Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

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, will submit 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 0955-0002, scheduled to expire on October 31, 2012. 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 November 19, 2012.

ADDRESSES:

Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395-5806. See SUPPLEMENTARY INFORMATION for other information about submitting comments.

FOR FURTHER INFORMATION CONTACT:

Information Collection Clearance staff, Information.CollectionClearance@hhs.gov, (202) 690-6162.

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the OMB control number 0955-0002 and document identifier HHS-OS-17657-30D for reference.

Information Collection Request Title: Facts for Consumers about Health IT Service Providers.

OMB No.: 0955-0002.

Abstract: ONC is proposing to revise current OMB approved Facts for Consumers about Health IT Service Providers. The current OMB approval is applicable through October 31, 2012. It includes iterative rounds of in-depth consumer testing to assess and analyze consumer understanding and input about a model privacy notice for personal health records (PHRs). ONC intends to revise the project to use the same focus group and cognitive usability interview testing process for the development of a model notice of privacy practices (NPP).

Need and Proposed Use of the Information: 45 CFR 164.520 requires covered entities to make available a NPP for protected health information to their patients or health plan members. The notice must, among other things, outline the purposes for which the covered entity is permitted to use and disclose health information, the rights of individuals with respect to their health information, the entities' duties to protect that information, and the process for filing a complaint concerning possible violations of the HIPAA Privacy Rule, such as an improper use or disclosure of information. 45 CFR 164.520 requires that the notice be written in plain language, but studies have shown that these notices are often difficult for patients to understand due to their length and complexity.

The Federal Health IT Strategic Plan identifies the Fair Information Practice Principles (FIPPS) an important guidepost in the development of privacy policies and programs. Openness and Transparency is a key principle of fair information practices. The NPP is an important component of fulfilling this principle. If patients cannot adequately understand the notice because of its length or complexity, then the use and disclosure of their health information is not open and transparent.

In addition, each participant will have been recruited through a 15-minute screening interview. The participants will be recruited according to U.S. census statistics for race/ethnicity, age, marital status, gender, and income.

Likely Respondents: Respondents to this information collection are members of the General Public.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.