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Full-Text Articles in Health Law and Policy

100% All Natural Ambiguity: A Comparative Approach To Food Labeling Requirements For The Term “Natural” By The Food And Drug Administration And The European Union, Andréa Maehara Jan 2019

100% All Natural Ambiguity: A Comparative Approach To Food Labeling Requirements For The Term “Natural” By The Food And Drug Administration And The European Union, Andréa Maehara

Washington University Global Studies Law Review

Despite being the only regulatory agency empowered to establish definitions for food product labeling, the Food and Drug Administration (FDA) has not formally defined the term “natural.” The FDA’s reluctance to fully define the term increases consumer distrustful of the FDA as a regulatory body and has also led to a dramatic increase in class action lawsuits against major food corporations. This Note will argue that the FDA should issue a formal definition in order to standardize usage of “natural” on food labeling by incorporating the European Union (EU)’s approach. First, this Note will examine the origins of ...


The Ethics Of Big Data In Genomics: The Instructive Icelandic Saga Of The Incidentalome, Donna M. Gitter Jan 2019

The Ethics Of Big Data In Genomics: The Instructive Icelandic Saga Of The Incidentalome, Donna M. Gitter

Washington University Global Studies Law Review

DeCODE Genetics, Inc., a pioneering Icelandic biotech firm, recently introduced a free website that permits Icelanders to learn whether they carry mutations in the BRCA2 gene that are known to increase cancer risk, even if these citizens have never participated in genetic testing. Approximately five thousand Icelanders have elected thus far to receive their status. This site is made possible by the consanguinity of Icelandic citizens, who number fewer than 350,000, and their detailed genealogical records dating back centuries, a set of circumstances that presents a unique opportunity to study genetic mutations and the medical disorders associated with them ...


The New Chinese Mental Health Laws, Zhiyuan Guo, Floyd Feeney Jan 2018

The New Chinese Mental Health Laws, Zhiyuan Guo, Floyd Feeney

Washington University Global Studies Law Review

The United Nations Convention on the Rights of Persons with Disabilities is by far the most important international agreement yet developed concerning the mentally disabled. China adopted this Convention in 2008. In 2012 China went further—making major changes in the way that China deals with mental health issues in both its criminal and its civil law. Coming first was a new Criminal Procedure Code that adds a whole new dimension to the way that China deals with the mentally ill who are charged with crimes. Equally important was the new civil mental disabilities law that China adopted later in ...


Waiting To Be Heard: Fairness, Legal Rights, And Injustices The Deaf Community Faces In Our Modern, Technological World, Justin Chavez Jan 2018

Waiting To Be Heard: Fairness, Legal Rights, And Injustices The Deaf Community Faces In Our Modern, Technological World, Justin Chavez

Washington University Global Studies Law Review

This note will examine the existing access to legal aid, employment, recourse, and education in various deaf cultures and societies. The goal is a comparative study into how the DHH communities are accepted, valued, and prioritized in different countries, and how that translates into legal infrastructure, in the form of governmentally-mandated statues, regulations, public accommodations, and legal education. This will consist of a brief history into the recognition, labeling, and acceptance of deaf citizens in ancient and modern cultures, the path to a society’s awareness and eventual recognition of deaf citizens, and how the various levels of awareness differ ...


Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim Jan 2018

Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim

Washington University Law Review

Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma ...


"Your Old Road Is/ Rapidly Agin'": International Human Rights Standards And Their Impact On Forensic Psychologists, The Practice Of Forensic Psychology, And The Conditions Of Institutionalization Of Persons With Mental Disabilities, Michael L. Perlin Jan 2018

"Your Old Road Is/ Rapidly Agin'": International Human Rights Standards And Their Impact On Forensic Psychologists, The Practice Of Forensic Psychology, And The Conditions Of Institutionalization Of Persons With Mental Disabilities, Michael L. Perlin

Washington University Global Studies Law Review

For years, considerations of the relationship between international human rights standards and the work of forensic psychologists have focused on the role of organized psychology in prisoner abuse at Guantanamo Bay and Abu Ghirab. That issue has been widely discussed and debated, and these discussions show no sign of abating. But there has been virtually no attention given to another issue of international human rights, one that grows in importance each year: how the treatment (especially, the institutional treatment) of persons with mental and intellectual disabilities violates international human rights law, and the silence of organized forensic psychology in the ...


No Pay For Sexist Performance: How Gender Disparities In Healthcare Hurt Hospitals’ Pay For Performance Reimbursements, Emily C. Bartlett Jan 2018

No Pay For Sexist Performance: How Gender Disparities In Healthcare Hurt Hospitals’ Pay For Performance Reimbursements, Emily C. Bartlett

Washington University Law Review

Gender disparities and discrimination in healthcare treatment are vast. Women in pain are deemed hysterical, heart attacks in women are caught less frequently than in men due to symptom presentation differences, and women are screened less often than men for some cancers. Meanwhile, in order to be fully reimbursed for healthcare services, legislative reforms increasingly evaluate hospitals and physicians based on their performance as it relates to quality measurements, otherwise known as pay for performance. This particular method of reimbursement expanded after the Patient Protection and Affordable Care Act (ACA) enacted pay for performance standards, particularly for hospitals and physicians ...


Plain Tobacco Packaging’S Impact On International Trade And The Family Smoking Prevention And Tobacco Control Act In The U.S. And Drafting Suggestions, Sunil S. Gu Jan 2017

Plain Tobacco Packaging’S Impact On International Trade And The Family Smoking Prevention And Tobacco Control Act In The U.S. And Drafting Suggestions, Sunil S. Gu

Washington University Global Studies Law Review

Despite its legal status, tobacco products, due to the potential harmful effects on health, have never been free from various governmental regulations. However, it was easier said than done to regulate them as governments wished, and in fact there were numerous failed attempts. Thus, governments tried to come up with a better and more effective regulation that will reduce the tobacco consumption thereby promoting public health, under the name of public health of their citizens. And plain tobacco packaging measures are the latest solution suggested.

The introduction of the plain tobacco measures has stirred huge controversy (understandably so), since it ...


The Future Of Gmo Labeling: How A New Federal Labeling Scheme Will Alter Public Disclosure, Maria Degiovanni Jan 2017

The Future Of Gmo Labeling: How A New Federal Labeling Scheme Will Alter Public Disclosure, Maria Degiovanni

Washington University Law Review

Genetic modification is a process used for a myriad of purposes, including the cultivation of plant species that ultimately find their way into countless food products across the world.1 As the usage of genetically modified organisms (GMOs) has grown, so has the public debate surrounding their presence in food, and, more specifically, their undisclosed presence in food. Until recently, the United States maintained next to no regulation on the labeling of GMO products.2 After many state legislatures began proposing and passing GMO-labeling laws, Congress passed one of its own.3 This Note will discuss the implications of the ...


Consumer Financial Protection In Health Care, Erin C. Fuse Brown Jan 2017

Consumer Financial Protection In Health Care, Erin C. Fuse Brown

Washington University Law Review

There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of- network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees ...


Wrongly “Identified”: Why An Actual Knowledge Standard Should Govern Health Care Providers’ False Claims Act Obligations To Report And Return Medicare And Medicaid Overpayments, Nicholas J. Goldin Jan 2017

Wrongly “Identified”: Why An Actual Knowledge Standard Should Govern Health Care Providers’ False Claims Act Obligations To Report And Return Medicare And Medicaid Overpayments, Nicholas J. Goldin

Washington University Law Review

In 2015, Medicare spent $632 billion on health care for America’s elderly (and other covered groups). Medicaid spent another $554 billion to provide health care to America’s needy. The government estimates that improper payments account for as much as 10% of Medicare and Medicaid spending. Given the vast amount of money at stake, and the fact that there is bipartisan support for recovering taxpayer dollars, it is no surprise the federal government has made it a priority to recoup the money lost to health care fraud each year. The results are noticeable: annual recoveries for health care fraud ...


Are We Adopting The Orphans, Or Creating Them? Medical Ethics And Legal Jurisprudential Guidance For Proposed Changes To The Orphan Drug Act, Lydia Raw Jan 2017

Are We Adopting The Orphans, Or Creating Them? Medical Ethics And Legal Jurisprudential Guidance For Proposed Changes To The Orphan Drug Act, Lydia Raw

Washington University Jurisprudence Review

This Note traces the subtle changes in the underlying purposes of the Orphan Drug Act, and evaluates those purposes from the perspectives of medical ethics and legal jurisprudence. Part I begins with the history of the Orphan Drug Act discussed issue by issue, to elucidate the subtle changes in the purpose of the Orphan Drug Act through its history. Part II explores the moral and ethical issues presented by the Orphan Drug Act to identify eleven guiding principles from medical ethics and legal jurisprudence. Lastly, Part III applies these guiding principles to the most common proposed amendments to the Orphan ...


Whose Responsibility Is It To Prep For Safe Sex? Archaic Hiv Criminalization And Modern Medicine, Brigid Bone Jan 2017

Whose Responsibility Is It To Prep For Safe Sex? Archaic Hiv Criminalization And Modern Medicine, Brigid Bone

Washington University Journal of Law & Policy

This Note traces the history of HIV and its impact on the homosexual community, with a focus on criminal statutes that attempted to regulate the actions of individuals with HIV, and how those statutes can be evaluated considering modern advancements against the virus. Bone addresses the state of HIV criminalization bearing in mind medical treatments, such as Highly Effected Antiretroviral Treatment (HAART) and Pre-Exposure Prophylaxis (PrEP), as well as conviction rates among those who engage in sexual activity while HIV positive. Bone proposes amending current criminalization statutes in a way that would de-stigmatize the conversation that surrounds the virus while ...


Research Ethics Committees (Recs)/Institutional Review Boards (Irbs) And The Globalization Of Clinical Research: Can Ethical Oversight Of Human Subjects Research Be Standardized?, Andrea S. Nichols Jan 2016

Research Ethics Committees (Recs)/Institutional Review Boards (Irbs) And The Globalization Of Clinical Research: Can Ethical Oversight Of Human Subjects Research Be Standardized?, Andrea S. Nichols

Washington University Global Studies Law Review

Current United States’ policy requires federally funded research studies involving human subjects to be approved by an interdisciplinary committee called an institutional review board (IRB). IRBs exist to protect the safety and welfare of human subjects participating in research studies. Although oversight of human subjects research and, consequently, IRBs, is governed by federal regulations, the operation of IRBs remain largely mysterious to those other than IRB members themselves. This Note reviews the establishment of both United States regulations and international guidelines governing human subjects research, the changing environment of biomedical research, and potential reforms for improving the efficiency and efficacy ...


Adverse Events: The Need For The United States And Japan To Reform Patient Safety, Rocco Giovanni Motto Jan 2016

Adverse Events: The Need For The United States And Japan To Reform Patient Safety, Rocco Giovanni Motto

Washington University Global Studies Law Review

After the Institute of Medicine released a report in 1999 a startling discovery was apparent: between 44,000 and 98,000 hospital patients in the United States died in 1997 as a result of an adverse event. An adverse event is an unfavorable event that is caused by a medical product rather than the primary condition of the patient. In other words, an adverse event describes any harm to a patient as a result of medical care. A later study estimated that between 220,000 and 440,000 hospital patients in the United States suffer from some type of adverse ...


Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma Marouf Jan 2016

Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma Marouf

Washington University Law Review

In the Affordable Care Act (“ACA”), passed in 2010, Congress provided that only “lawfully present” individuals could obtain insurance through the Marketplaces established under the Act. Congress left it to the Department of Health and Human Services (“HHS”) to define who is “lawfully present.” Initially, HHS included all individuals with deferred action status, which is an authorized period of stay but not a legal status. After President Obama announced a new policy of Deferred Action for Childhood Arrivals (“DACA”) in June 2012, however, HHS amended its regulation specifically to exclude DACA recipients from the definition of “lawfully present.” The revised ...


Introduction, Elizabeth Sepper Jan 2016

Introduction, Elizabeth Sepper

Washington University Journal of Law & Policy

No abstract provided.


Informed Consent As Compelled Professional Speech: Fictions, Facts, And Open Questions, Nadia N. Sawicki Jan 2016

Informed Consent As Compelled Professional Speech: Fictions, Facts, And Open Questions, Nadia N. Sawicki

Washington University Journal of Law & Policy

This article explores the relationship between a physician’s First Amendment right to free speech and state informed consent mandates. Sawicki details the convoluted jurisprudence surrounding consent mandates, focusing on one-sided and controversial subject matter that many states require physicians to disclose. Sawicki then offers a legal framework for how a physician-challenged consent mandate may pass through the court system based on existing Supreme Court jurisprudence.


Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher Jan 2016

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Washington University Journal of Law & Policy

This article focuses on the unique nature of prohibited disclosures within the health care field. Specifically, this article details the relationship between restrictions on off-label drug use advertising and constitutionally protected free speech. Orentlicher explores the conflict between regulation of off-label drug use through direct prohibition versus regulation through indirect advertising restrictions. Ultimately, Orentlicher argues that pharmaceutical companies should not be able to invoke first amendment arguments against off-label advertising restrictions due to the potential for harm to the consumer.


The First Amendment And The Politics Of Reproductive Health Care, B. Jessie Hill Jan 2016

The First Amendment And The Politics Of Reproductive Health Care, B. Jessie Hill

Washington University Journal of Law & Policy

This article explores the detailed nuances of contraception and reproductive care as distinct and individual entities within the healthcare system as a whole. Hill discusses the relationship between the First Amendment and reproductive rights, highlighting the discrepancies in judicial opinions based on whether or not reproductive rights are considered essential or elective care. Hill closes with a defense of reproductive rights, advocating them as an essential component of care as opposed to an elective moral choice.


Clarifying Standards For Compelled Commercial Speech, Micah L. Berman Jan 2016

Clarifying Standards For Compelled Commercial Speech, Micah L. Berman

Washington University Journal of Law & Policy

This article analyzes the compelled commercial speech doctrine within the context of public health warnings and mandated disclosures. Berman details the complex nature of compelled speech, tracing its history and focusing on identifying the appropriate level of constitutional scrutiny that should be applied. Berman then suggests that communities should be given “flexibility to mandate warnings geared towards protecting the public’s health.”


Nafta Largely Responsible For The Obesity Epidemic In Mexico, Alana D. Siegel Jan 2016

Nafta Largely Responsible For The Obesity Epidemic In Mexico, Alana D. Siegel

Washington University Journal of Law & Policy

This note examines the link between the obesity epidemic in Mexico and NAFTA. Siegel argues that NAFTA’s leniency towards Foreign Direct Investments as well as its limitations on governmental regulation has impeded Mexico’s ability to address detrimental public health concerns, directly contributing to their obesity epidemic. Siegel then attempts to reconcile the desire for free trade with public health regulation by proposing changes to NAFTA’s language in order to create the flexibility necessary to directly address public health concerns.


A Natural Food Fight: The Battle Between The “Natural” Label And Gmos, Colleen Gray Jan 2016

A Natural Food Fight: The Battle Between The “Natural” Label And Gmos, Colleen Gray

Washington University Journal of Law & Policy

This note addresses the complex nature of food labeling in the United States, specifically in relation to the rise of “natural” products. Gray analyzes the history of food labeling, focusing on the use of the term “natural” in relation to products containing genetically modified organisms (GMOs). Gray then argues that due to a lack of regulation by the FDA on what the term “natural” means, consumers have a right to know that the “natural” product they are consuming may contain GMOs.


“Right To Try” Legislation And Its Implications For The Fda Drug Approval Process, Emily Hogan Jan 2016

“Right To Try” Legislation And Its Implications For The Fda Drug Approval Process, Emily Hogan

Washington University Journal of Law & Policy

This note analyzes the regulation of experimental drugs by the FDA within the context of “right-to-try” laws. Hogan explores the FDA’s drug approval process, highlighting the specific options for terminally ill patients to fast-track their access to potentially life-saving drugs. Hogan then turns to state “right-to-try” laws, addressing them in relation to federal preemption, pharmaceutical companies, and actual assistance to terminally ill patients. Hogan recommends a relaxation of the FDA’s drug approval process, specifically streamlining the “expanded access” program to give terminally ill patients access to experimental drugs.


More Doctors, More Problems: Exploring Brazil’S Mais Médicos Program And The Legal Challenges It Has Provoked, Julia Cammack Jan 2015

More Doctors, More Problems: Exploring Brazil’S Mais Médicos Program And The Legal Challenges It Has Provoked, Julia Cammack

Washington University Global Studies Law Review

Brazil is among the growing number of countries that guarantee the right to health. Its Constitution provides that the state has a duty to implement policies that promote universal access to health care services, with the ultimate goal of improving the health outcomes of all Brazilians. Despite this constitutional guarantee and the creation of the Unified Health Service to facilitate its realization, access to health care services and medical personnel is unevenly distributed across the country, with a high concentration of physicians in wealthier urban zones and a comparatively low density of medical personnel in impoverished urban and rural areas ...


Increasing Transparency Of Clinical Trial Data In The United States And The European Union, Rebecca Choi Jan 2015

Increasing Transparency Of Clinical Trial Data In The United States And The European Union, Rebecca Choi

Washington University Global Studies Law Review

The Internet is becoming the greatest source of health information for most consumers, which reinforces the importance of making online information about clinical trials accessible in a reliable, unbiased format. Non-reporting and distorted reporting of clinical trials impede the betterment of scientific knowledge and public health.

There have been increasing demands for public transparency and the complete disclosure of clinical trial data. Hoarding data causes researchers to duplicate efforts, repeat mistakes, and potentially cause avoidable injuries or deaths to research subjects. Changes in the administration of clinical trials is necessary to safeguard public health and maximize effective use of clinical ...


The Evolution Of Federal Courts’ Healthcare Antitrust Analysis: Does The Ppaca Spell The End To Hospital Mergers?, Collin Z. Groebe Jan 2015

The Evolution Of Federal Courts’ Healthcare Antitrust Analysis: Does The Ppaca Spell The End To Hospital Mergers?, Collin Z. Groebe

Washington University Law Review

Traditionally, hospital mergers were seen as a benefit to consumers. That is no longer the case. After years of nonprofit hospitals engaging in price inflation and misreporting charity care, new hospital mergers will be more heavily scrutinized. Specifically, the United States government has implemented policies that are intended to shrink the relevant market, separate hospital services into individual lines, and require more than a good faith standard for evidence of proposed efficiencies. These policies were created as a response to the findings in antitrust court cases that hospital executives were increasing prices as a monopolist. These cases have worked to ...


Salus Populi Suprema Lex Esto: Balancing Civil Liberties And Public Health Interventions In Modern Vaccination Policy, Phoebe E. Arde-Acquah Jan 2015

Salus Populi Suprema Lex Esto: Balancing Civil Liberties And Public Health Interventions In Modern Vaccination Policy, Phoebe E. Arde-Acquah

Washington University Jurisprudence Review

Vaccine policy still stirs up similar contentions and controversial sentiments today as it did in 1905 due to the enduring tension between public health interventions and individual liberties, between the rights of the individual and the claims of the collective. This Note considers the rationale for granting vaccine exemptions in one case, but withholding them in another; why one court gives substantial deference to state power regarding vaccination, and another demonstrates considerable regard for civil liberties in vaccine policy.

It has been suggested that pragmatism and political acuity, rather than a doctrinal adherence to epidemiological theory or ethical principles has ...


Hobby Lobby And The Zero-Sum Game, Kathryn E. Kovacs Jan 2014

Hobby Lobby And The Zero-Sum Game, Kathryn E. Kovacs

Washington University Law Review

No abstract provided.


Why Do Cities Innovate In Public Health? Implications Of Scale And Structure, Paul A. Diller Jan 2014

Why Do Cities Innovate In Public Health? Implications Of Scale And Structure, Paul A. Diller

Washington University Law Review

Big cities have frequently enacted public health regulations—especially with respect to tobacco use and obesity—that go beyond the state and federal regulatory floors. That cities innovate in public health at all is remarkable. They have less to gain financially from more stringent regulation than higher levels of government, which shoulder more of the burden of Medicare and Medicaid. Cities are supposed to fear mobile capital flight; if they regulate, businesses will leave. Moreover, because innovation is costly and likely to be copied by others when successful, a free-rider problem might inhibit local policy innovation generally.

Cities’ prolific regulation ...