The role of law in public health preparedness: opportunities and challenges

We report the results of a study designed to assess and evaluate how the law shapes the public health system's preparedness activities. Based on 144 qualitative interviews conducted in nine states, we used a model that compared the objective legal environment with how practitioners perceived the laws. Most local public health and emergency management professionals relied on what they perceived the legal environment to be rather than on an adequate understanding of the objective legal requirements. Major reasons for the gap include the lack of legal training for local practitioners and the difficulty of obtaining clarification and consistent legal advice regarding public health preparedness. Narrowing the gap would most likely improve preparedness outcomes. We conclude that there are serious deficiencies in legal preparedness that can undermine effective responses to public health emergencies. Correcting the lack of legal knowledge, coupled with eliminating delays in resolving legal issues and questions during public health emergencies, could have measurable consequences on reducing morbidity and mortality.     

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.     

Xenotransplantation: consent, public health and charter issues

There is a growing body of literature and commentary analyzing the ethical and public policy concerns associated with xenotransplantation. While this technology holds great promise to provide an almost limitless supply of organs for transplantation, there remains grave concern about possible public health ramifications. As a result, it has been recommended that patients who undergo xenotransplantations will need to agree, inter alia, to a lifetime of close health monitoring, participation in an international database and autopsy upon death. It has been suggested that this agreement would transform the nature of informed consent into a "binding contract." Though such draconian measures are understandable given the magnitude of the risks involved, would existing common law and legislation allow their implementation? This paper analyzes relevant Canadian consent and public health law in the context of the xenotransplantation. Canada is a country with a particularly rich body of informed consent jurisprudence--jurisprudence firmly rooted (rightly or not) in the ethical principle of autonomy. In this climate, many of the suggested monitoring strategies would find little support from Canadian law. Before xenotransplantations proceed, policy makers must be sensitive to the legal barriers which exist to the implementation [of] effective public health measures. Effective surveillance programs will require novel approaches to consent and the enactment of specific public health laws.     

New opportunities for the public to shape the nation's institutional health care services.

The author of this Comment describes how recent federal legislation (P.L. 93-641, signed into law in January, 1975)--and improved scientific techniques for integrating (1) community medical needs assessment, (2) institutional budgeting linked to regional/state health plans, and (3) budget ceilings--have given the public new authority and technology to shape the nation's institutional health services. He urges administrators and trustees of health institutions--both proprietary and charitable--to become aware of recent developments in this area, and says that active consumer and provider participation in Health Systems Agencies and Statewide Coordinating Councils is necessary if the new federal expectations concerning health planning and regulation are to be met. Given the rising costs of medical care, stronger federal control might be forthcoming if the purposes of P.L. 93-641 are not achieved.     

Prison mental health services: results of a national survey of standards, resources, administrative structure, and litigation

The formation of adequate mental health systems within prisons has accelerated as a result of successful class action lawsuits. Our recent national survey questioned all state correctional departments about the existence of standards in each system, compliance with such standards, prevalence of class action lawsuits involving the issue of providing adequate mental health services for inmates, issues related to consent decrees, available mental health resources within the correctional system, and the administrative structure of the mental health system. Our purpose was to identify those factors correlated with certified class action lawsuits involving issues related to mental health services. Twenty-one states were involved in such litigation. Only the presence of psychiatric hospitals operated by the department of corrections correlated with the presence of certified class action lawsuits involving mental health services. Prison systems larger than 15,000 inmates were at higher risk for such litigation. Smaller systems having psychiatric hospitals run by the state mental health agency appeared to be at less risk for such litigation.     

Danger to public health: Medical devices,toxicity, virus and fraud

The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient's safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure.     

Disclosure obligations of the newly public healthcare company: practical strategies for the company and its counsel

Founders of healthcare companies, like entrepreneurs in general, dream of the opportunity to take their companies public. The benefits flowing from access to the public markets, however, carry with them additional responsibilities that are enforceable both by the regulatory authorities and the well-organized plaintiffs' securities bar. The authors of this Article provide the newly public company and its counsel extensive guidance for the navigation of this regulatory maze.