Health Law and Policy Commons^™

Functional Statehood In Contemporary International Law, William Thomas Worster

Brooklyn Journal of International Law

The international community lacks a form of territorial-based, international legal personality distinct from statehood, and yet, non-state, territorial entities of varying degrees of autonomy or independence need to function within the international community in some form. Some of these entities cannot be recognized as states because their creation violates jus cogens norms, though others are not recognized based on an assessment that they may not fully qualify as a state or that there are political reasons to refuse recognition. However, existing states still need to engage with these territorial quasi-states through the only paradigm the international community has—statehood. For example, …

The Regulatory Production Of Vaccine Hesitancy, Eugene Mccarthy

Brooklyn Law Review

This article argues that U.S. vaccine law produces the “anti-vax” movement. The anti-vax movement is a growing problem, as more than half of American parents have concerns about vaccinating their children. Remarkably, these “vaccine-hesitant” individuals tend to be highly educated, wealthy, and experienced parents. Three legal structures cause vaccine hesitancy: strict immunization mandates, lax regulatory oversight, and blanket limited liability for vaccine manufacturers. The United States stands alone with regard to its vaccine mandates—no other developed democracy requires its citizens to receive such a large number of childhood vaccines. Meanwhile, the law permits financial conflicts of interest in vaccine approval …

Directors’ Duty Of Care In Times Of Financial Distress Following The Global Epidemic Crisis, Leon Yehuda Anidjar

Brooklyn Journal of International Law

The global COVID-19 pandemic is causing the large-scale end of life and severe human suffering globally. This massive public health crisis created a significant economic crisis and is reflected in a recession of global production and the collapse of confidence in the functions of markets. Corporations and boards of directors around the world are required to design specific strategies to tackle the negative consequences of the crisis. This is especially true for small and medium-sized enterprises (SMEs) that suffered tremendous economic loss, and their continued existence as ongoing concern is under considerable risk. Given these uncertain financial times, this Article …

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

The "People's Total War On Covid-19": Urban Pandemic Management Through (Non-)Law In Wuhan, China, Philipp Renninger

Washington International Law Journal

Although COVID-19 was first detected in the People’s Republic of China, the pandemic now appears contained there. Western and Chinese media attribute this apparent success to the central level of the Chinese state and the Communist Party. However, this article reveals that local entities provided critical contributions to China’s COVID-19 management, particularly in the pandemic’s first epicenter: Wuhan city in Hubei province. Chinese cities like Wuhan can fight public health emergencies through legal and nonlegal instruments. Although Wuhan had prepared for possible pandemics, its existing plans, institutions, and warning systems initially failed against COVID-19. The city did not contain the …

Right To Health In Gats: Can The Public Health Exception Pave The Way For Complementarity?, Swati Gola

Pace International Law Review

This paper demonstrates how a right to health approach in the interpretation of the public health exception outlined in GATS Article XIV(b) can bring about a harmonious application of international human rights and international trade law regimes. Focusing on the interpretive value of the right to health for the public health exception in GATS, it examines whether a WTO Member, who has committed itself under GATS to fully liberalize all service sectors that have implications for health (e.g., hospital and other healthcare services), still retains the regulatory space to undertake measures to fulfill their right to health obligations and can …

An Australian Conundrum: Genomic Technology, Data, And The Covidsafe App, David Morrison, Patrick T. Quirk

Pace International Law Review

This paper examines the difficulties that have arisen in Australia in the use of its contact-tracing app. We examine the privacy implications around the use of the app, the wider economic imperative, and the balancing of those concerns against the health threat of the COVID-19 pandemic. We posit that default options are superior in times of emergency and rather than begging for the adoption of lifesaving technology, we suggest that the evidence gathered by behavioral economists provides an apposite and powerful alternative worthy of consideration.

Proposed Federal Osha Standards For Wildfire Smoke, Keenan Layton

Seattle Journal of Technology, Environmental, & Innovation Law

With the rise of global temperatures, climatologists predict a corresponding increase in the frequency and severity of wildfires in the Pacific Northwest. Rising temperatures are expected to create drier conditions in forests, thereby creating environmental conditions more prone to forest fires. Wildfires have become a common enough occurrence in the Pacific Northwest that summers have become synonymous with smoky conditions, but the issue is not constrained to this region. Though the Pacific Northwest has recently acted as a harbinger of increasing wildfires, environmental scientists forecast an increase in fire risk throughout the Western United States. The predicted rise in forest …

The Crossroads Of Wellness And Second Victim Syndrome: Identifying Factors That Alter The Pathway Of Caregiver Recovery Following An Unanticipated Adverse Patient Outcome, Kimia Zarabian, A. Katharine Hindle, Ivy Benjenk, Anita Vincent, Jamil M. Kazma, Benjamin Shambon, Raymond Pla, Eric Heinz

Journal of Wellness

Introduction: Second Victim Syndrome (SVS) describes the phenomenon in which a caregiver experiences a traumatic psychological and emotional response to an adverse patient event or medical error. Using quantitative survey analysis, we aim to better understand the personal factors that affect SVS development and recovery.

Methods: Caregivers at a small urban academic medical center who had experienced an adverse patient event in the past six months were invited to take part in this institution-wide, voluntary, quantitative, cross-sectional study. Three surveys were administered; the Holmes-Rahe Life Stress Inventory (HRLSI) was used as a surrogate to measure stressful life events. The …

The Ethical Challenge For Hipaa’S Privacy Rule In The Genomics Era Of Data Analytics., Reem Shinawi

Electronic Theses and Dissertations

The thesis of this dissertation focuses on the Ethical Challenge for HIPAA’s Privacy Rule in the Genomics Era of Data Analytics. Data Analytics in Genomic Medicine challenges the individuals’ right to privacy. Hence, a balance is needed between the previous centrality of individual privacy and the need for population information to make breakthroughs in Genomic Medicine using Data Analytics. Such a problem demands regulatory solutions. And such solutions require the collaboration of professionals. Genomic Medicine is a field that deals with sensitive genetic information in both medicine, and research, it is essential to view it through HIPAA as it is …

The Clean Air Act: How It Can Be Localized To Promote Both Environmental And Social Justice, Tate Kirk

Seattle Journal of Technology, Environmental, & Innovation Law

Legislators attempt to achieve intended goals by enacting laws that provide for regulatory enforcement. However, many times laws are unable to achieve their stated goals and in some ways may create new or exacerbate existing issues. Luckily, upon review, many of these issues can be fixed with quick modifications to either their implementation or enforcement mechanisms. In its current form, the Clean Air Act does not effectively account for differences in regional climate patterns, and, moreover, it perpetuates environmental injustice. If local governments were given more autonomy to enforce the Clean Air Act, they could shape its enforcement to more …

The Stellenbosch Consensus On Legal National Responses To Public Health Risks: Clarifying Article 43 Of The International Health Regulations, Roojin Habibi, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Margherita Cinà, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to global health emergencies such as the ongoing COVID-19 pandemic. Countries are permitted to exercise their sovereignty in taking additional health measures to respond to such emergencies if these measures adhere to Article 43 of this legally binding instrument. Overbroad measures taken during recent public health emergencies of international concern, however, reveal that the provision remains inadequately understood. A shared understanding of the measures legally permitted by Article 43 is a necessary step in …

The Stellenbosch Consensus On The International Legal Obligation To Collaborate And Assist In Addressing Pandemics: Clarifying Article 44 Of The International Health Regulations, Margherita Cinà, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Roojin Habibi, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to potential global health emergencies such as the ongoing covid-19 pandemic. While Article 44 of this binding legal instrument requires countries to collaborate and assist each other in meeting their respective obligations, recent events demonstrate that the precise nature and scope of these legal obligations are ill-understood. A shared understanding of the level and type of collaboration legally required by the IHR is a necessary step in ensuring these obligations can be acted upon …

Cost, Coverage, And The Underuse Of Medications Among People With Cf, Semret Seyoum, Marsha Regenstein, Lea Nolan

Health Policy and Management Issue Briefs

No abstract provided.

Caps On Capsules: Prescription For Lower Drug Prices In The United States, Christine Chasse

Student Scholarship

The United States is the foremost innovator of pharmaceutical therapies in the world. That innovation, however, comes at a price—literally. Americans pay more for their medications than any other country. In a country without universal healthcare, the topics of economics, human rights, and healthcare intersect at the crossroads of pharmaceutical pricing. In contrast to most other countries, the United States has no regulations on pharmaceutical price control. One major argument against government regulation is its inherent opposition to the free market system: the heart of the American economy. Further still is the argument that profit restriction would create a chilling …

Health Insurance Portability And Accountability Act Of 1996: Health & Public Welfare, Erin L. Hayes, Kathryn A. Vance

Georgia State University Law Review

The Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) establish a standard for the use and protection of individuals’ health information and apply to certain covered entities or their business associates. Covered entities may only disclose an individual’s protected health information in limited situations. Covered entities or individuals that fail to comply with the Privacy Rule standards may be subject to civil or criminal penalties.

A Path To Data-Driven Health Care Enforcement, Jacob T. Elberg

Utah Law Review

The Department of Justice (“DOJ”) has a long-stated goal of encouraging companies to engage in what the author refers to as “compliant behaviors”—maintenance of an effective pre-existing compliance program, post-enforcement adoption of an effective compliance program, cooperation with a government investigation, and self-disclosure of misconduct. Substantial DOJ guidance over the past two decades, along with the concrete incentive structure of the United States Sentencing Guidelines, have increasingly made clear to organizations when and how such behaviors will be rewarded in criminal matters. Recently, DOJ has made transparency and clarity regarding the benefit of compliant behaviors a priority in calculating and …

Sonograms And Speech: Informed Consent, Professional Speech, And Physicians' First Amendment Rights, Oliana Luke

Washington Law Review

Abortion is an extremely divisive topic that has caused waves of litigation. The right to access abortion has traditionally been challenged based on due process, equal protection, and privacy grounds. However, in a more recent string of cases, physicians have been challenging laws that require the physician to narrate an ultrasound before an abortion as an abridgment of their First Amendment rights. These cases require courts to balance the government’s ability to reasonably regulate a physician through professional licensing with the physician’s First Amendment protections against government-compelled speech. This Comment argues that, to balance these ideals and survive First Amendment …

Mandatory Quarantine: Administrative Order By The Georgia Department Of Public Health For Public Health Control Measures: Isolation Protocol, Matthew C. Daigle, Carissa L. Lavin

Georgia State University Law Review

The Administrative Order for Public Health Control Measures and its subsequent amendments outlined the Isolation and Quarantine Protocols for individuals who either tested positive for COVID-19 or were suspected of COVID-19 infection based on symptoms or prolonged exposure to the virus.

Forced Business Closures: Executive Orders By The Governor Closing Private Businesses, Baylee A. Culverhouse, Alexa R. Martin

Georgia State University Law Review

Governor Brian Kemp (R) issued Executive Orders in response to the COVID-19 pandemic that required businesses to close in an effort to limit the spread of the virus. Business owners often challenged those forced business closures as unconstitutional or as exceeding the State’s police power, and those challenges were met with varying degrees of success.

Bioethics: Ethical Considerations Of Ventilator Triage During A Pandemic, Susannah J. Gleason, William J. Keegan

Georgia State University Law Review

In the midst of the COVID-19 pandemic, hospitals across the country faced unprecedented volumes of patients seeking treatment related to the respiratory complications of the virus. As a result, states were forced to reassess existing scarce resource allocation guidelines to appropriately accommodate the high demand. This Peach Sheet analyzes the ethical considerations implicated in enacting and following these guidelines when treating patients, specifically in the context of ventilator triage in response to the COVID-19 pandemic.

First Amendment: Executive Order By The Governor Limiting Large Gatherings Statewide, Alex N. Estroff, Boris W. Gautier

Georgia State University Law Review

Beginning in March 2020, Georgia Governor Brian Kemp (R) issued a series of Executive Orders addressing the State’s response to the COVID-19 pandemic. Included in these Orders was a prohibition on large groups of people gathering in a single location. Though an effective means of curtailing the virus’s rapid transmission, this specific provision became a source of controversy for groups who believed such a prohibition infringed upon their First Amendment rights.

Public Health State Of Emergency: Executive Order By The Governor Declaring A Public Health State Of Emergency, Rebecca Hu, Ellen Y. Min

Georgia State University Law Review

The Executive Order primarily functions to enumerate the Governor’s emergency powers during a Public Health State of Emergency. The Executive Order allows for the Governor to assist health and emergency management officials by deploying available resources for the mitigation and treatment of COVID-19 within Georgia.

Torts: Covid-19 Pandemic Business Safety Act & Executive Order By The Governor Designating Auxiliary Management Workers And Emergency Management Activities, Angelena Velaj, Troy Viger

Georgia State University Law Review

The Executive Order expanded immunity from liability for volunteer health care workers as emergency management workers performing emergency management activities. The Order was not limited to only COVID-19-related activities. When the legislature reconvened, legislators passed the Georgia COVID-19 Pandemic Business Safety Act, which provided liability limitation to businesses against tort claims arising from the pandemic.

Elections: Elections And Primaries Through The Pandemic, Joseph M. Brickman, Logan D. Kirkes

Georgia State University Law Review

The 2020 election cycle was all but normal. Due to certain health concerns associated with the COVID-19 pandemic, Georgia delayed its primary election three months from March to June and summarily mailed absentee ballot request forms to all active, registered voters. From presidential social media postings to a federal lawsuit, debate ensued over the widespread usage of absentee ballots, their overall effectiveness and security, who would receive request forms, and whether postage requirements qualified as an impermissible poll tax. To further compound these uncertainties, Georgia legislators, who are not permitted to fundraise or campaign during the forty-day legislative session, had …

Preemption: Executive Order By The Governor To Ensure A Safe & Healthy Georgia, Marisa P. Ahlzadeh, Fanny Chac

Georgia State University Law Review

The doctrine of preemption expresses the idea that “a higher authority of law will displace a lower authority of law when the two authorities come into conflict.” Preemption exists on both the federal and state level. According to the Georgia Constitution, local laws are permissible if they do not conflict with the state law on the subject. During a Public Health State of Emergency, the Governor of Georgia maintains certain expanded powers to take necessary action for the health and safety of the public. On April 2, 2020, Governor Brian Kemp (R) used these expanded powers to enact an Executive …

Laboratories Of Exclusion: Medicaid, Federalism & Immigrants, Medha D. Makhlouf

Faculty Scholarly Works

Medicaid’s cooperative federalism structure gives states significant discretion to include or exclude various categories of immigrants. This has created extreme geographic variability in immigrants’ access to health coverage. This Article describes federalism’s role in influencing state policies on immigrant eligibility for Medicaid and its implications for national health policy. Although there are disagreements over the extent to which public funds should be used to subsidize immigrant health coverage, this Article reveals that decentralized policymaking on immigrant access to Medicaid has weakened national health policy. It has failed to incentivize the type of state policy experimentation and replication that justifies federalism …

Crimes And Offenses: Proposed Constitutional Carry Act Of 2019 & Executive Order By The Governor Temporarily Extending Renewal Requirements For Weapons Carry Licenses, Kristin Harripaul, Briana A. James

Georgia State University Law Review

In March 2020, Governor Brian Kemp (R) issued an Executive Order declaring a Public Health State of Emergency due to COVID-19. The Supreme Court of Georgia also issued a Judicial Order declaring a Statewide Judicial Emergency. The Council of Probate Court Judges subsequently characterized the processing of weapons carry licenses as non-essential and temporarily suspended license issuances to limit the spread of COVID-19. HB 2 would have eliminated the license requirement and the need for probate judges to process applications. However, HB 2 never received a hearing before the 2019–20 legislative session ended. Gun rights advocates called on Governor Kemp …

Does “No, Not Without A Condom” Mean “Yes, Even Without A Condom”?: The Fallout From R V Hutchinson, Lise Gotell, Isabel Grant

Dalhousie Law Journal

In R v Kirkpatrick, the Court of Appeal for British Columbia held that consent to sexual activity cannot be established where a man proceeds with unprotected vaginal intercourse when his sexual partner has insisted on a condom. While this finding should be uncontroversial, it is in fact contrary to the Supreme Court of Canada ruling in R v Hutchinson. In this comment we argue that the approach taken in Kirkpatrick is correct and consistent with the landmark decision in R v Ewanchuk. We urge the Supreme Court of Canada to reconsider its majority judgment in Hutchinson in order to fully …

Faith And/In Medicine: Religious And Conscientious Objections To Maid, Daphne Gilbert

Dalhousie Law Journal

Across Canada, health care institutions that operate under the umbrella of religious traditions refuse to offer medical assistance in dying (MAiD) on the grounds that it violates their Charter-protected rights to freedom of religion and conscience. This article analyses the Supreme Court jurisprudence on section 2(a) and concludes that it should not extend to the protection of institutional rights. While the Court has not definitively pronounced a view on this matter, its jurisprudence suggests that any institutional right to freedom of religion would not extend to decisions on publicly-funded and legal health care. MAiD is a constitutionally-protected option for individuals …