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

All Faculty Scholarship

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 …

Race And Regulation Podcast Episode 8 - Vaccination Equity By Design, Olatunde C. Johnson

Penn Program on Regulation Podcasts

Racial disparities have occurred in COVID-19’s health effects and fatalities. They have persisted through the rollout of COVID-19 vaccines too, which saw a greater uptake in socioeconomically privileged segments of the population. These outcomes did not have to occur. Olatunde Johnson of Columbia Law School discusses how regulators could have made different policy design choices to promote greater equity in the vaccine rollout—and she draws key lessons not only for the next public health emergency but also for improving racial equity more generally.

Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher

Penn Program on Regulation Podcasts

As mandated by the U.S. Food and Drug Administration, clinical trials for new pharmaceuticals enroll healthy people as paid research participants to test for drug safety and tolerability. But the social injustices from these trials are too often overlooked. Drawing on her award-winning book, Adverse Events, Jill Fisher of UNC-Chapel Hill’s Center for Bioethics explains how clinical drug trials attract disproportionate participation by racial and ethnic minorities who then disproportionately assume risks of participating in these trials, often just to stay financially afloat.

Pandemic Governance, Yanbai Andrea Wang, Justin Weinstein-Tull

All Faculty Scholarship

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

All Faculty Scholarship

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, …

Why Aim Law Toward Human Survival, John William Draper

Librarian Scholarship at Penn Law

Our legal system is contributing to humanity’s demise by failing to take account of our species’ situation. For example, in some cases law works against life and supports interests such as liberty or profit maximization.

If we do not act, science tells us that humanity bears a significant (and growing) risk of catastrophic failure. The significant risk inherent in the status quo is unacceptable and requires a response. We must act. It is getting hotter. When we decide to act, we need to make the right choice.

There is no better choice. You and all your relatives have rights. The …

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

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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 …

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

All Faculty Scholarship

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 …

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

All Faculty Scholarship

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 …

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

All Faculty Scholarship

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’ …

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

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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

All Faculty Scholarship

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 …

The American Pathology Of Inequitable Access To Medical Care, Allison K. Hoffman, Mark A. Hall

All Faculty Scholarship

What most defines access to health care in the United States may be its stark inequity. Daily headlines in top newspapers paint the highs and lows. Articles entitled: “We Mapped the Uninsured. You’ll notice a Pattern: They tend to live in the South, and they tend to be poor” and op-eds with titles like “Do Poor People Have a Right to Health Care?” and “What it’s Like to Be Black and Pregnant when you Know How Dangerous That Can Be” run side-by-side with headlines touting “The Operating Room of the Future,^” and advances in gene therapy that promise cures …

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

All Faculty Scholarship

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 …

Regulating E-Cigarettes: Why Policies Diverge, Eric A. Feldman

All Faculty Scholarship

This paper, part of a festschrift in honor of Professor Malcolm Feeley, explores the landscape of e-cigarette policy globally by looking at three jurisdictions that have taken starkly different approaches to regulating e-cigarettes—the US, Japan, and China. Each of those countries has a robust tobacco industry, government agencies entrusted with protecting public health, an active and sophisticated scientific and medical community, and a regulatory structure for managing new pharmaceutical, tobacco, and consumer products. All three are signatories of the World Health Organization’s Framework Convention on Tobacco Control, all are signatories of the Agreement on Trade-Related Aspects of Intellectual Property Rights, …

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

All Faculty Scholarship

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 …

Health Care's Market Bureaucracy, Allison K. Hoffman

All Faculty Scholarship

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 …

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

All Faculty Scholarship

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

All Faculty Scholarship

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 …

Preserving Life By Ranking Rights, John William Draper

Librarian Scholarship at Penn Law

Border walls, abortion, and the death penalty are the current battlegrounds of the right to life. We will visit each topic and more in this paper, as we consider ranking groups of constitutional rights.

The enumerated rights of the Due Process Clauses of the Fifth and Fourteenth Amendments—life, liberty, and property—merit special treatment. They have a deeper and richer history that involves ranking. Ranking life in lexical priority over liberty and property rights protects life first and maximizes safe liberty and property rights in the absence of a significant risk to life. This is not new law; aspects of it …

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

All Faculty Scholarship

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 …