Until recently, genetics counselors and medical geneticists considered themselves lucky if they could provide parents with predictive information about a small number of severe genetic disorders. Testing and counseling were indicated primarily for conditions of thithis s sort. Out of respect for the autonomy of parental reproductive decision making, the prevailing ethic of genetic counseling stressed nondirectiveness and value neutrality As summarized by Arthur Caplan, the hallmarks of this stance include

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.

Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the (human) objects of study.

The law of unintended consequences is generally applied to technological advances that solve one problem but cause another. In this view, the problem created may be worse than that which was solved, hence the law is used as an argument against technological advances. Concern about intent and consequence comes to mind when reading the article by Ronald Green on parental decision making and prenatal genetics. Green's analysis, combined with the realities of genetic practice, raises questions about parental power, eugenics, and the interests of children affected by genetic or congenital disorders. Green proposes rules and draws conclusions that are not useful for clinicians and that promise harm to families and individuals affected by genetic disorders. Green's analysis may be an example of a corollary that could be viewed as the Law of Unintended Ethics.

Green's paper begins with an apparently contradictory dual thesis. First, he supports unfettered parental decision making about their fetuses and children. Second, he suggests that we should strive to give our children lives unimpaired by serious genetic (or congenital) disorders.

Organizations often release and receive medical data with all explicit identifiers, such as name, address, telephone number, and Social Security number (SSN), removed on the assumption that patient confidentiality is maintained because the resulting data look anonymous. However, in most of these cases, the remaining data can be used to reidenafy individuals by linking or matching the data to other data bases or by looking at unique characteristics found in the fields and records of the data base itself. When these less apparent aspects are taken into account, each released record can map to many possible people, providing a level of anonymity that the recordholder determines. The greater the number of candidates per record, the more anonymous the data.

I examine three general-purpose computer programs for maintaining patient confidentiality when disclosing electronic medical records: the Scrub System, which locates and suppresses or replaces personally identifying information in letters between doctors and in notes written by clinicians; the Datafly System, which generalizes values based on a profile of the data recipient at the time of disclosure; and the μ-Argus System, a somewhat similar system which is becoming a European standard for disclosing public use data.

Prostate cancer has become a major health concern of male Americans. It is now the most common nondermatologic cancer and the second leading cause of cancer death among men. The incidence of detected prostate cancer rose rapidly in recent years, partly because of prostate-specific antigen (PSA) testing; it is only now tapering off. Screening for prostate cancer with PSA is widespread in the United States, yet controversial: the American Urological Association recommends PSA screening and the American Cancer Society recommends offering screening; however, the United States Preventive Services Task Force (USPSTF) and the American College of Physicians (ACP) recommend against routine screening; and the American Academy of Family Physicians believes that the decision to screen should be left to the patient.

The term duty is used in philosophy and law to de scribe the obligation one person owes to another. Yet what these two disciplines mean by duty often differs. Perhaps even more important, a determination by the law that a duty exists has different social consequences than does a similar assessment by philosophy Moral or ethical obligations between individuals make living in society possible, but breach of these obligations usually results only in social opprobrium, personal guilt, or shame. A legal duty, by contrast, enables a person to use the power of the state to enforce claims against another, either by injunction to make the duty-ower fulfill his/her responsibilities or more commonly by award of damages in the event the duty-ower fails to meet these obligations. In some cases, society itself chooses to impose criminal penalties on those who fail to meet certain important obligations.

The use of the term duty in both disciplines creates the temptation to extend a definition formulated in one setting to the other discourse. Ronald Green does not bite this apple, but his efforts to draw on the law to support his moral arguments, while not clearly identifying the distinctions between legal and moral obligations, may make it easier for others to see moral and legal duties as the same. Yielding to the enticement to equate moral and legal duties can lead to a host of difficulties. My purpose here is to demonstrate why the duties and privileges proposed by Professor Green are not and should not be adopted and enforced by the law.

Genetic testing for cancer susceptibility is an application of biotechnology that has the potential both to improve the psychosocial and physical wellbeing of the population and to cause significant psychosocia1 and physical harms. In spite of the uncertain value of genetic testing, it has captured the interest of biotechnology companies, researchers, health care providers, and the public. As more tests become feasible, pressure may increase to make the tests available and reimbursable. Both the benefits and harms of these tests lie not as much in the tests themselves, as in their power to predict or alter the future. The value of the tests does not derive from the information per se, but from the ability to communicate effectively the information to patients and providers, and the behavioral responses of patients, providers, and others to this information.

A powerful movement is afoot to create a national computerized system of health records. Advocates claim it could save the health delivery system billions of dollars and improve the quality of health services. According to Lawrence Gostin, a leading commentator on privacy and health records, this new infrastructure is “already under way and [has] an aura of inevitability.” When it is in place, almost any information that is viewed as relevant to a decision in the health care delivery system would be available to a large and yet undetermined number of individuals. The transformation of the collection and communication of health information from texts housed by health care providers and facilities to data electronically transmitted through networks of linked computers has significant implications for confidentiality and for data collection in scientific research. The best evidence clearly indicates that most people in the United States consider confidentiality for health information important and worry that the increased computerization of health records will result in inappropriate disclosure.

The ability to determine genetic predisposition to cancer represents an opportunity to expand cancer control efforts in a manner that was previously unimaginable. This possibility also forces individual patients, families, health care professionals, and society to confront difficult questions about genetic knowledge. Although genetic testing or screening for cancer risk may hold promise of cancer control benefits, this prospect also raises significant ethical and legal concerns that must inform and shape policy decisions. In “Cancer Genetic Susceptibility Testing,” Benjamin Wilfond and the Cancer Genetic Screening Consortium (CGSC) present a status report and an ambitious agenda for future examination of ethical and policy issues in this embryonic field. The paper provides a provocative and timely discussion of some extremely vexing issues, but it also misses on several critical points.

Consensus is growing among ethicists and lawyers that medical decision making for incompetent patients who were previously competent should be made in accordance with that person's prior wishes and desires. Moreover, this legal and ethical preference for the substituted judgment standard has found its way into the daily practice of medicine. However, what appears on the surface to be an agreement between jurists, bioethicists, and clinicians obscures the very real differences between disciplines regarding the actual implementation of the sub stituted judgment standard. Ethicists and judges have carefully outlined how substituted judgments ought to be made and evaluated. Although differences arise, especially at the state court level, regarding the scope of the substituted judgment standard and its relation to other standards of surrogate decision making, agreement is fairly widespread on the priority of substituted judgment and on the necessity of sufficient evidence being available in order to support a particular substituted judgment.

Health information by its nature is personal and sensitive. At the same time, significant public value has resulted from research with health records about determinants of health and effective provision of health services. In Canada, certain legislation and processes have been established to balance the individual's right to privacy and the public good associated with analysis of health information.

My purpose is to describe privacy and confidentiality practices in Canada with respect to access to health data for research purposes. I provide an overview of the Canadian health care system and the legislative framework used to regulate research related to health information and Canada's major national data bases. Then I describe the confidentiality and privacy policies and procedures of Statistics Canada, of the Canadian Institute for Health Information (CIHI), and of health policy research organizations in three provinces. I conclude with comments on some current issues in health information in Canada.

During the past decade, Medicaid has experienced extraordinary growth, in both number of beneficiaries and total expenditures. Between 1988 and 1993, the number of Medicaid beneficiaries grew from 22 million to 32 million. While the number of Medicaid beneficiaries increased by 45 percent, expenditures increased by 145 percent, from 51 billion to 125 billion. Expressed in terms of its percentage of state budgets, Medicaid doubled from 10 percent to 20 percent over the same time period, to the point that it is currently the second largest budget item for most states.

Faced with unsustainable rates of program budget growth and serious concerns about the level of access and the continuity of care afforded by the Medicaid program, states have turned to managed care. Almost every state has introduced some form of managed care for a subset of their Medicaid beneficiary population. Twenty-three states have gone farther, and implemented, proposed, or are developing section 1115 waivers to overhaul their Medicaid programs. These waivers allow states to develop and introduce nonstandard approaches to benefits, eligibility, service delivery, and financing for the Medicaid beneficiary population.

In the last few years, a great deal of attention has been paid to the effects that the achievements of the Human Genome Project will have on the confidentiality of medical information. The Genetic Privacy Act (GPA) is an attempt to address the privacy, confidentiality, and property rights relating to obtaining, requesting, using, storing, and disposing of genetic material. The GPA grew out of concerns over the vast amount of genetic information that is a product of the Human Genome Project. The central goals of the GPA are twofold: (1) to define an individual's right to control access to their genetic material and the privilege to control the information derived therefrom; and (2) to prevent potential and actual abuse of genetic information by third parties, such as insurance companies, employers, and government. The GPA is one of a group of proposals that seek to control the flow of medical information from the individual to health care professionals and to other persons.

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically permissible to involve persons in research who are too decisionally impaired to provide their own consent.

It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections.

In the past twelve to eighteen months, another perceived threat to the safety of America's blood supply has arisen. The fear is that Creutzfeldt-Jakob disease (CJD) will join hepatitis, HW and AIDS in the public and medical consciousness as the 1990s next infectious disease epidemic. A particular kind of ethical dilemma has arisen causing much debate and consternation for hospitals, regulators, and blood suppliers, and has elicited a remarkably varied response.

CJD is a rare but uniformly fatal neurological disease: it affects the brain and the rest of the central nervous system. Its incidence in the population of the developed world is about one per million per year, although some geographic anomalies exist. CJD manifests itself in two broad ways. First, the disease is associated with symptoms of mental deterioration and dementia, including memory loss, anxiety, and cognitive impairment. Second, CJD is also associated with a range of neurological symptoms, including muscle rigidity, seizures, tremors, muscle twitching, and spasticity, as well as problems with muscle coordination and unsteady gait, sometimes resulting in total disability.