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  1. Article ; Online: The Need for Balance in Evaluating Opioid-Prescribing Policies.

    Hoffmann, Diane E

    American journal of public health

    2022  Volume 112, Issue S1, Page(s) S28–S29

    MeSH term(s) Analgesics, Opioid/adverse effects ; Drug Prescriptions ; Humans ; Opioid-Related Disorders/drug therapy ; Opioid-Related Disorders/epidemiology ; Policy
    Chemical Substances Analgesics, Opioid
    Language English
    Publishing date 2022-02-01
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 121100-6
    ISSN 1541-0048 ; 0090-0036 ; 0002-9572
    ISSN (online) 1541-0048
    ISSN 0090-0036 ; 0002-9572
    DOI 10.2105/AJPH.2021.306696
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  2. Article ; Online: Introduction: The Promise and Challenges of Microbiome-Based Therapies.

    Hoffmann, Diane E

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2020  Volume 47, Issue 4, Page(s) 476–481

    MeSH term(s) Clinical Trials as Topic ; Dissent and Disputes ; Fecal Microbiota Transplantation/ethics ; Fecal Microbiota Transplantation/trends ; Female ; Government Regulation ; Humans ; Male ; Microbiota ; Policy ; United States ; United States Food and Drug Administration/legislation & jurisprudence ; Vagina/microbiology
    Language English
    Publishing date 2020-01-20
    Publishing country United States
    Document type Introductory Journal Article
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1177/1073110519897725
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  3. Article ; Online: Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation.

    Goodman, Katherine E / Morgan, Daniel J / Hoffmann, Diane E

    JAMA

    2023  Volume 329, Issue 4, Page(s) 285–286

    MeSH term(s) Liability, Legal ; Medical Device Legislation ; Prejudice/legislation & jurisprudence ; Prejudice/prevention & control ; United States ; Algorithms ; Delivery of Health Care/legislation & jurisprudence ; Delivery of Health Care/methods
    Language English
    Publishing date 2023-01-05
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2022.23870
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  4. Article ; Online: The Woman Who Cried Pain: Do Sex-Based Disparities Still Exist in the Experience and Treatment of Pain?

    Hoffmann, Diane E / Fillingim, Roger B / Veasley, Christin

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2022  Volume 50, Issue 3, Page(s) 519–541

    Abstract: Over twenty years have passed ... ...

    Abstract Over twenty years have passed since
    MeSH term(s) Male ; Humans ; Female ; Chronic Pain/therapy
    Language English
    Publishing date 2022-11-18
    Publishing country England
    Document type Journal Article
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1017/jme.2022.91
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  5. Article ; Online: Reciprocity and Liability Protections during the Covid-19 Pandemic.

    Koch, Valerie Gutmann / Hoffmann, Diane E

    The Hastings Center report

    2021  Volume 51, Issue 3, Page(s) 5–7

    Abstract: During the Covid-19 pandemic, as resources dwindled, clinicians, health care institutions, and policymakers have expressed concern about potential legal liability for following crisis standards of care (CSC) plans. Although there is no robust empirical ... ...

    Abstract During the Covid-19 pandemic, as resources dwindled, clinicians, health care institutions, and policymakers have expressed concern about potential legal liability for following crisis standards of care (CSC) plans. Although there is no robust empirical research to demonstrate that liability protections actually influence physician behavior, we argue that limited liability protections for health care professionals who follow established CSC plans may instead be justified by reliance on the principle of reciprocity. Expecting physicians to do something they know will harm their patients causes moral distress and suffering that may leave lasting scars. Limited liability shields are both appropriate and proportionate to the risk physicians are being asked to take in such circumstances. Under certain narrow circumstances, it remains unclear that the standard of care is sufficiently flexible to protect physicians from liability. Given this uncertainty, the likelihood that physicians would be sued for such an act, and their desire for such immunity, this limited protection is morally legitimate.
    MeSH term(s) COVID-19/epidemiology ; Health Care Rationing/legislation & jurisprudence ; Humans ; Liability, Legal ; Pandemics ; Physicians/legislation & jurisprudence ; SARS-CoV-2 ; Standard of Care/ethics ; Standard of Care/legislation & jurisprudence
    Language English
    Publishing date 2021-05-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 194940-8
    ISSN 1552-146X ; 0093-0334
    ISSN (online) 1552-146X
    ISSN 0093-0334
    DOI 10.1002/hast.1255
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  6. Article ; Online: The DTC microbiome testing industry needs more regulation.

    Hoffmann, Diane E / von Rosenvinge, Erik C / Roghmann, Mary-Claire / Palumbo, Francis B / McDonald, Daniel / Ravel, Jacques

    Science (New York, N.Y.)

    2024  Volume 383, Issue 6688, Page(s) 1176–1179

    Abstract: Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm. ...

    Abstract Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm.
    MeSH term(s) Genetic Testing/standards ; Humans ; Direct-To-Consumer Screening and Testing/standards ; Microbiota/genetics
    Language English
    Publishing date 2024-03-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 128410-1
    ISSN 1095-9203 ; 0036-8075
    ISSN (online) 1095-9203
    ISSN 0036-8075
    DOI 10.1126/science.adk4271
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  7. Article ; Online: Probiotics: Promise, Evidence, and Hope.

    Khoruts, Alexander / Hoffmann, Diane E / Britton, Robert A

    Gastroenterology

    2020  Volume 159, Issue 2, Page(s) 409–413

    MeSH term(s) Digestive System Diseases/diet therapy ; Digestive System Diseases/microbiology ; Digestive System Diseases/prevention & control ; Gastrointestinal Microbiome/physiology ; Humans ; Probiotics/administration & dosage ; Probiotics/adverse effects
    Language English
    Publishing date 2020-06-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80112-4
    ISSN 1528-0012 ; 0016-5085
    ISSN (online) 1528-0012
    ISSN 0016-5085
    DOI 10.1053/j.gastro.2020.05.058
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  8. Article ; Online: The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.

    Khoruts, Alexander / Hoffmann, Diane E / Palumbo, Francis B

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2020  Volume 47, Issue 4, Page(s) 482–504

    Abstract: In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota ... ...

    Abstract In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation.
    MeSH term(s) Biological Products ; Clostridium Infections/therapy ; Drug Approval/legislation & jurisprudence ; Drugs, Investigational/therapeutic use ; Fecal Microbiota Transplantation ; Government Regulation ; History, 20th Century ; History, 21st Century ; Humans ; Orphan Drug Production ; Policy Making ; United States ; United States Food and Drug Administration/legislation & jurisprudence
    Chemical Substances Biological Products ; Drugs, Investigational
    Language English
    Publishing date 2020-01-20
    Publishing country United States
    Document type Historical Article ; Journal Article
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1177/1073110519897726
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  9. Article ; Online: Probiotics and the Microbiome-How Can We Help Patients Make Sense of Probiotics?

    Britton, Robert A / Hoffmann, Diane E / Khoruts, Alexander

    Gastroenterology

    2020  Volume 160, Issue 2, Page(s) 614–623

    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 ... ...

    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. These developments have provided a boost to the probiotics industry, which continues to experience exponential growth driven mainly by creative marketing. Consumers, patients, and most health care providers are not able to discern the underlying science or differentiate the permitted claims that promise vague health benefits from disease-specific claims reserved for drugs. No probiotic product has been able to satisfy the regulatory requirements to be categorized as a drug, a substance intended to cure, mitigate, or prevent disease. However, patients take probiotic products in the belief that they will help to treat their intestinal or systemic diseases. Thus far, the regulators have failed to create policies that would assist to inform the public in this area. In fact, the existing regulatory regime actually creates formidable barriers to research that could provide evidence for clinical efficacy of probiotic products. We propose a potential solution to this vexing problem, where a committee created through a partnership of academia, professional organizations, and industry, but free of potential conflicts of interest, would be charged with rigorous evaluation of specific probiotic products and the evidence in support of their different claims. Companies that would submit to this process would earn the trust of consumers and healthcare providers, as well as a distinction in the marketplace.
    MeSH term(s) Biomedical Research/economics ; Biomedical Research/legislation & jurisprudence ; Dietary Supplements/standards ; Drug Industry/economics ; Drug Industry/legislation & jurisprudence ; Gastrointestinal Microbiome/drug effects ; Gastrointestinal Microbiome/physiology ; Humans ; Legislation, Drug/economics ; Legislation, Drug/standards ; Probiotics/pharmacology ; Probiotics/standards ; Probiotics/therapeutic use
    Language English
    Publishing date 2020-12-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80112-4
    ISSN 1528-0012 ; 0016-5085
    ISSN (online) 1528-0012
    ISSN 0016-5085
    DOI 10.1053/j.gastro.2020.11.047
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  10. Article: Teaching health law. A health law practice workshop: bridging externship placements and the classroom.

    Hoffmann, Diane E

    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

    2009  Volume 37, Issue 3, Page(s) 513–518

    MeSH term(s) Education, Professional ; Health Services Administration/legislation & jurisprudence ; Humans ; Jurisprudence ; Teaching/methods ; United States
    Language English
    Publishing date 2009
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1168812-9
    ISSN 1748-720X ; 1073-1105 ; 0277-8459
    ISSN (online) 1748-720X
    ISSN 1073-1105 ; 0277-8459
    DOI 10.1111/j.1748-720X.2009.00412.x
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