[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Page 9570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-776]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


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

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

ACTION:  Notice of audio conference.

-----------------------------------------------------------------------

SUMMARY: 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 http://www.academyhealth.org/ahrq/psoaudio/.

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

ADDRESSES: The proposed regulation can be viewed on the Federal 
eRulemaking Portal at http://www.regulations.gov/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: http://www.regulations.gov/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.

FOR FURTHER INFORMATION CONTACT: Ellen Crown, Agency for Healthcare 
Research and Quality, 301-427-1258 or [email protected].
SUPPLEMENTARY INFORMATION: 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.

    Dated: February 13, 2008.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 08-776 Filed 2-20-08; 8:45am]
BILLING CODE 4160-90-M