Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, (...) and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, (...) from global to local.Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher. (shrink)

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, (...) from global to local.Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher. (shrink)

Today, public health regulation at all levels faces unprecedented challenges both at home and abroad. The September 11, 2001 attacks on New York and Washington, D.C., by the Al Qaeda terrorist network and the anthrax bioterrorism that followed shortly thereafter have put public health regulation at the forefront of homeland security. The anthrax scare, in particular, has greatly tested the American public health system, calling into question whether the United States and its component states and localities are prepared to handle (...) a major outbreak of infectious disease, such as smallpox, in a future bioterrorist action. While the response of public health agencies was commendable, especially in light of the magnitude of the assaults, it is manifestly clear that the American public health system will be hard pressed to meet similar challenges that may lie ahead.The events of fall 2001 follow a period of major challenges for public health. The AIDS pandemic has killed millions of people throughout the globe, especially in Africa and other parts of the developing world. (shrink)

Today, public health regulation at all levels faces unprecedented challenges both at home and abroad. The September 11, 2001 attacks on New York and Washington, D.C., by the Al Qaeda terrorist network and the anthrax bioterrorism that followed shortly thereafter have put public health regulation at the forefront of homeland security. The anthrax scare, in particular, has greatly tested the American public health system, calling into question whether the United States and its component states and localities are prepared to handle (...) a major outbreak of infectious disease, such as smallpox, in a future bioterrorist action. While the response of public health agencies was commendable, especially in light of the magnitude of the assaults, it is manifestly clear that the American public health system will be hard pressed to meet similar challenges that may lie ahead.The events of fall 2001 follow a period of major challenges for public health. The AIDS pandemic has killed millions of people throughout the globe, especially in Africa and other parts of the developing world. (shrink)

With the North American Free Trade Agreement , the health care sectors of the United States, Canada, and Mexico are becoming more economically integrated. NAFTA poses major challenges to the realization of the international human right. These include: Cross Border Trade in Medical Products, Cross Border Trade in Medical Services, and the attendant investment protections, Portability and Comparability of Health Insurance Coverage, and Protection of Public Health Insurance Programs. The United States, Mexico, and Canada all provide public health insurance programs (...) either to the entire population as in Canada or to vulnerable groups as in the United States. In none of these countries have private, for-profit providers and insurers been able to provide universal and affordable health coverage and care in a truly free market. Private insurers and for-profit providers should not profit from the care of the healthy and wealthy in ways that compromise the public programs that serve the poor and seriously ill. Nor should they be allowed to use NAFTA processes to compromise public programs. Policy makers must consider implications of NAFTA and move toward assuring access to affordable health care for all people on the North American continent. (shrink)

During World War II, the Allies created the United Nations and its associated international institutions to stabilize the post-war world. The Allies envisioned a coordinated world in which human rights for all were respected, economic and social progress for all promoted, and global warfare prevented. This was a phenomenally fantastic vision that seemed unattainable in the wake of the most devastating global war in history.Today, the world is witnessing some of the fruits of these mid-20th century events and aspirations, especially (...) since the collapse of Communism in 1989. Economic integration and free trade has become much more prevalent as exemplified by astounding developments such as the European Union. And there is a greater appreciation of human rights, including the international human right to health. This article examines the evolution of trade policy and the impact of free trade policies on the health care sectors of the three countries of North America and the realization of the human right to health in North America. (shrink)

The key to wealth in health care is the physician, who certifies to third-party payers that health care items and services are necessary for patient care. To compete more effectively for this wealth, physician specialists are organizing their practices into for-profit corporations and employing other physicians. Focusing on neonatology, this article describes the prevailing business model of these for-profit medical groups as controlling employed physicians through restrictive employment contract provisions, e.g., non-compete and mandatory arbitration clauses. With this business model and (...) because of deficiencies in current law, for-profit medical groups eliminate competition from other physician specialists to the detriment of patients and consumers. (shrink)

With new, effective, and expensive health care services, the American health care sector has become an even greater source of business and wealth opportunities. All kinds of health care providers and suppliers are competing for patients and dollars. The key to wealth in today’s health care sector is the physician. Only physicians can certify to third-party payers that health care services, medical devices, or pharmaceutical products are necessary for patient care. That certification initiates the process by which the item, service, (...) or treatment modality is ordered, delivered, and paid for. Thus, organizations that can exert control over physicians stand to gain financially. (shrink)