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

ICR 201309-0945-001

OMB: 0945-0003

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-09-06
IC Document Collections
IC ID
Document
Title
Status
208577
New
208576
New
208575
New
208574
New
208573
New
208572
New
190153
Modified
190152
Modified
190151
Modified
190150
Modified
190149
Modified
190148
Removed
190147
Modified
190146
Modified
190145
Modified
190144
Modified
190143
Modified
10428
Modified
ICR Details
0945-0003 201309-0945-001
Historical Active 201302-0945-001
HHS/OCR 20296
Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164
Revision of a currently approved collection   No
Regular
Approved without change 01/24/2014
Retrieve Notice of Action (NOA) 09/10/2013
  Inventory as of this Action Requested Previously Approved
01/31/2017 36 Months From Approved 12/31/2015
836,457,025 0 1,229,233,732
32,762,920 0 62,254,161
0 0 0

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.

PL: Pub.L. 104 - 191 1 Name of Law: Health Insurance Portability and Accountability Act of 1996
  
None

0945-AA03 Final or interim final rulemaking 78 FR 5566 01/25/2013

  78 FR 5566 01/25/2013
78 FR 54467 09/04/2013
No

17
IC Title Form No. Form Name
Business Associates Needing to establish or Modify Business Associate Agreements with Subcontrractors
Revision of Notice of Privacy Practices for Protected Health Information (drafting revised language health plan
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 which consent individual authorization or opportunity to agree or Object is not required
Notice of privacy Practices for Protected Health Information/health plan by distibution by paper mail
Notice of Privacy Practices for Protected Health Information (health care providers - dissemination/acknowledgement
Rights to Request Privacy Protection for Protected Health Information/distribution by electronic mail
Access of Individuals to Protected Health Information (disclosures)
Amendment of Protected Health Information (requests)
Amendment of Protected Health Information (denials)
Accounting for Disclosures of Protected Health Information
Documentation of Security Rule Policies and Procedures and Administrative safeguards business associates
Rights to request privacy protection for protected health information
Dissemination of Notice of Privacy Practices for Protected Health Information(health Plans)
Revison of Notice of Privacy Practices (providers)
Notice of Privacy Practices for Protected Health Information (health care providers - acknowledgement)

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$0
No
No
No
No
No
Uncollected
Sherrette Funn-Coleman 2026905683

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/10/2013


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