What can be done against public corruption and fraud: Expert views on strategies to protect public integrity

A number of questions dominate the debate about public corruption and fraud. First of all, of course, there is the question of the content of these phenomena. What is corruption, what is fraud and how is it related to power abuse and public waste? Some scholars stress that these questions are unanswerable if ethnocentrism is to be avoided. Others are more positive about the possibility to grasp the central meaning of the concepts. A second type of questions has to do with understanding public corruption and fraud. To define a concept is something; to understand it is something different. Understanding means knowing the causes and consequences. To be able to understand it, corruption should be given a place in the framework of knowledge about public structure, culture and behavior. This is all but a simple endeavor because it will make a difference which theoretical and methodological framework is chosen as a starting point. This article seeks to avoid this obstacle by choosing an approach which could be categorized as pragmatic and eclectic, trying to discover whether there are causes which are seen as important by a variety of experts with different academical and occupational backgrounds: is there a common core present in different approaches? Third, there is the normative debate. What are the positive and negative consequences of corruption and fraud and how can cost and benefits be compared and judged? Nowadays, most scholars and practitioners in the field stress the negative consequences of public corruption and fraud. Such a critical attitude almost automatically leads to a fourth type of debate, about the question “what to do about it?”. Which methods and strategies are thinkable and what works? This subject is the central one in this article.     

Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies." This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.     

Coexistence, conflict, and cooperation: public policies toward medical devices

Medical devices include thousands of products, many of which have greatly contributed to the quality of health care. As devices have proliferated, so have public policies that affect them. The federal government intervened to promote three fundamental values: safety by federal regulation, innovation through federal funding of research and development, and access by providing services under Medicare. The policies generally coexisted without conflict. However, two recent developments--the advent of cost containment and the expansion of the tort liability system--present a potentially disruptive influence on these policies, and threaten to undermine the values they serve. Because cost restraints are inevitable and the tort system provides consumer protection, the challenge for policymakers is to reconcile them with the values of safety, innovation, and access. The proposals presented here seek to promote coordination to protect those values without imposing unacceptable costs on the health care system.     

Publication of OIG Special Fraud Alerts: home health fraud, and fraud and abuse in the provision of medical supplies to nursing facilities--HHS. Notice

This Federal Register notice sets forth two recently issued OIG Special Fraud Alerts concerning fraud and abuse practices in the home health industry and in the provision of medical supplies to nursing facilities. For the most part, the OIG Special Fraud Alerts address national trends in health care fraud, including potential violations of the Medicare anti-kickback statute. These two Special Fraud Alerts, issued directly to the health care provider community and now being reprinted in this issue of the Federal Register, specifically address fraud and abuse in the provision of (1) home health services and (2) medical supplies to nursing facilities, including the submission of false claims and anti-kickback violations.     

Medical devices: immunology and microbiology devices: classification of in vitro human immunodeficiency virus drug resistance genotype assay. Final rule

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay." FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.     

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.     

Concussions and youth football: using a public health law framework to head off a potential public health crisis

Concussion from sport is increasingly recognized as a public health priority. In response, all states and the District of Columbia have enacted youth concussion legislation. This paper first examines key developments in concussion-related policy and legislation and then uses the findings from recent scientific studies to highlight the need to incorporate evolving scientific evidence into concussion legislation in order to better protect youth and adolescent athletes. Next, the paper discusses the framework of empirical health law research and why it should be applied in the case of concussion legislation. Finally, this paper argues that empirical health law research should be considered in any decision about whether legislation can help improve the health and safety of young players, a particularly vulnerable population whose unique needs have not yet been adequately addressed.     

Medical devices: cardiovascular devices: reclassification of the arrhythmia detector and alarm. Final rule

The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia occurs. An atrial or ventricular arrhythmia occurs during a premature contraction or ventricular fibrillation. FDA is reclassifying this device based on new information contained in reclassification petitions regarding the device submitted by the Health Industry Manufacturers Association (HIMA) (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (the FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).     

Using Raman Spectroscopy to solve crime: inks, questioned documents and fraud

Raman microscopy is becoming a tool of major importance in forensic analysis, particularly of drugs and explosives. It is a non-invasive, non-destructive chemical probe allowing samples to be examined in their entirety without any preparation. This paper demonstrates the use of the technique as a general tool for inks analysis. Furthermore, it addresses two important issues that historically have been extremely difficult for the professional document examiner, namely, comparison of black ballpoint inks and the chronological sequencing of crossed ink lines. We show that Raman can successfully distinguish between a representative sample of commercially available black ballpoint inks. This data has been converted into a database for future reference. A method for chronological sequencing of crossed ink lines has been developed using confocal Raman microscopy. Case study work has shown the feasibility of this approach.