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

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

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

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

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

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

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

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

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

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

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

PurposeThis article is part of an ongoing body of investigation examining the experiences of lawyers with diverse and multiple minority identities, with particular focus on lawyers with disabilities; lawyers who identify as lesbian, gay, bisexual, transgender, and queer (“LGBTQ+” as an overarching term); and lawyers with minority identities associated with race and ethnicity, gender, and age. The focus

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

Haley Moss was diagnosed with autism at age three. At the time, her parents were told that achievements such as obtaining a driver’s license, graduating from high school, or even making friends were unlikely. Even after she proved the experts wrong and gained acceptance to law school, Moss saw continued challenges for students with disabilities. “I remember in my first year of law school, there was

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

“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+

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,

Diversity, equity, and inclusion (“DEI”) in the workplace is a complex issue at any time and in any organization. However, in this time of great upheaval—COVID-19, a renewed racial reckoning in the United States, and increased climate consciousness and social justice awareness—profound issues about work and the role of organizations are being raised simultaneously. This confluence of systemic issues

The rapid growth of medical technology gives rise to difficult dilemmas concerning the appropriateness of, and access to, new equipment and devices capable of maintaining life or improving its quality. Such a dilemma already exists, for example, with regard to kidney dialysis machines. In 1972, Congress amended the Social Security Act to make such machines available under Medicare to all who needed

While state medical licensure laws ostensibly are intended to promote worthwhile goals, such as the maintenance of high standards in health care delivery, this Article argues that these laws in practice are detrimental to consumers. The Article takes the position that licensure contributes to high medical care costs and stifles competition, innovation and consumer autonomy. It concludes that delicensure

In Roe v. Wade, the Supreme Court held that the constitutionally protected right to privacy includes a woman's right to terminate pregnancy. Following the decision, anti-abortion groups turned to Congress to limit or negate that right. As a result of their efforts, several "human life" statutes and constitutional amendments have been proposed. This Article focuses on the implications of proposed amendments

The author of this Comment describes how recent federal legislation (P.L. 93-641, signed into law in January, 1975)—and improved scientific techniques for integrating (1) community medical needs assessment, (2) institutional budgeting linked to regional/state health plans, and (3) budget ceilings—have given the public new authority and technology to shape the nation's institutional health services

City of Revere v. Massachusetts General Hospital presented the United States Supreme Court with its first opportunity to consider whether a state or municipality has a constitutional duty to pay for medical treatment received by an individual in police custody. The Supreme Judicial Court of Massachusetts had held that the city had an eighth amendment duty to pay for an arrestee's treatment. The U.S

One way to increase cooperation between the professions of law and medicine is to teach law in medical schools in a way that emphasizes methods of approaching problems, and seeks to dispel the major myths that doctors have about the law. In this Article, Professor George Annas presents an outline of a core course in legal medicine “tailor-made” for inclusion in the medical (and, with appropriate modifications

Several Massachusetts laws, including the recently enacted Patients’ Bill of Rights, protect the rights of nursing home patients. Although these laws address many of the problems that such patients face, they do not adequately meet all of the unique needs of this vulnerable group. This Comment discusses safeguards afforded by current Massachusetts law that are particularly important for nursing home

The struggle for control of this nation's life-giving blood resources was, up until five years ago, largely a private affair between representative organizations of the blood collectors. The system that emerged from that struggle was declared unhealthy by several experts who complained that blood was too often unsafe or unavailable. Then in 1972 the government, predominantly the federal government

This Article examines the legal status of hospital committee proceedings and reports, focusing on how they may be used in a medicolegal context. Specific topics dealt with include the hospital medical staff in legal perspective, the concept of institutional responsibility, liability considerations arising from committee work, and the discovery and admissibility of committee records in litigation cases

A federal requirement that donor blood be labelled as either “paid” or “volunteer” took effect on May 15, 1978. A major rationale for requiring such labelling is that physicians, now that they can distinguish between categories of blood, will fear liability for post-transfusion hepatitis resulting from the use of paid blood. Thus, supporters of the labelling requirement hope that it will deter the

Today, it is readily apparent that the legal and moral aspects of medical practice are becoming increasingly complex. This is not to say that the practitioners of, say, twenty years ago did not face complex legal and ethical questions. Certainly they did. But for them, such questions were not raised in such diverse ways as they are today.

Psychiatric and psychological predictions of dangerousness are used in a number of American jurisdictions to convince a judge or jury that a convicted murderer should be sentenced to death. Empirical research has demonstrated, however, that psychiatric and psychological predictions of dangerousness generally are inaccurate. This Article describes the current use of such predictions in capital sentencing

Founded in 1968, the American Society of Hospital Attorneys of the American Hospital Association is the country's oldest and largest association of attorneys specializing in hospital and health law. It is a measure of the rapid growth of this legal specialty that although the Society only recently held its Eleventh Annual Meeting, it has over 2100 active duespaying members on its rolls. The Board of

The Internal Revenue Service typically grants health maintenance organizations (HMOs) an I.R.C. section 501(c)(4) exemption from federal income taxation. If these prepayment group medical providers were classified as section 501 (c) (3) tax exempt organizations, however, they would receive many additional advantages including increases in private funding and decreases in material and operating costs

The medical malpractice crisis of the early and mid-1970s prompted many states to enact legislation creating medical malpractice screening tribunals. This legislation often failed to define clearly the role and jurisdiction of the tribunals. The lack of statutory definition is particularly apparent where a claim before a tribunal raises primarily nonmedical issues. The changing doctrines of hospital

In Vitek v. Jones, the United States Supreme Court interpreted the due process clause as requiring that certain procedures be followed before transferring prisoners to mental institutions. This Note analyzes the Court's reasons for concluding that the existing transfer procedures embodied in the state's commitment statutes infringed on the prisoner's liberty interests and, therefore, were constitutionally

In this Article, Dr. Arnold S. Relman, the Editor of The New England Journal of Medicine, takes issue with the 1977 Saikewicz decision of the Massachusetts Supreme Judicial Court, which addressed the question of whether chemotherapy should be provided to a severely retarded 67-year-old man who had developed acute leukemia. Dr. Relman interprets Saikewicz as requiring that medical treatment decisions

Approximately 1.3 million of our nation's elderly live in nursing homes. Despite the increasingly important role of Medicare and Medicaid, many must bear the costs of their care. This Note examines one means of financing nursing home care—the life care contract. These require residents to pay an entrance fee and transfer to the nursing home all or part of their property in return for the home's promise

Within the physicians' services industry, doctors of osteopathy are the only "full line" competitors of medical doctors. Given the current interest in merger of the two schools of practice, this Article examines the benefits of having an independent osteopathic school. These benefits include: (1) reduction of the monopoly power of medical doctors in malpractice litigation, fee negotiations with third

This Article by Professor Arnold J. Rosoff concerns the passage of the Health Maintenance Organization Act of 1973, the problems which have been experienced thus far in its implementation, and the current proposals for amendment of the Act in order to make it more viable.

In Payton v. Abbott Laboratories, U.S. District Court Judge Walter J. Skinner recently granted class certification to an action brought by twentyseven Massachusetts women against major manufacturers of DES. This is the first case in which a judge has interpreted the requirements of Rule 23 of the Federal Rules of Civil Procedure to allow women exposed in utero to DES to sue as a class to determine

The use of placebos by physicians for therapeutic purposes is a common part of clinical medical practice. This Article examines the legal and ethical ramifications of placebo prescription. In particular, ethical concerns are related to substantive legal theories that may be advanced to attack or defend the practice of placebo therapy in particular cases. The author concludes that, under certain strictly

The relations between physicians and lawyers have deteriorated rapidly over the past several decades, most particularly since the early 70s when the perception that a medical malpractice crisis existed in America became widespread. Some believe that the factors dividing the two professions are linked (1) to professional jealousy, (2) to sometimes conflicting economic interests, or (3) to difficulties

The Massachusetts Department of Public Welfare recently proposed a “Family Responsibility Plan” which would impose a financial obligation upon adult children in the state for the nursing-home care of their parents who receive Medicaid. By examining the Massachusetts plan, this Note seeks to evaluate the viability of a concept of family responsibility, under which adult children contribute to the state

The birth of the world's first “test-tube baby,” a child conceived by in vitro fertilization (IVF), raises serious medical, ethical, and legal problems. This Note explores the present controversy over the use of IVF and advocates federal regulation of the technique. Furthermore, this Note argues that, in order to deter unduly hazardous use of IVF and to compensate its victims, an experimenter should

In 1965 Congress, through amendments to the Social Security Act, established the Medicare and Medicaid programs and mandated that hospitals participating in those programs be reimbursed for the “reasonable cost” of providing inpatient services to Medicare and Medicaid patients. In this Article, the Chairman of the Massachusetts Rate Setting Commission contends that HEW—which, like Congress, was anxious

The Chad Green case has again focused national and international attention on the unproven cancer remedy known as laetrile. Laetrile has attracted considerable attention in recent years as a result of claims that it is a nontoxic form of cancer treatment. Twenty-one states have legalized prescription of laetrile within their borders, despite the efforts of the Food and Drug Administration (FDA) to

Having argued in Part One against extensive judicial or regulatory interference with private personnel credentialing in the health care field, this Article now shifts its focus to emphasize the anticompetitive hazards inherent in credentialing as practiced by professional interests. Competitor-sponsored credentialing is shown to be a vital part of a larger cartel strategy to curb competition by standardizing

American employers have traditionally relied on age as the criterion for mandatory retirement. Yet advances in medicine indicate the inadequacy of age as a measure of job competence and suggest the potential for a more reliable measure. With current social and economic conditions pressing many employees to seek to work beyond mandatory retirement ages set by their employers, transition to more reliable

It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness … it was the spring of hope, it was the winter of despair … we were all going direct to Heaven, we were all going direct the other way.—Charles DickensThe Human Genome Project (HGP) provides information about the human genome that will forever alter society and the way we view ourselves. The

By now everyone is familiar with the recent accomplishments of the Human Genome Project. Accomplished in ten, rather than the initially expected fifteen, years, the human genome has been fully sequenced. Genetics is in its golden age. A product of the technology era, genetics has, in a short time, offered vast amounts of information. This increased knowledge promises potential benefits for our understanding

Proposals to ration health care in the United States meet a number of objections, symbolic and literal. Nonetheless, an acceptance of the idea of rationing is a necessary first step toward universal health insurance. It must be understood that universal health care requires an acceptance of rationing, and that such an acceptance must precede enactment of a program, if it is to be economically sound

Electronic fetal monitoring (EFM) has been criticized as ineffective, unsafe and costly. Despite existing controversy regarding the risks involved in using EFM, this monitoring procedure continues to be widely employed. In many jurisdictions, in fact, the use of EFM during labor may be considered the customary practice. This Article analyzes the medical and legal issues arising from a physician's use