0
0
0
0
Annual Time Burden (Hours)
953,982,239
953,982,239
0
0
0
0
Annual Cost Burden (Dollars)
163,499,411
163,499,411
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:
No
Burden Reduction Due to:
Short Statement:
Burdens increased due to updated estimates for the number of covered entities, costs of postage, wage rates, number of breaches, and number of individuals requesting access to copies of their protected health information. Burdens increased for the one-time activities of updating policies and procedures, updating employee training, revising business associate agreements, and revising the NPP, and the recurring activity of obtaining an attestation for certain requests for copies of protected health information. Hourly burdens decreased for providing individual breach notification due to a drop in the number of affected individuals per breach in the most recent published reports.
Annual Cost to Federal Government:
$216,000
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)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Sherri Morgan 202 774-3042 sherri.morgan@hhs.gov
Common Form ICR:
No
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:
11/13/2025
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