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Abstract: Many experts predict the advent of a public health emergency resulting from a flu pandemic or bioterrorism attack in the foreseeable future. At the same time, many health care providers express significant concern about liability arising from emergency response activities, because it is unlikely that they would be able to provide optimal care in crisis conditions. They also state that this concern will likely influence their willingness to be involved in response activities. This article addresses issues that have received little attention in the legal literature: liability and immunity in public health emergencies. The article provides a first-of-its-kind comprehensive analysis of the different theories of liability that might be used by plaintiffs and the sources of immunity that are currently available to public health emergency responders. I will argue that the existing immunity scheme is a patchwork that leaves many gaps and unanswered questions. In particular, it largely excludes paid individual and corporate health care providers who may bear the greatest burden during a public health emergency as hundreds or thousands of patients simultaneously seek medical treatment. The specter of liability may induce these parties to refuse to participate in emergency response efforts, and thus, the unavailability of immunity could significantly compromise public welfare. Moreover, the risk of liability raises questions of justice because those that, unlike their more risk-averse counterparts, do treat patients, perhaps at great risk to their own health, would face potential liability rather than being rewarded for their altruism or professionalism. Consequently, the Article will craft recommendations for statutory reforms to remedy the piecemeal and deficient liability protection system that applies to health care providers responding to public health emergencies.
liability, immunity, public health emergencies
Abstract: In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements.
Electronic Health Record (EHR), E-Health, provider liability, health law, health care providers, health information technology, administrative law, clinical practice guidelines, medical malpractice, electronic medical records, American Recovery and Reinvestment Act of 2009
Abstract: In the foreseeable future, it is likely that the familiar, paper-based patient medical files will become a thing of the past. On April 26, 2004, President George W. Bush announced a plan to ensure that all Americans' health records are computerized within ten years and to establish a National Health Information Network. Many advocates are enthusiastically promoting the adoption of health information technology (HIT) and electronic health record (EHR) systems as a means to improve U.S. health care.
EHR systems often not only serve as record-keeping systems, but also have multiple capabilities, including drug ordering, decision support, alerts concerning patient allergies and potential drug interactions, reminders concerning routine tests, and various treatment management and data analysis tools. Because these capabilities require sophisticated software, significant risks of software failure exist, which can lead to life-threatening medical errors. Thus far, scholars have not provided a comprehensive assessment of the benefits and risks of this complex technology and evaluated the need for careful regulatory oversight akin to that required, in principle, by the FDA for life-critical medical devices. This paper begins to fill that gap. It analyzes EHR systems from both legal and technical perspectives and focuses on how the law can be used as a tool to promote HIT. It is the first law journal article to provide an extensive proposal for regulations to maximize the technology's benefits and reliability.
We argue that the advantages of EHR systems will outweigh their risks only if these systems are developed and maintained with rigorous adherence to best software engineering and medical informatics practices. To ensure that these goals are achieved, regulatory intervention is needed. The paper carefully delineates recommendations that address the questions of who should regulate EHR systems and how they should be regulated, including their approval and continual monitoring. It also proposes requirements for several significant features, including decision support mechanisms, audit trails, and interoperability. Because EHR systems are safety-critical, the public's health and welfare will depend upon their effective oversight.
Electronic health record, National Health Information Network, medical files, health information technology, computerized physician order entry systems, health care, medical record, patient privacy, HIPAA, evidence-based medicine, medical software, FDA, clinical practice guidelines
Abstract: What does "race" mean? The word "race" is omnipresent in American social, political, and legal discourse. The concept of "race" is central to contemporary debate about affirmative action, racial profiling, hate crimes, health inequities, and many other issues. Nevertheless, the best research in genetics, medicine, and the social sciences reveals that the concept of "race" is elusive and has no reliable definition. This article argues that "race" is an unnecessary and potentially pernicious concept. As evidenced by the history of slavery, segregation, the Holocaust, and other human tragedies, the idea of "race" can perpetuate prejudices and misconceptions and serve as justification for systematic persecution. "Race" suggests that human beings can be divided into subspecies, some of which are morally and intellectually inferior to others. The law has important symbolic and expressive value and is often efficacious as a force that shapes public ideology. Consequently, it must undermine the notion that "race" is a legitimate mechanism by which to categorize human beings. Furthermore, the focus on rigid "racial" classifications obfuscates political discussion concerning affirmative action, scientific research, and social inequities. When we speak of "racial" diversity, discrimination, or inequality, it is unclear whether we are referring to color, socio-economic status, continent of origin, or some other factor. Because the term "race" subsumes so many different ideas in people's minds, it is not a useful platform for social discourse. The article proposes that "race" be replaced in future statutory and jurisprudential texts by other, more precise terminology, including "color," "continent of origin," "national origin," and "descent from ancestors of a particular color, national origin, or religion." Thus, legislators would engage in more careful statutory drafting and determine their legislative goals more precisely. In addition, the law would teach that, at most, the attributes we have called "race" refer only to superficial characteristics such as skin color or birthplace of one's ancestors, a lesson that could make a valuable contribution to social progress.
Civil rights, employment, race, discrimination, jurisprudence
Abstract: Both patients and health care providers have much to gain from the electronic processing of health data. Its advantages include speed, efficiency, and flexibility of information processing, which can result in long-term cost savings and improved patient outcomes. Unfortunately, many of the positive attributes of medical record computerization enable the operation of a market in illicitly-obtained private health information. The Internet provides a nearly ideal channel for trafficking in health information because it allows data to be transmitted anywhere in the world quickly, inexpensively, and with relatively little risk of detection. The threat to data security associated with the electronic storage and transmission of health information is serious enough that it has merited regulatory intervention, which came in the form of the HIPAA Security Rule, promulgated as part of the HIPAA Privacy Rule on April 20, 2005. Based on a close reading of the Security Rule and on empirical evidence, we argue that the Rule has thus far fallen far short of fulfilling its goal of safeguarding the security of electronic health information. This article briefly describes the provisions of the Security Rule and then offers a critique of it. It details the Rule's major shortcomings, emphasizing the many ways in which it fails to provide meaningful compliance guidance to covered entities. The article also develops recommendations for revisions to the Rule, focusing on a proposed "best practices" standard.
HIPAA, HIPAA Security Rule, Health Data, Data Security, Internet, Health Privacy
Abstract: The biomedical research oversight system in the United States delegates most responsibilities to local review entities known as institutional review boards (IRBs). The IRBs are charged with responsibility for safeguarding the welfare of research participants and ensuring that clinical studies involving human subjects comply with federal regulations. During the past three decades, the United States has experienced a dramatic proliferation of biomedical research studies. Contemporary critics often voice serious concerns about the adequacy of the regulations as a mechanism to insure the safety of study participants. Several lawsuits in recent years have named IRBs and IRB members as defendants, and these may portend a future fraught with litigation against IRBs. Such litigation poses new challenges for the IRB oversight system, including difficulty in recruiting IRB members, increased research costs, and potential over-deterrence that may adversely affect IRB deliberations and decision-making. Frequent litigation, therefore, could have profound implications for the research community that should be considered and addressed proactively. This article argues that retroactive review can be a useful adjunct to prospective oversight, but that it should be limited in scope. First, we recommend that all claims against IRBs be brought before the FDA or HHS for mandatory administrative review prior to the commencement of litigation. Such review would serve a useful gate-keeping role by filtering out or deterring frivolous actions and resolving some claims quickly, privately, and efficiently. Second, for cases that advance to the courthouse, we recommend that IRB members be given qualified immunity similar to that available for peer reviewers under The Health Care Quality Improvement Act of 1986 (HCQIA). IRB members should be immune from liability for civil damages so long as they had a good faith belief that the challenged decision protected the welfare of human subjects and so long as they complied with all federal regulatory requirements concerning protocol review. These safeguards should promote both the welfare of human subjects and the integrity of the oversight system.
Biomedical Research, Safety of Biomedical Research Participants, Oversight, Institutional Review Boards (IRBs), Oversight System, Qualified Immunity, Litigation as Oversight System
Abstract: The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the Security Rule from both legal and technical perspectives. We argue that the Rule suffers from several defects relating to its narrow definition of "covered entities," to the limited scope of information it allows data subjects to obtain about their health information, to the vagueness and incompleteness of the Rule's standards and implementation specifications, and to the lack of a private cause of action. The article explores the difficult problem of crafting static regulations to adequately address rapidly changing computer and communications technologies and associated security threats to private health information. In addition, it develops detailed recommendations for improving safeguards for electronically processed health records.
Cyberspace, Health Information, Privacy, HIPAA Security Rule, Administrative Law, Computer Security, Internet, Software
Abstract: During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task. Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical research, however, an increasing number of critics are voicing serious concerns about inadequate enforcement of the regulations and unacceptable research risks. In recent years, several subjects have died as a result of treatment received in clinical trials and several well-publicized lawsuits have been filed against researchers, research institutions, and Institutional Review Boards (IRBs). Intensifying concerns about both human subject welfare and potential liability are stimulating urgent calls for regulatory reforms. This symposium issue article provides a brief historical overview of Twentieth Century research abuses and the development of regulatory oversight in the United States. It discusses informed consent, IRBs, and the regulations that govern them. Finally, it analyzes contemporary deficiencies in the regulatory system and offers recommendations for reform.
Abstract: Analysis of cases decided under Title I of the Americans with Disabilities Act (ADA), which addresses employment discrimination, reveals that defendants have consistently prevailed in well over 90% of cases since the ADA's inception. This empirical evidence has led many commentators to conclude that the ADA's Title I has failed to improve workplace conditions for individuals with disabilities. This article attempts to assess the efficacy of Title I through a different lens. It focuses on several data sets that have previously received little attention. It examines Equal Employment Opportunity Commission merit resolutions, lawsuit settlement statistics, and reports concerning reasonable accommodation requests processed by private and public sector employers. These statistics reveal that employers are reasonably responsive to Title I claimants outside of the courthouse setting and that the ADA has in fact improved workplace conditions for employees with disabilities. The more general point made by this article is that the efficacy and impact of statutory mandates cannot be judged based solely on reported court opinions. Rather, data concerning the behavior of those covered by the statutes and extra-judicial dispute resolution are essential to an assessment of whether a statute has achieved the societal changes that it was designed to effect. Consequently, the paper emphasizes the need for more comprehensive empirical studies concerning ADA claim resolutions and outlines a proposal for mandatory reporting of settlement outcomes and the processing of reasonable accommodation requests by employers.
ADA, Americans with Disabilities Act, EEOC, workplace accommodations, employment discrimination, disability employment policies and procedures, settlement statistics, extra-judicial resolutions, expressive power of the law
Abstract: Contemporary developments in reproductive technology have generated extensive debate among lawyers, ethicists, legislators, the media, and the public. Concern has intensified recently in light of claimed attempts to clone human beings. One implication of the new reproductive technologies upon which few commentators have focused is their effect on the Rule Against Perpetuities. For example, what impact should the possible existence of frozen sperm or frozen embryos have upon the execution of wills and implementation of the Rule? This Article provides a thorough analysis of the Rule Against Perpetuities, its policies, and reformulations of the Rule. It further describes the serious problems that the new reproductive technologies pose for the viability of the Rule. Finally, it recommends reforms designed to protect the policy interests served by the Rule while addressing the implications of the new reproductive technologies.
Abstract: In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling. This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical mistakes, stigmatizations, discrimination, exacerbation of health disparities, and violation of anti-discrimination mandates. The author does not argue against the pursuit of attribute-based therapies, but cautions that the attribute or attributes at issue must be carefully determined and will not be equivalent to what is conventionally thought of as "race." The article develops recommendations for safeguards that should be implemented by scientific review boards, IRBs, researchers, health care providers, and journalists involved with attribute-based research and therapeutic practices to ensure that this new approach promotes rather than diminishes public health and welfare.
BiDil, Federal Drug Administration, Race, Medicine, Discrimination, Race-based Medicine, Racially-tailored Medicine, Attribute-based Medicine, Racial Profiling, Institutional Review Boards, Scientific Review Boards
Abstract: Many federal, state, local and private entities are investing significant resources in disaster readiness initiatives. Often disregarded, however, are the special needs of vulnerable populations during disasters. In the context of emergencies, vulnerable groups may include individuals with disabilities, pregnant women, children, the elderly, prisoners, members of ethnic minorities, people with language barriers, and the impoverished. The fate of the disadvantaged during disasters has received little attention in the legal literature, and this article begins to fill that gap. It examines ethical theories of distributive justice and existing federal and state civil rights and emergency response laws and argues that vulnerable populations are entitled to significant protection under existing legal and ethical frameworks. It also, however, highlights the shortcomings of the contemporary statutory scheme insofar as it addresses the needs of the disadvantaged during disasters and urges that it be supplemented by additional requirements. The Article argues that for vulnerable populations, successful disaster response is dependent upon careful planning and develops a detailed proposal for statutory provisions that will mandate adequate preparation to safeguard the welfare of the vulnerable in emergencies.
Disaster Readiness, Vulnerable Populations, Distributive Justice, Civil Rights, Director of At-Risk Individuals, The Post-Katrina Emergency Management Reform Act, Voluntary Registries, Electronic health record system
Abstract: Traditionally, health insurers have enjoyed the freedom to determine their own terms of coverage, to decide to what extent, if any, patients should be reimbursed for different kinds of treatment, and to establish premium prices. Health insurers typically deny coverage for speech therapy, eye glasses, hearing aids, most foot care, and treatment for infertility. Many insurance providers also exclude or severely limit coverage for mental health, dental care, AIDS, diabetes mellitus, morbid obesity, epilepsy, and alcoholism or drug abuse. Therefore, while some Americans enjoy full coverage for all their health needs, others who have insurance and suffer from serious or even life-threatening conditions, such as AIDS, must incur the expense of costly therapy or forego treatment if it is unaffordable. At the same time, a significant number of federal laws exist that prohibit various forms of discrimination with respect to health insurance coverage. These include: the Americans with Disabilities Act (ADA), addressing disability discrimination; Title VII of the Civil Rights Act of 1964 (Title VII), addressing gender, race, national origin and religious discrimination relating to employment-provided health benefits; The Equal Pay Act (EPA), addressing differences in employment-provided benefits based on gender; The Age Discrimination in Employment Act (ADEA), focusing on employment discrimination based on age; and the Health Insurance Portability and Accountability Act (HIPAA), which prohibits certain discriminatory conduct by health insurers. The article argues that in the arena of health insurance, the statutory scheme that purports to protect individuals against disability, gender, and age discrimination is characterized by significant gaps and loopholes. Consequently, while the statutes prohibit some discriminatory insurance practices, their reach is confined, and their effectiveness is limited. The article provides a detailed analysis of the language of the ADA, Title VII, and other statutes, as they apply to health insurance. It also critiques the courts' interpretation of the statutory language in the areas of disability and gender discrimination. The article concludes with a discussion of various means by which the statutory gap could be remedied and protection for health insurance beneficiaries could be enhanced.
Abstract: Electronic Health Record (EHR) systems may soon become a fixture in most medical settings. President Obama’s 2009 stimulus legislation includes $19 billion to promote their implementation. The sophisticated features and efficiencies of EHR systems have the potential to improve health outcomes and enhance patient welfare considerably. However, this emerging technology also poses significant challenges and risks, not the least of which are its workplace impacts. This article provides a first of its kind analysis of the ramifications of EHR systems for workers and employers.
The potential effects of health information computerization on the workplace are numerous. Employers may obtain and process EHRs for purposes of fitness for duty determinations, reasonable accommodations, workers’ compensation, and payment of medical claims. Digitized records could enable employers to obtain unprecedented amounts of information in response to lawful requests and thus intensify workers’ concerns about privacy and discrimination. At the same time, employers may find EHRs to be cumbersome and difficult to interpret and, if they store health information electronically, may worry about security breaches. EHR systems could also affect employers’ insurance costs, impact discovery in litigation, and profoundly affect the work habits of health care providers. This article argues that these concerns can best be addressed by specific changes to the ADA, the HIPAA Privacy and Security Rules, and parallel state laws as well as by technological advances and appropriate federal oversight. As the country transitions to computerization in the medical field, proactive steps must be taken to protect stakeholders in all settings, including the American workplace.
Electronic Health Record (EHR), Employment Discrimination, Privacy, Americans with Disabilities Act (ADA), Health Insurance Portability and Accountability Act (HIPPA), Genetic Information Non-Discrimination Act (GENIA), Electronic Medical Records, Regulatory Oversight, Health Information Technology
Abstract: Several recent studies have shown that employment discrimination plaintiffs filing lawsuits in federal court under Title I of the Americans with Disabilities Act (ADA) win only approximately five percent of their cases. This Article argues that this phenomenon is attributable at least in part to the ADA's very flawed definition of the term "disability." It suggests that the current definition be abandoned and that a new approach be adopted, one that would reshape the ADA's protected class so that it more closely resembles a discrete and insular minority, such as those traditionally protected by the civil rights laws. While Title I of the ADA embraces the goals of participatory and distributive justice for all individuals with disabilities, these objectives should be subordinated to the goal of providing corrective justice for those who commonly suffer discrimination. "Individuals with disabilities" should be redefined as those with mental or physical impairments that have been targeted for systematic discrimination by public policy or widespread private practice. The ADA should further authorize the Equal Employment Opportunity Commission (EEOC) to develop an exclusive list of covered impairments and categories of conditions that are known to be associated with discrimination, such as mental illness, disfigurement, and paralysis. The proposed definition and the list of covered categories would provide much clearer guidance to plaintiffs, employers, and the courts and would significantly enhance the efficacy of Title I of the ADA.
Abstract: Developments in medical research have been occurring at a rapidly increasing rate during the past two decades. Expanding budgets, augmented computer capabilities, and new research tools have all dramatically enhanced research technology. Accompanying the proliferation of medical research are increasing concerns about research risks. This article focuses on placebo-controlled clinical trials. The use of placebos enables clinical investigators to compare results from subjects taking an experimental intervention to results from a group that is receiving an inactive substance, such as a sugar pill, in order to determine the efficacy of the new medication. In recent years, some surgeons have also conducted clinical trials involving sham operations, the equivalent of placebos in the surgical arena. Placebo-controlled trials are of particular concern because of the possible adverse consequences for study participants who could otherwise benefit from receiving active treatment. Some critics of placebo-controlled clinical trials contend that it is always unethical to deprive patients of available therapy. By contrast, proponents of placebos argue that placebo-controlled studies are cheaper, easier to interpret, and provide more definitive results than other study designs. The use of placebo controls raises profound questions regarding the ethical principle of beneficence, that is, the responsibility of physicians to avoid harming patients and to maximize benefits while minimizing risks for human subjects. Other troubling questions relate to personal autonomy and the ability of individuals to provide meaningful consent to participation in research that might require them to forgo beneficial therapy. This article analyzes the advantages and disadvantages of placebo controls as well as the many ethical dilemmas associated with their use. It suggests guidelines that elucidate the circumstances in which utilization of placebo controls is appropriate and the factors that militate against their inclusion in studies in particular instances.
Clinical research, Institutional Review Board, placebos, FDA, HHS,research regulation, research ethics, autonomy, beneficence
Abstract: On September 17, 1999, Jesse Gelsinger, an eighteen-year-old man with a rare metabolic disease, died while undergoing experimental genetic therapy administered in a clinical trial at the University of Pennsylvania. Jesse Gelsinger's death focused public attention on the problem of effective monitoring of clinical trials, otherwise known as continuing review. In recent years several major government reports have been highly critical of contemporary research oversight. In addition, the Department of Health and Human Services' Office for Human Research Protection has found it necessary to suspend research at a growing number of institutions due to regulatory violations, including failure to conduct appropriate continuing reviews. Providing adequate protection to all research participants through effective continuing review of clinical trials is a challenging and onerous task, but also an extremely important one. Many believe that limited resources, inadequate personnel, and significant time constraints currently prevent IRBs from performing thorough and effective continuing reviews. Thus far, however, there has been minimal evaluation of mechanisms by which IRB functioning in the area of continuing reviews could be improved. This article provides a rigorous analysis of the problem of continuing review and suggests a variety of means by which to enhance the review process. The article describes the current oversight system for clinical research under the federal regulations and assesses its deficiencies. It further discusses the importance of the continuing review process in light of relevant ethical principles, economic incentives, and liability concerns. Finally, the author offers a series of recommendations relating to the staffing of IRBs, funding for IRBs, the content of continuing reviews, and other aspects of IRB monitoring operations.
Clinical research, Institutional Review Board, continuing review of clinical studies, FDA, HHS, research regulation
Abstract: Health insurers are generally guided by the principle of actuarial fairness, according to which they distinguish among various risks on the basis of cost-related factors. Thus, insurers often limit or deny coverage for vision care, hearing aids, mental health care, and even AIDS treatment based on actuarial justifications. Furthermore, approximately 42 million Americans have no health insurance at all, because most of these individuals cannot afford the cost of insurance. This Article argues that Americans have come to demand more than actuarial fairness from health insurers and are increasingly concerned about what I call moral fairness. This is evidenced by the hundreds of laws that have been passed to constrain insurers' discretion with respect to particular coverage decisions. Legislative mandates are frequent, but seemingly haphazard, following no systematic methodology. The Article suggests an analytical framework that can be utilized to determine which interventions are appropriate and evaluates a variety of means by which moral fairness could be promoted in the arena of health care coverage.
Health Care Coverage, Health Insurance, Uninsured, Moral fairness in health, distributional justice, health care reform, universal health care
Abstract: Medical testing in the workplace is raising growing concern in light of increasingly available genetic tests and what is perceived as a general assault on individual privacy in the United States. Almost seventy percent of major U.S. firms require individuals who receive job offers to undergo medical testing prior to the commencement of employment, and the law does not restrict the scope of these examinations. Thus, employers test job candidates not only for fitness for duty and use of illegal substances, but also for a variety of conditions including susceptibility to workplace hazards, breast and colon cancer, sexually transmitted diseases, HIV infection, sickle cell anemia, pregnancy, and Huntington Disease. Over fifteen percent of employers require applicants to provide family medical histories, nearly forty percent utilize psychological testing, and a small percentage already conduct genetic testing. This article explores the legal and policy implications of preplacement medical examinations. It recommends that the Americans with Disabilities Act be amended so that it would prohibit employers from conducting preplacement examinations that are not job-related. The author argues that non-job-related medical testing constitutes an unjustifiable invasion of the examinee's privacy and creates temptations and opportunities for discrimination on the part of employers. Furthermore, individuals who undergo testing and receive unexpected and distressing results without obtaining appropriate counseling may suffer significant psychological trauma. For employers, medical examinations that are not job-related constitute an unnecessary financial expenditure and create a risk of litigation based on invasion of privacy, discrimination, and other theories. In addition, invasive medical testing can erode morale and productivity in the workplace.
Americans with Disabilities Act, disability discrimination, employment discrimination, pre-employment medical testing, genetic discrimination,privacy
Abstract: Health insurance coverage for experimental treatments has generated significant debate and frequent litigation in recent years. In many cases, denials of coverage for investigational therapies constitute economically and ethically sound policy. This article argues, however, that health insurance providers should be required to cover experimental treatments in limited circumstances, namely, when they are administered in phase III clinical trials to patients with terminal illnesses who are likely to die within two years. This coverage mandate would help the sickest patients, who have no other treatment options, and would benefit medical researchers, who often face a dearth of patients willing to enroll in clinical trials. The author recommends that the coverage requirement be included in federal law, perhaps as an amendment to HIPAA. In addition, federal law should mandate health insurance reimbursement for off-label drug use so long as the particular use is recognized in a standard reference compendia or in a national, peer-reviewed professional journal. Finally, the article argues that the proposed federal legislation should require insurers to provide independent, expert reviews of any decisions to deny a terminally ill patient coverage for off-label drug use or experimental treatment administered in a Phase III clinical trial. Such reviews would eliminate much litigation and avoid emotionally draining and costly delays for patients desperately waiting for decisions regarding potentially life-saving therapy.
Abstract: Currently, approximately 1.8 million people are incarcerated in the United States at any given time. A disproportionately large percentage of the prisoner population has serious illnesses, such as AIDS and tuberculosis. Prisoners most often, however, are barred from participation in clinical trials, even when conventional therapy has failed, and experimental treatment might provide them with their only hope of survival. Much of the reluctance to include prisoners in biomedical research is based on history. In the past, prisoners have been severely abused and even tortured in medical studies conducted in the Nazi death camps, Japanese prisoner camps, and correctional facilities in the United States. By 1969, eighty-five percent of new drugs were tested on incarcerated persons in forty-two American prisons. In the 1970s regulations regarding the use of biomedical experimentation on prisoners were issued by the federal government, designed to provide rigorous review of research protocols involving prisoners and to protect inmates from abuse in the research context. Abuse of prisoner subjects in clinical studies can lead to violations of their constitutional rights. The author argues, however, that prohibiting seriously ill prisoners from participating voluntarily in clinical research may constitute an equivalent contravention of their constitutional rights under the Eighth Amendment and the Due Process and Equal Protection clauses. The article reviews the history of prisoner participation in biomedical research, analyzes the relevant constitutional issues, and encourages the inclusion of prisoners in clinical studies involving potentially beneficial experimental treatment for life-threatening diseases.
Abstract: As modern human genetics moves from the research setting to the clinical setting, it will encounter the managed care system. Issues of cost, access, and quality of care will affect the availability and nature of genetic testing, genetic counseling, and genetic therapies. This articles explores such issues as professional education, coverage of genetic services, privacy and confidentiality, and liability. It concludes with a series of recommendations for the practice of genetic medicine in the age of managed care.
genetics, managed care, genetic counseling, human genome project, genetic medicine, quality of care
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