Law Commons^™

Pathogen Genomes As Global Public Goods (And Why They Should Not Be Patented), Jorge L. Contreras

Utah Law Faculty Scholarship

During past viral outbreaks, researchers rushed to patent genomic sequences of the viruses as they were discovered, leading to disputes and delays in research coordination. Yet similar disputes did not occur with respect to the genomic sequence of SARS-CoV-2, the virus responsible for COVID-19. With respect to COVID-19, global research collaboration occurred rapidly, leading to the identification of new variants, the ability to track the spread of the disease, and the development of vaccines and therapeutics in record time. The lack of patenting of SARSCoV-2 is likely due the U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. …

Pathogen Genomes As Global Public Goods (And Why They Should Not Be Patented), Jorge L. Contreras

Utah Law Faculty Scholarship

During past viral outbreaks, researchers rushed to patent genomic sequences of the viruses as they were discovered, leading to disputes and delays in research coordination. Yet similar disputes did not occur with respect to the genomic sequence of SARS-CoV-2, the virus responsible for COVID-19. With respect to COVID-19, global research collaboration occurred rapidly, leading to the identification of new variants, the ability to track the spread of the disease, and the development of vaccines and therapeutics in record time. The lack of patenting of SARS-CoV-2 is likely due the U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. …

Federalism And The Right To Travel: Medical Aid In Dying And Abortion, Leslie P. Francis, John Francis

Utah Law Faculty Scholarship

This article explores how rights to movement may limit state efforts to restrict abortions, either directly or indirectly. We use the language of “movement” to encompass short-term visits, longer-term residency changes, and the movement of goods or services across state lines. We prefer “movement” to “travel” or “tourism,” as this language risks trivializing the seriousness of what might be at stake. However, since “travel” is the term used in many U.S. court decisions and other discussions concerning the right,7 we use that term as relevant to these. The centerpiece of our defense is the relationship between freedom of movement and …

Securing A Permanent Homeland: The Federal Government’S Responsibility To Provide Clean Water Access To Tribal Communities, Heather Tanana

Utah Law Faculty Scholarship

Water is life—critical to the health, socioeconomic, and cultural needs of any community. Every household in the United States needs and deserves access to clean, reliable, and a ordable drinking water. Yet, tribal communities face high rates of water insecurity. More than a half million people—nearly 48 percent of tribal homes in Native communities across the United States—do not have access to reliable water sources, clean drinking water, or basic sanitation. In comparison, as a whole, less than 1 percent of households in the United States lack these facilities. This persistent problem became a matter of life or death during …

Supported Decisions As The Patient’S Own?, Leslie Francis

Utah Law Faculty Scholarship

This brief commentary addresses what I regard as the thorniest challenge to supported decision making: how to determine if a supported decision really is the decision of the supported person, rather than an insidious form of concealed paternalism or conflicts of interest. The risk that apparent supported decision-making really becomes the decision of the supporter looms as capacities wane. Peterson, Karlawash and Largent (PK&L), who offer a defense of supported decision making in health care for people with dynamic and diminishing capacity, are alert to these problems but skirt their implications. The authors’ model for supported decisionmaking is incomplete; at …

Universal Access To Clean Water For Tribes In The Colorado River Basin, Heather Tanana, Jaime Garcia, Ana Olaya, Chelsea Colwyn, Hanna Larsen, Ryan Williams, Jonathan King

Utah Law Faculty Scholarship

The coronavirus pandemic has tragically highlighted the vast and long standing inequities facing Tribal communities, including disparities in water access. According to the Centers for Disease Control and Prevention (CDC), American Indians and Alaska Natives (AI/AN) are at least 3.5 times more likely than white persons to contract COVID-19. Limited access to running water is one of the main factors contributing to this elevated rate of incidence.

This report describes current conditions among Tribes in the Colorado River Basin. It outlines the four main challenges in drinking water access: (1) Native American households are more likely to lack piped water …

Debilitating Southeastern Community College V. Davis: Achieving The Promise Of Disability Civil Rights, Leslie Francis

Utah Law Faculty Scholarship

Disability civil rights law today continues to be shaped by troubling precedent created in initial decisions of the Supreme Court under the Rehabilitation Act. This article explores the first of these decisions, Southeastern Community College v. Davis, demonstrates Davis’ continuing impact, and analyzes how this impact may be addressed. Davis was a suit brought by a hearing-impaired student who had been refused accommodations and denied admission to the College’s nursing program. Critical litigation decisions on behalf of Davis at the trial court did not contest the College’s failure to provide accommodations that are common today, such as sign interpretation, or …

Health Information Beyond Pandemic Emergencies: Privacy For Social Justice, Leslie Francis

Utah Law Faculty Scholarship

Moving beyond notice and choice is necessary if data are to be used responsibly for public health. But what directions might this movement take? Transparency and enactment of statutory limits on data uses are the two most prominent possibilities.

Transparency could require entities collecting, possessing and using information drawn from more than a specified number of individuals to make public disclosures of their information collection, possession, and use. There are models for developing such transparency requirements. The California CPPA could provide a model for delineating the size of entities required to make such disclosures. The requirements to disclose the results …

Covid-19 As An Example Of Why Genomic Sequence Data Should Remain Patent Ineligible, Jorge L. Contreras

Utah Law Faculty Scholarship

The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no …

Beyond The Pandemic: Historical Infrastructure, Funding, And Data Access Challenges In Indian Country, Heather Tanana, Aila Hoss

Utah Law Faculty Scholarship

The COVID-19 pandemic has disproportionately impacted Tribal communities, in part, due to the historical inequities that Tribes have faced for centuries. As sovereign nations, Tribes have the authority to self-govern their people and land. However, the federal government has a special trust responsibility and treaty obligations to Tribes that it often has failed to fulfill. As a result, many Tribal communities live in inferior living conditions as compared to their non-Native counterparts. This Chapter builds on the prior report to explore the historical inequities Tribes experience and how they have been compounded by the pandemic. More specifically, it identifies persistent …

Understanding The Ethics Of Natural Experiments In A Pandemic, Leslie Francis

Utah Law Faculty Scholarship

Pandemics invite natural experiments: testing hypotheses through observing the effects of interventions without manipulating exposure to the intervention. With novel infections like COVID-19 that spread rapidly and widely, knowledge gaps may be extensive. Quick action may be necessary and randomized trials impracticable if not downright impossible. But what can justify such interventions ethically, given that they are in some sense widescale experiments upon unaware members of the public who have no opportunity to choose not to participate? And what ethical limits to them should there be?

Negative Freedom In Crisis Times, Leslie Francis

Utah Law Faculty Scholarship

Contemporary U.S. jurisprudence thus treats public health orders requiring masks or limiting attendance at religious services as conflicts between individual freedoms and the public safety. Courts have left unquestioned the scope of individual liberties. Choices about whether to cover one’s face or attend religious services are not, however, fully analogous to protections from physical injury by others. Instead, they are choices that may result in risks to others. It is thus at least open to question whether they are within the scope of protected individual liberties in the first place. The scope of personal liberty—whether liberty is distinct from license—is …

Expanding Access To Patents For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases …

Upholding Tribal Sovereignty And Promoting Tribal Public Health Capacity During The Covid-19 Pandemic, Heather Tanana, Aila Hoss

Utah Law Faculty Scholarship

Tribes are sovereign nations with authorities and responsibilities over their land and people. This inherent sovereign authority includes the right to promote and protect the health and welfare of their communities. The COVID-19 pandemic has brought national attention to the health inequities experienced by American Indian and Alaska Native communities. The sovereign legal authority for Tribes to respond to this pandemic has received less attention. This Chapter describes some, but not all, of the urgent legal issues impacting Tribal response to the COVID-19 pandemic. It describes and identifies gaps in federal Indian health policies and highlights how Tribes have exercised …

Crisis At The Pregnancy Center: Regulating Pseudo-Clinics And Reclaiming Informed Consent, Teneille R. Brown

Utah Law Faculty Scholarship

Crisis Pregnancy Centers (CPCs) adopt the look of medical practices — complete with workers in scrubs, ultrasound machines, and invasive physical exams — to deceive pregnant women into thinking they are being treated by licensed medical professionals. In reality, CPCs offer exclusively Bible-based, non-objective counseling. Numerous attempts to regulate CPCs have faced political roadblocks. Most recently, in NIFLA v. Becerra, the Supreme Court held that state efforts to require CPCs to disclose that they are not medically licensed are unconstitutional violations of CPCs’ First Amendment right to free speech. In the wake of that decision, pregnant women in crisis — …

Why We Fear Genetic Informants: Using Genetic Genealogy To Catch Serial Killers, Teneille R. Brown

Utah Law Faculty Scholarship

Consumer genetics has exploded, driven by the second-most popular hobby in the United States: genealogy. This hobby has been co-opted by law enforcement to solve cold cases, by linking crime-scene DNA with the DNA of a suspect's relative, which is contained in a direct-to-consumer (DTC) genetic database. The relative’s genetic data acts as a silent witness, or genetic informant, wordlessly guiding law enforcement to a handful of potential suspects. At least thirty murderers and rapists have been arrested in this way, a process which I describe in careful detail in this article. Legal scholars have sounded many alarms, and have …

Frontiers In Precision Medicine Iv: Artificial Intelligence, Assembling Large Cohorts, And The Population Data Revolution, Adam Bress, Rich Albrechtsen, Monika Baker, Jorge L. Contreras, Zachary Fica, Austin Gamblin, Chelsea Ratcliff, Bianca E. Rich, Matt A. Szaniawski, Alyssa Thorman, Chad Vansant-Webb, Willard Dere

Utah Law Faculty Scholarship

Large cohort studies and more recently electronic medical records (EMR) are being used to collect massive amounts of genetic information. Implementation of artificial intelligence has become increasingly necessary to interpret this data with the goal of augmenting patient care. While it is impossible to predict what the future holds, policy makers are challenged to create guiding principles and responsibly roll out these new technologies. On March 22, 2019, the University of Utah hosted its fourth annual Precision Medicine Symposium focusing on artificial intelligence, assembling large cohorts, and the population data revolution. The symposium brought together experts in medicine, science, law …

Data Re-Use And The Problem Of Group Identity, Leslie Francis, John G. Francis

Utah Law Faculty Scholarship

Reusing existing data sets of health information for public health or medical research has much to recommend it. Much data repurposing in medical or public health research or practice involves information that has been stripped of individual identifiers but some does not. In some cases, there may have been consent to the reuse but in other cases consent may be absent and people may be entirely unaware of how the data about them are being used. Data sets are also being combined and may contain information with very different sources, consent histories, and individual identifiers. Much of the ethical and …

Addiction As Disease, Teneille R. Brown

Utah Law Faculty Scholarship

The opioid addiction epidemic is the most overwhelming public health crisis our country has faced. It is now creating a legal crisis, as the its poisonous fruits spill over into the criminal, tort, and family courts. The epidemic costs the U.S. economy about $500 billion every year, and the pressure is crippling our legal systems. This Article is an attempt to relieve some of that pressure, by advocating for a comprehensive public health campaign based upon a new model of addiction. Research shows that the prevalent “moral choice” model of addiction has facilitated stigma and discouraged treatment, by viewing affected …

The False Promise Of Health Data Ownership, Jorge L. Contreras

Utah Law Faculty Scholarship

In recent years there have been increasing calls by patient advocates, health law scholars and would-be data intermediaries to recognize personal property interests in individual health information (IHI). While the propertization of IHI appeals to notions of individual autonomy, privacy and distributive justice, the implementation of a workable property system for IHI presents significant challenges. This essay addresses the issues surrounding the propertization of IHI from a property law perspective. It first observes that IHI does not fit recognized judicial criteria for recognition as personal property, as IHI defies convenient definition, is difficult to possess exclusively, and lacks justifications for …

Conflicts Of Interest And Academic Research, Jorge L. Contreras, Mark Rinehart

Utah Law Faculty Scholarship

This chapter discusses financial conflicts of interest in academic research. After exploring the definition of conflicts of interest, the chapter focuses on the manner in which conflicts are addressed by policies promulgated by the U.S. federal government, research institutions and scholarly journals. It concludes with suggestions for further research and policy analysis.

Needles, Haystacks, And Next-Generation Genetic Sequencing, Teneille R. Brown

Utah Law Faculty Scholarship

Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as “incidental” or “secondary” findings. In 2013, the American College of Medical Genetics (“ACMG”) recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG’s recommendations galvanized critical responses by the genetics and ethics …

Making "Meaningful Access" Meaningful: Equitable Healthcare For Divisive Times, Leslie Francis

Center for Law and Biomedical Sciences (LABS)

Another anniversary of President Bush’s signing of the Americans with Disabilities Act (ADA) is coming up in late July, yet the nation remains far from offering even a semblance of equitable societal opportunity to most individuals with disabilities.

For them, full social participation is dismissed as merely an idealistic dream. With its focus on restoration of full functioning for patients, the health care delivery system might be supposed an exception, but a closer look shows the opposite is true.

Physicians’ offices, clinics, and hospitals too often have not been made accessible. Too frequently, these facilities have diagnostic or treatment equipment …

Reading Alexander V. Choate Rightly: Now Is The Time, Leslie Francis, Anita Silvers

Utah Law Faculty Scholarship

Whatever happens to the Affordable Care Act (ACA) over the next few years, it is fair to assume that state Medicaid programs will be subjected to cost control measures. Despite the recent deployment of substantial arguments to the contrary, the belief still persists that the Supreme Court’s decision in Alexander v. Choate over thirty years ago stands for the proposition that disability anti-discrimination law does not impose requirements on the structure of Medicaid benefits. This belief is misleading at best. In this article, we challenge the access/content distinction and the straitened interpretation of Alexander v. Choate that has resulted from …

Erisa And Graham-Cassidy: A Disaster In Waiting For Employee Health Benefits And For Dependents Under 26 On Their Parents’ Plans, Leslie Francis

Utah Law Faculty Scholarship

Graham Cassidy § 105 would repeal the ACA “employer mandate”. Although its sponsors claim that the bill will give states a great deal of flexibility, it will do nothing to help states ensure that employers provide their employees with decent health insurance; quite the reverse. It will also give employers the freedom to ignore the popular ACA requirement that allows children up to age 26 to receive coverage through their parent’ plans, at least when their parents get health insurance from their employers. Here’s why.

Recognizing Women's Rights At Work: Health And Women Workers In Global Supply Chains, Erika George, Candace D. Gibson, Rebecca Sewall, David Wofford

Utah Law Faculty Scholarship

In 2002, shortly after Paul Hunt was named as the first UN Special Rapporteur on the right to health, he presented his vision for promoting the right to health as a fundamental human right, clarifying the content of this right and identifying good practices at the community, national, and international levels. His vision remains true today for women’s health at the workplace in global supply chains. In an era where women and families must often migrate to find work, leaving behind their homes and support networks, the workplace can be a site where they can access resources and information to …

Is Surrogacy Ethically Problematic?, Leslie P. Francis

Utah Law Faculty Scholarship

This chapter takes up less well-trodden questions about whether a surrogacy arrangement in which one person carries a pregnancy for another is ethically problematic in itself—and if so, why. Pregnancy and delivery are quintessential bodily labor. One set of arguments tests whether carrying a pregnancy is the type of bodily labor one person ethically may perform for another, whether or not for pay. These arguments contend that surrogacy cannot be a permissible service, no matter how well intended or structured. Another set of questions probes the value and identity of the child, asking whether surrogacy is inevitably akin to baby …

Transparency, Leslie P. Francis

Utah Law Faculty Scholarship

Transparency is one of the key concepts of privacy protection. Transparency means openness about data collection, use, and retention. Individuals need to know what information about them is being collected, how it is being collected, how it is to be used and shared, how it is protected, what has been learned from data use, how what has been learned might benefit them, and how they can seek correction or redress for security breaches or other unjustified uses or disclosures of data. This chapter begins with a highly salient recent example of transparency in action: the principled commitment to transparency in …

Medical Futility And Religious Free Exercise, Teneille R. Brown

Utah Law Faculty Scholarship

A tragic scenario has become all too common in hospitals across the United States. Dying patients pray for medical miracles when their physicians think that continuing treatment would render no meaningful benefit. This situation is unfortunately referred to as “medical futility.” In these cases, physicians, who are less likely than their patients to rely on God as a means of coping with major illness, are at an impasse. Their patients request everything be done so that they can have more time for God to intervene, but in the physician’s professional experience, everything will probably do nothing. What is the physician …

Frontiers In Precision Medicine Ii: Cancer, Big Data And The Public, Emily Coonrod, Jorge L. Contreras, Willard Dere, Jeffrey Botkin, Leslie Francis, Jim Tabery

Utah Law Faculty Scholarship

Precision medicine is being developed within a complex landscape of public policy, science, economics, law, and regulation. In these and other policy areas, the goal of developing individually-tailored therapies poses novel challenges for health care research, delivery and policy. In this symposium, a range of experts in genetics, medicine, bioinformatics, intellectual property, health economics and bioethics identified and discussed many of the pressing questions raised by the development and practice of precision medicine. These and other issues will need to be taken into account as precision medicine moves ahead and becomes the standard of medical practice and care in the …