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.

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.

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.

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.

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.

During the past two decades, several reports have documented substantial support from clinicians, policy-makers, and the general public for the use of advance directives, yet studies continue to find that only a minority of individuals (10 to 25 percent) have completed these legal documents. Advance directives are written instructions, such as living wills or durable powers of attorney for health care, which describe an individual's medical treatment wishes in the event that individual becomes incapacitated in the future. The completion and use of advance directives is one of several components of the broader activity of advance care planning, that is, the overall planning and communication of personal wishes concerning future medical care.

In December 1991, the federal Patient Self-Determination Act (PSDA) became effective. Promoted as a federal initiative to enhance an individual's control over medical treatment decision making and, therefore, patient autonomy and self-determination, PSDA placed several new requirements on health care organizations receiving Medicare or Medicaid payments.

The risk of tort liability for health maintenance organizations (HMOs) and other managed care plans has dramatically increased in recent years. This is due in part to the growing percentage of health care rendered through managed care plans. The cost-containment mechanisms commonly used by managed care plans, such as limiting access to services and/or choice of providers, creates a climate ripe for disputes that may end up in court. As dissatisfied patients and providers seek recourse in the courts, tort doctrines are extended and new legal theories emerge as needed. For example, the concepts of direct and vicarious tort liability developed in the hospital context have been extended by courts to encompass HMOs. vicarious liability claims, based on ostensible agency or respondeat superior doctrines, have been brought against HMOs and managed care plans for negligent treatment by physicians selected to provide care to members.

Having a serious illness like breast cancer is a calamity for individuals and families. Along with the pain, discomfort, and dislocation comes the issue of how to pay the medical expenses for the care and treatment of the disease. If the seriously ill person has inadequate or no insurance, these problems are aggravated.

Stories abound about seriously ill people losing private health insurance following diagnosis with a catastrophic disease, remaining in jobs just to maintain health insurance, or facing financial hardship because of gaps in coverage. Yet surprisingly little research has focused on the problems that people with serious illness face with health coverage and, in particular, how concerns about access to health insurance coverage shape their lives.

Further, despite profoundly moving anecdotes of cancer victims and other seriously ill people about their problems with health insurance and despite recent federal and state efforts to reform the private health insurance market in ways discussed below, neither the federal government, states, nor the private sector has crafted comprehensive strategies to enhance health coverage for the seriously ill.

It is often claimed that managed care organizations (MCOs) involve physicians in conflicts of interest by creating financial incentives for physicians to refrain from ordering treatments or making referrals. Such incentives, the argument goes, force the physician to balance the patient's health interests against the MCO's interests and the physician's own financial interest. I assume, for the sake of argument, that such arrangements at least provide reason to believe that physicians in MCOs are involved in conflicts of interest. Two approaches have evolved for dealing with these conflicts. On one approach, MCOs disclose the financial arrangements under which their physicians work so that patients can consent to the managed care plan and thereby to the plan's limitations. The chief proponent of this approach is Mark Hall, whose recent book Making Medical Spending Decisions applies prior consent to a variety of decisions regarding medical financing and allocation. The other approach is simply to forbid conflicts of interest through regulations.

In February 1997, the Committee on Bioethics of the American Academy of Pediatrics (AAP) updated its position on religious exemptions to medical care. In its earlier statement, the committee noted that forty-four states have religious exemptions to the child abuse and neglect statutes, and they argued for the repeal of these exemptions. The committee did not indude in its statement a position on religious exemptions to childhood immunization requirements that exist in forty-eight states, although this issue was discussed in committee meetings. In its revised statement, the committee concluded that “The AAP does not support the stringent application of medical neglect laws when children do not receive recommended immunizations.” In this paper, we consider whether failure to immunize one's child is a form of medical neglect and, if so, whether states should repeal their religious exemptions to the immunization statutes. We argue that failure to vaccinate a child properly is medical neglect.