06-5226. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Agency for Healthcare Research and Quality, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection as part of an AHRQ contract for “Privacy and Security Solutions for Interoperable Electronic Health Information Exchange” (the Assessment). In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ is submitting a request to OMB for emergency review.

AHRQ is requesting an emergency review of this collection because the information is needed for subsequent health information technology projects later this year. Because subcontracts were solicited and awarded to the States, it was not possible to accurately quantify the public burden earlier this year. Data collection subcontract proposals were solicited from States and until they were reviewed, selected, awarded and accepted, it was not possible to accurately quantify the public burden earlier.

DATES:

Comments on this notice must be received by July 7, 2006.

ADDRESSES:

Written comments should be submitted to John Kraemer, Human Resources and Housing Branch, Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, Washington, DC 20503, [phone].

Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ clearance officer, Doris Lefkowitz, 540 Gaither Road, Suite 5036, Rockville, MD 20850, [phone].

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ, Reports Clearance Officer, 540 Gaither Road, Suite 5036, Rockville, MD 20850, [phone].

SUPPLEMENTARY INFORMATION:

Proposed Project

The Assessment Plan

Regulations promulgated pursuant to the Health Insurance Portability and Accountability Act (HIPAA) established baseline privacy requirements for protected health information and security requirements for protected health information. Many States, institutions, and health care providers have adopted policies that go beyond HIPAA. The manner in which hospitals, physicians, and other health care organizations implement security and privacy policies varies and is tailored to meet their individual organizations' needs. These variations in policies present challenges for widespread electronic health information exchange.

The proposed data collection is the foundational part of a project under AHRQ's Assessment contract. The project seeks to: Identify variations in privacy and security practices and laws affecting electronic health information exchange; learn about and develop best practices and proposed solutions to address identified challenges; and increase expertise in communities about health information privacy and security protections. The project, being managed by RTI International and the National Governors Association, is a public-private collaboration. The contractor will work with up to 33 States and Puerto Rico to assess variations in organization-level business policies and practices, and the underlying laws that affect the electronic exchange of health information, identify and propose practical solutions while preserving privacy and meeting security concerns addressed in applicable Federal and State laws, and develop detailed plans to implement solutions. RTI International, a private, nonprofit corporation, was selected as the contract recipient to conduct this study.

The use of health information technology (IT) and the adoption of electronic health records (EHRs) are intended to enable health information to follow patients throughout their care in a seamless and secure manner. Widespread use of EHRs offers a unique means of improving quality, lowering health care costs, and preventing medical errors which contribute to the deaths of between 50,000 and 100,000 Americans per year.

This privacy and security assessment project is a key part of the Department of Health and Human Services' health IT plan to accomplish the President's initiative to foster and accelerate widespread use of electronic health records. Information collected by this effort is critical for the advancement of health IT and will be used to achieve the goal of developing seamless and secure electronic health records nationwide.

Methods of Collection

Participation in the Assessment will be fully voluntary and non-participation will have no affect on eligibility for, or receipt of, future AHRQ health services research support or on future opportunities to participate in research or to obtain informative research results. In each of the 33 States and Puerto Rico, 15 meetings will be held with stakeholder groups. Each group will have approximately 25 participants who will represent providers of health services, entities supporting health delivery systems, public health agencies, patients, individual consumers, and consumer groups. During these stakeholder meetings, participants will discuss different “scenarios” describing practical examples of health information exchanges (e.g., patient care, emergency/disaster response, payments, research, compliance with mandatory statutory reporting, law enforcement requests for information, etc.). The objective of these meetings is to identify and assess the affect of organization-level business policies and practices that promote or pose challenges to health information exchange.

Estimated Annual Respondent Burden

Type of research activity	Number of respondents	Estimated time per respondent (hours)	Total burden hours
Stakeholder Meetings	12,750	3	38,250
Total	12,750	3	38,250

Estimated Costs to the Federal Government

Expenses (equipment, overhead, printing and support staff) will be incurred by AHRQ components as part of their normal operating budgets. No additional cost to the Federal Government is anticipated.

Request for Comments

In accordance with the above-cited Paperwork Reduction Act, comments on the AHRQ information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of AHRQ, including whether the information will have practical utility; (b) the accuracy of the AHRQ's estimate of burden (including hours and cost) of the proposed collection of information; and (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques of other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Dated: June 2, 2006.

Carolyn M. Clancy,

Director.