Law Commons^™

Procedural Due Process And Intramural Hospital Dispute Resolution Mechanisms: The Texas Advance Directives Act, Thaddeus Pope

Faculty Scholarship

Increasingly, clinicians and commentators have been calling for the establishment of special adjudicatory dispute resolution mechanisms to resolve intractable medical futility disputes. As a leading model to follow, policymakers both around the United States and around the world have been looking to the conflict resolution provisions in the 1999 Texas Advance Directives Act (TADA).

In this article, I provide a complete and thorough review of the purpose, history, and operation of TADA. I conclude that TADA is a commendable attempt to balance the competing goals of efficiency and fairness in the resolution of these time-sensitive, life-and-death conflicts. But TADA is …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

Drinking From The Data Well: Response To Gamete Donor Anonymity And Limits On Numbers Of Offspring: The Views Of Three Stakeholders, Martha M. Ertman

Faculty Scholarship

No abstract provided.

Access To Essential Medicines In African Countries: An Introduction, Peter G. Danchin, Diane Hoffmann

Faculty Scholarship

No abstract provided.

Criminal Laws On Sex Work And Hiv Transmission: Mapping The Laws, Considering The Consequence, Aziza Ahmed, Sienna Baskin, Anna Forbes

Faculty Scholarship

Lawmakers historically justify the mobilization of criminal laws on prostitution and HIV as a means of controlling the spread of disease. Over time, however, public health research has conclusively demonstrated that criminal laws on prostitution and HIV significantly impede the ability of sex workers to access services and to live without the stigma and blame associated with being a transmitter of HIV. In turn, mainstream public health approaches to sex work and HIV emphasize decriminalization as a way to improve the lives of sex workers in need of care, treatment, and services. Our current legal system, which criminalizes both prostitution …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai

Faculty Scholarship

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.

In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …

We Have The Tools To End Hiv: Benefits, Barriers, And Solutions To Expanded Utilization Of Pre-Exposure Prophylaxis (Prep) In The Us Deep South, Jason Ervin, Allison Weller Tikare, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Just Compensation: A No-Fault Proposal For Research-Related Injuries, Leslie Meltzer Henry, Megan E. Larkin, Elizabeth R. Pike

Faculty Scholarship

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been …

Respect And Dignity: A Conceptual Model For Patients In The Intensive Care Unit, Leslie Meltzer Henry, Cynda Rushton, Mary Catherine Beach, Ruth Faden

Faculty Scholarship

Although the concept of dignity is commonly invoked in clinical care, there is not widespread agreement—in either the academic literature or in everyday clinical conversations—about what dignity means. Without a framework for understanding dignity, it is difficult to determine what threatens patients’ dignity and, conversely, how to honor commitments to protect and promote it. This article aims to change that by offering the first conceptual model of dignity for patients in the intensive care unit. The conceptual model we present is based on the notion that there are three sources of patients’ dignity—their shared humanity, personal narratives, and autonomy—each of …

Markets, Morals, And Limits In The Exchange Of Human Eggs, Kimberly D. Krawiec

Faculty Scholarship

No abstract provided.

Hiv Infrastructure Study Birmingham, Alabama, Susan S. Reif, Kristen Sullivan, Carolyn Mcallaster, Miriam Berger

Faculty Scholarship

No abstract provided.

One Size Does Not Fit All: What Does High Impact Prevention Funding Mean For Community-Based Organizations In The Deep South?, Carolyn Mcallaster, Jerry Fang

Faculty Scholarship

No abstract provided.

Hiv Infrastructure Study Jackson, Mississippi, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Miriam Berger

Faculty Scholarship

No abstract provided.

A Closer Look: Deep South Has The Highest Hiv-Related Death Rates In The United States, Susan S. Reif, Donna Safley, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Finding Fault?: Exploring Legal Duties To Return Incidental Findings In Genomic Research, Elizabeth R. Pike, Karen H. Rothenberg, Benjamin E. Berkman

Faculty Scholarship

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must …

Setting The Stage: Enhancing Understanding Of Bioethical Challenges With Theatre, Karen H. Rothenberg

Faculty Scholarship

Theatre provides a dynamic platform to reflect upon the ethical, legal, and social implications of medical innovations and the powerful impact on personal and professional relationships. This article explores the last four to five decades of theatre, which coincide with the evolution of the formal discipline of bioethics and the field of medical humanities, to aid in the understanding of the bioethical challenges we face today and to place them in an historical and societal context. Four plays are discussed that reflect the ethical and legal context of their eras and reveal significant ethical challenges for us to consider.

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank A. Pasquale, Tara Adams Ragone

Faculty Scholarship

This Article examines how new technologies generate privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is …

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Faculty Scholarship

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 …

The Separation Of Politics And Science, Joanna K. Sax

Faculty Scholarship

This article proposes that scientific inquiry regarding questions of fact should have an autonomous zone that is protected from politics. Although many scholars promote the idea that science is politicized, little empirical data exists to support this conclusion. This article contains an empirical study that demonstrates that the public received inaccurate information in the debate over a highly politicized and controversial area of scientific inquiry, embryonic stem cell research.

This article utilizes the data from the empirical study and public choice theory to explain that there are process defects; this economic model can help explain, but cannot be used to …

Limiting Liberty To Prevent Obesity: Justifiability Of Strong Hard Paternalism In Public Health Regulation, Thaddeus Mason Pope

Faculty Scholarship

Because of the largely self-regarding nature of obesity, many current and proposed public health regulatory measures are paternalistic. That is, these measures interfere with a person’s liberty with the primary goal of improving that person’s own welfare.

Paternalistic public health measures may be effective in reducing obesity. They may even be the only sufficiently effective type of regulation. But many commentators argue that paternalistic public health measures are not politically viable enough to get enacted. After all, paternalism is repugnant in our individualistic culture. It is "wrong" for the government to limit our liberty for our own good.

In this …

Hiv Infrastructure Study Columbia, Sc, Susan S. Reif, Elena Wilson, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Hiv Infrastructure Study Baton Rouge, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Casteel Scherger

Faculty Scholarship

No abstract provided.

Neurotechnologies At The Intersection Of Criminal Procedure And Constitutional Law, Amanda C. Pustilnik

Faculty Scholarship

The rapid development of neurotechnologies poses novel constitutional issues for criminal law and criminal procedure. These technologies can identify directly from brain waves whether a person is familiar with a stimulus like a face or a weapon, can model blood flow in the brain to indicate whether a person is lying, and can even interfere with brain processes themselves via high-powered magnets to cause a person to be less likely to lie to an investigator. These technologies implicate the constitutional privilege against compelled, self-incriminating speech under the Fifth Amendment and the right to be free of unreasonable search and seizure …

The Future Of Hipaa In The Cloud, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values …

Het Gebruik Van Risicotaxatie Instrumenten Onder Spv-En (The Use Of Risk Assessment Instruments Among Community Psychiatric Nurses), Sophie De Valk, Corine De Ruiter, Jorge Folino, Matthew Large, Thierry Pham, Kim Reeves, Carolina Condemarin, Louise Nielsen, Martin Rettenberger, Robyn Mei Yee Ho, Verónica Godoy-Cervera, Kimberlie Dean, Maria Francisca Rebocho, Karin Arbach-Lucioni, Martin Grann, Katharina Seewald, Michael W. Doyle, Sarah Desmarais, Richard Van Dorn, Randy Otto, Jay Singh

Faculty Scholarship

Dutch Abstract: Auteur en een groot aantal alumni-collega's van de Universiteit van Maastricht, hebben gekeken welke risicotaxatie-instrumenten SPV-en gebruiken om het risico van recidive in te schatten bij clienten uit de forensische psychiatrie. Met behulp van START kan volgens hen het risico voor anderen, het risico op victimisatie, risico op zelfbeschadigend gedrag, suïcidegevaar, ongeoorloofde afwezigheid, middelenmisbruik en zelfverwaarlozing bij deze forensische groep vastgesteld worden.

English Abstract: The author and colleagues from the University of Maastricht investigated the use of structured risk assessment instruments in forensic psychiatry. Using instruments such as the START may aid in the assessment of violence, victimization, …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale, Elizabeth A. Reilly, Jeffery Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations, Karen H. Rothenberg, Lynn W. Bush

Faculty Scholarship

Transformative innovations in medicine and their ethical complexities create frequent confusion and misinterpretation that color the imagination. Placed in historical context, theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped -- and been shaped by -- personal and professional relationships. The drama of these human interactions is powerful and has the potential to generate fear, create hope, transform identity, and inspire empathy -- a vivid source to observe the complex implications of translating research into clinical practice through …

Accountable Care Organizations In The Affordable Care Act, Frank Pasquale

Faculty Scholarship

No abstract provided.

Neuroscience And The Child Welfare System, Clare Huntington

Faculty Scholarship

Increasingly, scholars and policymakers are calling for programs that take a preventive approach to child abuse and neglect, rather than our current tendency to respond only after a crisis. There are significant social and economic arguments supporting this shift. The Nurse-Family Partnership, developed by David Olds and discussed in this symposium, illustrates how specific investments in family functioning can lower rates of child abuse and neglect, leading to a host of positive outcomes for children and society, from greater educational attainment to less involvement in the criminal justice system. Thinking about child well-being more broadly, the Nobel laureate James Heckman …