This passage prefaces a landmark report on the application to health care of quality improvement methods used successfully in other industries.

The incidence of HIV infection and AIDS in children has grown at an alarming rate. Approximately one million children worldwide have HIV infection. By the year 2000, an estimated ten million children will suffer from the disease. Currently, the United States has a population of an estimated 10,000 to 20,000 HIV-infected children. As of June 30, 1993, the Centers for Disease Control and Prevention (CDC) reported 4,710 known AIDS cases in children twelve years-old and younger. At that point, New York City reported 1,124 pediatric AIDS cases which represented twenty-four percent of all cases in the United States.

With the rising number of HIV-infected children, the medical community in the United States has begun to search for HIV-and AIDS-related treatments particularized for children. In addition to establishing guidelines for HIV-infected children's frequent check-ups and timely immunizations, the medical community has initiated research studies involving HIV-infected children.

American culture reflects a paradox: the more openly we discuss death and its inevitability, the more money we spend to postpone and deny it. Sherwin Nuland's book How We Die, a frank description of the way our bodies deteriorate with and without medical intervention, topped the New York Times best seller list in the spring of 1994. At the same time, Jack Kevorkian, arguably the world 's best known physician, was being acquitted of violating Michigan 's law against assisted suicide, while a Michigan commission was debating legislative changes to permit physicians to help their terminally ill patients kill themselves. Despite such open discussion of death and expansion of the informed consent doctrine, U.S. medical expenditures at the end of life remain astronomically high. Most of this elevated spending is attributable to new medical technology.

In J.G. Ballard 's Empire of the Sun, the United States, British and Japanese cultures are contrasted through the eyes of a young British boy incarcerated by the Japanese army in China during World War II.

During the last year, the proposal of “enterprise” liability for medical malpractice became a major issue in debates about health care and malpractice reform. The idea, however, was not new. In scholarly work over an extended period, we have been developing the systematic case for the concept of enterprise — or, as we originally termed it, “organizational” — liability for medical malpractice. After several years of debating the critics of our proposal to shift the focus of liability for medical injury from individual physicians to the organizations that deliver health care, we were naturally gratified that the idea was now on the national agenda.

In particular, we recommended adoption of enterprise liability to President Clinton's Health Care Task Force. The Task Force did embrace a version of the idea as its own, but then encountered stiff resistance from a number of special interests.

For twenty years scientists have worked to find an effective treatment to ease the quivering, the stiffness, and the difficulty in controlling bodily movements which are the primary symptoms of Parkinson's disease. The disease can be treated with L-dopa, a drug that mimics the dopamine that coordinates neural transmission in the human brain, which Parkinson's sufferers have ceased to produce in sufficient quantities. The L-dopa, however, produces damaging side-effects and sometimes proves ineffectual. Researchers discovered in animal experiments that the effects of a laboratory-developed disease simulating Parkinson's disease could be mitigated using fetal brain tissue transplants, which produced the natural dopamine the animals’ cells failed to produce adequately.

These experiments were replicated with human subjects, and fetal tissue transplants have shown great potential as a treatment for Parkinson's disease. Fetal tissue is ideal for transplantation because it is in a stage of primitive development in which it adjusts easily to a new environment.

Neither bioethics nor health law is old as an established discipline. Modern bioethics dates from the late 1960s or early 1970s. Health law as a domain characterized by its own casebooks, courses, and specialists arguably began somewhat earlier. While each has far older precursors, the two fields have seen a modern resurgence in the last thirty years or so. Yet each in these three decades has been dominated by a certain method or paradigm. In bioethics that has come to be known as “principlism, ” deductive reasoning from a limited set of middle-level ethical principles, albeit with some reciprocal attention to the implications of the case at hand for those principles. No comparable term has emerged in health law, and the field has arguably been less enamored of philosophical abstraction. But the pattern has often been similar: the creation of middle-level rules (on informed consent, surrogate decision-making, advance directives and so on) and then their downward application with insufficient attention to the clinical context, the specific characteristics of the disputants (such as insurance status, race or ethnicity, and gender), and whether the rules will actually work in medical settings.

If the fundamental goals of the health care reform effort are to ensure universal access to an acceptable quality of health care at an affordable cost, then the threshold question for reform is: What health care services should be provided in an efficient, equitable system?

Answering this question requires weighing a complex mix of medical and social policy factors, a process not attempted in this article. But the starting point for that process should be determining what health care services “work” and what they cost. Outcomes assessment holds considerable promise in finding answers to these subsidiary questions, because it is intended to assess the effectiveness of health care services, that is, what works and what does not work for patients. It holds promise, not only for improving the quality of care, but also for identifying unnecessary or wasteful practices that increase health care costs.

Prenatal genetic diagnosis represents one of the most important recent advances in the field of clinical genetics. Each year in the United States, a significant number of children are born with some type of hereditary genetic defect that can be diagnosed in utero. Of the over 4000 genetic traits which have been distinguished to date, more than 300 are identifiable via prenatal genetic testing. With increasing frequency, various diagnostic procedures are being used to evaluate the probability that a fetus will be born with a serious physical or mental handicap caused by a genetic abnormality. These procedures identify disabling or potentially fatal genetic disorders, including cystic fibrosis, trisomy 21 (Down syndrome), P-Thalassemia, and neural tube defects (NTDs).

Prenatal diagnosis may be achieved by utilizing one or more techniques from three basic methods of testing. The most commonly performed means, amniocentesis, is a procedure in which a small sample of the fluid surrounding the developing fetus is extracted from the amniotic sac.

Community-based, long-term care has become an increasingly popular and needed service for the aged and disabled populations in recent years. These services witnessed a major expansion in 1981 when Congress created the Home and Community-Based Waiver authority for the Medicaid program. Currently, all states offer some complement of community-based, long-term care services to their elderly and disabled populations and nearly all states have Medicaid Home and Community-Based Services waivers which extend these services to their Medicaid eligible clients.

An ever increasing proportion of the population is in need of community-based, long-term care services. Between nine and eleven million Americans of all ages are chronically disabled and require some help with tasks of daily living. In 1990, thirty percent of the elderly with at least one impaired activity of daily living used a community-based, long-term care service. Not surprisingly, expenditures for community-based, long-term care have increased.

I began teaching Health and the Law in January, 1985. Louise Brown, the world's first “test tube” baby, was six years old. Karen Ann Quinlan, whose ventilator had been disconnected years earlier, was still alive and being tube fed in a New Jersey nursing home. Acquired Immune Deficiency Syndrome (AIDS) was a still little understood disease. Although forward looking scholars had been writing important books about access to expensive health care, few legal challenges had been made to alleged treatment (whether ordinary or extraordinary) refusals. Oh, what a difference a decade makes! In keeping with the theme of this issue, this article focuses on law and bioethics in the year 2000, particularly the teaching of bioethics. In some ways the challenges of teaching bioethics in the year 2000, or anytime, are the challenges of teaching any course in the year 2000, or anytime. In other ways, the special topics covered in a bioethics (or any health law) course and the dramatic impact on the area of health law by science, medicine, and technology make the challenges far more difficult than in many other areas of the law.

As consumers have become enlightened to the dangers of the sun, they have turned increasingly to sunscreens to stave off not only a sunburn but also life-threatening skin cancer. In the last decade, the incidence of skin cancer has grown a startling 500%. The increase in the number of skin cancers in adults is most likely the result of exposure to the sun as a child. Therefore, the current and continued rise in the number of skin cancers in adults is not remediable. However, as adult consumers seek to prevent further damage to their skin and protect their children from the same fate, the market for sunscreens has grown and is estimated to be worth between $170 and $650 million dollars. The increased demand for sunscreens, combined with the incorporation of sunprotection ingredients into everyday products such as makeup and skin lotions, has led the United States Food and Drug Administration (FDA) to subject sunscreens to increased regulatory scrutiny.

Health law and medical ethics are both integral parts of undergraduate medical curricula. The literature has addressed the importance of teaching law and ethics separately in medical school settings, yet there have been few descriptions of teaching law and ethics together in the same curriculum. A combined program in law and ethics required for first-year medical and dental students was developed and implemented by Professor Joseph (Jay) M. Healey, Jr., at the University of Connecticut Schools of Medicine and Dental Medicine from 1975 until his death in 1993. This Article describes the thirty-hour, interactive, case-based course he created. The course, Legal and Ethical Aspects of Medicine and Dental Medicine (LEA), has continued after Jay 's death, and is one of his many legacies to us. LEA consists of fifty-six actual and hypothetical cases written by Jay from which basic legal and ethical principles are extracted by participants and reinforced by instructors.

Implicit in any discussion of quality in health care are ideas about responsibility: who is responsible to define quality, who is responsible to deliver it, and who is responsible when the quality of care is unsatisfactory. The thesis of this article is that due to economics, ethics, and law, we have placed these responsibilities almost exclusively on physicians, but that powerful economic changes now require a reallocation of the responsibilities of providers, patients, and payers in defining and delivering quality in health care.

In the past half-century an extraordinarily generous, uncritical reimbursement system has empowered physicians to define and deliver quality that is interventionist and highly technological. Longstanding ethical precepts hold that physicians are responsible for their patients, and modern economic arrangements have encouraged physicians to focus on their patients’ welfare, virtually to the exclusion of costs or other competing considerations.

Writing in 1988, Arnold Relman heralded the dawning of the “third revolution“ in medical care. The first revolution, at the end of World War II, had inaugurated an Era of Expansion, with an explosion of hospitals, physicians, and research. Medicare and Medicaid were passed, and medicine experienced a golden age of growth. Inevitably, according to Relman, this yielded to an Era of Cost Containment starting in the 1970s. The federal government and private employers revolted against soaring costs, brandishing the weapons of prospective payment, managed care, and global budgeting. Yet these blunt instruments of cost-cutting eventually produced concern over how to evaluate the quality of health care, to promote the good while trimming the bad. Thus Relman announced the arrival of the Era of Assessment and Accountability.

This chronology helps explain the current importance of quality. Quality assessment and more recently, quality improvement techniques, occupy a central place in this new era.

During the past three decades, the pages of major newspapers, magazines, and professional journals across the country have chronicled a tragic dilemma confronting persons with mental disabilities. On the one hand are the horror stories of thousands of individuals with mental disabilities locked away in institutions. They live years in isolation or neglect when many could have received treatment and enjoyed fuller lives in the community. Thousands more have endured a different hell in the “freedom” of the outside world, receiving no treatment or support services necessary for their survival, often causing harm to themselves or others as their condition deteriorated. This lack of treatment and support is largely the result of states' failure to shift mental health resources into the community when state institutions released their patients under the policy of deinstitutionalization.

In the twenty-year-long debate over medical malpractice reform, obstetrics is unique. No other area of specialty medical practice has managed to argue successfully that its malpractice victims should be singled out and barred from obtaining relief through the tort system. Yet, following a well-organized lobbying effort by OB/GYNs, the state legislatures in Virginia and Florida have enacted so-called “bad baby bills” that create workers-compensation-type programs for victims of birth-related injuries. Such statutes provide the exclusive remedy for this and only this class of plaintiffs. Other states are considering following suit: bills have been introduced in North Carolina, Illinois and New York.

What justifies this extraordinary legislative action? Proponents of the reforms admit that the effect of these statutes is to reduce the malpractice burden on OB/GYNs. But they are careful to portray patients rather than physicians as the primary beneficiaries of their efforts.