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Articles by Diane Hoffmann
Evaluating the analytical performance of direct-to-consumer gut microbiome testing services - Communications Biology
Abstract Consumer interest in personal microbiome health has given rise to numerous direct-to-consumer (DTC) microbiome testing services despite questions regarding their analytical and clinical validity, and consumer safety. These tests straddle the line between more strictly regulated medical devices and minimally regulated general health and wellness products; a distinction that may not be readily apparent to consumers.
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While the use of race in algorithms for clinical decision-making has received attention in legal scholarship, the use of sex, another protected class, has been largely ignored, despite being commonly used in many algorithms. During the COVID-19 pandemic, men were more likely to be hospitalized and to die than women. This was true across geography and age.
Evaluating the Analytical Performance of Direct-to-Consumer Gut Microbiome Testing Services
Abstract Consumer interest in personal microbiome health has given rise to numerous direct-to-consumer (DTC) microbiome testing services despite questions regarding their analytical and clinical validity, and consumer safety. These tests straddle the line between more strictly regulated medical devices and minimally regulated general health and wellness products; a distinction that may not be readily apparent to consumers.
The DTC microbiome testing industry needs more regulation
Policy Forum Biomedical Technology Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm Diane E. Hoffmann dhoffmann@law.umaryland.edu, Erik C. von Rosenvinge, [...] , Mary-Claire Roghmann, Francis B. Palumbo, [...] , Daniel McDonald, and Jacques Ravel+3 authors +1 authors fewerAuthors Info & Affiliations Abstract A growing body of research has suggested the potential for improving human health by better understanding the human microbiome.
The DTC microbiome testing industry needs more regulation
Published In Science Volume 383 | Issue 6688 15 March 2024 Article versions Submission history Published in print: 15 March 2024 Permissions Request permissions for this article. We thank the members of the DTC microbiome-based testing working group for their valuable contributions to the conceptualization of this article. Members of the working group are listed at ().
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The DTC microbiome testing industry needs more regulation Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm By DIANE E. HOFFMANN , ERIK C. VON ROSENVINGE, MARY-CLAIRE ROGHMANN, FRANCIS B. PALUMBO, DANIEL MCDONALD, AND JACQUES RAVEL A growing body of research has suggested the potential for improving human health by better understanding the human microbiome.
Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation
January 5, 2023 JAMA. Published online January 5, 2023. doi:10.1001/jama.2022.23870 Clinical algorithms are ubiquitous across modern medicine and US health care delivery. Complex, automated algorithms such as sepsis alert systems have received recent high-profile attention,1 but clinical algorithms also encompass simpler prediction models, risk calculators, and clinical scoring rules.
Legal Challenges To Allocating New COVID-19 Antibody Therapies To Those Who Need Them Most
The Food and Drug Administration’s (FDA’s) emergency use authorization (EUA) of two new COVID-19 monoclonal antibody treatments could soon bring some welcome relief for the alarming surge in COVID-19 hospitalization rates throughout the country. For the first time since the pandemic began, doctors now have treatments that—if given within the first few days of infection—may prevent some hospitalizations and perhaps even deaths.
Probiotics and the Microbiome: How can we help patients make sense of probiotics?
This paper is only available as a PDF. To read, Please Download here. Abstract The notion of probiotics as microbes that confer health benefits has its origins in the speculative ideas that are more than a century old, yet remain largely unsubstantiated by scientific evidence. The recent advances in microbiome science have highlighted the importance of intestinal microbes in human physiology and disease pathogenesis.
Probiotics: promise, evidence, and hope
AGA Clinical Practice Guidelines on the Role of Probiotics in the Management of Gastrointestinal Disorders
Why Do Most Churches Not Talk About the End Times?
shutterstock.com It is indeed amazing how few churches teach or preach on the end times. Yet, many church goers and unchurched ask questions about it, especially now, as we see the chaos and frightening events taking place increasingly around us. According to write-ups on the question of why most churches don’t talk about the end times, there are diversified reasons given. Some churches don’t take the Bible literally, particularly on the topics of prophecies and end-times.
Improving regulation of microbiota transplants
The Human Microbiome Project and similar research has generated great interest in potential health benefits of microbiota transplantations (MTs). The use of fecal microbiota transplantation (FMT), the transfer of stool from a human donor to a human recipient, for recurrent Clostridium difficile infection (CDI) is considered by many to be standard-of-care therapy, and data on its safety and effectiveness are accumulating (1–3).
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