The Institute of Medicine (IOM) has returned the problem of medical error to the top of the health-care agenda. Its report that 44,000 to 98,000 patients die each year as a result of medical errors in American hospitals has renewed scholarly interest in health system quality control. In To Err Is Human, the IOM provides a vivid picture of a health-care system riven with serious quality problems. It calls for systems-based error-reduction methods borrowed from other high-risk industries and forcefully argues against the traditional tendency to assign accountability primarily to individual physicians. Most errors, the IOM argues, can be successfully addressed by engineering systemic fail-safe protections against the inevitable failings of human actors.

Pain in the United States is widely recognized to be undertreated; however, the capacity to treat pain has never been greater. The causes of this undertreatment are varied. As we focus on pain and why it is too often ineffectively treated, we also discover that this undertreatment afflicts some more than others. What divides the some from the others isn't limited to one factor, but one particularly disturbing factor is race and ethnicity. Racial and ethnic minority populations are at higher risk for oligoanalgesia, or the ineffective treatment of pain. Only through further study of the differences in pain treatment based on race and ethnicity can we develop strategies to reduce the disparities in care.

Those objecting to human DNA patenting frequently do so on the grounds that the practice violates or threatens human dignity. For example, from 1993 to 1994, more than thirty organizations representing indigenous peoples approved formal declarations objecting to the National Institutes of Health's (NIH) bid to patent viral DNA taken from subjects in Papua New Guinea and the Solomon Islands. Although these were not patents on human DNA, the organizations argued that the patents could harm and exploit indigenous peoples and violate their cultural values. NIH eventually dropped one of its patent applications.

On May 18, 1995, 180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference objecting to DNA patenting in Washington, D.C. In their “Joint Appeal against Human and Animal Patenting,” these leaders decried any attempt to patent nature. Some of the more outspoken members of the Joint Appeal likened DNA patenting to slavery, while others objected to treating human beings as marketable commodities. In his recent book, The Biotech Century, Rifkin rehashed the objections to DNA patenting voiced by members of the Joint Appeal.

Thirteen years ago, commenting on the treatment of the human body and its cell lines as patentable commodities, Mary Taylor Danforth wrote:

In his insightful article, David Resnik would have us travel further down the path of allowing the patenting of DNA in order to advance scientific research and the welfare of humankind. Dr. Resnik suggests that that the acquisition of such proprietary rights in DNA research must proceed cautiously

There have always been medical standards of care in the American health-care sector. However, never before have they been so deeply incorporated in the delivery of health care as they are today. With the increased delivery of care through integrated delivery systems, as well as the development of the computerized patient record, medical standards of care are now used in innovative ways by providers and health plans in delivering health care to individual patients. There is great potential for even more innovative uses of medical standards of care in the future.

This article first presents a taxonomy of the medical standards of care that are involved in health-care delivery today Next, the article traces the historical evolution of medical standards of care since the early 1980s. Included in this discussion are the origins of the standard-setting movement as well as the developments that led to the way standards of care are currently used by large institutional providers and managed care plans to improve the quality of their health-care services. The article concludes with a brief analysis of the key legal issues that affect how standards of care can be used to improve the health care of patients.

Federal and state laws create a tightly controlled system for distribution of those drugs that have recognized value in therapy, but also have the potential for abuse. The challenges pharmacists face in keeping controlled substances within the closed system are many and complex. Drug abusers and drug dealers have at times seen pharmacists as easy marks for access to abusable drugs. Unfortunately, pharmacists often find themselves in a game with criminals, who use both sophisticated and dangerous methods of inducing pharmacists to divert controlled substances. The effects of this problem on the health-care system have been judicially noted:

For more than twenty years, Opinion 6.01 of the American Medical Association's (AMA) Code of Medical Ethics has specified that “a physician's fee for medical services should be based on the value of the service provided by the physician to the patient.” In 1994, the AMA amended Opinion 6.01, adding a new statement that “a physician's fee should not be made contingent on the successful outcome of medical treatment.”

We believe that the amendment is wholly indefensible. Therefore, in this essay, we argue that the AMA should lift this prohibition and encourage the use of result-based compensation for medical services in appropriate circumstances.

The 1994 amendment dramatically changed the significance and scope of Opinion 6.01. Result-based compensation arrangements clearly satisfy the original version of Opinion 6.01 because they base compensation on the “value of the services provided … to the patient.” Yet, it is equally clear that result-based compensation arrangements violate the amended version of Opinion 6.01 because they necessarily make compensation “contingent on the successful outcome of medical treatment.”

In what is clearly an important development related to research integrity and the protection of human research subjects, the U.S. government has instituted two new training requirements as a condition of receiving federal financial support. First, the National Institutes of Health (NIH) is requiring, as a condition of funding, that key research personnel involved in human subject research complete education “in the protection of human subjects.” Evidence that key personnel have completed this training must be provided in NIH grant applications or contract proposals.

The NIH education policy will eventually be superseded by a more broadly applicable instructional policy for the “responsible conduct of research,” which will be promulgated by the Department of Health and Human Service's Office of Research Integrity and the Public Health Service (PHS). The instructional policy will apply to all persons engaged in any research or research training with PHS support. Presently, the only version of the policy is in draft form.

Tort claims have been studied for various reasons. Several studies have found that most tort claims are not related to negligent adverse events and most negligent adverse events do not result in tort claims. Several studies have examined the disposition of tort claims to understand the likelihood of payment once a claim has been made. Still others have proposed that tort-claims trend analysis may help administrators target their quality-improvement efforts and identify problems with quality that would not otherwise be captured.

In this article, we conduct a tort-claims analysis to explore areas for quality improvement, specifically for patient safety, in the Veterans Health Administration (VHA). Patient safety is an increasingly highlighted aspect of health-care delivery. Failure to assure patient safety can result in bad clinical outcomes, additional costs of care, and a negative organizational image. Filing a tort claim is one way for an individual to express concern about an organization. For our analysis, we draw from resolved tort claims in the Veterans Health Administration from fiscal years 1989 to 2000.

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine report To Err Is Human was released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes.

David Hyman and Charles Silver are quite right. Opinion 6.01 in the American Medical Association's (AMA) Code of Medical Ethics is difficult to defend. Ties between compensation and outcomes need not mislead patients into thinking that results are guaranteed; they are widely used in other fields with considerable success, even if they have some disadvantages; they can potentially bring patients more actively into decision-making about whether and from whom to purchase which medical care; and, if carefully tuned, they can promote quality by aligning providers’ welfare more closely with patients’.

The purpose of this commentary is thus not to disagree with the fundamental thesis that result-based compensation arrangements (RBCAs) can be appropriate and useful in the health-care setting. Rather, the objective is to “cut the next swath,” so to speak. While Hyman and Silver are right that RBCAs have potential to do good, they may be overly optimistic about benefits, while underestimating the potential limitations and hazards.

Too many patients are injured in the course of care. Clinicians may mistakenly cause new harm to a patient or fail to take established steps to improve the presenting condition. Medical institutions within which they work may lack mechanisms to reduce errors or prevent them from harming patients. Many, perhaps even most, injuries are preventable, probably numbering in the hundreds of thousands a year for hospital care alone. Long ignored by medical practitioners and health-care payers and little appreciated by the public, the problem of medical injury is finally receiving high-level policy attention. Much credit goes to the Institute of Medicine (IOM) for its landmark report of November 1999, which marshaled the evidence about medical injuries and highlighted new approaches to systematic improvement of safety within systems of care.

Ever since the 1960s, when medical science became capable of prolonging the dying process beyond bounds that many patients would find acceptable, people have sought “death with dignity,” or “a natural death,” or “a good death.” Once debilitation from a fatal affliction has reached a personally intolerable point, dying patients have sought to control the manner and timing of death via diverse techniques. Some sought the disconnection of life-sustaining medical interventions, such as respirators and dialysis machines. Beyond freedom from unwelcome interventions, some patients intent on avoiding suffering sought access to pain relief medication—even in dosages posing some risk (perhaps even a certainty) of hastening death. Other dying patients sought access to deep sedation, even knowing that they would never emerge from the resultant unconsciousness. Still other patients voluntarily refused to eat or drink or to accept artificial nutrition and hydration.

Health-care provider liability has again taken center stage in American political debate, but with an ironic twist. In the seventies, physicians wanted tort reform, but they measured such reform solely by a reduction in both the risk of being sued and the size of any judgment a plaintiff could win. Malpractice reforms in many states in the seventies therefore capped damages, reduced contingency awards to lawyers, and restricted other tort rules to limit plaintiff success. Today physicians are conflicted. They want an increase in liability exposure — not for themselves, but for managed care plans. We have therefore ended up with a series of overlapping debates, with the same debaters taking contradictory positions. Should managed care organizations—until now protected by ERISA preemption from liability—be liable? Physicians say yes. But should physicians be protected from the threat of suit, which they argue acts as an in terrorem device that drives disclosure of medical errors into hiding?

In recent years, courts have increasingly found them-selves arbiters of disputes in the emotionally charged area of assisted reproductive technologies. Legal disputes are hardly surprising in the world of infertility medicine, where millions of patients spend billions of dollars in efforts to have a child. Increasingly, these efforts produce embryos that are frozen for later use, at once maximizing a couple's chances for success and minimizing the medical intrusiveness that necessarily accompanies most forms of assisted reproductive technologies. But with over 100,000 embryos in frozen storage in the United States and a divorce rate of 40 to 50 percent, it is not surprising that disputes over the disposition of these embryos are arising, causing the legal landscape surrounding these technologies to continue to expand.