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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:
202011-0945-001
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:
05/10/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/01/2021
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.
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.
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-AA00
Proposed rulemaking
86 FR 6446
01/21/2021
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
57
IC Title
Form No.
Form Name
Notice of Fees for Copies of PHI―Post fee schedule online
500 or More Affected Individuals (investigating and documenting breach)
Access of Individuals to Protected Health Information (disclosing copies of ePHI to health plans and providers)
Access of Individuals to Protected Health Information (disclosing copies of ePHI to other third parties)
Access of Individuals to Protected Health Information (disclosures)
Access of Individuals to Protected Health Information (submitting requests for individuals to direct copies of ePHI to plans and providers)
Accounting for Disclosures of Protected Health Information
Administrative Requirements - Training (right of access and fee estimates - medical records staff)
Administrative Requirements – Policies & Procedures (disclosures for Uniformed Services & Telecommunications Relay Services)
Administrative Requirements – Policies & Procedures (disclosures under 164.510; uses and disclosures to prevent harm, 164.512)
Administrative Requirements – Policies & Procedures (minimum necessary and social services agencies for care coordination)
Administrative Requirements – Policies & Procedures (revising the Notice of Privacy Practices)
Administrative Requirements – Policies & Procedures (right of access & fee estimates)
Administrative Requirements – Policies & Procedures (verification of identity)
Administrative Requirements – Training (disclosing PHI under 164.510; uses and disclosures to prevent harm, 164.512(j))
Administrative Requirements – Training (disclosures for Uniformed Services, 164.512(k); disclosures to Telecommunications Relay Services for treatment, payment and health care operations)
Administrative Requirements – Training (minimum necessary, 164.514)
Administrative Requirements – Training (notice of privacy practices, changes in content & right to discuss privacy practices, 164.520)
Administrative Requirements – Training (right of access and fee estimates)
Administrative Requirements – Training (verification of identity)
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
Minimum necessary evaluations for treatment, payment, and health care operations - uses and disclosures
Notice of Access and Authorization Fees - Individualized estimates
Notice of Access and Authorization Fees - Itemized list of charges
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
Notice of Privacy Practices for Protected Health Information (right to discuss privacy practices)
Notice of Privacy Practices for Protected Health Information – Post updated notice online
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:
Yes
Burden Reduction Due to:
Changing Regulations
Short Statement:
HHS is: (1) Adjusting the number of covered entities (CEs) from 700,000 to 774,331 due to more recent data. (2) Adjusting the number of access requests for copies of protected health information (PHI) from 200,000 to 2,460,000 annually based on a review of available data. (3) Increasing the estimated burden hours for responding to access requests from 3 to 5 minutes per request and allocating 1 minute as uncompensated due to changes in technology and reassessment of the types of access requests. (4) Increasing the burden hours by a factor of 2 for responding to individuals’ requests for restrictions on disclosures of their PHI because easing the minimum necessary requirements for disclosures for care coordination by health plans may cause some individuals to seek to narrow the scope of some permitted disclosures; (5) Newly estimating the burdens resulting from the pre-existing, ongoing requirement for CEs to make minimum necessary evaluations before using or disclosing PHI for payment and health care operations purposes (and before using PHI for treatment) in the amount of 18 hours annually per CE, and decreasing the annual minimum necessary burden by 4 hours per CE due to easing the minimum necessary requirement for care coordination disclosures, resulting in a total ongoing annual burden of 14 hours per CE; (6) Recognizing for the first time burdens associated with providing electronic copies of PHI to third parties designated by individuals in the amount of 2 minutes per request for 25 percent of 615,000 such requests received annually based on reassessment of CEs’ burdens due to the Ciox v. Azar court decision; (7) Recognizing for the first time burdens associated with providing electronic copies of PHI to health plans and health care providers as third parties designated by individuals in the amount of 4 minutes per request for 25 percent of 615,000 such requests received annually based on a reassessment of CEs’ burdens following the Ciox v. Azar decision; and (8) Decreasing the estimated burden for disseminating the Notice of Privacy Practices (NPP) and obtaining an acknowledgement of receipt, from 3 minutes to 1 minute and 15 seconds due to the proposal to eliminate the requirements relating to the acknowledgement of receipt. New Burdens Resulting from Program Changes In addition to these changes above, HHS is proposing to add new burdens as a result of program changes: (1) An annualized burden of 10 minutes per CE for posting an updated NPP due to changes to the required content; (2) An annualized burden of 3.5 minutes per request for submitting an access request for an individual to another provider for an estimated 92,250 annual requests, a proposed new individual right; (3) An annualized 10-minute burden per CE for posting an access and authorization fee schedule online, a proposed new regulatory requirement; (4) An annualized 7-minute burden for each of an estimated 6,130,000 annual requests from individuals to discuss their direct treating health care provider’s NPP, a proposed new individual right; (5) An annualized 3-minute burden for each of an estimated 73,800 annual requests from individuals for an individualized estimate of the fees to provide copies of requested PHI, a proposed new individual right; (6) An annualized 1-minute burden for each of an estimated 24,600 annual requests from individuals for an itemized list of charges for copies of PHI, a proposed new individual right; (7) A 1-time burden of 6 hours and 55 minutes for each CE to update its policies and procedures due to multiple proposed changes to the Privacy Rule access and disclosure requirements; and; (8) A 1-time burden of 4 hours and 40 minutes for each CE to update the content of its HIPAA training program and a 1-time burden of 7 additional minutes of time spent in training on the right of access per CE due to proposed changes to the right of access and fees for copies of PHI.
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.
Yes
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
Agency Contact:
Sherri Morgan 202 774-3042 sherri.morgan@hhs.gov
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:
03/01/2021
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