Digital Commons Network^™

Health Justice For Immigrants, Medha D. Makhlouf

Faculty Scholarly Works

Should universal health coverage include immigrants within the “universe?” Should federal taxpayers subsidize health insurance coverage for immigrants, even those who are undocumented? Should all immigrants be required to purchase health insurance? Although the Affordable Care Act (ACA) is conceived as a progressive project to expand access to coverage and promote equity in health care, it intentionally left out the 12.5 million undocumented immigrants living in the United States and preserved the existing restrictions on subsidized coverage for lawfully present non-citizens. In fact, it increased the disparity in access to health care between U.S. citizens and immigrants. As a result, …

Law In The Time Of Zika: Disability Rights And Reproductive Justice Collide, Seema Mohapatra

Brooklyn Law Review

This article focuses on finding common ground between those seeking to ensure abortion access and those advocating for disability rights, using the reaction to the Zika virus as a case study. Although the symptoms of Zika in women were often mild, the correlation of Zika infection in pregnant women to microcephaly affecting their newborns led to travel advisories and alarm bells for pregnant women in areas where the Zika virus was prevalent. Although the rise of microcephaly and its connection to Zika was a cause for concern and investigation, the condition itself is not a death sentence, as headlines suggested. …

Liability (And) Rules For Health Information, Jorge L. Contreras, Francisca Nordfalk

Health Matrix: The Journal of Law-Medicine

The recent trend toward propertization of health data could pose significant challenges to biomedical research and public health. Property rule systems can result in sizable up-front costs in the acquisition of consent from individual data subjects, as well as the ongoing risk that data subjects will retract consent or object to unanticipated data uses, thus compromising existing data resources and analyses. Instead, we propose that research using individual health data should be subject to a regulatory regime, enforceable by government/public repositories, while at the same time permitting private enforcement actions to address particularized individual injury. Thus, while the physical collection …

Constitutional Cohesion And The Right To Public Health, James G. Hodge, Daniel G. Aaron, Haley R. Auger, Ashley Cheff, Joseph Daval

Utah Law Faculty Scholarship

Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally are realities of our existing constitutional infrastructure. In essence, there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and malfeasance). Structural …

Constitutional Cohesion And The Right To Public Health, James G. Hodge Jr., Daniel Aaron, Haley R. Augur, Ashley Cheff, Joseph Daval, Drew Hensley

University of Michigan Journal of Law Reform

Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally are realities of our existing constitutional infrastructure. In essence, there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and malfeasance). Structural …

Going Rogue: Mobile Research Applications And The Right To Privacy, Stacey A. Tovino

Faculty Articles

This Article investigates whether nonsectoral state laws may serve as a viable source of privacy and security standards for mobile health research participants and other health data subjects until new federal laws are created or enforced. In particular, this Article (1) catalogues and analyzes the nonsectoral data privacy, security, and breach notification statutes of all fifty states and the District of Columbia; (2) applies these statutes to mobile-app-mediated health research conducted by independent scientists, citizen scientists, and patient researchers; and (3) proposes substantive amendments to state law that could help protect the privacy and security of all health data subjects, …

Exploring Legal And Policy Responses To Opioids: America's Worst Public Health Emergency, James G. Hodge Jr., Chelsea Gulinson, Leila F. S. Barraza, Walter G. Johnson, Drew Hensley, Haley R. Augur

South Carolina Law Review

No abstract provided.

Constitutional Cohesion And The Right To Public Health, Daniel G. Aaron, James G. Hodge, Haley Augur, Ashley Cheff, C. Joseph Ross Daval, Drew Hensley

Utah Law Faculty Scholarship

Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally is an interpretive reality of our existing constitutional infrastructure. In essence there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and …

Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group

Articles, Book Chapters, & Popular Press

Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …

The Intersection Of Indigenous Public Health With Law And Policy In Canada, Constance Macintosh

Articles, Book Chapters, & Popular Press

This chapter presents an overview of the law, policy and governance practices that are most directly implicated in the population health of Indigenous people who reside in Canada. The first section provides a general description of the socio-legal categories that are drawn upon in health policy, programming and legislation regarding Indigenous peoples. It briefly describes roles in funding and delivering community health services and programming, as well as disputes about responsibilities and some shortcomings.

The second section provides an overview of the population health status of Indigenous peoples. Epidemiological data is presented, and select social determinants of health are also …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Robbing The Grave: Amending The Uniform Anatomical Gift Act To Curtail Abuses Within The Whole-Body Donation Industry, Andrew Y. Schiefer

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Administering Housing Law As Health Care: Attorneys As Healthcare Providers, Frank Griffin

South Carolina Law Review

No abstract provided.

State Benchmark Plan Coverage Of Opioid Use Disorder Treatments And Services: Trends And Limitations, Stacey A. Tovino

Faculty Articles

Professor Tovino offers a survey of state benchmark plan coverage of opioid use disorder treatments and services, and identifies trends and limitations relevant thereto. Part II of the article provides background information regarding opioid use disorder and the treatments and services available for individuals with this disorder. Part III reviews federal mental health parity law and federal mandatory mental health and substance use disorder law as applied to insurance coverage of treatments and services for opioid use disorder, with a focus on the Affordable Care Act's (ACA's) state benchmark health plan selection requirement and the effect on that requirement of …

Water And Life. A Cross-Sectional Study On Determinants Of Beverage Consumption And Water Access In One Tribal Community, Christina White

All Master's Theses

Increasingly, poor diet has been shown to be one of the most crucial factors associated with cause of death, even more critical than smoking. Research in the past two decades has consistently linked increased consumption of sugar-sweetened beverages (SSB) to the obesity epidemic contributing to a public health crisis all over the United States. Native Americans, among other minority groups, suffer obesity disproportionately from the rest of the US population, yet they continually fail to be included in research on the subject. Traditional research methods, sparse care coverage on reservations, consolidation of unique tribes into one classification, and failure to …

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

A Black Box For Patient Safety?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Technology now makes it possible to record surgical procedures with striking granularity. And new methods of artificial intelligence (A.I.) and machine learning allow data from surgeries to be used to identify and predict errors. These technologies are now being deployed, on a research basis, in hospitals around the world, including in U.S. hospitals. This Article evaluates whether such recordings – and whether subsequent software analyses of such recordings – are discoverable and admissible in U.S. courts in medical malpractice actions. I then argue for reformulating traditional "information policy" to accommodate the use of these new technologies without losing sight of …

Exploring The Development Of Three Law-Based Competency Models For Public Health Practitioners, Montrece Mcneill Ransom, Brianne Yassine

Journal of Social, Behavioral, and Health Sciences

As public health promotion and protection become increasingly complex and integrated into various fields, public health law is emerging as an important tool for public health professionals. To ensure that public health professionals are adequately trained public health law, public health law-related competencies should to be integrated into educational and other programming. This article provides three competency models developed by the Public Health Law Program at the Centers for Disease Control and Prevention: (a) the public health emergency law competency model, (b) the public health law competency model, and (c) the legal epidemiology competency model. These competency models provide a …

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Tamar F. Barlam, Jake R. Morgan, Warren A. Kaplan, Kevin Outterson, Stephen I. Pelton

Faculty Scholarship

We compared antibiotic prescribing for children with and those without an underlying chronic condition associated with increased risk for invasive pneumococcal disease. Children with a chronic condition had significantly greater cumulative exposure to antibiotics and higher rates of prescriptions per person-year than those without a chronic condition; this population is at increased risk for the emergence of multidrug-resistant pathogens.

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting …

The Global Preclinical Antibacterial Pipeline, Ursula Theuretzbacher, Kevin Outterson, Aleks Engel, Anders Karlén

Faculty Scholarship

Antibacterial resistance is a great concern and requires global action. A critical question is whether enough new antibacterial drugs are being discovered and developed. A review of the clinical antibacterial drug pipeline was recently published, but comprehensive information about the global preclinical pipeline is unavailable. This Review focuses on discovery and preclinical development projects and has found, as of 1 May 2019, 407 antibacterial projects from 314 institutions. The focus is on Gram-negative pathogens, particularly bacteria on the WHO priority bacteria list. The preclinical pipeline is characterized by high levels of diversity and interesting scientific concepts, with 135 projects on …

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping …

State Benchmark Plan Coverage Of Opioid Use Disorder Treatments And Services: Trends And Limitations, Stacey A. Tovino

Scholarly Works

Professor Tovino offers a survey of state benchmark plan coverage of opioid use disorder treatments and services, and identifies trends and limitations relevant thereto. Part II of the article provides background information regarding opioid use disorder and the treatments and services available for individuals with this disorder. Part III reviews federal mental health parity law and federal mandatory mental health and substance use disorder law as applied to insurance coverage of treatments and services for opioid use disorder, with a focus on the Affordable Care Act's (ACA's) state benchmark health plan selection requirement and the effect on that requirement of …

Going Rogue: Mobile Research Applications And The Right To Privacy, Stacey A. Tovino

Scholarly Works

This Article investigates whether nonsectoral state laws may serve as a viable source of privacy and security standards for mobile health research participants and other health data subjects until new federal laws are created or enforced. In particular, this Article (1) catalogues and analyzes the nonsectoral data privacy, security, and breach notification statutes of all fifty states and the District of Columbia; (2) applies these statutes to mobile-app-mediated health research conducted by independent scientists, citizen scientists, and patient researchers; and (3) proposes substantive amendments to state law that could help protect the privacy and security of all health data subjects, …

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 …

Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess

Pharmacy Faculty Articles and Research

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. …

70 Years Of Human Rights In Global Health: Drawing On A Contentious Past To Secure A Hopeful Future, Lawrence O. Gostin, Benjamin Mason Meier, Rebekah Thomas, Veronica Magar, Tedros A. Ghebreyesus

Georgetown Law Faculty Publications and Other Works

The Universal Declaration of Human Rights, adopted on Dec 10, 1948, established a modern human rights foundation that has become a cornerstone of global health, central to public health policies, programmes, and practices. To commemorate the 70th anniversary of this seminal declaration, we trace the evolution of human rights in global health, linking the past, present, and future of health as a human right. This future remains uncertain. As contemporary challenges imperil continuing advancements, threatening both human rights protections and global health governance, the future will depend, as it has in the past, on sustained political engagement to realise human …

Rape Messaging, Alena Allen

Fordham Law Review

When feminists began advocating for rape reform in the 1970s, the rape message was clear: rape was not a crime to be taken seriously because women lie. After decades of criminal law reform, the legal requirement that a woman vigorously resist a man’s sexual advances to prove that she was raped has largely disappeared from the statute books, and, in theory, rape shield laws make a woman’s prior sexual history irrelevant. Yet, despite what the law dictates, rape law reforms have not had a “trickle-down” effect, where changes in law lead to changes in attitude. Women are still believed to …

Preparing For The Apocalypse: A Multi-Prong Proposal To Develop Countermeasures For Chemical, Biological, Radiological, And Nuclear Threats, Constance E. Bagley, Anat Alon-Beck

Cardozo Law Review

The false alarm of a Hawaiian nuclear attack in January 2018 is an example of the lack of U.S. preparedness for attacks using nuclear and other weapons of mass destruction. To address such threats, this Article proposes the establishment of a nationwide integrated defense of health countermeasures initiative (DHCI). DHCI is a multi-prong program to create a defensive triad comprising government, private industry, and academia to develop countermeasures for health threats posed by chemical, biological, radiological, and nuclear (CBRN) attacks. Key elements of our proposal include the use of the government's Other Transaction Authority to simplify procurement arrangements, the establishment …

Public Health Emergency Preparedness: Globalizing Risk, Localizing Threats, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Infectious diseases are a constant reality, yet it takes a shock to jolt the public’s attention and spur political action. The past weeks saw such as a shock at busy US airports, with the emergency quarantine of 3 flights. At the same time, seemingly a world away, insecurity, weak health systems, and distrust are fueling a second major Ebola outbreak in the Democratic Republic of Congo (DRC) this year. Yet reacting to periodic shocks won’t safeguard our collective future. Emergency preparedness requires proactive planning and funding, with US leadership pivotal.