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Full-Text Articles in Law
Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz
Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz
Diane Hoffmann
In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …
Health Claim Regulation Of Probiotics In The Usa And The Eu: Is There A Middle Way?, Diane Hoffmann
Health Claim Regulation Of Probiotics In The Usa And The Eu: Is There A Middle Way?, Diane Hoffmann
Diane Hoffmann
In both the USA and Europe, supermarkets and pharmacies are brimming with probiotics—products containing live micro-organisms claiming they improve health. The availability of these products corresponds to a growing consumer demand for foods that improve or maintain health and wellness. The most persuasive include claims that consumption may confer health benefits. While some of these claims may have merit, others have not been substantiated. For a number of products, claims are based on insufficient research, underpowered studies, or mixed research results, yet individual consumers find that the product is of benefit to them. In attempting to regulate health claims, as …
Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel
Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel
Diane Hoffmann
This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.
Legal Impediments To The Diffusion Of Telemedicine, Diane E. Hoffmann, Virginia Rowthorn
Legal Impediments To The Diffusion Of Telemedicine, Diane E. Hoffmann, Virginia Rowthorn
Diane Hoffmann
No abstract provided.
Proxy Consent To Participation Of The Decisionally Impaired In Medical Research - Maryland's Policy Initiative, Diane E. Hoffmann
Proxy Consent To Participation Of The Decisionally Impaired In Medical Research - Maryland's Policy Initiative, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg
Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg
Diane Hoffmann
The use of DNA tests for identification has revolutionized court proceedings in criminal and paternity cases. Now, requests by litigants to admit or compel a second generation of genetic tests – tests to confirm or predict genetic diseases and conditions – threaten to affect judicial decision-making in many more contexts. Unlike DNA tests for identification, these second generation tests may provide highly personal health and behavioral information about individuals and their relatives and will pose new challenges for trial court judges. This article reports on an original empirical study of how judges analyze these requests and uses the study results …
The Influence Of Law And Lawyers On Patient Care, Diane E. Hoffmann
The Influence Of Law And Lawyers On Patient Care, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
Physicians Who Break The Law, Diane E. Hoffmann
Physicians Who Break The Law, Diane E. Hoffmann
Diane Hoffmann
This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …
Treating Pain V. Reducing Drug Diversion And Abuse: Recalibrating The Balance In Our Drug Control Laws And Policies, Diane E. Hoffmann
Treating Pain V. Reducing Drug Diversion And Abuse: Recalibrating The Balance In Our Drug Control Laws And Policies, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
The Maryland Health Care Decisions Act: Achieving The Right Balance?, Diane E. Hoffmann
The Maryland Health Care Decisions Act: Achieving The Right Balance?, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
The Biotechnology Revolution And Its Regulatory Evolution, Diane E. Hoffmann
The Biotechnology Revolution And Its Regulatory Evolution, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
Building Public Health Law Capacity At The Local Level, Diane Hoffmann, Virginia Rowthorn
Building Public Health Law Capacity At The Local Level, Diane Hoffmann, Virginia Rowthorn
Diane Hoffmann
No abstract provided.
Introduction To The Tenth Anniversary Issue Of The Journal Of Health Care Law & Policy , Karen H. Rothenberg, Diane E. Hoffmann
Introduction To The Tenth Anniversary Issue Of The Journal Of Health Care Law & Policy , Karen H. Rothenberg, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
When Should Judges Admit Or Compel Genetic Tests?, Diane Hoffmann, Karen Rothenberg
When Should Judges Admit Or Compel Genetic Tests?, Diane Hoffmann, Karen Rothenberg
Diane Hoffmann
No abstract provided.
Emergency Care And Managed Care - A Dangerous Combination, Diane E. Hoffmann
Emergency Care And Managed Care - A Dangerous Combination, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz
Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz
Diane Hoffmann
No abstract provided.
The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian
The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian
Diane Hoffmann
In general, women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively. The authors investigate this paradox from two perspectives: Do men and women in fact experience pain differently - whether biologically, cognitively, and/or emotionally? And regardless of the answer, what accounts for the differences in the pain treatment they receive, and what can we do to correct this situation?
Achieving Quality And Responding To Consumers - The Medicare Beneficiary Complaint Process: Who Should Respond?, Diane E. Hoffmann, Virginia Rowthorn
Achieving Quality And Responding To Consumers - The Medicare Beneficiary Complaint Process: Who Should Respond?, Diane E. Hoffmann, Virginia Rowthorn
Diane Hoffmann
No abstract provided.
Are Health Care Conflicts All That Different? A Contrarian View, Diane E. Hoffmann
Are Health Care Conflicts All That Different? A Contrarian View, Diane E. Hoffmann
Diane Hoffmann
No abstract provided.
Medical Marijuana And The Law, Diane Hoffmann, Ellen Weber
Medical Marijuana And The Law, Diane Hoffmann, Ellen Weber
Diane Hoffmann
No abstract provided.
Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg
Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg
Diane Hoffmann
No abstract provided.