The advent of artificial intelligence (“AI”) holds great potential to improve clinical diagnostics. At the same time, there are important questions of liability for harms arising from the use of this technology. Due to their complexity, opacity, and lack of foreseeability, AI systems are not easily accommodated by traditional liability frameworks. This difficulty is compounded in the health care space where various actors, namely physicians and health care organizations, are subject to distinct but interrelated legal duties regarding the use of health technology. Without a principled way to apportion responsibility among these actors, patients may find it difficult to recover for injuries. In this Article, I propose that physicians, manufacturers of clinical AI systems, and hospitals be considered a common enterprise for the purposes of liability. This proposed framework helps facilitate the apportioning of responsibility among disparate actors under a single legal theory. Such an approach responds to concerns about the responsibility gap engendered by clinical AI technology as it shifts away from individualistic notions of responsibility, embodied by negligence and products liability, toward a more distributed conception. In addition to favoring plaintiff recovery, a common enterprise strict liability approach would create strong incentives for the relevant actors to take care.

The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.1 Inarguably, significant problems with the multi-faceted system of drug and vaccine innovation and regulation manifested long before the COVID-19 pandemic.2 The pandemic, however, has laid bare the inextricable connections among federal funding, patents, product review and approval mechanisms, and the eventual medical products and resulting costs.

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to take a blood transfusion.” His aunt, whose custodial rights seem not to have included medical decisionmaking, was adamant that “[t]his is Dennis’s decision.”

The hospital social worker assigned to Dennis’s case assured his aunt that “having just turned 14, [he] could be considered mature enough to make his own decisions.” But hospital psychologists declined to evaluate Dennis’s maturity because they did “not have the tools for such an assessment.” Established hospital policy described the failure to provide a minor with necessary, life-saving care as medical neglect. Hospital ethicists advised that Dennis’s autonomy interests were outweighed by the benefits associated with treatment. And, standard oncology practice norms are that doctors should push back against minors’ lifesaving treatment refusals. Still, Dennis’s doctor agreed with his social worker and aunt, saying, “We owe respect to a 14-year-old[.]” In this view, he was supported by colleagues on staff and by hospital counsel.

A county judge got the case only at the eleventh hour, on an emergency motion filed by Dennis’s parents and Child Protective Services for a declaration of dependency and to compel the necessary transfusion. Although Dennis was degrading rapidly, his doctor testified that if a transfusion were ordered that day, Dennis still had a 70% chance of survival. The judge had no background in the applicable law and no time to research the issues; nevertheless, he denied the motion concluding, “It is time to do what Dennis has decided.” “Seven hours later, at 6 p.m., on Nov. 28, Dennis died.”1

In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one’s home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies.

In Part II, I identify two types of tailored policies: activity-based and group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and dining indoors. Group-based restrictions consider differences between groups with respect to risk and benefit. Examples are policies that treat children or senior citizens differently, policies that require travelers to quarantine when traveling to a new destination, and policies that treat individuals differently based on whether they have COVID-19 symptoms, have tested positive for COVID-19, have previous COVID-19 infection, or have been vaccinated against COVID-19.

In Part III, I consider the public health law grounding of tailored policies in the principles of “least restrictive means” and “well-targeting.” I also examine how courts have analyzed tailored policies that have been challenged on fundamental rights or equal protection grounds. I argue that fundamental rights analyses typically favor tailored policies and that equal protection does not preclude the use of tailored policies even when imperfectly crafted.

In Part IV, I consider three critiques of tailored policies, centering on the claims that they produce inequity, cause harm, or unacceptably limit liberty. I argue that we must evaluate restrictions comparatively: the question is not whether tailored policies are perfectly equitable, wholly prevent harm, or completely protect liberty, but whether they are better than untailored ones at realizing these goals in a pandemic. I also argue that evaluation must consider indirect harms and benefits as well as direct and apparent ones.

The past decade has seen numerous positive developments in both legal and policy protections for those who identify as lesbian, gay, bisexual, trans, or queer (“LGBTQ+”). Progress in this area has been decidedly uneven, however, and significant barriers still exist which thwart the full legal and societal acceptance of LGBTQ+ individuals. Unfortunately, as the groundbreaking study by Peter Blanck, Fitore Hyseni, and Fatma Altunkol Wise shows, LGBTQ+ identifying lawyers, especially those with intersectional identities, continue to experience discrimination and bias in their workplaces.1

How can an agency like the U.S. Food & Drug Administration (“FDA”) effectively regulate software that is constantly learning and adapting to real-world data? Continuously learning algorithms pose significant public health risks if a medical device can change overtime to fundamentally alter the nature of a device post-market. This Article evaluates the FDA’s proposed regulatory framework for artificially intelligent medical devices against the backdrop of the current technology, as well as industry professionals’ desired trajectory, to determine whether the proposed regulatory framework can ensure safe and reliable medical devices without stifling innovation. Ultimately, the FDA succeeds in placing effective limits on continuously learning algorithms while giving manufacturers freedom to allow their devices to adapt to real-world data. The framework, however, does not give adequate attention to protecting patient data, monitoring cybersecurity, and ensuring safety and efficacy. The FDA, medical device industry, and relevant policymakers should increase oversight of these areas to protect patients and providers relying on this new technology.

This Article presents the first comprehensive analysis of the contribution of behavioral science to the legal response to the COVID-19 pandemic. At the descriptive level, the Article shows how different psychological phenomena such as loss aversion and cultural cognition influenced the way policymakers and the public perceived the pandemic, and how such phenomena affected the design of laws and regulations responding to COVID-19. At the normative level, the Article compares nudges (i.e., choice-preserving, behaviorally informed tools that encourage people to behave as desired) and mandates (i.e., obligations backed by sanctions that dictate to people how they must behave). The Article argues that mandates rather than nudges should serve in most cases as the primary legal tool used to regulate behavior during a pandemic. Nonetheless, this Article highlights ways in which nudges can complement mandates.

The posture of American regulation of medicine is negative—we assume that a new drug is unsafe and ineffective until it is proven safe and effective.1 This regulatory posture is a heuristic normative principle, a specific instance of the so-called precautionary principle in public health law.2 It is defensible, if debatable, in many ordinary circumstances.3 But like many normative heuristics, this negative posture may compel suboptimal decision-making in emergencies, where context-specific decisions must be made and a range of unique values may apply.

The COVID-19 pandemic brought critical debates regarding private equity ownership of long-term care facilities to the forefront of political, legal, and social landscapes. Like many of the historical concerns about long-term care, these debates center around low quality patient care. While the concerns present important challenges to overcome, this note theorizes the kinds of organizational incentives that may provide opportunities to align patient quality care with the financial goals of private equity investing. After a discussion of the historical context of long term care facilities and the more recent trends towards for-profit and private equity ownership of these facilities (Parts II and III), I engage with value-based models as a starting point to consider organizational level incentive possibilities (Part IV). In Part V, I consider an organizational-level pay for performance model, a time-bound incentive structure, and investor-specific incentives as three distinct possibilities for addressing the patient care issues identified.

“Bring your whole self to work” remains a common mantra of supporters of workplace diversity, equity, and inclusion (“DEI”).1 For example, disability rights advocates have long contended that hiding or downplaying one’s disability from one’s colleagues at work “create[s] an invisible layer of additional work for the individual” in being accepted at the job and negatively affects productivity.2 LGBTQ+ rights advocates have raised similar points, noting that hiding or downplaying one’s sexual orientation or gender identity from one’s colleagues hinders internal advancement of LGBTQ+ workers.3 As recently as 2019, however, a Deloitte study found that sixty-one percent of workers hid or downplayed one or more of their identities from their colleagues at work.4

Far too many—if not most—of us in the legal profession who belong to both the disability and LGBTQ+ communities have known informally, through our own experiences and those of others like us, that workplace bias and discrimination on the basis of disability, sexuality, and gender identity is still widespread. The new study by Blanck et al. on diversity and inclusion in the U.S. legal profession provides empirical proof of this phenomenon, which might otherwise be dismissed as being based on anecdotal evidence.1 Its findings lend credibility to our position that the legal profession must make systemic changes to address workplace ableism, heterosexism, and transmisia.2 They also suggest possibilities as to where and how it might start to do so through providing information on who employers discriminate against most often and in what forms.3

Individuals with disabilities are sixteen times more likely to be killed by officers during a law enforcement encounter than other individuals. As the ever-growing list of victims demonstrates, law enforcement violence against individuals with disabilities is a national crisis. Yet, the current test, developed under Graham v. Connor, for whether officers’ use of force is excessive during an arrest considers only three factors: severity of the crime, immediacy of the threat, and resistance to arrest or attempts to flee. On its face, Graham’s three-factor test does not contemplate whether an arrestee’s individual characteristics are relevant to an officer’s use of force. Recognizing that the Graham factors are “non-exhaustive” and “flexible,” some lower federal courts have relaxed the excessive force test to account for particular circumstances. However, there is no consensus among the circuit courts and the Supreme Court has not revisited the Graham test.

Over three decades later, courts still do not have sufficient guidance on how to address individual disability under Graham. This Note advocates that in adherence to Graham’s expressed flexibility, its three-factor test should be reformulated to add in a fourth factor inspired by Title II of the Americans with Disabilities Act to account for whether “reasonable modifications” of an individual’s disability were made in situations when law enforcement employs force during the course of an arrest. Applying this standard in cases where an officer “reasonably should know” the arrestee has a disability promotes a baseline assumption that law enforcement officers have an active role in accommodating all disabilities.

As the coronavirus pandemic intensified, many communities in the United States experienced shortages of ventilators, intensive care beds, and other medical supplies and treatments. Currently, there is no single national response to provide guidance on allocation of scarce health care resources. Accordingly, states have formulated various “triage protocols” to prioritize those who will receive care and those who may not have the same access to health care services when the population demand exceeds the supply. Triage protocols address general concepts of “fairness” under accepted medical ethics rules and the consensus is that limited medical resources “should be allocated to do the greatest good for the greatest number of people.”1 The actual utility of this utilitarian ethics approach is questionable, however, leaving many questions about what is “fair” unanswered. Saving as many people as possible during a health care crisis is a laudable goal but not at the expense of ignoring patients’s legal rights, which are not suspended during the crisis. This Article examines the triage protocols from six states to determine whose rights are being recognized and whose rights are being denied, answering the pivotal question: If there is potential for disparate impact of facially neutral state triage protocols against Black Americans and other ethnic groups, is this legally actionable discrimination? This may be a case of first impression for the courts to resolve.

“[B]lack Americans are 3.5 times more likely to die of COVID-19 than [W]hite Americans … . Latinx people are almost twice as likely to die of the disease, compared with [W]hite people.” 2

“Our civil rights laws protect the equal dignity of every human life from ruthless utilitarianism … . HHS is committed to leaving no one behind during an emergency, and this guidance is designed to help health care providers meet that goal.” — Roger Severino, Office of Civil Rights Director, U.S. Department of Health and Human Services. 3

Diversity and Inclusion in the American Legal Profession: Discrimination and Bias Reported by Lawyers with Disabilities and Lawyers Who Identify as LGBTQ+ (“Blanck et al.”) is an incredibly careful, thoughtful, and powerful article, and may and should lead to changes in the stigma, bias, and discrimination landscape in the legal profession.1

The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA’s credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA’s public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.