The Physician-Patient Relationship and a National Health Information Network

The growing use of interoperable electronic health records is likely to have significant effects on the physician-patient relationship. This relationship involves two-way trust: of the physician in patients, and of the patients in their providers. Interoperable records opens up this relationship to further view, with consequences that may both enhance and undermine trust. On the one hand, physicians may learn (from additional records) that information from their patients is — or is not — to be trusted. On the other hand, patients may learn from the increased oversight made possible by electronic records that their trust in their physicians is — or is not — warranted. Release of information through new methods of surveillance may also undermine patient trust. The article concludes that because trust is fragile, attention to transparency and confidentiality in the use of interoperable electronic records is essential.     

Ethics, Information Technology, and Public Health: New Challenges for the Clinician-Patient Relationship

Increasingly widespread adoption of health information technology tools in clinical care increases interest in ethical and legal issues related to the use of these tools for public health and the effects of these uses on the clinician-patient relationship. It is argued that patients, clinicians, and society have generally uncontroversial duties to support civil society's public health mission, information technology supports this mission, and the effects of automated and computerized public health surveillance are likely to have little if any effect on the clinician-patient relationship. It is also suggested, nevertheless, that electronic public health surveillance raises interesting and important ethical issues, some of which can be addressed if not resolved by empirical research, especially regarding patient preferences about secondary use of health data and their moral obligation to contribute to population- based health.     

Ethical issues in HealthConnect's shared electronic health record system

Many countries are in the process of implementing systems of shared electronic health records. This article explores some of the ethical concerns raised by Australia's proposed HealthConnect system which aims to create electronic event summaries of health information. Three areas of ethical concern relating to confidentiality, consent and the involvement of the private sector are examined. It is argued that unless the HealthConnect system is firmly grounded in policy based on ethical considerations, patients may not want to "opt in" to it.     

The who, what, and why of risk adjustment: a technology on the cusp of adoption

Risk adjustment (RA) consists of a series of techniques that account for the health status of patients when predicting or explaining costs of health care for defined populations or for evaluating retrospectively the performance of providers who care for them. Although the federal government seems to have settled on an approach to RA for Medicare Advantage programs, adoption and implementation of RA techniques elsewhere have proceeded much more slowly than was anticipated. This article examines factors affecting the adoption and use of RA outside the Medicare program using case studies in six U.S. health care markets (Baltimore, Seattle, Denver, Cleveland, Phoenix, and Atlanta) as of 2001. We found that for purchasing decisions, RA was used exclusively by public agencies. In the private sector, use of risk adjustment was uncommon and scattered and assumed informal and unexpected forms. The most common private sector use of RA was by health plans, which occasionally employed RA in negotiations with purchasers or to allocate resources internally among providers. The article uses classic technology diffusion theory to explain the adoption and use of RA in these six markets and derives lessons for health policy generally and for the future of RA in particular. For health policy generally, the differing experiences of public and private actors with RA serve as markers of the divergent paths that public and private health care sectors are pursuing with respect to managed care and risk sharing. For the future of RA in particular, its history suggests the need for health service researchers to consider barriers to use adoption and new analytic technologies as they develop them.     

The Hippocratic Bargain and Health Information Technology

The shift to longitudinal, comprehensive electronic health records (EHRs) means that any health care provider (e.g., dentist, pharmacist, physical therapist) or third-party user of the EHR (e.g., employer, life insurer) will be able to access much health information of questionable clinical utility and possibly of great sensitivity. Genetic test results, reproductive health, mental health, substance abuse, and domestic violence are examples of sensitive information that many patients would not want routinely available. The likely policy response is to give patients the ability to segment information in their EHRs and to sequester certain types of sensitive information, thereby limiting routine access to the totality of a patient's health record. This article explores the likely effect on the physician-patient relationship of patient-directed sequestration of sensitive health information, including the ethical and legal consequences.     

Data and Safety Monitoring Boards: Some Enduring Questions

Data Safety and Monitoring Boards (DSMBs) have been referred to as a "growth industry," and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to change. The recently appointed director of the Office for Human Research Protections (OHRP), Jerry Menikoff, is on record as regarding current practices — where consent forms often promise what the DSMB has been assembled to specifically not provide — as constituting fraudulent behavior. That is, a subject may inherently rely on, to their detriment, information that has been misrepresented in the consent document. In this paper, we assemble some of the enduring questions and top them off with Menikoff's tour de force to present what we hope will be a compelling argument to require that consent forms fairly represent what the DSMB will do — and not do — with trial data as they accumulate. We argue that DSMBs should be used only in rare circumstances, and question the practice of precluding principal investigators from DSMB membership, but our main thrust is to ensure that DSMBs, when used at all, are properly described in trial consent forms.     

Small area analysis: a review and analysis of the North American literature

Variations in health service use rates by geographic area have long interested researchers and policymakers. Typically, investigators comparing population-based health care utilization rates among geographic areas have demonstrated substantial variations in use among seemingly similar communities. One method of investigation is "small area analysis." Numerous areas in North America have been studied extensively using this technique. This research has attempted to document the amount of variation found in health care use rates among areas; determine whether or not there is a pattern to such use in high- versus low-use areas; and identify the variables that are associated with the variation and explain a portion of the variation. Beyond this, many researchers have attempted to ascertain whether such variables are associated with characteristics of the population, whether they reflect differences in access and need, or whether a substantial portion of the variation is associated with differences in the medical care system itself. This review discusses the methods used to define the areas, the dependent variables that have been studied and the patterns found within them, the independent variables that have been tested, the statistical methods and analysis procedures used, the results of each study, and the policy recommendations emanating from the research. More importantly, based on what has been learned, the paper provides researchers in small area analysis with a set of recommendations for both analyzing and reporting results. These recommendations are designed to facilitate the development of a common research methodology, increase the comparability across studies, and enhance the use of this technique in the health policy formulation process.     

Prescribing privacy: the uncertain role of the physician in the protection of patient privacy

Because medical records are now more comprehensive than ever before, they increasingly are being demanded for uses both inside and outside of the medical profession. Mr. Gellman contends that existing ethical and legal guidance is inadequate to aid physicians in dealing with the confidentiality issues raised when patient information is requested or demanded from them, and supports this contention by examining the dilemmas faced by physicians presented with such requests or demands. He concludes that ethical and judicial guidance will continue to be inadequate, and that the only practical way to develop suitable guidance is through legislation.     

A consideration of user financial incentives to address health inequalities

Health inequalities and user financial incentives to encourage health-related behavior change are two topical issues in the health policy discourse, and this article attempts to combine the two; namely, we try to address whether the latter can be used to reduce the former in the contexts of the United Kingdom and the United States. Payments for some aspects of medical adherence may offer a promising way to address, to some extent, inequalities in health and health care in both countries. However, payments for more sustained behavior change, such as that associated with smoking cessation and weight loss, have thus far shown little long-term effect, although more research that tests the effectiveness of different incentive mechanism designs, informed by the findings of behavioral economics, ought to be undertaken. Many practical, political, ethical, and ideological objections can be waged against user financial incentives in health, and this article reviews a number of them, but the justifiability of and limits to these incentives require more academic and public discourse so as to gain a better understanding of the circumstances in which they can legitimately be used.     

Public preferences and the challenge to genetic research policy

Modern genetic research requires scientists to collect, store, and study DNA samples and health information from thousands of people. Longstanding policy allows researchers to use samples and information without a person''s informed consent as long as the person''s identity is protected. Under existing policy, researchers must neither disclose study results to interested research participants nor compensate people who contribute to genetic research. Research and ethics experts developed these policy approaches without input from the people whose contributions are essential to the genetic research enterprise. A growing body of evidence shows that many research participants and would-be participants disagree with the current policy approaches. For ethical and practical reasons, participants should have a greater role in determining how genetic research is conducted.     

Breaking the stalemate: a prospective regulatory framework for unforseen research uses of human tissue samples and health information

The legal and ethical issues raised by new research uses of previously collected human tissues and health information are increasingly important to genetics research. This Article discusses and criticizes current positions on such uses, including the recent report of the National Bioethics Advisory Commission, Research Involving Human Biological Materials. It then proposes a new regulatory framework for tissue and information collected in the future that would better protect the interests of the people who provide them. It ends by suggesting a resolution for the problems of previously collected tissue and information.     

Privacy Act of 1974; system of records--PHS. Notification of establishment of a new Privacy Act system of records

5n accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act system of records: 09-20-0162, "Records of Subjects in Agent Orange, Vietnam Experience, and Selected Cancers Studies, HHS/CDC/CEH." We are also proposing routine uses for this system. The Center for Environmental Health (CEH), Centers for Disease Control (CDC), will use this system of records to support studies of the health effects of human exposure to the herbicide Agent Orange and to other environmental factors associated with service in Vietnam, and to assess the risks for selected cancers among Vietnam veterans. PHS invites interested persons to submit comments on the proposed routine uses on or before July 30, 1984.     

The Impact of Web 2.0 on the Doctor-Patient Relationship

Web 2.0 innovations may enhance informed patient decision-making, but also raise ethical concerns about inaccurate or misleading information, damage to the doctor-patient relationship, privacy and confidentiality, and health disparities. To increase the benefits and decrease the risks of these innovations, we recommend steps to help patients assess the quality of health information on the Internet; promote constructive doctor-patient communication about new information technologies; and set standards for privacy and data security in patient-controlled health records and for point-of-service advertising.     

Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers

In the "post-genomic" age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a "syncretic" approach to policy-making, for those who wish to generate new policy, or streamline existing policy relating to tissue banking research.     

Immigrant workers: health, law, and public policy

Immigrant workers are a large segment of the lower echelon of the U.S. labor force, and as many as 3.6 to 6 million of these workers and their families are living in the U.S. illegally. This paper examines who the recent immigrants are: explains why their current situation in the U.S. is an important public health matter; discusses the ethical and policy issues stemming from their health needs and from illegal status; and concludes with a brief look at some implications of the Simpson-Mazzoli Immigration and Reform Act, currently before Congress. The paper suggests that the illegal status of undocumented workers intensifies their health risks; that the immigrants' responsibility for budget short-falls in public services is not as clearcut as frequently assumed; and that legislation aimed at regulating the status of immigrant workers in the U.S. is unlikely to solve many of the central problems.     

The ethics of profession in dental medicine

Changes in technology, public policy, and the multi-dimensional relationships of professionals have resulted in renewed interest in the ethics of health care practitioners. This article considers the obligation of dentists to a life of morality in common with all humanity. Additional responsibilities are incurred by a practitioner of dental medicine in keeping the moral rule to "do your duty." These duties are explicated utilizing three classical characteristics of a professional. The Principles of Ethics and Code of Professional Conduct of the American Dental Association are the dental profession's guide to ethical conduct. The Principles and Code are traced in their development, reviewed in their content, and critiqued in comparison to the ethical obligations of the dentist as previously delineated. The use of the Principles and Code as a basis for professional self-government is evaluated.     

Beyond competition: the normative implications of consumer-driven health plans

The Federal Trade Commission/Department of Justice 2004 report Improving Health Care: A Dose of Competition appeals to efficiency arguments in promoting a wide range of health care market reforms. But the market-based reforms discussed in Improving Health Care are not simply neutral with regard to equity in access to services; they are likely to have substantial and inequitable distributional effects. We use the case of consumer-driven health plans (CDHPs), the pillar of the Bush administration's private-sector health reform efforts, to illustrate the limitations of viewing health policy reform through the lens of Improving Health Care. We conclude that the speculative efficiency gains from CDHPs need to be balanced against well-documented equity concerns within a normative framework. Moreover, other important ethical issues arise with regard to the risks imposed on the population by the introduction of policies that are based on a faith in markets rather than empirical evidence.