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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0945-0003
ICR Reference No:
201309-0945-001
Status:
Historical Active
Previous ICR Reference No:
201302-0945-001
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:
01/24/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/10/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2017
36 Months From Approved
12/31/2015
Responses
836,457,025
0
1,229,233,732
Time Burden (Hours)
32,762,920
0
62,254,161
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:
0945-AA03
Final or interim final rulemaking
78 FR 5566
01/25/2013
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 5566
01/25/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 54467
09/04/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
17
IC Title
Form No.
Form Name
Access of Individuals to Protected Health Information (disclosures)
Accounting for Disclosures of Protected Health Information
Amendment of Protected Health Information (denials)
Amendment of Protected Health Information (requests)
Business Associates Needing to establish or Modify Business Associate Agreements with Subcontrractors
Dissemination of Notice of Privacy Practices for Protected Health Information(health Plans)
Documentation of Security Rule Policies and Procedures and Administrative safeguards business associates
Notice of Privacy Practices for Protected Health Information (health care providers - acknowledgement)
Notice of Privacy Practices for Protected Health Information (health care providers - dissemination/acknowledgement
Notice of privacy Practices for Protected Health Information/health plan by distibution by paper mail
Process for Requesting Exception Determinations (states or persons)
Revision of Notice of Privacy Practices for Protected Health Information (drafting revised language health plan
Revison of Notice of Privacy Practices (providers)
Rights to Request Privacy Protection for Protected Health Information/distribution by electronic mail
Rights to request privacy protection for protected health information
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
Uses and Disclosures-Organizational Requirement
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
836,457,025
1,229,233,732
0
220,223,293
-613,000,000
0
Annual Time Burden (Hours)
32,762,920
62,254,161
0
1,158,759
-30,650,000
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:
Miscellaneous Actions
Short Statement:
We have decreased the number of requests for an exception determination (45 CFR 160.204) from 16 to one, based on our experience over the last three years. As a result the total burden hours associated with this requirement is now 16 hours as compared with 640 hours at a cost of $687, reduced from $15,539. We have also decreased the estimated number of requests for an accounting of disclosures (45 CFR 164.528) based on our experience and feedback from regulated entities. Many fewer such requests are made each year when compared to the requests for access or amendment. Feedback we have received from covered entities suggests that, in any given year, the majority of such entities receive no requests to provide an accounting of disclosures. As such, we estimate that 10 percent of the approximately 700,000 covered entities will receive only one request per year, for approximately 70,000 requests annually. This reduces the burden hours to provide an accounting from 90,000 hours to 5,833 hours and the related costs from $2.2 million to $250,586. We have also used the updated covered entity count of 700,000 in calculating the burden hours in uses and disclosures in 45 CFR 164.504 and 164.508, but have not otherwise altered the assumptions for these collection burdens. The burden hours for the organizational requirements in 45 CFR 164.504 is now 58,333 (down from 63,733 burden hours in the 2009 ICR) and 700,000 burden hours for authorizations in 45 CFR 164.508 (down slightly from 764,799 in the 2009 ICR). However, the costs for these two items actually increased due to the change, explained below, in the hourly wage rate.
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]?
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
Agency Contact:
Sherrette Funn-Coleman 2026905683
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:
09/10/2013
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