Law Commons^™

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany Lee

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Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

Equal Protection In Dobbs And Beyond: How States Protect Life Inside And Outside Of The Abortion Context, Reva Siegel, Serena Mayeri, Melissa Murray

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In two paragraphs at the beginning of Dobbs v. Jackson Women’s Health Organization, the Supreme Court rejected the Equal Protection Clause as an alternative ground for the abortion right. As the parties had not asserted an equal protection claim on which the Court could rule, Justice Alito cited an amicus brief we co-authored demonstrating that Mississippi’s abortion ban violated the Equal Protection Clause, and, in dicta, stated that precedents foreclosed the brief’s arguments. Yet, Justice Alito did not address a single equal protection case or argument on which the brief relied. Instead, he cited Geduldig v. Aiello, a 1974 case …

Public Health Product Hops, Michael S. Sinha

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Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

Dobbs In A Technologized World: Implications For Us Data Privacy, Jheel Gosain, Jason D. Keune, Michael S. Sinha

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In June of 2022, the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, overturning 50 years of precedent by eliminating the federal constitutional right to abortion care established by the Court’s 1973 decision in Roe v. Wade. The Dobbs decision leaves the decision about abortion services in the hands of the states, which created an immediately variegated checkerboard of access to women’s healthcare across the country. This in turn laid bare a profusion of privacy issues that emanate from our technologized world. We review these privacy issues, including healthcare data, financial data, website tracking and …

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

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As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

Pandemic Governance, Yanbai Andrea Wang, Justin Weinstein-Tull

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The COVID-19 pandemic created an unprecedented need for governance by a multiplicity of authorities. The nature of the pandemic—globally communicable, uncontrolled, and initially mysterious—required a coordinated response to a common problem. But the pandemic was superimposed atop our decentralized domestic and international governance structures, and the result was devastating: the United States has a death rate that is eighteenth highest in the world, and the pandemic has had dramatically unequal impacts across the country. COVID-19’s effects have been particularly destructive for communities of color, women, and intersectional populations.

This Article finds order in the chaos of the pandemic response by …

How A Pandemic Plus Recession Foretell The Post-Job Based Horizon Of Health Insurance, Allison K. Hoffman

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For many years, the health insurance that people received through their jobs was considered the gold standard, so much so that it came to be called “Cadillac coverage.” Just as Cadillac has lost its sheen, so has job-based health insurance coverage in many cases. This decline predated the COVID-19 pandemic, yet it has been, and will continue to be, hastened by it. The changes to job-based coverage have prompted people to ask: what’s next? This Article suggests that the lessons from the pandemic could offer an opportunity fundamentally to rethink the way to pay for healthcare in the United States, …

Access To Medicines And Pharmaceutical Patents: Fulfilling The Promise Of Trips Article 31bis, Ezinne Miriam Igbokwe, Andrea Tosato

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The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) is one of the cornerstones of the World Trade Organization (WTO). TRIPS requires all WTO member countries (Members) to adopt minimum standards for the protection of intellectual property (IP). This international treaty is highly controversial. Its critics claim that TRIPS imposes a wealth transfer from poorer Members (net IP importers) to richer ones (net IP exporters). Its supporters maintain that trade between developing and developed economies cannot thrive without an internationally-harmonized IP framework. The most contentious issue has long been the impact of the TRIPS patents regime on access to medicines. …

Rationing, Racism, And Justice: Advancing The Debate Around 'Colourblind' Covid-19 Ventilator Allocation, Dorothy E. Roberts, Harald Schmidt, Nwamaka D. Eneanya

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Withholding or withdrawing life-saving ventilators can become necessary when resources are insufficient. In the USA, such rationing has unique social justice dimensions. Structural elements of dominant allocation frameworks simultaneously advantage white communities, and disadvantage Black communities—who already experience a disproportionate burden of COVID-19-related job losses, hospitalisations and mortality. Using the example of New Jersey’s Crisis Standard of Care policy, we describe how dominant rationing guidance compounds for many Black patients prior unfair structural disadvantage, chiefly due to the way creatinine and life expectancy are typically considered.

We outline six possible policy options towards a more just approach: improving diversity in …

Pandemic Federalism, Cary Coglianese

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Legislators, agency officials, and the public have a lot to learn from the United States’ experience in responding to the COVID-19 pandemic. If policymakers take seriously their responsibility to identify past mistakes, and then act now to prepare for future viral outbreaks, the nation can do better in the next crisis. One needed change will take the form of clarifying the essential role for the national government and its leadership in responding to pandemics. The United States needs to create a structure for a pandemic federalism that temporarily but responsively allows for a reconfiguration of public health authority, such that …

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi Walsh, Kari Baldwin, James M. Dubois

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State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

What Covid-19 Laid Bare: Adventures In Workers’ Compensation Causation, Michael C. Duff

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This essay performs a close analysis of workers’ compensation coverage of COVID-19 and arrives at the conclusion that it should not be “impossible” to prove in a legal sense that an employee’s COVID-19 was caused by work. Scientific proof is not the same as legal proof: workers’ compensation law has never required that claims must be supported by irrefutable scientific proof of workplace causation. Yet repeatedly one heard this suggestion during public discussion on workers’ compensation coverage of employees.

Still, there is good evidence that even when workers’ compensation undisputedly covers work-related disease employers seldom pay benefits (and states do …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

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New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Periods For Profit And The Rise Of Menstrual Surveillance, Michele E. Gilman

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Menstruation is being monetized and surveilled, with the voluntary participation of millions of women. Thousands of downloadable apps promise to help women monitor their periods and manage their fertility. These apps are part of the broader, multi-billion dollar, Femtech industry, which sells technology to help women understand and improve their health. Femtech is marketed with the language of female autonomy and feminist empowerment. Despite this rhetoric, Femtech is part of a broader business strategy of data extraction, in which companies are extracting people’s personal data for profit, typically without their knowledge or meaningful consent. Femtech can oppress menstruators in several …

A Public Option For Employer Health Plans, Allison K. Hoffman, Howell E. Jackson, Amy Monahan

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Following the 2020 presidential election, health care reform discussions have centered on two competing proposals: Medicare for All and an individual public option (“Medicare for all who want it”). Interestingly, these two proposals take starkly different approaches to employer-provided health coverage, long the bedrock of the U.S. health care system and the stumbling block to many prior reform efforts. Medicare for All abolishes employer-provided coverage, while an individual public option leaves it untouched.

This Article proposes a novel solution that finds a middle ground between these two extremes: an employer public option. In contrast to the more familiar public option …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

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Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Is There A Cure For Vaccine Nationalism?, Ana Santos Rutschman

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“[V]accine nationalism . . . should serve as a reality check for the status of global health cooperation in the twenty-first century.”

Compliance Management Systems: Do They Make A Difference?, Cary Coglianese, Jennifer Nash

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Regulatory compliance is vital for promoting the public values served by regulation. Yet many businesses remain out of compliance with some of the regulations that apply to them—presenting not only possible dangers to the public but also exposing themselves to potentially significant liability risk. Compliance management systems (CMSs) may help reduce the likelihood of noncompliance. In recent years, managers have begun using CMSs in an effort to address compliance issues in a variety of domains: environment, workplace health and safety, finance, health care, and aviation, among others. CMSs establish systematic, checklist-like processes by which managers seek to improve their organizations’ …

The Irony Of Health Care’S Public Option, Allison K. Hoffman

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The idea of a public health insurance option is at least a half century old, but has not yet had its day in the limelight. This chapter explains why if that moment ever comes, health care’s public option will fall short of expectations that it will provide a differentiated, meaningful alternative to private health insurance and will spur health insurance competition.

Health care’s public option bubbled up in its best-known form in California in the early 2000s and got increasing mainstream attention in the lead up to the 2010 health reform, the Patient Protection and Affordable Care Act (ACA). The …

Ending The War On People With Substance Use Disorders In Health Care, Kelly K. Dineen, Elizabeth Pendo

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Earp et al. (2021) provide a robust justification for the decriminalization of drugs based on the systemic racism that fuels the “war on drugs” and the ongoing harms of drug policies to individuals. The authors’ call for decriminalization is a necessary but insufficient step in addressing the entrenched structural, institutional, and individual discrimination that leads to the inequitable and unjust treatment of people with substance use disorder (PWSUD). Nothing short of robust enforcement of existing legal protections and sweeping legal reforms in the regulation of addiction treatment, controlled substances, health care finance, and civil rights law will be adequate to …

Editor, Ethical Challenges In Discharge Planning: Stories From Patients, Elizabeth Pendo

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This symposium includes twelve personal narratives from patients and their caregivers who have navigated challenges in planning for discharge from the hospital and transition to care at home, a rehabilitation facility, long-term care facility, or hospice. Three commentaries on these narratives are also included, authored by experts and scholars in the fields of medicine, bioethics, and health policy with particular interest in vulnerable populations. The goal of this symposium is to call attention to the experiences of patients during transitions in care and to enrich discussions of ethical issues in discharge planning.

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

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This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

China’S Response To Covid-19, Jacques Delisle, Shen Kui

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No abstract provided.

Administrative Law In A Time Of Crisis: Comparing National Responses To Covid-19, Cary Coglianese, Neysun A. Mahboubi

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Beginning in early 2020, countries around the world successively and then together faced the same rapidly emerging threats from the COVID-19 virus. The shared experience of this global pandemic affords scholars and policymakers a comparative lens through which to view how differences in countries’ governance structures and administrative responses affected their ability to manage the various crisis posed by the pandemic. This article introduces a special series of essays in the Administrative Law Review written by leading administrative law experts across the globe. Case studies focus on China, Chile, Germany, Italy, New Zealand, South Africa, and the United States, as …

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

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Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Property And Intellectual Property In Vaccine Markets, Ana Santos Rutschman

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As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that [h]appy families are all alike; every unhappy family is unhappy in its own way.¹ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy's principle² in the field of biopharmaceutical innovation.

Protecting The Rights And Wellbeing Of People With Disabilities During The Covid-19 Pandemic, Elizabeth Pendo

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The COVID-19 pandemic has exposed and exacerbated significant inequities experienced by people with disabilities. It has also emphasized the value of legal protections against discrimination based on disability. The Americans with Disabilities Act was enacted 30 years ago to eliminate discrimination against people with disabilities and ensure equal opportunity across major areas of American life (ADA, 2008). Together with an earlier law, the Rehabilitation Act of 1973 Rehabilitation Act, 2012), this landmark civil rights law impacts a broad range of issues raised by the COVID-19 pandemic and protects a large and growing number of Americans. This Chapter focuses on application …

Gaps In Worker Protections That Increase Essential Workers’ Exposure To Covid-19, Ruqaiijah Yearby

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States and localities designated more than 55 million Americans as essential workers. Essential workers not only comprise those employed by the health care and food and agriculture industry, but also include teachers, grocery store workers, transit and airline workers, mail and delivery workers, energy sector and utility workers, and domestic workers (Petition for Emergency, 2020). Racial and ethnic minorities are disproportionately employed as essential workers, with Black Americans the most likely to be essential workers (Petition for Emergency, 2020). Essential workers have been left vulnerable to workplace COVID-19 infections and deaths in large part due to the federal and state …

Lessons Learned: Strengthening Medicaid To Address Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

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COVID-19 has disproportionately harmed low-income people, especially Black and Latino populations, seniors, and people with disabilities. Medicaid plays an essential role in providing coverage and access to care for these populations. As COVID-19 disrupted employment, earnings, and insurance coverage, Medicaid enrollment increased, in part because Congress offered states increased Medicaid funding in return for maintaining eligibility and enrollment for the duration of the public health emergency (PHE). At the same time, many states expanded eligibility and streamlined enrollment to assure that people could secure and keep coverage. Such policies resulted in more than 5.3 million more Americans having Medicaid coverage …

Covid-19, Courts, And The 'Realities Of Prison Administration.' Part Ii: The Realities Of Litigation, Chad Flanders

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Lawsuits challenging prisons and jails for not doing enough to stop the spread of COVID-19 among inmates have faced mixed results in the courts: wins at the district court level are almost always followed by losses (in the form of stays of any orders to improve conditions) at the appeals court level or at the Supreme Court. This short article tries to explain why this is happening, and makes three comparisons between how district courts and appeals courts have analyzed these lawsuits. First, district courts and appeals courts tend to emphasize different facts in their decisions. District courts focus more …