Notwithstanding the continuing debate over the future of managed care and the appropriate protections to be included in a Patient's Bill of Rights, the safeguarding of patient privacy and the reduction of medical error have emerged as the dominant health law issues. Displacing even the implications of the advances in genomics from the front and editorial pages of our newspapers, privacy and medical error have left the cozy world of professional journals and political platitudes to demand corrective action.

The backlash against managed care, in general, and Health Maintenance Organizations (“HMOs”), in particular, is a major health policy issue. It has led to the formation of major commissions at the national and state levels, and to a great outpouring of legislative activity. The U.S. Congress has been deadlocked over various versions of a Patients’ Bill of Rights for the past two years. As a nation, we are far from resolving the many problems consumers report experiencing with their HMOs. However, to prescribe an effective solution to the problem, it is important to understand the root causes of the consumer backlash. It is, after all, possible that a Patients’ Bill of Rights will do little if it is not targeted to correct what is really bothering people about HMOs.

The United States is currently entering a period in which the demand for longterm care services is growing at a particularly rapid rate; it is projected that the inflation-adjusted expenditures for long-term care will double between 1993 and 2018. As the population continues to age and become more chronically ill and disabled, the need to expand our long-term care capacity, and the long-term care options available, has become self-evident. The question is how we can meet this need in a cost-effective manner that is satisfactory to the consumer of services.

Financial conflict of interest has become one of the most contentious issues in medicine today. Several decades ago studies disclosed that physicians who had investments in medical facilities were referring patients for more tests and procedures than physicians who had no such investments. More recently, physicians who forego expensive tests and treatments for patients have been accused of skimping on care for personal financial gain. Physicians who emphatically tout certain treatments have been criticized for possessing hidden financial ties to the manufacturer of the products. Some physicians engaged in clinical trials have been suspected of enrolling patients who do not strictly conform to the research protocols so that they can collect fees from contract research organizations. And in the aftermath of deaths and complications in gene therapy experiments, some scientists and their institutions have been criticized for possessing a financial stake in companies that are involved in the studies.

Managed care was designed to bring stability and balance to healthcare delivery in the United States, but its experience in the legal system has involved only moderate stability and very little balance. There has been a trend toward broad deference to the industry, so that managed care organizations (MCOs) are largely immune from liability. At the same time, some courts have suggested that the entire managed care model rests on sketchy legal ground. Meanwhile, commentators have disagreed on such fundamental questions as whether legal disputes arising under managed care should be resolved according to contract law or tort law. Moreover, the extent to which the Employee Retirement Income Security Act of 1974 (ERISA) governs, or moots, patients’ claims against MCOs has never been entirely clear—and because ERISA controls a vast number of health insurance plans, this legal issue is extremely significant.

In 1964 President Lyndon B. Johnson declared a “War on Poverty.” By 1965 Congress had enacted several key weapons in that war, including two massive revisions to the Social Security Act designed to provide broad access to healthcare for if. the elderly, the disabled and poor, uninsured pregnant women and infants. The current Medicare and Medicaid health insurance programs, along with the State Children's Health Insurance Program, provide health insurance and thus, access to healthcare, for 60% of people living in poverty. Medicaid alone pays for half of all nursing home care in this country. Medicare pays for hospital care for over 32.4 million elderly Americans, and for 3.7 million disabled Americans. Medicare and Medicaid have been called the “lynch pin” in the nation's strategy to assure access to healthcare for low income Americans. In short, the War on Poverty is not effective without the access to healthcare Medicare and Medicaid afford to the poor, elderly and disabled.

The most publicized finding of the Institute of Medicine (IOM) report is that between 44,000 and 98,000 patients die each year as a result of “adverse events” in medical care. The core concern of the report is to argue that a "systems" approach to medical practice holds out considerable promise for the elimination of the subset of those “adverse events” which are the result of medical error. The report outlines the “systems” approach and proposes various public policies which might encourage the adoption of that approach, enhance its effectiveness and protect it from potentially undermining legal assaults.

The debate surrounding the legalization of assisted suicide has been galvanized in recent years by reports of specific cases of assisted suicide, primarily involving physicians such as Kevorkian and Quill, and by impassioned pleas for legalization and assistance in suicide from individuals suffering in the throes of terminal or agonizing diseases, such as Sue Rodriguez. Media attention on criminal trials of individuals accused of assisting in a suicide has heightened public awareness of the issue. The constitutionality of criminal prohibitions on assisted suicide has been tested in various jurisdictions, and has recently been considered by the Supreme Courts of both the United States and Canada. Following two narrowly unsuccessful attempts to enact dignified death provisions by referenda in Washington and California, Oregon voters passed the first of such proposed laws in November 1994, providing for physician-assisted suicide under certain specified conditions. Attempts to introduce legislation to legalize assisted suicide in other jurisdictions have been galvanized by the success in Oregon. A model statute has been drafted by a group of law professors, philosophers and medical professionals.

One of the most controversial aspects of the World Trade Organization (WTO) is its trade policy governing pharmaceutical products that treat AIDS and other diseases. Critics contend that the WTO unreasonably restricts the trade of pharmaceuticals in order to protect the profit margin of western drug producers at the expense of infected populations in developing countries. Supporters of the WTO's trade policy argue that protecting the intellectual property (IP) rights of pharmaceutical products is essential to providing an incentive for further drug research and development.

The possibility of cloning human beings, although widely contemplated for several decades, became scientifically feasible in 1997 when the first mammal created through cloning procedures was born. Although the scientists who created the sheep named Dolly did not intend to apply cloning techniques to human beings, news media worldwide began predicting such an application.

In the United States, public and political outcry against the possibility of cloning human beings was loud and swift. Almost immediately, President Clinton announced a ban on federal funding of cloning research and requested the National Bioethics Advisory Commission to prepare a report evaluating the technology and making recommendations concerning its use. Several bills were introduced in Congress which prohibited federal funding and/or banned cloning in both the public and private sectors. As of yet, none of these bills have been passed.

Medical error and health care fraud are hot topics these days. Since the Fall 1999 publication of the Institute of Medicine (“IOM”) Report, To Err is Human, medical errors have received a great deal of attention in the popular and academic press. Error reporting bills have been introduced at both the state and federal levels, and industry and government representatives have undertaken a variety of cooperative error-reduction efforts.

Tort “crises” and serious interest among policy-makers in tort reform are inter-related, cyclical phenomena in the United States. In the mid-1970s, and again in the mid-1980s, medical malpractice markets across the country experienced rapid increases in the frequency of claims, rising premiums, and in some places, shrinking options for professional indemnity coverage. A wave of tort reform measures followed, the majority of which were designed to chill the interest of plaintiffs' attorneys in bringing suit.