Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
12_2_2022_HIPAA_Part_2_Supporting_Statement.docx	Supporting Statement A	Uploaded 2022-12-02	Repair queued
published 60-FRN day 0945-0003.pdf	Supplementary Document	Uploaded 2019-09-30	Repair queued
30-day FRN 0945-0003 HIPAA 2019 ICR Extension.doc	Supplementary Document	Uploaded 2019-09-30	Repair queued
0945-0003 Change Request.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2017-10-12	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257001	Administrative Requirements― Policies & Procedures― Revising the Notice of Privacy Practices, 164.520		New
237898	Business Associate Notice to Covered Entity – Less than 500 affected individuals		Unchanged
237897	Business Associate Notice to Covered Entity – 500 or more affected individuals		Unchanged
221884	Less than 500 Affected Individuals (investigating and documenting breach) breaches affecting <10 individuals		Unchanged
221883	Less than 500 Affected Individuals (investigating and documenting breach)		Unchanged
221882	500 or More Affected Individuals (investigating and documenting breach)		Unchanged
221881	Notice to Secretary (notice for breaches affecting fewer than 500 individuals)		Unchanged
221880	Notice to Secretary (notice for breaches affecting 500 or more individuals)		Unchanged
221879	Media Notice		Unchanged
221878	Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information)		Unchanged
221877	Individual Notice-Substitute Notice (staffing toll-free number)		Unchanged
221876	Individual Notice- Substitute Notice (posting or publishing)		Unchanged
221875	Individual Notice-Written and E-mail Notice(processing and sending)		Unchanged
221874	Individual Notice-Written and E-mail Notice (preparing and documenting notification)		Unchanged
221872	Individual Notice- Written and E-mail Notice (drafting)		Unchanged
221871	Documentation - Review and Update		Modified
221870	Security Incidents- Business Associate reporting of incidents (other than breach) to Covered Entities		Unchanged
221869	Maintenance Records		Modified
221868	Contingency Plan- Criticality Analysis		Modified
221866	Contingency Plan- Testing and Revision		Modified
221862	Security Incidents (other than breaches)- Documentation		Modified
221861	Security Reminders- Periodic Updates		Modified
221860	Information System Activity Review- Documentation		Modified
221859	Risk Analysis-Documentation		Modified
208573	Rights to request privacy protection for protected health information		Modified
190153	Accounting for Disclosures of Protected Health Information		Unchanged
190152	Amendment of Protected Health Information (denials)		Unchanged
190151	Amendment of Protected Health Information (requests)		Unchanged
190150	Access of Individuals to Protected Health Information (disclosures)		Unchanged
190149	Notice of Privacy Practice for Protected Health Information (Health plans- periodic distribution of NPPs by electronic mail)		Unchanged
190147	Notice of Privacy Practices for Protected Health Information (health care providers - dissemination/acknowledgement		Unchanged
190146	Notice of privacy Practices for Protected Health Information/health plan distribution paper mail		Unchanged
190145	Uses and Disclosures for Research Purposes		Unchanged
190144	Uses and Disclosures for which Individual authorization is required		Modified
190143	Uses and Disclosures-Organizational Requirement		Modified
10428	Process for Requesting Exception Determinations (states or persons)		Modified

ICR Details

OMB Control No: 0945-0003	ICR Reference No: 202211-0945-001
Status: Historical Inactive	Previous ICR Reference No: 201909-0945-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 01/05/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/02/2022
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	03/31/2023
Responses	1,097,206,223	0	1,097,206,223
Time Burden (Hours)	921,158,940	0	921,158,940
Cost Burden (Dollars)	0	0	0

---

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. The Department has proposed changes to the HIPAA Notice of Privacy Practices (NPP), 45 CFR 164.520, that are associated with proposed changes to 42 CFR part 2. 87 FR 74216 (December 2, 2022). Changes to the NPP are required by section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136.

---

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 (CARES) Act
  

Citations for New Statutory Requirements: PL: Pub.L. 116 - 136 3221 Name of Law: Coronavirus Aid, Relief, and Economic Security (CARES) Act

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0945-AA16	Proposed rulemaking	87 FR 74216	12/02/2022

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 36

table that charts list of burden

IC Title	Form No.	Form Name
500 or More Affected Individuals (investigating and documenting breach)
Access of Individuals to Protected Health Information (disclosures)
Accounting for Disclosures of Protected Health Information
Administrative Requirements― Policies & Procedures― Revising the Notice of Privacy Practices, 164.520
Amendment of Protected Health Information (denials)
Amendment of Protected Health Information (requests)
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 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

---

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: Covered entities are required to update their HIPAA Notice of Privacy Practices due to Section 3221 of the CARES Act. In addition, OCR is updating its estimates of the number of covered entities, resulting in an increase in the total number of estimated burden hours for many of the information collections associated with the HIPAA Rules. OCR is also update the wage rates associated with burden hours for all of the ICs.

---

Annual Cost to Federal Government: $35,600

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

---

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: 12/02/2022

---