AGENCY:
Office of the Secretary, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0945-0003, scheduled to expire on January 1, 2017. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
DATES:
Comments on the ICR must be received on or before June 20, 2016.
ADDRESSES:
Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION:
When submitting comments or requesting information, please include the OMB control number 0945-0003-30D for reference.
Proposed Project: HIPAA Privacy, Security, and Breach Notification Rules, and Supporting Regulations Contained in 45 CFR parts 160 and 164.
Abstract: This revision does not change any requirements of the HIPAA Privacy, Security, and Breach Notification Rules. Among other updates summarized below, the ICR requests to rename the information collection and incorporate into it the substance of two other information collections (#0945-0004, set to expire on May 31, 2016; and #0945-0001, expiring on September 30, 2016), which then would be discontinued. The ICR addresses the burden on regulated entities for compliance with the information collection requirements of the HIPAA Privacy, Security, and Breach Notification Rules; the voluntary burden on members of the public for obtaining information from covered entities regarding breaches of their protected health information; and the information collection burden on the Office for Civil Rights (OCR) associated with administering aspects of the HIPAA Breach Notification program. Combining the three existing information collections identified above will allow the regulated community, the public, and OCR to more easily view and track the estimated burdens associated with the HIPAA Rules that are administered and enforced by OCR. In addition to combining the ICRs, the proposed updates take into account our experience administering the Rules to more accurately reflect the burdens of compliance with the applicable regulatory requirements; remove the estimated burden of initial compliance with the Omnibus HIPAA Final Rule, because we are well past the compliance dates; and incorporate increases in wages for the job categories that we expect to be involved in compliance activities.
Estimated Annualized Burden Table
| Section | Type of respondent | Number of respondents | Number of responses per respondent | Average burden hours per response | Total burden hours |
|---|---|---|---|---|---|
| 160.204 | Process for Requesting Exception Determinations (states or persons) | 1 | 1 | 16 | 16 |
| 164.308 | Risk Analysis—Documentation | 1,700,000 | 1 | 10 | 17,000,000 |
| 164.308 | Information System Activity Review—Documentation | 1,700,000 | 12 | .75 | 15,300,000 |
| 164.308 | Security Reminders—Periodic Updates | 1,700,000 | 12 | 1 | 20,400,000 |
| 164.308 | Security Incidents (other than breaches)—Documentation | 1,700,000 | 52 | 5 | 442,000,000 |
| 164.308 | Contingency Plan—Testing and Revision | 1,700,000 | 1 | 8 | 13,600,000 |
| 164.308 | Contingency Plan—Criticality Analysis | 1,700,000 | 1 | 4 | 6,800,000 |
| 164.310 | Maintenance Records | 1,700,000 | 12 | 6 | 122,400,000 |
| 164.314 | Security Incidents—Business Associate reporting of incidents (other than breach) to Covered Entities | 1,000,000 | 12 | 20 | 240,000,000 |
| 164.316 | Documentation—Review and Update | 1,700,000 | 1 | 6 | 10,200,000 |
| 164.404 | Individual Notice—Written and Email Notice (drafting) | 58,481 | 1 | .5 | 29,240 |
| 164.404 | Individual Notice—Written and Email Notice (preparing and documenting notification) | 58,481 | 1 | .5 | 29,240 |
| 164.404 | Individual Notice—Written and Email Notice (processing and sending) | 58,481 | 353 | .008 | 165,150 |
| 164.404 | Individual Notice—Substitute Notice (posting or publishing) | 2,746 | 1 | 1 | 2,746 |
| 164.404 | Individual Notice—Substitute Notice (staffing toll-free number) | 2,746 | 1 | 5.75 | 15,789 |
| 164.404 | Individual Notice—Substitute Notice (individuals' voluntary burden to call toll-free number for information) | 11,326,440 | 1 | .125 | 1,415,805 |
| 164.406 | Media Notice | 267 | 1 | 1.25 | 333 |
| 164.408 | Notice to Secretary (notice for breaches affecting 500 or more individuals) | 267 | 1 | 1.25 | 333 |
| 164.408 | Notice to Secretary (notice for breaches affecting fewer than 500 individuals) | 58,215 | 1 | 1 | 58,215 |
| 164.414 | 500 or More Affected Individuals (investigating and documenting breach) | 267 | 1 | 50 | 13,350 |
| 164.414 | Less than 500 Affected Individuals (investigating and documenting breach) | 2,479 (breaches affecting 10-499 individuals) | 1 | 8 | 19,832 |
| 55,736 (breaches affecting <10 individuals) | 1 | 4 | 222,944 | ||
| 164.504 | Uses and Disclosures—Organizational Requirements | 700,000 | 1 | 5/60 | 58,333 |
| 164.508 | Uses and Disclosures for Which Individual authorization is required | 700,000 | 1 | 1 | 700,000 |
| 164.512 | Uses and Disclosures for Research Purposes | 113,524 | 1 | 5/60 | 9,460 |
| 164.520 | Notice of Privacy Practices for Protected Health Information (health plans—periodic distribution of NPPs by paper mail) | 100,000,000 | 1 | 0.25 minutes [1 hour per 240 notices] | 416,667 |
| 164.520 | Notice of Privacy Practices for Protected Health Information (health plans—periodic distribution of NPPs by electronic mail) | 100,000,000 | 1 | 0.167 minutes [1 hour per 360 notices] | 278,333 |
| 164.520 | Notice of Privacy Practices for Protected Health Information (health care providers—dissemination and acknowledgement) | 613,000,000 | 1 | 3/60 | 30,650,000 |
| 164.522 | Rights to Request Privacy Protection for Protected Health Information | 20,000 | 1 | 3/60 | 1,000 |
| 164.524 | Access of Individuals to Protected Health Information (disclosures) | 200,000 | 1 | 3/60 | 10,000 |
| 164.526 | Amendment of Protected Health Information (requests) | 150,000 | 1 | 5/60 | 12,500 |
| 164.526 | Amendment of Protected Health Information (denials) | 50,000 | 1 | 5/60 | 4,166 |
| 164.528 | Accounting for Disclosures of Protected Health Information | 5,000 | 1 | 3/60 | 250 |
| Total | 921,813,702 |
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2016-11785 Filed 5-18-16; 8:45 am]
BILLING CODE 4153-01-P