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Office for Civil Rights: Audio Conference on Proposed Regulations Related to Patient Safety

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Agency for Healthcare Research and Quality, HHS; Office for Civil Rights, HHS.


Notice of audio conference.


The U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality Director Dr. Carolyn Clancy and Office for Civil Rights Deputy Director of Health Information Privacy Susan McAndrew will host a joint audio conference February 29, 2008 from 2-3 p.m. (Eastern Standard Time) to discuss the recently published proposed regulation regarding Patient Safety and Quality Improvement and statutory confidentiality protections. The purpose of this audio conference is to facilitate public understanding of the proposed regulation and rulemaking process outlined in the Notice of Proposed Rulemaking published in the Federal Register February 12, 2008. To register for the audio conference, log on to​ahrq/​psoaudio/​.


The live audio conference will be Feb. 29 from 2-3 p.m. (Eastern Standard Time).


The proposed regulation can be viewed on the Federal eRulemaking Portal at​fdmspublic/​ContentViewer?​objectId=​09000064803acce8&​disposition=​attachment&​contentType=​html.

The audio conference is open to everyone; however, discussions during this forum will not be included in official public comments.

Public comment on the proposed regulations will be accepted through April 14, 2008.

Comments can be submitted by any of the following methods: Federal eRulemaking Portal:​fdmspublic/​component/​main?​main=​SubmitComment&​o=​09000064803acce8.

Comments should include the agency name (Agency for Healthcare Research and Quality and/or Office for Civil Rights) and RIN 0919-AA01.

Mail/Hand Delivery/Courier: Center for Quality Improvement and Patient Safety, Attention: Patient Safety Act Notice of Proposed Rulemaking Comments, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, Maryland 20850.

Comments sent by facsimile (FAX) transmission or electronic mail will not be accepted.

Comments received through the eRulemaking Portal can be viewed online at either of the Web sites listed above. All comments received through the eRulemaking Portal, mail, and hand delivery/courier are available for public inspection at the AHRQ Information Resources Center, which is located at 540 Gaither Road, Rockville, Maryland 20850. The Information Resources Center is open from 8:30 a.m. to 5 p.m. Eastern Standard Time, Monday through Friday.

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Ellen Crown, Agency for Healthcare Research and Quality, 301-427-1258 or

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Under the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), the Secretary is authorized to list Patient Safety Organizations (PSOs), organizations that will work with providers to collect and analyze patient safety related data. The Statute sets forth and the recently published proposed regulation explains certifications that must be submitted by entities in order to be listed as PSOs. PSOs will provide analysis of data and feedback to providers to assist them in improving patient safety.

The Patient Safety Act protects the confidentiality of data shared by providers prepared by the PSO as well as other related materials, defined in the statute and proposed regulations. This legal protection of information addresses significant barriers that currently exists—the fear of legal liability or sanctions that can result from reporting a patient safety event. Strong confidentiality provisions are key to encouraging voluntary reporting, and facilitating the aggregation of large volumes of data which in turn aids in identifying patterns of patient safety events. Under the Patient Safety Act, the imposition of civil monetary penalties is authorized for breaches of its confidentiality provisions. The confidentiality protections of patient safety information are to be implemented in a way that does not interfere with other health care reporting obligations of providers, e.g., under State or local laws.

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Dated: February 13, 2008.

Carolyn M. Clancy,

AHRQ, Director.

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[FR Doc. 08-776 Filed 2-20-08; 8:45am]