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
01/06/2025
Requested
Previously Approved
36 Months From Approved
07/31/2027
1,202,562,864
1,154,350,069
925,144,026
953,982,239
163,499,411
163,499,411
The individually identifiable health information collected is used by patients and by more than 800,000 covered entities and 1,000,000 business associates affected by the HIPAA Privacy, Security, and Breach Notification Rules. The information is routinely used by covered entities and business associates 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
PL: Pub.L. 116 - 136 3221 Name of Law: Coronavirus Aid, Relief, and Economic Security Act
As a result of proposed program changes that would establish new requirements, the Department added new estimated burdens, as follows:
(1) For each regulated entity to conduct a Security Rule compliance audit.
(2) For each business associate (including each subcontractor) to provide verification of compliance with technical safeguards.
(3) For each regulated entity to obtain verification of business associatesâ and subcontractorsâ compliance with technical safeguards.
(5) For each regulated entity to provide notification to other regulated entities of workforce members' termination of access to ePHI.
(6) For each regulated entity to deploy multi-factor authentication.
(7) For each regulated entity to perform network segmentation.
(8) For approximately 75 percent of regulated entities to disable unused ports and remove extraneous software.
(9) For each regulated entity to conduct penetration testing.
(10) For each regulated entity to notify covered entities or business associates, as applicable, upon activation of a contingency plan.
(11) For each insurer and third-party administrator to update health plan documents.
(12) For each regulated entity to update the content of its cybersecurity awareness and Security Rule training program.
(13) For each regulated entity to update its policies and procedures.
(14) For each regulated entity to update business associate agreements.
(15) For each health plan sponsor that has access to ePHI to implement the Security Ruleâs administrative, physical, and technical safeguards in their relevant electronic information systems.
In addition, the Department is making updates and adjustments to certain estimates. The Department has revised the estimated annual burdens of compliance by:
(1) Increasing the number of covered entities from 774,331 to 822,600.
(2) Updating hourly wage rates from 2022 to 2023 rates.
(3) Decreasing the number of respondents requesting exceptions to state law preemption under 45 CFR 160.204 from 27 to 1 to return to the previous baseline of 1 request per year.
(4) Decreasing the estimated hourly burden for a business associate to report security incidents (other than breaches) to a covered entity from 20 hours per monthly report to 10 hours per monthly report.
(5) Increasing the estimated number of disclosures for research from approximately 147,000 to 153,857.
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.
2024_12_18_HIPAA Security Rule NPRM_ICR_Supporting_Statement.docx
Notification of Contingency Plan Activation - Health Plan Sponsors