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

Forms and Documents

Document Name	Status
0990-0294 rev2_07_21_09.doc Supporting Statement A	2009-07-21

IC Document Collections

IC ID	Document Title	Status
190153	Accounting for Disclosures of Protected Health Information	New
190152	Amendment of Protected Health Information (denials)	New
190151	Amendment of Protected Health Information (requests)	New
190150	Access of Individuals to Protected Health Information (disclosures)	New
190149	Rights to Request Privacy Protection for Protected Health Information	New
190148	Notice of Privacy Practices for Protected Health Information (health care providers - acknowledgement)	New
190147	Notice of Privacy Practices for Protected Health Information (health care providers - dissemination	New
190146	Notice of privacy Practices for Protected Health Information	New
190145	Uses and Disclosures for which consent individual authorization or opportunity to agree or Object is not required	New
190144	Uses and Disclosures for which Individual authorization is required	New
190143	Uses and Disclosures-Organizational Requirementw	New
10428	Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164	Modified

ICR Details

OMB Control No: 0990-0294	ICR Reference No: 200907-0990-004
Status: Historical Active	Previous ICR Reference No: 200512-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164
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: 09/21/2009
	Date Received in OIRA: 07/31/2009
Terms of Clearance: This ICR is approved without change for 3 years on the understanding that none of these changes stem from rulemaking. HHS shall, as appropriate, submit a separate ICR to reflect any burden changes that do stem from regulatory changes.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved	09/30/2009
Responses	1,229,233,732	0	776,224,162
Time Burden (Hours)	62,254,161	0	2,210,715
Cost Burden (Dollars)	0	0	0

---

Abstract: The individually identifiable health information collected is used by patients and by more than 500,000 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
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 20481	05/04/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 37712	07/29/2009
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Uses and Disclosures-Organizational Requirementw
Uses and Disclosures for which Individual authorization is required
Uses and Disclosures for which consent individual authorization or opportunity to agree or Object is not required
Rights to Request Privacy Protection for Protected Health Information
Access of Individuals to Protected Health Information (disclosures)
Notice of privacy Practices for Protected Health Information
Notice of Privacy Practices for Protected Health Information (health care providers - dissemination
Notice of Privacy Practices for Protected Health Information (health care providers - acknowledgement)
Amendment of Protected Health Information (requests)
Amendment of Protected Health Information (denials)
Accounting for Disclosures of Protected Health Information
Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164

---

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	1,229,233,732	776,224,162	0	0	453,009,570	0
Annual Time Burden (Hours)	62,254,161	2,210,715	0	0	60,043,446	0
Annual Cost Burden (Dollars)	0	0	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:

---

Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

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: 07/31/2009

---