Transparency for consumers through nutrition labeling should be the last, not the first, step in a transformative food policy that would reduce dramatic health disparities and raise the United States to the health standards of other nations with similar resources. Nonetheless, transparency in the food system is a key focal point of efforts to improve health by providing consumers with necessary information to make good nutritional choices, as well as to achieve sustainable food chains and ensure food safety and quality. In fact, nutrition labeling on packaging and in restaurants is the centerpiece of policy designed to decrease obesity, a condition many health advocates consider to be the most urgent public health crisis of the twenty-first century. The resulting increased transparency about food ingredients has led to some changes in industry practices and allowed many middle- and upper-income consumers to make informed choices about the products they purchase and consume. Unfortunately, however, research reveals that increased nutritional information does not improve health.

Pregnancy is a biological process that usually takes forty weeks. The more advanced pregnancy is in terms of gestational age, the higher the chances that the fetus would survive in case of a premature and unnatural delivery. Hence, when a pregnant woman is struck by brain death, the fetus’ chances of survival are seriously and immediately threatened. Until recently, there were two choices in such a situation: letting the mother (and the fetus) naturally die without further intervention or delivering the fetus through a cesarean section when the death of the fetus was a tragic but likely result.

Recent advances in medical technology, however, have provided physicians with an ability to control over the time and manner of death in ways that were never previously considered by their patients.

The emergence of in-store retail health clinics (RHCs) has sparked a debate that pits quality of care concerns against the advantages of consumer choice in the marketplace for health care. RHCs appear in pharmacies, grocery stores, and big-box retailers like Wal-Mart, offering basic health care services on a walk-in basis that are administered primarily by nurse practitioners (NPs). Proponents of these clinics hail their pro-market effects: convenience and cost-savings associated with consumer-driven health care; lower prices from increased competition between providers; and increased access to basic health care. Critics of RHCs raise concerns that quality of care is hindered by the lack of physician oversight, disruption of the “medical home,” and the conflicts of interest arising from prescribing drugs at pharmacy-housed clinics.

Perceived threats to medical privacy arouse intense emotion, even among those who might otherwise approach complex health policy issues with academic dispassion. The author of an August 2001 editorial in the New England Journal of Medicine describes medical records as “sacred secrets,” and decries the use of medical information for purposes unrelated to patient care as “an abridgement of individual rights” and “an unfolding American tragedy.

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

A recent measles outbreak in the United States was linked to a single source, yet it spanned eighteen jurisdictions and infected 121 people. Forty-seven states currently allow legal exemption from vaccination on religious grounds, eighteen of which also allow it on philosophical grounds. Recent research usually accepts a fundamental right to vaccine exemption and primarily seeks ways to protect herd immunity while also respecting that right, for example, by keeping the exemption available yet harder to procure or by imposing torts for infection-related injury. We argue that when herd immunity is at risk, any moral claim to exemption from vaccination on conscientious, philosophical, or religious grounds is overridden.

Our argument rests on an analogy to a series of situations in which a person puts others at risk through philosophically or religiously motivated choices. In these situations, intuitively, there is no claim-right to compromise the safety of others. Similarly, we propose, there is no claim-right to refuse vaccination, regardless of one's conscience, when refusal is sufficiently likely to seriously affect herd immunity and the safety of others. We also address several counterarguments. The lack of a claim-right to exemption when herd immunity is at risk does not mean, however, that it is always prudent for the state to force vaccination, or even that forcing vaccinations must be legal. Alternatives to forced vaccination may prove wiser and more conducive to high vaccination rates.

The pace of medical innovation is quickening, pushed by advances in biotechnology and pulled by growing demand for healthcare. Completion of the Human Genome Project has provided a multitude of data for determining genes and their functions, and stimulated the application of information technology and private capital for the development of new individualized drugs, gene therapies, and biomaterials for tissue and organ regeneration. Concurrently, demand for healthcare continues to grow, expanding the market for medical innovations that are proven in clinical trials to be safe and effective.

Environmental pollution threatens public health. The search for solutions has advanced the frontiers of science and law. Efforts to protect the environment and public health begin with describing potential adverse consequences of human activities and characterizing the predicted risk. The National Environmental Policy Act requires the preparation of environmental impact statements to describe the effects of proposed federal projects and provide information for agency decisionmakers and the public.

Risks to public health are particularly difficult to quantify because of uncertainty about the relation between exposure to environmental contamination and disease. Risk assessment is the current scientific tool to present estimates of risk. The methodology has created controversy, however, when underlying assumptions and uncertainties are not clearly presented. Critics caution that the methodology is vulnerable to bias. This Note evaluates the use of risk assessment in the environmental impact statement process and offers recommendations to ensure informed decisions.

Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration (“FDA”). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authority and directive presented itself in the 21st Century Cures Act, reflecting an important role for patient perspectives in the regulatory process. This Article explores recent developments in patient-focused product development efforts at the FDA and offers modest insights on the increasing role of patients, and patient advocacy groups, in agency decision-making. The Article terms this era “21st century citizen pharma.”

Physicians-in-training generally have insufficient exposure to legal medicine to prepare them for the medicolegal problems they will encounter in practice. This Article outlines the current structure of the field of legal medicine in America, and sets forth two strategies with clinical orientations for teaching legal medicine to physicians-in-training: (1) providing a didactic course offering accurate and practical information on medicolegal emergency situations; and (2) establishing a consultation service in legal medicine capable of providing clinical information or training in such settings as the emergency room, the outpatient departments, and the inpatient wards.

Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from (1) establishment of a healthcare relationship, (2) state licensure laws, and (3) reimbursement. We analyze these areas because of the legal ambiguities or inconsistencies they raise depending on the state, which seem to be hampering telehealth growth without necessarily improving quality of care. We propose several solutions for a more unified approach to telehealth regulation that incorporate core bioethics principles of doctor-patient relationship, competence, patient autonomy, as well as population-wide questions of resource allocation and access. Lawmakers should clarify that healthcare relationships may be established outside of in-person meetings, align licensure laws via an interstate compact or federal preemption, and expand Centers for Medicare and Medicaid plans to reimburse telehealth delivery in the home.

Artificial intelligence (AI) machines hold the world's curiosity captive. Futuristic television shows like West World are set in desert lands against pink sunsets where sleek, autonomous AI fulfill every human need, desire, and kink. But I, Robot, a movie where robots turn against the humans they serve, reminds us that AI is precarious. Academicians who study how AI interacts with tort law, such as Jessica Allain, David Vladeck, and Sjur Dyrkoltbotn, claim that the current legal regime is incapable of addressing the liability issues AI present. Both Allain and Vladeck focus their research on whether tort law can accommodate claims against fully autonomous AI machines, while Dyrkoltbotn explores how AI can be leveraged to help plaintiffs identify the genesis of their injuries. The solution this article presents is not exclusively tailored to fully autonomous AI and does not identify how technology can be used in tort claims. It instead demonstrates that the current tort law regime can provide relief to plaintiffs who are injured by AI machines. In particular, this article argues that the manner in which Watson for Oncology is designed presents a new context in which courts should adopt a per se rule of liability that favors plaintiffs who bring damage claims against AI machines by expanding the definition of what it means for a device to be unreasonably dangerous.

Historically, government has been given more leeway when invoking its interests in safeguarding the public health than when asserting other state interests. Thus, for example, when considering a constitutional challenge to mandatory smallpox immunization in Jacobson v. Massachusetts, the Supreme Court employed its highly deferential, rational basis review rather than the stricter level of scrutiny that it normally employs when individuals assert interests in bodily integrity. Similarly, Congress and the Food and Drug Administration (FDA) have imposed greater restrictions on the speech of pharmaceutical companies than have been considered acceptable for speech in other commercial settings.

In recent years, however, it appears that a trend is developing toward applying the same level of constitutional scrutiny to health regulation. In Abigail Alliance, a three-judge panel in the U.S. Court of Appeals for the D.C. Circuit overrode FDA regulations to recognize a constitutional right of access for patients to experimental chemotherapy.

In one year, you will watch roughly sixteen hours of pharmaceutical advertisements. Sometime during those sixteen hours, you may recognize in yourself the symptoms portrayed in the advertisements. You may even wonder whether you would benefit from a particular drug. But will you visit your doctor with the fear that you may be suffering from a previously undiagnosed disease? Will you encourage your doctor to prescribe the medication you saw in the advertisements? Will your insurance cover the costs of your medication? More importantly, will you even need the medication at all?

The trend in the pharmaceutical industry to increase yearly spending on direct-to-consumer pharmaceutical advertising (DTCA) seems almost disrespectful considering the magnitude of the healthcare crisis in which the United States is currently embroiled. This notion is inflamed when accounting for the fact that (arguably) one of the biggest problems in our healthcare system is the amount of money spent on healthcare each year.

Genetic identification tests — better known as DNA profiling — currently allow criminal investigators to connect suspects to physical samples retrieved from a victim or the scene of a crime. A controversial yet acclaimed expansion of DNA analysis is the creation of a massive databank of genetic codes. This Note explores the privacy concerns arising out of the collection and retention of extremely personal information in a central database. The potential for unauthorized access by those not investigating a particular crime compels the implementation of national standards and stringent security measures.

In the American health care system, payers are rapidly moving toward the use of capitation as the preferred method for paying for health care services for sponsored patients. n capitation, the payer pays a provider organization a set rate per patient to care for a group of patients. The provider organization assumes the risk of the actual costs of caring for these covered lives. The theory of capitation is that providers, by assuming risk, will have incentives to contain their costs.

The provider entity that provides the care can take many corporate forms. A capitated provider can be a small group of physicians with admitting privileges at a single hospital or a complex integrated delivery network comprised of hospitals, physicians, and other health care professionals and institutions with integrated case management and data systems. Currently such integrated delivery networks assume a variety of organizational forms, ranging from traditional staff model health maintenance organizations (HMOs) in which physicians are employees of the health plan to physician hospital organizations (PHOs) in which physicians and hospitals join together for purposes of contracting with payers. Hospitals and physicians belonging to their medical staffs are motivated to form integrated delivery networks or other consolidated business organizations in order to contract with payers that seek providers willing to accept financial risk for the care of sponsored patients. Providers join such arrangements out of fear of losing patients if they do not.

Breast Cancer remains a leading cause of death among American women, yet little is known about its etiology and prevention. Screening mammography is currently the best preventative measure available to women, but comprehensive oversight of this procedure is necessary in order to minimize and, ultimately, eliminate “errors” that compromise quality and accuracy and give too many women a false sense of security. This Note describes our nation's battle against Breast Cancer, emphasizes the need for uniform, mandatory quality and safety standards for screening mammography, and outlines The Mammography Quality Standards Act of 1992, which seeks to provide the framework necessary to implement such standards and restore the preventative power of this procedure. This Note analyzes the terms of the Act and concludes that the Act could provide women with the true sense of security that has eluded so many women - too many women - for so long.

In the context of the bicentennial of the Constitution and science's relationship to society, it has been argued that “the advance of science and technology in the West has changed not only the relation of man to nature but of man to man.“ This seemingly immodest statement may soon prove an understatement. In the arena of human reproduction, the marriage of science and technology in medicine may change not only the relationship of man to nature and man to man, but more significantly, the very concept of what it means to be human. This, in turn, will directly affect how we define the “rights” this “new human” may properly claim.

This article begins to explore developing reproductive medical technology with a view toward examining the way it might change our concept of humanness, and how this change might be accommodated, encouraged, or truncated by the relationship between the government and its pregnant citizens as defined by the United States Constitution and the “right to privacy.”

For several decades now we have been acutely aware of the increasingly intensifying effect that environmental degradation has on human health. While many of these effects are localized, given the increasingly global nature of environmental problems their impact on human health has also become global in dimension. Health experts are becoming more and more concerned about the potential impact on public health if no precautionary measures are taken to deal with these global environmental problems.

Of course, environmental problems have consequences beyond their public health impact. The emphasis in this Article on public health should not be taken as advocating an anthropocentric approach to environmental problems. This Article focuses on public health as a way of drawing attention to the enormity of the problem.