Law Commons^™

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

All Faculty Scholarship

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 …

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. …

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 …

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 …

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. …

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 …

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

All Faculty Scholarship

No abstract provided.

Privacy In The Age Of Contact Tracing: An Analysis Of Contact Tracing Apps In Different Statutory And Disease Frameworks, Christopher S. Yoo, Apratim Vidyarthi

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The Covid-19 pandemic is a historic pandemic that has affected the lives of virtually everyone on the globe. One approach to slowing the spread of the disease is to use contact tracing, facilitated by our internet-connected smartphones. Different nations and states have partnered to develop a variety of contact tracing apps that use different technologies and architectures.

This paper investigates how five contact tracing apps—Germany’s Corona-Warn-App, Israel’s HaMagen, North Dakota’s Care19 Diary and Alert apps, and India’s Aarogya Setu—fare in privacy-oriented statutory frameworks to understand the design choices and public health implications shaped by these statutes. The three statutes—the Health …

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 …

Pandemic Response As Border Politics, Michael R. Kenwick, Beth A. Simmons

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Pandemics are imbued with the politics of bordering. For centuries, border closures and restrictions on foreign travelers have been the most persistent and pervasive means by which states have responded to global health crises. The ubiquity of these policies is not driven by any clear scientific consensus about their utility in the face of myriad pandemic threats. Instead, we show they are influenced by public opinion and preexisting commitments to invest in the symbols and structures of state efforts to control their borders, a concept we call border orientation. Prior to the COVID-19 pandemic, border orientation was already generally …

How Medicalization Of Civil Rights Could Disappoint, Allison K. Hoffman

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This essay reflects on Craig Konnoth’s recent Article, Medicalization and the New Civil Rights, which is a carefully crafted and thought-provoking description of the refashioning of civil rights claims into medical rights frameworks. He compellingly threads together many intellectual traditions—from antidiscrimination law to disability law to health law—to illustrate the pervasiveness of the phenomenon that he describes and why it might be productive as a tool to advance civil rights.

This response, however, offers several reasons why medicalization may not cure all that ails civil rights litigation’s pains and elaborates on the potential risks of overinvesting in medical rights-seeking. …

The Paradox Of Insurance, Gideon Parchomovsky, Peter Siegelman

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In this Article, we uncover a paradoxical phenomenon that has hitherto largely escaped the attention of legal scholars and economists, yet it has far-reaching implications for insurance law: loss-creation by uninsured parties caused by the presence of insurance. Contrary to the conventional wisdom, we show that insurance can create significant negative externalities by inducing third parties to engage in antisocial, illegal and unethical activities in order to extract money from insureds or insurers. Moreover, as the amount and scope of insurance grows, so does its distortionary effect on third parties. We term this phenomenon the paradox of insurance. The risk …

Lessons From China's Response To Covid-19: Shortcomings, Successes, And Prospects For Reform In China's Regulatory State, Jacques Delisle, Shen Kui

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China’s response to COVID-19 offers a case study of law, the regulatory state and governance in China. The costly delay in the initial response reflected distinctive features of the Chinese system, including perverse incentives local-level officials face to try to cover up problems, fragmentated institutions and rules, and politically weak public health bureaucracies. After the initial shortcomings, China’s largely successful efforts to contain the pandemic also reflected defining features of the Chinese system, including a highly capable, centralized and authoritarian party-state that could mobilize vast resources, coordinate across fractious institutions, create ad hoc government and party leadership bodies, and deploy …

Choice Architecture For Healthier Insurance Choices: Ordering And Partitioning Can Improve Decisions, Benedict G.C. Dellaert, Eric J. Johnson, Tom Baker

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Health insurance decisions are a challenge for many consumers and influence welfare, health outcomes, and longevity. Two choice architecture tools are examined that can improve these decisions: informed ordering of options (from best to worst) and choice set partitioning. It is hypothesized that these tools can improve choices by changing: (1) decision focus: the options in a set on which consumers focus their attention, and (2) decision strategy: how consumers integrate the different attributes that make up the options. The first experiment focuses on the mediating role of the hypothesized decision processes on consumer decision outcomes. The outcome results are …

Health Care's Market Bureaucracy, Allison K. Hoffman

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The last several decades of health law and policy have been built on a foundation of economic theory. This theory supported the proliferation of market-based policies that promised maximum efficiency and minimal bureaucracy. Neither of these promises has been realized. A mounting body of empirical research discussed in this Article makes clear that leading market-based policies are not efficient — they fail to capture what people want. Even more, this Article describes how the struggle to bolster these policies — through constant regulatory, technocratic tinkering that aims to improve the market and the decision-making of consumers in it — has …

How Liability Insurers Protect Patients And Improve Safety, Tom Baker, Charles Silver

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Forty years after the publication of the first systematic study of adverse medical events, there is greater access to information about adverse medical events and increasingly widespread acceptance of the view that patient safety requires more than vigilance by well-intentioned medical professionals. In this essay, we describe some of the ways that medical liability insurance organizations contributed to this transformation, and we catalog the roles that those organizations play in promoting patient safety today. Whether liability insurance in fact discourages providers from improving safety or encourages them to protect patients from avoidable harms is an empirical question that a survey …

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

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Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons.

Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing …

Chapter: “Health Law And Ethics”, Allison K. Hoffman, I. Glenn Cohen, William M. Sage

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Law and ethics are both essential attributes of a high-functioning health care system and powerful explainers of why the existing system is so difficult to improve. U.S. health law is not seamless; rather, it derives from multiple sources and is based on various theories that may be in tension with one another. There are state laws and federal laws, laws setting standards and laws providing funding, laws reinforcing professional prerogatives, laws furthering social goals, and laws promoting market competition. Complying with law is important, but health professionals also should understand that the legal and ethical constraints under which health systems …

Falling Between The Cracks: Understanding Why States Fail In Protecting Our Children From Crime, Michal Gilad

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The article is the first to take an inclusive look at the monumental problem of crime exposure during childhood, which is estimated to be one of the most damaging and costly public health and public safety problem in our society today. It takes-on the challenging task of ‘naming’ the problem by coining the term Comprehensive Childhood Crime Impact or in short the Triple-C Impact. Informed by scientific findings, the term embodies the full effect of direct and indirect crime exposure on children due to their unique developmental characteristics, and the spillover effect the problem has on our society as …

Informed Consent And The Role Of The Treating Physician, Eric Feldman, Holly Fernandez Lynch, Steven Joffe

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In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,” informed consent has become a central feature of American medical practice. In an increasingly team-based and technology-driven system, however, who is — or ought to be — responsible for obtaining a patient’s consent? Must the treating physician personally provide all the necessary disclosures, or can the consent process, like other aspects of modern medicine, take advantage of specialization and division of labor? Analysis of Shinal v. Toms, …

Baby M Turns 30: The Law And Policy Of Surrogate Motherhood, Eric A. Feldman

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This article marks the 30th anniversary of the Supreme Court of New Jersey’s Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature.

First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can be …

What Congress's Repeal Efforts Can Teach Us About Regulatory Reform, Cary Coglianese, Gabriel Scheffler

All Faculty Scholarship

Major legislative actions during the early part of the 115th Congress have undermined the central argument for regulatory reform measures such as the REINS Act, a bill that would require congressional approval of all new major regulations. Proponents of the REINS Act argue that it would make the federal regulatory system more democratic by shifting responsibility for regulatory decisions away from unelected bureaucrats and toward the people’s representatives in Congress. But separate legislative actions in the opening of the 115th Congress only call this argument into question. Congress’s most significant initiatives during this period — its derailed attempts to repeal …

The Effect Of Health Insurance Coverage Expansions On Auto Liability Claims And Costs, Srikanth Kadiyala, Paul Heaton

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How do the Affordable Care Act health insurance coverage expansions affect payment for medical care provided through liability insurance, such as auto insurance? Theoretically, expanding coverage might lead to a substitution of health insurance disbursements for automobile insurance disbursements. Alternatively, expanding health insurance coverage might increase utilization of medical care, increasing auto liability claims payments. The net effect of these two mechanisms can only be determined empirically. We evaluate the health insurance-auto insurance interaction by examining the 2010 ACA dependent coverage expansion. Prior to 2010, individuals 19 and older were excluded from health insurance coverage under their parental health insurance …

Why Baby Markets Aren’T Free, Dorothy E. Roberts

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Creating families in the twenty-first century increasingly happens in markets where the buying and selling of reproductive goods and services are facilitated by advanced technologies, the internet, contracts, and state laws and policies. Thus, the title of this international congress—“Baby Markets”—aptly captures a key aspect of modern reproduction. The ability of potential parents to engage in market transactions involving children enhances parents’ autonomy over their family lives. The free market seems to liberate us from the constraints of biology and state control.

This Essay argues, however, that baby markets aren’t free. Three aspects of the way reproductive goods and services …

The Poverty Of The Neuroscience Of Poverty: Policy Payoff Or False Promise?, Amy L. Wax

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A recent body of work in neuroscience examines the brains of people suffering from social and economic disadvantage. This article assesses claims that this research can help generate more effective strategies for addressing these social conditions and their effects. It concludes that the so-called neuroscience of deprivation has no unique practical payoff, and that scientists, journalists, and policy-makers should stop claiming otherwise. Because this research does not, and generally cannot, distinguish between innate versus environmental causes of brain characteristics, it cannot predict whether neurological and behavioral deficits can be addressed by reducing social deprivation. Also, knowledge of brain mechanisms yields …

From The Technical To The Personal: Teaching And Learning Health Insurance Regulation And Reform, Allison K. Hoffman, Whitney A. Brown, Lindsay Cutler

All Faculty Scholarship

In the Fall of 2016, I taught Health Law and Policy for the fourth consecutive semester. Over time, one thing has become increasingly clear: the aspect of this course that I work with most closely as a scholar—the regulation of health care financing and insurance, including the Patient Protection and Affordable Care Act (ACA)—is also the material that I find the most challenging to teach. Every time I reflect on teaching this material, and hear from students about how they learn this material, the thing that stands out is how critical it is that my students understand the profound impact …

Reimagining The Risk Of Long-Term Care, Allison K. Hoffman

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U.S. law and policy on long-term care fail to address the insecurity American families face due to prolonged illness and disability — a problem that grows more serious as the population ages and rates of disability rise. This Article argues that, even worse, we have focused on only part of the problem. It illuminates two ways that prolonged disability or illness can create insecurity. The first arises from the risk of becoming disabled or sick and needing long-term care, which could be called “care-recipient” risk. The second arises out of the risk of becoming responsible for someone else’s care, which …