Author: Jon Merz
Date: 04-05-04 13:05
Source:
URL: http://
Date published: April 5th 2004
This came across my e-mail today. It\'s posted with permission of Thompson
Publishing.
Doc Muhlbaier
Duke
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SACHRP Considers Recommending HIPAA Changes
The Department of Health and Human Services (HHS) Secretary\'s Advisory
Committee on Human Research Protections (SACHRP) will consider a number of
recommendations to improve and clarify the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) privacy rule requirements for research at
its meeting in July.
SACHRP considered approving five recommendations proposed by the Association
of American Medical Colleges (AAMC) at its meeting March 30 but decided
instead to further develop those recommendations along with recommendations
made by the National Committee on Vital and Health Statistics (NCVHS).
SACHRP\'s recommendations would be sent to HHS Secretary Tommy Thompson, who
could forward them to the HHS Office for Civil Rights and Office for
Research Protections for action.
The five AAMC recommendations are:
(1) Eliminate the requirement for authorizations and waivers for research in
cases where there is informed consent and institutional review board (IRB)
approval.
(2) Harmonize the HIPAA and Common Rule requirements regarding research
disclosures.
(3) Relax the de-identification standard.
(4) Eliminate accounting of disclosures for research.
(5) Shift from an organizational to a functional focus for the standards and
requirements.
The NCVHS sent six recommendations for HIPAA changes to Thompson earlier
this month. Two of those recommendations dealt with research:
(1) HHS should make further efforts to harmonize the privacy rule with the
protection of human subjects rule.
(2) HHS should clarify that the privacy rule neither requires nor precludes
IRB review of stand-alone authorizations for use or disclosure of protected
health information for research.
Complete coverage of SACHRP meetings can be found in the Guide to Good
Clinical Practice. For more information about the Guide, go to:
http://www.thompson.com/libraries/fooddrug/clin/index.html .
Copyright 2004 Thompson Publishing Group, Inc. All rights reserved.
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