HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Friday, April 30, 2021

Difficulty of Care: Aligning Tax and Health Care Policy for Family Caregiving

Christine Speidel (Villanova University), Difficulty of Care: Aligning Tax and Health Care Policy for Family Caregiving, 52 Loyola U. Chic. L. J. (2021):

In the United States millions of people live with disabilities, many of whom require assistance with activities of daily life to remain in their homes and communities. However, financial support for this assistance is limited. Many caregivers forgo working outside the home in order to provide care to a family member. And while state and federal programs provide some compensation for caregiving, caregivers frequently face problems including poverty, lack of health insurance, lack of Social Security and Medicare credits, and lack of retirement savings. Our nation’s paltry support for caregiving threatens the practical ability of people with disabilities to choose community integration over institutional living.This Essay examines the little-known and little-used “difficulty of care” gross income exclusion under I.R.C. § 131 as a possible vehicle to improve this picture. While § 131 originated as an exclusion for foster payments, it was reinterpreted in IRS Notice 2014-7 to apply to contemporary programs for in-home services and supports. Unfortunately, the impact of this reinterpretation was complicated and hotly contested. This Essay juxtaposes the evolution of home and community-based health care services, the Affordable Care Act, and the evolution of tax expenditures for low-income taxpayers to explain how the tax and health care systems collided in the aftermath of Notice 2014-7.This Essay reveals tensions and contradictions between tax and health care policy, informed by case examples and by ground-level considerations of program administration. It suggests that a gross income exclusion is an ineffective means to implement policy preferences and that policymakers should undertake a broader examination of the interactions between health and tax provisions when considering financial supports for caregiving. Finally, the Essay offers preliminary considerations for redesigning tax supports for caregiving, both to better reflect the values of dignity and autonomy that underlie home-based services, and to prevent unintended harm to low-income families.

April 30, 2021 | Permalink | Comments (0)

Can Governments Push Providers to Collaborate? A Comparison of Hospital Network Reforms in France and the United States

Robert Field (Drexel University), Catherine Keller, Michael Louazel, Can Governments Push Providers to Collaborate? A Comparison of Hospital Network Reforms in France and the United States, Health Pol’y (2020):

France recently implemented a program to encourage greater collaboration among public hospitals, which represent about 65 percent of total capacity, by placing them into regional groupings known as Groupements Hospitalier Territoire (GHTs) and mandating that facilities within them share several core functions. The strategy echoes that of Accountable Care Organizations (ACOs) in the United States, which offer financial incentives to providers to form networks that foster collaboration. While the programs share an underlying strategy for improving care and reducing costs, the difference in approaches, mandatory versus voluntary, could significantly affect outcomes. We analyzed aspects of the programs that could lead to differences in their results. ACOs appear to have several advantages, as financial inducements have proven effective in shaping provider behavior in other contexts. GHTs may benefit from a more direct approach, but mandatory participation risks pushback. Regardless of whether the programs succeed in fostering effective care integration, they may accelerate provider consolidation, which could impair access in already underserved areas by concentrating resources in larger facilities and promoting the closure of smaller ones.

April 30, 2021 | Permalink | Comments (0)

Barriers to Abortion Access in Australia before and during the COVID-19 Pandemic

Ronli Sifris (Monash University), Tania Penovic (Monash University), Barriers to Abortion Access in Australia before and during the COVID-19 Pandemic, Women’s Studies Int’l Forum (2021):

Access to abortion in Australian has been the subject of significant legal reforms to the point that in some jurisdictions, most legal barriers to access have been dismantled. Nevertheless, research reveals that many Australian women will not be in a position to fully realise their reproductive rights until the non-legal barriers to access are adequately addressed. Between March 2017 and November 2020, the authors conducted qualitative research into the barriers faced by Australian women when accessing, or attempting to access, abortion services. Three of the primary non-legal barriers to access raised repeatedly in our research are financial barriers to access, geographic barriers to access; and deficiencies in practitioner attitudes, education and training. Part I of this article focuses on these barriers to abortion access while Part II considers the significant new challenges created by the COVID-19 pandemic for women’s access to reproductive health services. The paper concludes that the pandemic and the measures introduced in response have amplified pre-existing barriers and generated a disproportionate and intersectional impact on the most marginalised and disempowered women in society.

April 30, 2021 | Permalink | Comments (0)

Macromedical Regulation

Barak D. Richman (Duke University), Steven L. Schwarcz (Duke University), Macromedical Regulation, 82 Oh. St. L. J. (2021):

The COVID-19 pandemic has dramatically shown that a localized disease can be transmitted to  the broader population, nationally and worldwide. This Article analyzes how to design regulation to help control that transmission. To that end, we first observe that existing healthcare regulation focuses almost exclusively on regulating individual components of the medical and healthcare industry, while lacking a capacity to address how those components work together as a system—a system that pandemics can destabilize. Indeed, one factor that contributed to COVID-19’s spread was the inability of U.S. healthcare regulation to operate on a societal level, to protect certain components from the deficiencies of others. We contend that healthcare regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the healthcare sector as a system of interconnected parts. We find some useful analogies in the Dodd-Frank Act and other post-crisis financial regulation, particularly in macroprudential regulation designed to protect the financial system as a system.

April 30, 2021 | Permalink | Comments (0)

Thursday, April 29, 2021

Medical Robots and the Right to Health Care: A Progressive Realisation

Robin Pierce, Eduard Fosch Villaronga (Leiden University), Medical Robots and the Right to Health Care: A Progressive RealisationCambridge Handbook of Life Science, Information Technology and Human Rights, Cambridge University Press (2021):

Robotic technologies have shown to have clear potential for providing innovation in treatments and treatment modalities for various diseases and disorders that cover unmet needs and are cost-efficient. However, the emergence of technology that promises to improve health outcomes raises the question regarding the extent to which it should be incorporated, how, made available to whom, and on what basis. Since countries usually have limited resources to favour access to state-of-the-art technologies and develop strategies to realize the right to health progressively, in this article, we investigate whether the right to health, particularly the core obligations specified under this right, helps implement medical robots.

April 29, 2021 | Permalink | Comments (0)

Children's Rights and End of Life Decision-Making: In the Matter of JJ

Finn Keyes (Trinity College), Children's Rights and End of Life Decision-Making: In the Matter of JJ, Irish Judicial Studies Journal

This article analyses the decision of the Supreme Court in In the Matter of JJ [2021] IESC 1. The article observes that this case differs from previous end-of-life cases in that it countenances a mixture of acts and omissions leading to the death of the patient. It outlines the legal and ethical issues with respect to acts and omissions in end-of-life decision-making and analyses how the Court engaged with those issues. The article also observes that the decision provides the most authoritative guidance yet as to the effect of the Children's Rights Referendum on children's rights and the threshold for State intervention for failure of parental duty. It notes that while previous commentary had suggested that Art. 42A would not have a significant impact on the threshold for State intervention, the decision in Re JJ clearly signals that the Referendum has effected a significant change in the law in this regard. 

April 29, 2021 | Permalink | Comments (0)

Reimagining Rights and Responsibilities in the United States: Equal Access to Public Goods and Services

John Shattuck (Harvard University), Mathias Risse (Harvard University), Reimagining Rights and Responsibilities in the United States: Equal Access to Public Goods and Services, HKS Working Paper No. RWP21-007

A right of equal access to public goods and services is rooted in the rights to ‘Life, Liberty, and the pursuit of Happiness.’ With these rights, the Declaration of Independence asserts the concept of equality as a founding principle, while nearly a century later in the nation’s “second founding” after the Civil War, the 14th Amendment to the Constitution goes further in guaranteeing equal protection of the law. These documents create the principle from which a right of equal access is derived, including access to education, health care, housing, and environmental protection.Throughout American history, the concepts of liberty and equality have been intertwined but also conflicted. Current trends within public education, health care, housing, and environmental protection reflect burgeoning disparities in opportunity. Public policy in recent years has centered around the promotion of macroeconomic growth but has done little to guarantee individual and societal well-being, reinforcing the focus of the private sector on maximizing shareholder value, often at the expense of employees and consumers. These policies have exacerbated the inequality of access to public goods and services, such as health and education, among significant portions of the population, who lack the agency and the opportunity to sustain themselves. It is critical that the United States responds to the public health and economic crises by protecting liberty, equality, and securing equal access to public goods and services.

April 29, 2021 | Permalink | Comments (0)

Expanding Frontier of Neurolaw: Post Smt. Selvi V. State of Karnataka

Sidhartha Sekhar Dash, Harish Ch. Padhi, Biswadeep Das, Expanding Frontier of Neurolaw: Post Smt. Selvi V. State of Karnataka, 7 J. Critical Rev. (2020):

Crimes are committed in very sophisticated form these days. It is highly technical as well. The investigating agency can be benefited from the use of modern scientific developments to commensurate with the diversified and perplexed modus operandi of offences. The court of law can also take help of the expertise of science in this matter. One of the branches of biological science working to help in this regard is neuroscience. Neuroscience has various inclinations towards law. The neuroscience is such inclined towards the law that this new discipline is termed as Neurolaw. It is having the potential to address various complex questions of the motivation of crime and shall assist law in realising its objectives. However, in Salvi judgement of the Supreme Court of India, one such technique, Brain Mapping, was not allowed considering various factors. The apprehension of the Courts to allow the Brain Mapping, however, is affected by the recent development of neuroscience. The scope of the paper is to put forth the recent development after the decision of the court than towards shedding lights on the normative aspect of the decisions of the court, which is discussed incidentally.

April 29, 2021 | Permalink | Comments (0)

Wednesday, April 28, 2021

Toward a Reexamination of Global Health Law in Light of the Role of Cognitive Bias Displayed by Humans and Artificial Intelligence in Times of Crisis

Nourhene Chtourou, Toward a Reexamination of Global Health Law in Light of the Role of Cognitive Bias Displayed by Humans and Artificial Intelligence in Times of Crisis, SSRN:

“Leaders are called to stand in that lonely place between the no longer and the not yet and intentionally make decisions that will bind, forge, move, and create history.” Mary Lou Anderson.The novel SARS-CoV-2 pandemic has tested the legal foundations of the global health system. The result was unfortunately “positive”. The present legal framework has proven to be fragile. Yet, as difficult as it may be to imagine now, the pandemic might have served as an incentive to improve global health law.

April 28, 2021 | Permalink | Comments (0)

Bottleneck: The Place of County Jails in California’s COVID-19 Correctional Crisis

Hadar Aviram (UC Hastings Law), Bottleneck: The Place of County Jails in California’s COVID-19 Correctional Crisis, Hastings J. of Crime and Punishment (2021):

This Article examines a lesser-known site of the COVID-19 epidemic: county jails. Revisiting assumptions that preceded and followed criminal justice reform in California, particularly Brown v. Plata and the Realignment, the Article situates jails within two competing/complementary perspectives: a mechanistic, jurisdictional perspective, which focuses on county administration and budgeting, and a geographic perspective, which views jails in the context of their neighboring communities. The prevalence of the former perspective over the latter among both correctional administrators and criminal justice reformers has generated unique challenges in fighting the spread of COVID-19 in jails: paucity of, and reliability problems with, data, weak and decentralized healthcare policy featuring a wide variation of approaches, and serious litigation and legislation challenges. The Article concludes with the temptation and pitfalls of relying on the uniqueness of jails to advocate for vaccination and other forms of relief, and instead suggests propagating a geography-based advocacy, which can benefit the correctional landscape as a whole.

April 28, 2021 | Permalink | Comments (0)

The PrEP Penalty

Doron Dorfman (Syracuse University), The PrEP Penalty, 63 Boston College L. Rev. (2022):

Pre-exposure prophylaxis, or PrEP, is a novel treatment shown to be highly effective in preventing HIV infection. Although the treatment signals a new dawn in eliminating HIV/AIDS, this Article exposes the paradoxical legal treatment of PrEP. On one hand, PrEP use has been approved by the FDA, endorsed by the CDC, and promoted through financial incentives in the Affordable Care Act. On the other, the FDA restricts PrEP users, largely sexually active gay men, from donating blood through a legal policy known as the “blood ban.” This Article foregrounds how PrEP stigma, which connects the treatment with promiscuity, affects the implementation of and compliance with the blood ban. The Article uses an innovative experimental study to demonstrate counterintuitive and illogical responses to gay mens’ use of PrEP. Participants in the study were more reluctant to accept blood from a potential gay donor who takes PrEP, or to change the policy to allow him to donate, compared with a gay donor who is not taking PrEP. This PrEP penalty applied only to gay donors: participants were more inclined to accept a blood donation from a straight donor on PrEP. Concerning family status, participants were more reluctant to receive blood from gay fathers on PrEP than from gay fathers not on PrEP. The findings demonstrate how decisions related to public health, on the structural and individual levels, are colored by moral judgment. This is detrimental not only to LGBTQ individuals but also to society as a whole. The law’s paradoxical treatment of PrEP impedes major public health projects: fighting chronic blood scarcity, increasing the pool of donors who could give antibodies in times of a pandemic, and eliminating HIV. Building on these findings, I offer normative avenues to eliminate PrEP stigma and further public health goals. The Article makes four original contributions. First, although some literature discusses how PrEP stigma exists within the LGBTQ community, I demonstrate empirically for the first time how stigma around PrEP extends to the public at large, jeopardizing efforts to implement effective public health policies. Second, the Article introduces a process I call the “demedicalization of preventative measures.” Demedicalization refers to the ways in which legal discourse strips away the public health benefits of medical treatment and shifts focus to the patients’ individual behavior. Third, the Article provides a site for examining the theoretical and practical implications for the expressive function of the law, the ways in which it constructs identities and shapes common understandings regarding sexual minorities, in the area of public health law.

April 28, 2021 | Permalink | Comments (0)

Data-Driven Measures to Mitigate the Impact of Covid-19 in South America: How Do Regional Programmes Compare to Best Practice?

Taís Fernanda Blauth (University of Groningen), Oskar Josef Gstrein (University of Groningen), Data-Driven Measures to Mitigate the Impact of Covid-19 in South America: How Do Regional Programmes Compare to Best Practice? Int’l Data Privacy L. (2021):

This article analyses data-driven measures used in South America to mitigate the impact of COVID-19. Based on a broad review of relevant programmes in the region three selected cases from Argentina (Cuidar App), Brazil (use of personal data by IBGE), and Chile (CoronApp) are evaluated against best regional and international practices.Our findings suggest that programmes in South America mirror approaches in other global regions and as such face many similar challenges. There is no clearly defined purpose, a lack of transparency, and the need for readjustment soon after initial development.While the region is heavily affected by COVID-19, the three case-studies analysed demonstrate that policy makers in the region failed to establish trust in the measures. This can be deducted from low penetration rates of the programmes in Argentina and Chile.Finally, there are serious concerns regarding the long-term impact of these programmes upon human rights (especially privacy) and human dignity.

April 28, 2021 | Permalink | Comments (0)

Tuesday, April 27, 2021

Nationalizing Public Health Emergency Legal Responses

James G. Hodge (Arizona State University), Nationalizing Public Health Emergency Legal Responses, 49 J. L. Med. & Ethics (Forthcoming, 2021):

The fight for public health primacy in U.S. emergency preparedness and response to COVID-19 centers on which level of government—federal or state—should “call the shots” to quell national emergencies? Competing and conflicting priorities have contributed to a year-long federalism firestorm. As the melee subsides, a more dominant federal role is a predictable, long-term consequence in the battle plan for the next major public health threat.

April 27, 2021 | Permalink | Comments (0)

Systemically Important Platforms

Caleb N. Griffin (Belmont University), Systemically Important Platforms, Cornell L. Rev. (Forthcoming, 2021):

 Regulating Big Tech is now a matter of intense public debate. We ask how well Big Tech companies fulfill their role as gatekeepers of the public square. We ponder whether their dominant market positions merit an antitrust response. We assess their culpability and complicity in spreading online misinformation and hate. However, in the many normative debates over how Big Tech should use its power, the source of that power remains largely unexamined. Big Tech, like Big Tobacco before it, is an industry founded on addiction. Although typically “free” to use, the world’s largest digital platforms exploit users’ dopamine pathways to consume as much of their time and conscious attention as possible. Many of the problems currently gripping the public consciousness would be fundamentally less important if these platforms were not powerfully addictive. They would be private problems – issues to be resolved between the company and its users. A key reason they are significant, public problems that society can no longer ignore is that Big Tech has intentionally addicted billions of people.The business model of many large technology companies, or significant subsidiaries thereof, is built on maximizing the frequency and duration of use, what the industry refers to as “time on device.” In this, they have been remarkably successful. The average American spends just over 40% of their waking hours online, with that number approaching 60% for American teens. A growing body of research problematizes the “choice” to spend this much time online. Today’s dominant digital platforms are intentionally designed to produce structural and functional changes in various regions of the brain and to trigger the same brain reward pathways as nicotine and other addictive drugs. Thus far, such platforms have managed to almost entirely avoid liability for harms associated with their use.This Article surveys existing tools that may help to combat Big Tech’s manipulative design practices. It finds that existing laws and legal duties fail to protect users from exploitation. Accordingly, this Article proposes designating the largest manipulative technology platforms as “systemically important platforms.” Platforms so designated would be legally required to open their platforms to middleware, a type of software that can modify how data is presented. Such middleware would feature a control panel of tools that would enable users to curate their digital experience. In addition, these platforms would be subject to increased tax burdens and enhanced regulatory scrutiny with the goal of curbing manipulative design practices and providing billions of users with greater agency.

April 27, 2021 | Permalink | Comments (0)

How to Build More Equitable Vaccine Distribution Technology

Laura Moy (Georgetown University), Yael Cannon (Georgetown University), How to Build More Equitable Vaccine Distribution Technology, SSRN:

The COVID-19 pandemic and the distribution of vaccines that promise to bring it to an end have spotlighted inequities in our nation’s healthcare system. But the vaccine distribution problem illustrates a peculiar fact of our digital era: just how hard it is to ensure equitable delivery of services via the internet. This is especially the case when distributing a scarce critical resource as quickly as possible on a massive scale.In this Brookings Institution article, Professors Laura Moy and Yael Cannon argue that digital infrastructure is a critical determinant of health, and call for the restructuring of online vaccine appointment systems to ensure health equity.

April 27, 2021 | Permalink | Comments (0)

A Terrible Great Idea? COVID-19 ‘Vaccination Passports’ in the Spotlight

Oskar Josef Gstrein (University of Groningen), Dimitry Kochenov, Andrej Zwitter, A Terrible Great Idea? COVID-19 ‘Vaccination Passports’ in the SpotlightWorking Paper No. 153 The Centre on Migration, Policy & Society University of Oxford (2021):

This article looks at central opportunities and drawbacks of the ‘passportization’ approach to governing the current health emergency. It showcases the complexity of the ‘vaccination passports’ idea, the technological and organisational difficulties expected during implementation, as well as its regrettable appeal. We provide a comprehensive overview on the ongoing discussion with analysis of arguments relating to the ethical, social and legal perspective. We submit that vaccination passports will not become the main tool in the fight with the COVID-19 crisis and are unlikely to play a positive role in the mitigation of its impact. There is no clear and straightforward connection to safety and security, while their rapid introduction might have similar consequences to opening Pandora’s box of discrimination and stigmatization.

April 27, 2021 | Permalink | Comments (0)

Monday, April 26, 2021

A New Prescription for the Opioid Epidemic: 360-Degree Accountability for Pharmaceutical Companies and Their Executives

Rebecca Delfino (Loyola Law School), A New Prescription for the Opioid Epidemic: 360-Degree Accountability for Pharmaceutical Companies and Their Executives, Loyola L. School, LA Legal Studies Research Paper No. 2021-03:

We can no longer ignore this--A national crisis resulting in more than half-a-million American deaths, costing hundreds of millions of dollars in losses to the economy, ravaging the health care system, and devastating state and local communities. This narrative describes the COVID-19 pandemic and something else: the epidemic of opioid addiction and abuse. In the last twenty years, the opioid epidemic claimed the lives of more than 700,000 people at the cost of more than 500 billion dollars to the economy. The COVID-19 pandemic has made the opioid epidemic worse, causing a staggering increase in opioid-related overdose deaths. Even now, on average, 140 people die every day from an opioid overdose, making it a leading cause of injury-related death in the United States. And 70 percent of those deaths involve a prescription opioid. 

April 26, 2021 | Permalink | Comments (0)

Non-Consensual Disclosures

Nina Varsava (University of Wisconsin-Madison), Non-Consensual Disclosures, Brigham Young U. L. Rev. (Forthcoming):

In the course of biomedical research on humans—for example flu, imaging, and genomic studies—researchers often uncover information about participants that is important to their health and wellbeing and sometimes even the wellbeing of others. In many cases, the information is not anticipated in advance, and participants did not consent to receiving it. For example, when the first U.S. Covid-19 case appeared in Washington in early 2020, a group of researchers had already been collecting nasal swabs for the Seattle Flu Study and possessed thousands of recent samples. The researchers believed that they had an ethical duty to test their samples for the coronavirus and disclose results, and they accordingly proceeded to do so, despite regulatory obstacles and agency disapproval. Many samples tested positive, and the team reported their findings to public health officials and affected research participants. This Article examines the law and policy governing human subjects research, focusing on the set of regulations known as the “Common Rule,” which requires researchers to inform study participants, at the consent stage, whether individual findings will be returned to them. The Seattle Flu Study’s consent materials naturally did not inform participants that they might receive coronavirus results. Arguably, then, the consent materials did not support the return of those results, and the researchers violated the Common Rule when they disclosed them. 

April 26, 2021 | Permalink | Comments (0)

The Right Not to Be Subject to Automated Individual Decision-Making/Profiling Concerning Big Health Data. Developing an Algorithmic Culture

Ioannis Iglezakis (Aristotle University of Thessaloniki), Theodoros Trokanas, Panagiota Kiortsi, The Right Not to Be Subject to Automated Individual Decision-Making/Profiling Concerning Big Health Data. Developing an Algorithmic Culture, SSRN:

Τhis paper explores the legal issues that arise from the collection and processing of Big Health Data in the light of the EU legislation on Data Protection, placing particular emphasis on the General Data Protection Regulation. Whether Big Health Data can be characterised as “personal data” or not is really the crux of the matter. The legal ambiguity is compounded by the fact that, even though the processing of Big Health Data is premised on the de-identification of the data subject, the possibility of a combination of Big Health Data with other data circulating freely on the web or from other data files cannot be excluded. Moreover, data subject’s rights, e.g., the right not to be subject to a decision based solely on automated processing, are heavily impacted by the use of AI, algorithms and technologies that reclaim health data for further use, resulting in sometimes ambiguous results that have substantial impact on individuals. On the other hand, as the COVID-19 pandemic has revealed, Big Data analytics can offer crucial source of information. In this respect, this paper identifies and systematises the legal provisions concerned, offering interpretative solutions that tackle dangers concerning data subjects’ rights while embracing the opportunities that Big Health Data have to offer.

April 26, 2021 | Permalink | Comments (0)

Effects of a Longer Duration of Lockdown on COVID-19 Related Infected Individuals and Deaths, and on Economic Growth of Countries

Mario Coccia, Effects of a Longer Duration of Lockdown on COVID-19 Related Infected Individuals and Deaths, and on Economic Growth of Countries, Science of the Total Environment (2021):

The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes the Coronavirus Disease 2019 (COVID-19) is still circulating in 2021 with new mutations and the state of emergency remains in manifold countries. Countries have applied in 2020 nonpharmaceutical interventions to control the diffusion of the novel coronavirus within cities, such as lockdowns that were pursued to safeguard societies and economies, until effective vaccines and therapies are available and wide spread distributed. This study here analyze effects of lockdowns of different duration is some European countries. The policy response of lockdown has in theory the main goal, as containment measure, to reduce the impact of infectious diseases in society, but empirical results here suggest that in the presence of vast pandemics a longer duration of full lockdown has contradictory and not significant effects on reduction of fatality rates but sure it has negative effects on economic systems compared to a shorter length of lockdown. In fact, lockdowns of longer duration have generated negative effects on Gross Domestic Product (GDP) growth: contraction of GDP (index 2010=100) from second quarter 2019 to second quarter of 2020 in countries applying a longer period of lockdown (i.e., about two months) is about -21%, whereas it is -13% in countries applying a shorter period of lockdown of about 15 days. In addition, findings here suggest that higher investments in healthcare sector play a vital role to cope with unforeseen pandemics and environmental threats, alleviating negative effects on health of population and mortality in society.

April 26, 2021 | Permalink | Comments (0)