试论医疗机构及其医务人员的伦理困境与法律对策——以法定医疗伦理损害责任为背景

在医疗伦理损害责任背景下,医疗机构及其医务人员在具体履行医疗告知义务时、患者(特定情况下其近亲属)知情不同意时、以及面临具体法之局限性时,常常陷于对患者的知情权、生命健康权、自主决定权、乃至自身的法律责任风险进行个人抉择的伦理困境。尽管导致伦理困境的原因是多方面的,但从法律视角来看,制定明确、规范的医疗伦理行为指引,建立解决医疗伦理困境的常设机构,健全医疗风险规避、医疗社会保障和医疗伦理督察制度,应是现实可行的应对之策。     

Doctors and allocation decisions: a new role in the new Medicare

The role of the physician in the allocation of health care resources has come under renewed scrutiny in recent years. Doctors have always had to face the reality of scarce resources and to do their work in the context of social injustices. With the advent of Medicare and Medicaid came the rhetoric of universal access and the "right to health care." At the same time the field of bioethics was emerging and contributing ideas about other kinds of rights, such as the right to die with dignity. Physicians during this time did not see their role as that of gatekeeper, but rather as advocate for the best care for each individual patient. The 1980s has brought a new awareness of limited resources and the necessity for a rationale for allocation of resources. These social and professional shifts have confronted physicians with the need for yet another shift in their ethical stance. If they are to take part in allocation decisions, for the continued well-being of their patients and of the public health, they will need a new perspective on biomedical ethics. This role can be an ethical one for physicians providing certain criteria are met: there must be universal access to a basic minimum level of care, physicians' levels of income must not be directly related to treatment choices, there must be a closed financial system within which meaningful trade-offs can be made, and there must be an ethically acceptable framework for decision-making.     

The Federal Trade Commission, clinical integration, and the organization of physician practice

This article examines Federal Trade Commission (FTC) policy--in particular, the agency's controversial 1996 statements on clinical integration--toward joint negotiations for nonrisk contracts with health plans by physicians organized into independent practice associations (IPAs) and (with hospitals) into physician-hospital organizations (PHOs). The article concludes that the policy is consistent with anti-trust principles, consistent with current thinking on the use of organized processes to improve medical care quality, specific enough to provide guidance to physicians wanting to integrate clinically, and general enough to encourage ongoing innovations in physician organization. The FTC should consider stronger sanctions for IPAs and PHOs whose clinical integration is nothing more than a sham intended to provide cover for joint negotiations, should give the benefit of the doubt to organizations whose clinical integration appears to be reasonably consonant with the statements, and should clarify several ambiguities in the statements. Health plans should facilitate IPA and PHO efforts to improve care by rewarding quality and efficiency and by providing clinically integrated organizations with claims information on individual patients. Though creating clinically integrated organizations is difficult and expensive, physicians should recognize that clinical integration can help them both to gain some negotiating leverage with health plans and to improve the quality of care for their patients.     

The Department of Health and Human Services issues proposed regulations on physician incentive payments by hospitals

Hospitals tempted to operate their own physician incentive plans are reminded that, under OBRA 1986, they are precluded from paying physician incentives of any kind to reduce or limit Medicare or Medicaid covered services. In light of the proposed regulations and the guidance of the preamble, hospitals should review their incentive plans to determine whether physicians providing direct patient care are receiving prohibited payments. Further, supervising physicians who are receiving incentives for certain hospital departments may not influence direct care over patients served by those departments, even through other physicians. Some risk may also exist if incentives are based on a formula that considers patients of the supervising physician's medical group. Finally, it may be useful to develop a utilization and quality of care review program specifically designed to assure that patient undertreatment does not occur as a result of any supervising physician incentive program.     

The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research

This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.     

Physician participation in Medicaid: background and issues

Most Americans gain entry into the medical care system through office-based primary care physicians. The Medicaid program was created in 1965 in part to increase the access of low-income people to medical services in that mainstream. But, over the years, office-based physicians have reduced their treatment of Medicaid patients, and many have withdrawn from the program altogether. The result is not only that the original programmatic goal has not been fully achieved, but also that the costs of the program are higher than they would be otherwise. In this article, the importance of Medicaid participation by office-based primary care physicians is described, and a number of obstacles to their participation are identified. The obstacles include state policies regarding eligibility, coverage, and provider compensation. The article recommends actions pertaining to these policies that might increase participation.     

Medical confidentiality and partner notification in cases of sexually transmissible infections in belgium

Research has shown that HIV-positive patients sometimes refuse to take precautionary measures against sexual transmission as well as to notify their sexual partner(s) of their status. Faced with such a situation, physicians find themselves in a dilemma as they are forced to choose between honouring their duty of professional confidentiality and protecting their patients' partner(s). Recent advice from the Belgian Medical Council (BMC) for the first time accepts that physicians can exceptionally, and under certain conditions, invoke necessity to breach confidentiality and inform usual and occasional sexual partners of HIV-infected patients who refuse to take precautions against transmission. This article sketches the ethical evolution of this position from 1987 up to now in Belgium, and examines whether or not the BMC's opinion on the matter corresponds to the applicable substantive criminal law provisions and whether or not partner notification could also be defended for other sexually transmissible infections (STIs). A case study of the situation in Belgium illustrates how discussions about STIs can deeply influence the evolution of legal and ethical rules about medical confidentiality.     

The Ethical Health Lawyer: An Empirical Assessment of Moral Decision Making

Writing in 1999, legal ethics scholar Brad Wendel noted that "[v]ery little empirical work has been done on the moral decision making of lawyers." Indeed, since the mid-1990s, few empirical studies have attempted to explore how attorneys deliberate about ethical dilemmas they encounter in their practice. Moreover, while past research has explored some of the ethical issues confronting lawyers practicing in certain specific areas of practice, no published data exists probing the moral mind of health care lawyers. As signaled by the creation of a regular column "devoted to ethical issues arising in the practice of health law" in the Journal of Law, Medicine & Ethics , the time to address the empirical gap in the professional ethics literature is now. Accordingly, this article presents data collected from 120 health care lawyers. Presenting this population with a number of hypothetical scenarios relating to how they would respond when confronting an ethical dilemma without an obvious solution or when facing a situation in which their personal values were in tension with their professional obligations, this article represents a first step toward better understanding how lawyers who practice in health care settings understand and resolve the moral discomfort they encounter in their professional lives.     

Aligning Ethics with Medical Decision-Making: The Quest for Informed Patient Choice

Clinical evidence suggests that many patients undergo surgery that they would decline if fully informed. Failure to communicate the relevant risks, benefits, and alternatives of a procedure violates medical ethics and wastes medical resources. Integrating shared decision-making, a method of communication between provider and patient, into medical decisions can satisfy physicians' ethical obligations and reduce unwanted procedures. This article proposes a three-step process for implementing a nationwide practice of shared decision-making: (1) create model integration programs; (2) provide legal incentives to ease the transition; and (3) incorporate shared decision-making into medical necessity determinations.     

The federal government and academic texts as barriers to informed consent

Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link. By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected. Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care. Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.     

The ethics of promulgating principles of research ethics: the problem of diversion effects

There is an important distinction between ethical standards for the conduct of research with human subjects and the ethics of promulgating principles of research ethics. Those who promulgate ethical standards for the conduct of research have an ethical responsibility to consider the consequences to which those promulgations give rise. In particular, they must consider whether their promulgations will give researchers incentives not to conduct research or not to conduct research in locales in which participants would benefit from participation. I first show how such ‘diversion effects’ are possible and then examine four principles of research ethics in that light. I then consider several objections to the argument that those who promulgate principles of research ethics should consider diversion effects.     

Economic and legal analysis of medical ethics

In the last decade, the antityrust authorities have stricken one after another of the ethical rules of professional societies. Underlying this pokicy is the widelyaccepted notion that ethics are simply devices designed by the professions to limit competition and thereby to benefit their pecuniary interests. The antitrust assault does not consider the longstanding, nearly universal consumer support for controls on the activities of certain professions. In this paper, the narrow view ofcompetition adopted by the courts is assailed. Focusing on the case ofrestrictions on interactions between physicians and other nonmedical health care providers, some procompetitive effects of medical ethics are analyzed. Generally, professional ethics can only change the form of competition but not eliminate it. A proper legal policy requires recognition of the consumer concern with the form of competition and therefore requires a careful balancing of the beneficial competitive effects against any attendant limits on intraprofessional competition.     

Obligation to advise of options for treatment--medical doctors and complementary and alternative medicine practitioners

An important aspect of health professional's duty of care is to advise patients of the available options of treatment so that the patient can choose the form of treatment that suits her or his requirements. As CAM becomes more evidence-based and accepted, medical doctors need to consider the extent to which they should provide patients with information about those types of treatments. If a CAM treatment option is evidence-based, there is a strong argument that medical doctors should advise of this option for treatment to satisfy their duty. CAM practitioners should also provide details of options for treatment within their own modality but are not obliged to advise of medical options.     

Unwarranted variations in the quality of health care: can the law help medicine provide a remedy/remedies?

This Article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed consent to assure that patient preferences are respected in choice of treatment; we suggest that the law adopt a standard of informed patient choice in which patients are invited, not merely to consent to a recommended treatment, but to choose the treatment that best advances their preferences. In the case of supply-sensitive care, we suggest that physicians who seek to adopt more conservative patterns of practice be protected under the "respectable minority" or "two schools of thought" doctrine.     

Comparing ethics education in medicine and law: combining the best of both worlds

This article compares various models of ethics education and how these models are employed by both medical schools and law schools. The authors suggest ways in which each profession can enhance their ethical teaching and argue that ethics education in both medicine and law should combine the best elements of each education model, thereby producing graduates who are more knowledgeable and appreciative of ethical issues in practice.     

Roman concept of mental capacity to make end-of-life decisions

When assessing decisional competence of patients, psychiatrists have to balance the patients' right to personal autonomy, their condition and wishes against principles of medical ethics and professional discretion. This article explores the age-old legal and ethical dilemmas posed by refusal of vital medical treatment by patients and their mental capacity to make end-of-life decisions against the background of philosophical, legal and medical approaches to these issues in the time of the Younger Pliny (c62-c113 CE). Classical Roman discourse regarding mental competency and "voluntary death" formed an important theme of the vast corpus of Greco-Roman writings, which was moulded not only by legal permissibility of suicide but also by philosophical (in modern terms, moral or ethical) considerations. Indeed, the legal and ethical issues of evaluating the acceptability of end of life decisions discussed in the Letters are as pertinent today as they were 2000 years ago. We may gain valuable insights about our own methodologies and frames of reference in this area of the law and psychiatry by examining Classical Roman approaches to evaluating acceptability of death-choices as described in Pliny's Letters and the writings of some of his peers.     

Limits of guardian treatment refusal: a reasonableness standard

The debate concerning the legal and ethical bases of guardian refusal of medical treatment on behalf of incompetent patients often ignores critical distinctions among types of patients and guardians. For example, patients who have expressed preferences regarding treatment while competent are distinguishable from patients who have always lacked the competency requisite to expressing a treatment preference. "Bonded guardians," whose relationship with the patient preexisted guardianship, should have a different role in the decision-making process than "non-bonded guardians," who were strangers to the patient prior to the guardian-ward relationship. This Article proposes criteria for guardian treatment refusal on behalf of incompetent patients. Under the model for guardian decision making presented here, bonded guardians should be preferred over non-bonded guardians, and bonded guardians should be allowed discretion to make treatment choices, limited only by a standard of reasonableness policed by the courts. The Author presents legal and ethical justifications for the bonded guardian's heightened role. Finally, he considers the proper roles of health professionals, hospital ethics committees, and judges in the decision-making process.     

The doctor will e-mail you now: physicians' use of telemedicine to treat patients over the Internet

This article examines the problems currently associated with the practice of telemedicine and suggests that the best solution for this particular field of medicine is a national standard of care. This article also suggests that the Food and Drug Administration's (FDA) current functions are easily expandable to the telemedicine context; therefore, the agency should regulate the implementation of such a standard in the telemedicine field. This article proposes that the FDA use medical practice guidelines in developing the applicable standard. Other agencies, such as the American Medical Association (AMA) and other website alliances, could also aid the FDA in implementing this standard because of their experience in setting such guidelines for the traditional medical context. Finally, this article suggests that in implementing the national standard of care, the FDA should increase the standard of care that telephysicians, as compared to traditional physicians, owe their patients because of the risks associated with treating patients in the absence of hands-on consultations. By implementing a national standard of care, problems currently associated with telemedicine will be resolved, and physicians and patients will have more confidence in telemedicine.     

Reconciling Quinlan and Saikewicz: decision making for the terminally ill incompetent

One of the most perplexing problems in the medicolegal field concerns the criteria on which decisions not to treat terminally ill incompetent patients should be made. These decisions traditionally have been made by physicians in hospitals--sometimes with the assistance of the patient's family--on the basis of their perceptions of the patient's "best interests." Recently, two state supreme courts have ruled on this question. The New Jersey Supreme Court, in the Quinlan case, developed a medical prognosis criterion, and permitted the patient's guardian, family, and physicians to apply it with the concurrence of a hospital "ethics committee." The Massachusetts Supreme Judicial Court, in the Saikewicz case, adopted, on different facts, the test of "substituted judgment" to be applied by a probate court after an adjudicatory hearing. The two cases have been interpreted by many in the medical profession as representing conflicting viewpoints--one supportive of traditional medical decision making and the other distrustful of it. It is the thesis of this Article that Quinlan and Saikewicz are in fundamental agreement and can be reconciled by the next state supreme court that rules on this question. Both courts enunciate a constitutional right to refuse life-sustaining treatment, based on the right to privacy. They agree that incompetents should be afforded the opportunity to exercise this right, and that certain state interests can overcome it. They agree also that physicians should be permitted to make medical judgments, and that societal judgments belong in the courts. The differences in how the opinions are perceived result from the interplay of several factors: the differences in the facts of the cases; the inarticulate use of the term "ethics committee" by the Quinlan court; the literal interpretation of the role of such a committee by the Saikewicz court; a desire for 100 percent immunity on the part of physicians and hospital administrators in Massachusetts; and advice from their counsel on how such immunity can be guaranteed. It is the author's hope that this Article will help to dispel much of the misinformation surrounding these two cases, and to refocus the debate on how decisions should be made for the terminally ill incompetent patient on the real issues regarding criteria and the decision-making process that remain to be resolved.     

Ethics and AIDS: a summary of the law and a critical analysis of the individual physician's ethical duty to treat

Persons afflicted with acquired immune deficiency syndrome (AIDS) or its preceding medical conditions face a potential problem with assured access to basic threshold medical care. Subject to certain limitations, there is no guarantee that a physician will fulfill the health care needs of any population of patients. Individuals with AIDS, thus, have a considerable interest in the development of a duty on behalf of physicians to provide treatment. This Note first highlights the limits of the legal duty to treat. It then examines the theoretical impetus propelling an ethical duty to treat. The Note concludes that the grounds for imposing an ethical duty on physicians are too weak to support that result, but the creation of an AIDS-specific legal duty is a viable alternative.