Law Commons^™

Law Library Blog (March 2023): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

Human-Centered Design To Address Biases In Artificial Intelligence, Ellen W. Clayton, You Chen, Laurie L. Novak, Shilo Anders, Bradley Malin

Vanderbilt Law School Faculty Publications

The potential of artificial intelligence (AI) to reduce health care disparities and inequities is recognized, but it can also exacerbate these issues if not implemented in an equitable manner. This perspective identifies potential biases in each stage of the AI life cycle, including data collection, annotation, machine learning model development, evaluation, deployment, operationalization, monitoring, and feedback integration. To mitigate these biases, we suggest involving a diverse group of stakeholders, using human-centered AI principles. Human-centered AI can help ensure that AI systems are designed and used in a way that benefits patients and society, which can reduce health disparities and inequities. …

Strengthening A One Health Approach To Emerging Zoonoses, Samira Mubareka, John Amuasi, Arinjay Banerjee, Hélène Carabin, Joe Copper Jack, Claire Jardine, Bogdan Jaroszewicz, Greg Keefe, Jonathon Kotwa, Susan Kutz, Deborah Mcgregor, Anne Mease, Lily Nicholson, Katarzyna Nowak, Brad Pickering, Maureen Reed, Johanne Saint-Charles, Katarzyna Simonienko, Trevor Smith, J. Scott Weese, E. Jane Parmley

Articles & Book Chapters

Given the enormous global impact of the COVID-19 pandemic, outbreaks of highly pathogenic avian influenza in Canada, and manifold other zoonotic pathogen activity, there is a pressing need for a deeper understanding of the human-animal-environment interface and the intersecting biological, ecological, and societal factors contributing to the emergence, spread, and impact of zoonotic diseases. We aim to apply a One Health approach to pressing issues related to emerging zoonoses, and propose a functional framework of interconnected but distinct groups of recommendations around strategy and governance, technical leadership (operations), equity, education and research for a One Health approach and Action Plan …

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Concordance Of International Regulation Of Pediatric Health Research, Ellen W. Clayton, Mark A. Rothstein Jd, Et Al.

Vanderbilt Law School Faculty Publications

International, multi-site, pediatric health research has shown great promise by vastly increasing the amount and heterogeneity of biospecimens and clinical records. However, considerable impediments are created by the significant costs and delays associated with obtaining regulatory approval in numerous countries, which is often complicated by varying and sometimes opaque research ethics standards and procedures. Although it is unlikely that the global community could reach consensus on a single set of research ethics policies and procedures, voluntary policy pronouncements by countries agreeing to defer to the approval of research ethics bodies in other countries might be a way forward.

Deference is …

Law School News: Professor Of The Year 2022: Brittany Reposa 05/19/2022, Michael M. Bowden

Life of the Law School (1993- )

No abstract provided.

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Law School News: Professor Of The Year 2021: Brittany Raposa 05/20/2021, Michael M. Bowden

Life of the Law School (1993- )

No abstract provided.

The Ethics Of Research That May Disadvantage Others, Christopher Robertson

Faculty Scholarship

In prospective interventional research, a treatment may provide an advantage for the recipient over other humans not receiving it. If the intervention proves successful, the treated are better able to compete for a scarce ventilator, a class grade, or a litigation outcome, potentially risking the deaths, jobs, or incomes of non-treated persons. The concerns for “bystanders” have typically focused on direct harms (e.g., infecting them with a virus), unlike the mere competition for rivalrous goods at issue here.

After broadly scoping this problem, analysis reveals several reasons that such research is typically permissible, notwithstanding the potential setbacks to the interests …

Law Library Blog (May 2020): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

Complicated Lives: A Look Into The Experience Of Individuals Living With Hiv, Legal Impediments, And Other Social Determinants Of Health, Margaret B. Drew, Jason Potter, Caitlin Stover

Faculty Publications

Those living with HIV continue to have challenges that extend well beyond their medical needs Public misconceptions surrounding HIV transmission and treatment have resulted in systemic and pervasive discrimination against those living with the disease. Common misconceptions include overly optimistic perceptions of the modern state of medical treatment, leading the uninformed to conclude that people living with HIV are minimally impacted by the disease, and misunderstandings regarding how the disease is transmitted from person-to-person, leading to stigma and social prejudice. Because of these misconceptions, three professors from the University of Massachusetts Dartmouth formed a community partnership to determine the unmet …

Evaluating For-Profit Public Benefit Corporations As An Additional Structure For Antibiotic Development And Commercialization, Kevin Outterson, John H. Rex

Faculty Scholarship

While antibiotics are a key infrastructure underpinning modern medicine, evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial Market Entry Rewards or other pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such Market Entry Rewards or other similar incentives may be difficult to muster in …

Critical Reviews Of Flawed Research On Prostitution, Donna M. Hughes

Dignity: A Journal of Analysis of Exploitation and Violence

No abstract provided.

Due Process Supreme Court Appellate Division

Touro Law Review

No abstract provided.

A Rising Star: Maria Viveiros, Rwu Class Of 2017 (May 2018), Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

Law Library Blog (March 2018): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

Law Library Blog (November 2017): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Lessons Learned By An Interdisciplinary Research Team Evaluating Medical-Legal Partnership With The Department Of Veterans Affairs, Margaret Middleton, Jack Tsai, Robert Rosenheck

South Carolina Law Review

No abstract provided.

Neuroimaging And Jury Decision Making: In Defense Of The Defense?, Alana A. Snyder

Williams Honors College, Honors Research Projects

Neurobiological evidence in the form of brain scans (MRI images, PET images, etc.) is being introduced with increasing frequency in the courtroom as potentially mitigating evidence in criminal cases as part of an attempt to show regions of neurological abnormality affecting a defendant’s decision-making or emotional control. Empirical studies have shown two biases associated with the presentation of such evidence. One of these biases resides in that laypeople’s interpretation of such evidence may be weighted too heavily towards scientific fact – as is DNA evidence – rather than an association between a specific crime, and a brain region and its …

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

O. Carter Snead

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

"Sufficient" Capacity: The Contrasting Capacity Requirements For Different Documents, Mary F. Radford, Lawrence A. Frolik

Mary F. Radford

In Anglo-American law, the concept of mental "capacity" is used to measure the degree to which an individual has the "mental ability to understand the nature and effects of one's acts" as determined by a medical or cognitive assessment of an individual's mental ability. Based on an individual's mental capacity, the law decides whether the individual had sufficient capacity to engage in the action in question. The legal concept of mental capacity, therefore, is the basis for "when a state legitimately may take action to limit an individual's rights to make decisions about his or her own person or property." …

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Saint Louis University Journal of Health Law & Policy

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Dual Use Research Policy Implementation, Carole R. Baskin, Todd J. Richardson

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Life Sciences Dual Use Research Of Concern, Public Health And Safety, And The Doctrine Of Unconstitutional Conditions, Vickie J. Williams

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Regulating Dual Use Research To Promote Public Trust: A Reply To Dr. Franz, Robert Gatter

Saint Louis University Journal of Health Law & Policy

No abstract provided.