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

Forms and Documents

Document Name	Status
0945-0003 Supporting Statement HIPAA Combo Draft 5-27-16.docx Supporting Statement A	2016-06-10

IC Document Collections

IC ID	Document Title	Status
221884	Less than 500 Affected Individuals (investigating and documenting breach) breaches affecting	New
221883	Less than 500 Affected Individuals (investigating and documenting breach)	New
221882	500 or More Affected Individuals (investigating and documenting breach)	New
221881	Notice to Secretary (notice for breaches affecting fewer than 500 individuals)	New
221880	Notice to Secretary (notice for breaches affecting 500 or more individuals)	New
221879	Media Notice	New
221878	Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information)	New
221877	Individual Notice-Substitute Notice (staffing toll-free number)	New
221876	Individual Notice- Substitute Notice (posting or publishing)	New
221875	Individual Notice-Written and E-mail Notice(processing and sending)	New
221874	Individual Notice-Written and E-mail Notice (preparing and documenting notification)	New
221872	Individual Notice- Written and E-mail Notice (drafting)	New
221871	Documentation - Review and Update	New
221870	Security Incidents- Business Associate reporting of incidents (other than breach) to Covered Entities	New
221869	Maintenance Records	New
221868	Contingency Plan- Criticality Analysis	New
221866	Contingency Plan- Testing and Revision	New
221862	Security Incidents (other than breaches)- Documentation	New
221861	Security Reminders- Periodic Updates	New
221860	Information System Activity Review- Documentation	New
221859	Risk Analysis-Documentation	New
208577	Revison of Notice of Privacy Practices (providers)	Removed
208576	Revision of Notice of Privacy Practices for Protected Health Information (drafting revised language health plan	Removed
208575	Business Associates Needing to establish or Modify Business Associate Agreements with Subcontrractors	Removed
208574	Dissemination of Notice of Privacy Practices for Protected Health Information(health Plans)	Removed
208573	Rights to request privacy protection for protected health information	Modified
208572	Documentation of Security Rule Policies and Procedures and Administrative safeguards business associates	Removed
190153	Accounting for Disclosures of Protected Health Information	Modified
190152	Amendment of Protected Health Information (denials)	Modified
190151	Amendment of Protected Health Information (requests)	Modified
190150	Access of Individuals to Protected Health Information (disclosures)	Modified
190149	Notice of Privacy Practice for Protected Health Information (Health plans- periodic distribution of NPPs by electronic mail)	Modified
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	Modified
190145	Uses and Disclosures for Research Purposes	Modified
190144	Uses and Disclosures for which Individual authorization is required	Unchanged
190143	Uses and Disclosures-Organizational Requirement	Unchanged
10428	Process for Requesting Exception Determinations (states or persons)	Unchanged

ICR Details

OMB Control No: 0945-0003	ICR Reference No: 201603-0945-001
Status: Historical Active	Previous ICR Reference No: 201309-0945-001
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: Approved without change	Conclusion Date: 09/21/2016
	Date Received in OIRA: 06/10/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	01/31/2017
Responses	1,015,728,443	0	836,457,025
Time Burden (Hours)	921,822,708	0	32,762,920
Cost Burden (Dollars)	0	0	0

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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.

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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

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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:
	81 FR 14453	03/17/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 31646	05/19/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 33

IC Title	Form No.	Form Name
Amendment of Protected Health Information (requests)
Amendment of Protected Health Information (denials)
Accounting for Disclosures of Protected Health Information
Contingency Plan- Criticality Analysis
Maintenance Records
Individual Notice-Substitute Notice (staffing toll-free number)
Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information)
Less than 500 Affected Individuals (investigating and documenting breach)
Documentation of Security Rule Policies and Procedures and Administrative safeguards business associates
Dissemination of Notice of Privacy Practices for Protected Health Information(health Plans)
Revision of Notice of Privacy Practices for Protected Health Information (drafting revised language health plan
Revison of Notice of Privacy Practices (providers)
Risk Analysis-Documentation
Security Reminders- Periodic Updates
Security Incidents (other than breaches)- Documentation
Contingency Plan- Testing and Revision
Business Associates Needing to establish or Modify Business Associate Agreements with Subcontrractors
Information System Activity Review- Documentation
Individual Notice- Written and E-mail Notice (drafting)
Individual Notice- Substitute Notice (posting or publishing)
Security Incidents- Business Associate reporting of incidents (other than breach) to Covered Entities
Documentation - Review and Update
Individual Notice-Written and E-mail Notice (preparing and documenting notification)
Individual Notice-Written and E-mail Notice(processing and sending)
Notice to Secretary (notice for breaches affecting fewer than 500 individuals)
500 or More Affected Individuals (investigating and documenting breach)
Less than 500 Affected Individuals (investigating and documenting breach) breaches affecting <10 individuals
Rights to request privacy protection for protected health information
Media Notice
Notice to Secretary (notice for breaches affecting 500 or more individuals)
Process for Requesting Exception Determinations (states or persons)
Uses and Disclosures-Organizational Requirement
Uses and Disclosures for which Individual authorization is required
Uses and Disclosures for Research Purposes
Notice of privacy Practices for Protected Health Information/health plan distribution paper mail
Notice of Privacy Practices for Protected Health Information (health care providers - dissemination/acknowledgement
Notice of Privacy Practice for Protected Health Information (Health plans- periodic distribution of NPPs by electronic mail)
Access of Individuals to Protected Health Information (disclosures)

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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	1,015,728,443	836,457,025	0	179,271,418	0	0
Annual Time Burden (Hours)	921,822,708	32,762,920	0	889,059,788	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Cutting Redundancy

Short Statement: This information collection does not create any new requirements for regulated entities or individuals. As noted above, we have combined three existing information collections into a single collection addressing burdens associated with the HIPAA Privacy, Security, and Breach Notification Rules. In addition, we have made a number of adjustments to the estimated ongoing annual burdens to reflect our experience with the use of these provisions and increases in average wages for the applicable labor categories.

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Annual Cost to Federal Government: $300,000

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]? 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? 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: 06/10/2016

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