Law Commons^™

Human Rights For Health Across The United Nations, Benjamin Mason Meier, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The United Nations (UN) plays a central role in realizing human rights to advance global health. Looking beyond state obligations, the UN has called on all its specialized agencies to mainstream human rights across all their activities. With globalization compelling these UN institutions to meet an expanding set of global challenges to underlying determinants of health, human rights are guiding these international organizations in addressing public health. These international organizations within the UN system are actively engaged in implementing health-related human rights—in both their mission and their actions to carry out that mission. Through this mainstreaming of human rights, global …

Brief Of Amici Curiae National Health Law Program And National Network Of Abortion Funds Supporting Petitioners-Cross-Respondents, Maya Manian, Jill E. Adams, Sara Ainsworth, Abigail K. Coursolle, Yvonne Lidgren, Sarah Somers, Melanie R. Medalle

Amicus Briefs

No abstract provided.

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Pay Now, Play Later?: Youth And Adolescent Collision Sports, Vivian E. Hamilton

Faculty Publications

The routine and repeated head impacts experienced by athletes in a range of sports can inflict microscopic brain injuries that accumulate over time, even in the absence of concussion. Indeed, cumulative exposure to head impacts—not number of concussions—is the strongest predictor of sports-related degenerative brain disease in later life. The observable symptoms of disease appear years or decades after initial injury and resemble those of other mental-health conditions such as depression and dementia. The years-long interval between earlier, seemingly minor, head impacts and later brain disease has long obscured the connection between the two.

Risk of injury differs across demographics, …

Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, And Global Health, Govind Persad

Sturm College of Law: Faculty Scholarship

Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy private individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, …

Tensions And Exclusions: The Knotty Policy Encounter Between Sexual And Reproductive Health And Rights And Hiv, Susana T. Fried, Aziza Ahmed, Luisa Cabal

Faculty Scholarship

The International Conference on Population and Development or ICPD (Cairo, 1994) provided a global policy framework centred on reproductive rights instead of population control. Global standards on sexual and reproductive health and rights (SRHR) and on HIV rapidly expanded throughout the 1990s.1 Considerable activist mobilisation in both arenas advanced health issues as politically salient decision-making venues where human rights and health advocacy were urgently needed, rather than scientific and technical showcases.

The ICPD, quickly followed by the Fourth World Conference on Women (1995), stressed that reproductive rights are anchored in governments’ human rights obligations and development commitments, including to …

Public Health Research Priorities To Address Female Genital Mutilation Or Cutting In The United States, Holly G. Atkinson, Deborah Ottenheimer, Ranit Mishori

Publications and Research

Female genital mutilation or cut- ting (FGM/C), an age-old tradition that is still widely practiced around the world, is gaining recognition as an important public health issue in the United States. Increasingly, because of migration, women and girls affected by FGM/C have become members of host communities where the practice is not culturally acceptable.

According to recent conservative estimates, more than 513 000 immigrant women and girls living in the United States have undergone or are at risk for FGM/C, a significant increase from the 1990 estimate of 168 000. The arrests of physicians in Michigan in 2017 for performing …

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 …

Digital Health Privacy In Active-Aging Settings: Will The Law Let You Age Well?, Tara Sklar, Richard Carmona, Kathie Insel, Christopher Robertson

Faculty Scholarship

What is privacy and how are our interpretations of it changing with advances in technology? This question, and concerns around potentially violating a person’s right to privacy, have been emerging across industries around the world. Senior living providers have increased their exposure to privacy risks with the shift to implementing sensors throughout their communities. Typically located in digital health devices that can be worn on the body or placed in the environment, these sensors are capable of collecting and tracking data relevant to a person’s health and well-being on a continuous monitoring basis.

There are privacy laws and a growing …

Is Affording Undocumented Immigrants Health Coverage A Radical Proposal?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

During the Democratic presidential debate on July 31, all 10 candidates raised their hands when asked if they would provide health insurance to undocumented immigrants. Among all Democratic ideas for health reform, this is least popular. A recent poll found that only 38% of respondents approve. The idea drew extensive criticism, which is understandable: Why should the United States provide health coverage for people who don’t have a legal right to be here? Extending coverage could be seen as rewarding individuals who have violated the law.

There are, however, strong reasons to afford health coverage for this population: modest economic …

Ending Pandemics: Us Foreign Policy To Mitigate Today’S Major Killers, Tomorrow’S Outbreaks, And The Health Impacts Of Climate Change, Matthew M. Kavanagh, Harsha Thirumurthy, Rebecca Katz, Kristie L. Ebi, Chris Beyrer, Jamila Headley, Charles B. Holmes, Chris Collins, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Every U.S. President in recent decades has had to respond to at least one pandemic disease. Political leadership has proven decisive. In the coming years, U.S. foreign policy will face at least three inter-related issues: today’s major pandemics of AIDS, TB, and Malaria; future outbreaks with the potential to become pandemics; and rising risk from infectious diseases associated with climate change. A review of epidemiologic data shows global progress on each issue is threatened. A coordinated U.S. effort, across agencies and engaged with national and multilateral partners, could save lives and address significant foreign policy interests. Such an effort could …

Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

Articles

Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …

Affordability Boards: The States’ New Fix For Drug Pricing, Tara Sklar, Christopher Robertson

Faculty Scholarship

A new Maryland law that creates a prescription-drug affordability board to help the state regulate drug prices may be a harbinger of what’s to come in drug-pricing legislation. The law permits cost reviews when drug prices or price increases exceed specified thresholds. Establishing affordability boards may be a natural next step that more states take to exert a stronger influence over price spikes and still survive legal challenges.

Law & Health Care Newsletter, Fall 2019

Law & Health Care Newsletter

No abstract provided.

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja

Faculty Scholarship

This Article explores the political and policy appeal of work requirements for public benefit programs and concludes that inclusion of such requirements can be a reasonable design choice, but not in their current form. This Article’s proposals attempt to humanize these highly controversial work requirements while acknowledging the equity concerns they are designed to address. Drawing on expansive definitions of “work” found in guidance published by the Centers for Medicare and Medicaid (“CMS”) and in various state waiver applications, this Article proposes that work requirements be approved for Medicaid (as well as other benefit programs) only if they encompass various …

The American Pathology Of Inequitable Access To Medical Care, Allison K. Hoffman, Mark A. Hall

All Faculty Scholarship

What most defines access to health care in the United States may be its stark inequity. Daily headlines in top newspapers paint the highs and lows. Articles entitled: “We Mapped the Uninsured. You’ll notice a Pattern: They tend to live in the South, and they tend to be poor” and op-eds with titles like “Do Poor People Have a Right to Health Care?” and “What it’s Like to Be Black and Pregnant when you Know How Dangerous That Can Be” run side-by-side with headlines touting “The Operating Room of the Future,^” and advances in gene therapy that promise cures …

Medical Ai And Contextual Bias, W. Nicholson Price Ii

Articles

Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human experts — to identify malignancies as well as trained radiologists, to diagnose diabetic retinopathy as well as board-certified ophthalmologists, or to recommend tumor-specific courses of treatment as well as top-ranked oncologists — then those algorithms could be deployed in medical settings where human experts are not available, and patients could benefit. But there is a problem with this vision. Privacy law, malpractice, insurance reimbursement, and FDA approval standards all encourage developers …

Tax Talk And Reproductive Technology, Bridget J. Crawford

Elisabeth Haub School of Law Faculty Publications

The tax system both reacts to and helps create attitudes about the value of certain behaviors and choices. This Article makes three principal claims—one empirical, one normative, and one interpretative. The Article demonstrates through data that a representative sample of fertility clinics in the United States does not make information about the tax consequences of compensated human egg transfers—commonly called egg “donation”—publicly available. In 2015, in a case of first impression, the United States Tax Court decided in Perez v. Commissioner that a compensated egg transferor must report as income any amount she receives for her eggs. Although the Tax …

Biomedical Ethics And Responsible Conduct Of Research, Katherine Mendis

Open Educational Resources

This course is an introduction to the moral challenges that arise in the design and execution of biomedical research and the development of medical interventions. A historical review segues into detailed examination of key ethical concepts and principles, as well as topics of particular concern. At the culmination of the semester, students apply their knowledge of research ethics to an ethical analysis of their MTM BioDesign projects.

Assisted Dying For Prison Populations - Lessons From And For Abroad, Jocelyn Downie, Adelina Iftene, Megan Steeves

Articles, Book Chapters, & Popular Press

No abstract provided.

Designing Development Programs For Non-Traditional Antibacterial Agents, Kevin Outterson, John Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan Darrow

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits …

The Kids Are Not Alright: Leveraging Existing Health Law To Attack The Opioid Crisis Upstream, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The opioid crisis is now a nationwide epidemic, ravaging both rural and urban communities. The public health and economic consequences are staggering; recent estimates suggest the epidemic has contracted the U.S. labor market by over one million jobs and cost the nation billions of dollars. To tackle the crisis, scholars and health policy initiatives have focused primarily on downstream solutions designed to help those who are already in the throes of addiction. For example, the major initiative announced by the U.S. Surgeon General promotes the dissemination of naloxone, which helps save lives during opioid overdoses.

This Article argues that the …

Drowsy Driving Considerations In Non-Commercial Drivers For The Sleep Physician, Ann Marie Marciarille, Anand Bhat, David Ingram, Damien Stevens

Faculty Works

The sleep physician faces many challenges in the assessment of drowsy driving. The following article reviews current clinical evaluation methods and legal considerations at the state level in the United States.

Preparing Physicians To Contend With The Problem Of Dual Loyalty, Holly G. Atkinson

Publications and Research

Dual loyalty is defined as, particularly as it pertains to the field of medicine, a conflict or potential conflict between a healthcare professional’s simul- taneous obligations–expressed or implied–to a patient and to a third party. Dual loyalty situations often compromise physicians’ ethical behavior, lead- ing them to participate, either knowingly or unknowingly, in human rights violations perpetrated by a third party, often the state. Classic dual loyalty situations include the participation of physicians in state-sanctioned torture or the death penalty. However, there are a number of other dual loyalty scenarios that arise routinely in clinical practice in both closed institutions …

Choice Architecture For Healthier Insurance Choices: Ordering And Partitioning Can Improve Decisions, Benedict G.C. Dellaert, Eric J. Johnson, Tom Baker

All Faculty Scholarship

Health insurance decisions are a challenge for many consumers and influence welfare, health outcomes, and longevity. Two choice architecture tools are examined that can improve these decisions: informed ordering of options (from best to worst) and choice set partitioning. It is hypothesized that these tools can improve choices by changing: (1) decision focus: the options in a set on which consumers focus their attention, and (2) decision strategy: how consumers integrate the different attributes that make up the options. The first experiment focuses on the mediating role of the hypothesized decision processes on consumer decision outcomes. The outcome results are …

The Two Most Important Questions For Ethical Public Health, John Coggon, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health ethics is a distinct and established field, and it is important that its approaches and rationales are understood widely in the public health community. Such understanding includes the capacity to identify and combine principled and practical concerns in public health. In this paper, we present a background to the ideas that motivate public health ethics as a field of research and practice, and rationalize these through a critical ethico-legal approach to analysis. Two essential points of inquiry are identified and formulated to allow philosophical and practical agendas regarding public health to be combined. These come through asking the …

Mid-Atlantic Ethics Committee Newsletter, Summer 2019

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Newsletter, Summer 2019

Newsletter

No abstract provided.

Moving Beyond Medical Debt, Brook E. Gotberg, Michael D. Sousa

Faculty Publications

In recent years it has become clear that medical costs are imposing severe financial burdens on American families, sometimes to the point that bankruptcy becomes the only escape from crippling debt. When evaluating the well-established connection between outstanding medical debt and consumer bankruptcy, most existing empirical studies attempt to quantify the percentage of consumer bankruptcies that are "caused" by unmanageable medical indebtedness. This Article addresses what we believe to be a more significant line of empirical inquiry, namely, the connection between health insurance coverage and consumer bankruptcy as a more precise measurement of how national health insurance programs may or …

Transparency Trade-Offs Priority Setting, Scarcity, And Health Fairness, Govind Persad

Sturm College of Law: Faculty Scholarship

This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.