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IRBs and institutions might take away two important thoughts from the NIHs recent experience: First, it doesnt take more than the appearance of a conflict to harm ones reputation. Secondly, some of the measures NIH has taken in response might guide institutions in their own conflict of interest (COI) policy-making.
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The regulations regarding the use of prisoners in research have not changed since 1978, but the research communitys awareness and perception of these have changed. As a result its a good idea for IRBs to update policies regarding such research.
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Bernard Schwetz to head OHRP.
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Add up the number of citations of noncompliance related to IRB issues that the Office of Human Research Protections (OHRP) at the Department of Health and Human Services in Rockville, MD, handed out between October 1998 and June 2002 and the numbers are pretty staggering. Of the 1,120 citations given to 155 institutions, 1,014 of them say something about IRB noncompliance and deficiencies.
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The Department of Health and Human Services extended for one year the Sept. 16, 2004, expiration date for an interim final rule establishing procedures for imposition of civil money penalties on entities that violate HIPAA administrative simplification standards.
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Thinking creatively, but not expensively, is the key to meeting HIPAA requirements with a limited budget, according to Maria Woods, vice president for compliance and regulatory affairs at Saint Vincent Catholic Medical Centers of New York, who spoke at the Ninth Annual HIPAA Summit in September.
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The discussion of call centers that began in the October Hospital Access Management continues this month with some follow-up questions posed by Gillian Cappiello, CHAM, senior director of access services and chief privacy officer for Swedish Covenant Hospital in Chicago on staff training, balancing call workload, and other issues.
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The term black belt, taken from the concepts of martial arts, describes an expertise level pertaining to Six Sigma.
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Medicare continues to work closely with contractors, providers, billing agents, clearinghouses, and software vendors to achieve HIPAA goals and will be making greater use of the Internet and working on implementation of electronic attachments to electronic medical records.
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Centers for Medicare & Medicaid Services Office of HIPAA Standards staffer Dianne Faup says the agency has received more than 200 transaction/code set complaints, with some 58 still open at the time of her September presentation to the Ninth Annual HIPAA Summit.