Digital Commons Network^™

Automating Fda Regulation, Mason Marks

Duke Law Journal

In the twentieth century, the Food and Drug Administration (“FDA”) rose to prominence as a respected scientific agency. By the middle of the century, it transformed the U.S. medical marketplace from an unregulated haven for dangerous products and false claims to a respected exemplar of public health. More recently, the FDA’s objectivity has increasingly been questioned. Critics argue the agency has become overly political and too accommodating to industry while lowering its standards for safety and efficacy. The FDA’s accelerated pathways for product testing and approval are partly to blame. They require lower-quality evidence, such as surrogate endpoints, and shift …

Algorithm V. Algorithm, Cary Coglianese, Alicia Lai

Duke Law Journal

Critics raise alarm bells about governmental use of digital algorithms, charging that they are too complex, inscrutable, and prone to bias. A realistic assessment of digital algorithms, though, must acknowledge that government is already driven by algorithms of arguably greater complexity and potential for abuse: the algorithms implicit in human decision-making. The human brain operates algorithmically through complex neural networks. And when humans make collective decisions, they operate via algorithms too—those reflected in legislative, judicial, and administrative processes. Yet these human algorithms undeniably fail and are far from transparent. On an individual level, human decision-making suffers from memory limitations, fatigue, …

Empathy In The Digital Administrative State, Sofia Ranchordás

Duke Law Journal

Humans make mistakes. Humans make mistakes especially while filling out tax returns, benefit applications, and other government forms, which are often tainted with complex language, requirements, and short deadlines. However, the unique human feature of forgiving these mistakes is disappearing with the digitalization of government services and the automation of government decision-making. While the role of empathy has long been controversial in law, empathic measures have helped public authorities balance administrative values with citizens’ needs and deliver fair and legitimate decisions. The empathy of public servants has been particularly important for vulnerable citizens (for example, disabled individuals, seniors, and underrepresented …

Is A Rainbow Pink Or Blue? Creating Jail Policies For Transgender Inmates, Hunter Schultz

Master of Arts in Criminal Justice Leadership

The United States prison system functions on a binary of male and female inmates. Transgender, non-binary, gender non-conforming, and intersex individuals challenge the limits of these systems and their policies. This paper addresses how to create policy for transgender individuals and what the policies should include. The best practice for creating policies involves basing them in solid ethics. Looking at different ethical theories will help solve ethical dilemmas involving housing, searching, and other policies for transgender and gender non-conforming inmates. To ensure that policies coincide with the law, an examination of case law provides the legal background for these policies. …

Title Ix At 50: Exploring The Impact Of The Law On Cases Of Sexual Misconduct And Participation Equity In Athletics, Erica J. Zonder, Emily J. Houghton

Human Performance Department Publications

June 23, 2022 will mark the 50th anniversary of Title IX; during that time frame there has been a drastic increase in girl’s and women’s participation in sport. There has also been significant political debate and push back to Title IX which has threatened to undermine the impact of the law. Over the last 10 years, Title IX has been synonymous with litigation related to sexual harassment and transgender athlete participation in sport. Additionally, universities have continually sought to cut women’s sports under the guise of budgetary constraints. The purpose of this poster presentation is three-fold: 1) Review recent case …

Corporate Misconduct In The Pharmaceutical Industry, Richard C. Ausness

DePaul Law Review

No abstract provided.

In Your Own Defense: The Importance Of Immuno-Oncology And The Problem With Patenting Under The "Laws Of Nature", Laura Schwartz

Pace Law Review

No abstract provided.

Neutrality, Accommodation, Or Compromise: Comparing The Effectiveness Of Three Approaches Towards Protecting Religious Freedom, Beth Anne Patterson

Penn State Journal of Law & International Affairs (2012 - Present)

No abstract provided.

Crime And Punishment: An Empirical Study Of The Effects Of Racial Bias On Capital Sentencing Decisions, Matthew A. Gasperetti

University of Miami Law Review

Racism has left an indelible stain on American history and remains a powerful social force that continues to shape crime and punishment in the contemporary United States. In this article, I discuss the socio-legal construction of race, explore how racism infected American culture, and trace the racist history of capital punishment from the Colonial Era to the present. After framing the death penalty in cultural and historical context, I report original empirical results from one of the largest studies (n = 3,284) of mock juror capital sentencing decisions published to date. My results show that mock jurors who self reported …

“Incorrigibility Is Inconsistent With Youth”: The Supreme Court’S Missed Opportunity To Cure The Contradiction Implicit In Discretionary Jlwop Sentencing, Ana Ionescu

University of Miami Law Review

The juvenile life without parole (“JLWOP”) caselaw is based in part on the science underlying adolescent brain development. Numerous research studies have examined the behaviors and brain processes of adolescents. Courts have relied on these findings in reaching some of its most important decisions affecting juveniles implicated in the criminal justice system. The latest of those decisions came in 2021 with the Jones v. Mississippi case before the United States Supreme Court. The Court held that a sentencing court is not required to make a specific finding of permanent incorrigibility before sentencing the juvenile defendant to life without parole. This …

Costly Gadgets: Barriers To Market Entry And Price Competition For Generic Drug-Device Combinations In The United States, Michael S. Sinha

Minnesota Journal of Law, Science & Technology

No abstract provided.

Facial Recognition Technology And Privacy: Race And Gender - How To Ensure The Right To Privacy Is Protected, Lindsey Jacques

San Diego International Law Journal

This Article specifically focuses on the use of FRT by the five permanent members of the United Nations (“UN”) Security Council which are China, France, the Russian Federation, the United Kingdom, and the United States (the five nations). As permanent members of the Security Council, these five nations are tasked with maintaining international security under the UN Charter.

National leaders in these countries are forced to face the question of whether the national security mitigating benefits of FRT outweigh the privacy and equity concerns the technology imposes for populations often considered the most vulnerable. This Article proposes solutions to this …

The Current State Of Gene Doping And The Future Of Gene Therapy Regulations, Sean Costa

San Diego International Law Journal

Genome editing, also referred to as “gene editing” or “gene therapy,” is no longer a theoretical eventuality of scientific progression; it is a reality of modern life. One of the numerous groups affected by this technology is athletes as “gene doping” becomes a more viable option to improve athletic performance each year. Some international agencies have begun to address the issues presented by gene doping, but there is no comprehensive international framework or regulations on the proper standards of use or punishment for those who abuse this new technology. International agencies must work together to establish regulations for human genome …

The Legal Role In Building Sustainable Public Health- Speaker, Joanna Sax, E. Donald Shapiro Professor Of Law

Belmont Health Law Journal

No abstract provided.

The Legal Role In Building Sustainable Public Health: New Payment Models And Delivery Systems, Dakasha Winston Senior Vp & Chief Government Relations Officer, Mark Ison, Beth Swenson Deweese Episodes Of Care Strategy Specialist

Belmont Health Law Journal

No abstract provided.

Is Title Vii An "Anti-Discrimination" Law?, Anuj C. Desai

University of Colorado Law Review Forum

No abstract provided.

Transgender Athletes And International Sports Policy, Joanna Harper

Law and Contemporary Problems

No abstract provided.

Defining Sex, Edward Schiappa

Law and Contemporary Problems

No abstract provided.

Sex Neutrality, Doriane Lambelet Coleman

Law and Contemporary Problems

No abstract provided.

The Gatekeepers Of Research: Why A Data Protection Authority Holds The Key To Research In The New York Privacy Acts, Eric B. Green

Brooklyn Law Review

Biometric data is among the most sensitive of personal data because it is biologically tied and unique to the individual. Nonetheless, biometric data is an invaluable facet of the research that enables progressive scientific, technological, and medical innovation. Because a comprehensive federal data privacy act does not appear to be on the horizon, the torch has been passed to the states to create their own personal data protection regimes. New Yorkers’ personal biometric data is not aptly protected, partially because neither the New York Privacy Act nor the Biometric Privacy Act (collectively, the NY Privacy Acts) have matured to the …

Organizing And Arguing Sex And Gender, Anne B. Goldstein

Law and Contemporary Problems

No abstract provided.

Board Diversity: People Or Pathways?, June Carbone

Law and Contemporary Problems

No abstract provided.

Foreword, Doriane Lambelet Coleman, Kimberly D. Krawiec

Law and Contemporary Problems

No abstract provided.

The Importance Of Referring To Human Sex In Language, Kathleen Stock

Law and Contemporary Problems

No abstract provided.

A Current Model Of Sex Including All Biological Components Of Sexual Reproduction, Joshua D. Safer

Law and Contemporary Problems

No abstract provided.

Unlawful Genders, Anthony Michael Kreis

Law and Contemporary Problems

No abstract provided.

Stall Wars: Sex And Civil Rights In The Public Bathroom, Wickliffe Shreve

Law and Contemporary Problems

No abstract provided.

Feminism, Trans Justice, And Speech Rights: A Comparative Perspective, Madeleine Pape

Law and Contemporary Problems

No abstract provided.

Humpty Dumpty Derangement Syndrome, Jethro K. Lieberman

Other Publications

No abstract provided.

The Aoc In The Age Of Covid—Pandemic Preparedness Planning In The Federal Courts, Zoe Niesel

St. Mary's Law Journal

The 2020 COVID-19 pandemic created a crisis for American society—and the federal courts were not exempt. Court facilities came to a grinding halt, cases were postponed, and judiciary employees adopted work-from-home practices. Having court operations impacted by a pandemic was not a new phenomenon, but the size, scope, and technological lift of the COVID-19 pandemic was certainly unique.

Against this background, this Article examines the history and future of pandemic preparedness planning in the federal court system and seeks to capture some of the lessons learned from initial federal court transitions to pandemic operations in 2020. The Article begins by …