The constitutionality of current legal barriers to telemedicine in the United States: analysis and future directions of its relationship to national and international health care reform

The current health care crisis in the United States compels a consideration of the crucial role that telemedicine could play towards deploying a pragmatic solution. The nation faces rising costs and difficulties in access to and quality of medical services. Telemedicine can potentially help to overcome these challenges, as it can provide new cost-effective and efficient methods of delivering health care across geographic distances. The full benefits and future potential of telemedicine, however, are constrained by overlapping, inconsistent, and inadequate legal and regulatory frameworks, as well as the repertoire of standards imposed by state governments and professional organizations. Proponents of these barriers claim that they are necessary to protect public health and safety, and that the U.S. Constitution gives states exclusive authority over health and safety concerns. This Article argues that such barriers not only fail to advance these public policy goals, but are unconstitutional when they restrict the practice of telemedicine across state and national borders. Furthermore, the interstate and international nature of telemedicine calls for increasing the centralized authority of the federal government; this position is consistent with the U.S. Constitution and other governing principles. Finally, this Article observes that the U.S. experience bears some similarities to that of other nations, and represents a microcosm of the international community's need and struggle to develop a uniform telemedicine regime. Just as with state governments in the U.S., nations are no longer able to view health care as a traditional domestic concern and must consider nontraditional options to resolve the dilemmas of rising costs and discontent in the delivery of health care to their people.     

The new JCAHO patient safety standards and the disclosure of unanticipated outcomes. Joint Commission on Accreditation of Healthcare Organizations

This article looks at the newly-issued JCAHO standards and their increased focus on patient safety in performance standards for healthcare organizations. As part of these standards, hospitals are required to inform patients of outcomes of care, including unanticipated outcomes. This article examines this requirement and suggests varying interpretations of it. After looking at the current legal and ethical standards requiring disclosure of errors or negligent acts, the article suggests that hospitals are faced with many difficulties in implementing the standard. Specifically, the article argues that more details are necessary regarding what events must be reported and what hospitals are required to do when members of the medical staff refuse to inform patients of medical error.     

Setting the legal standard of care for treatment and evidence-based medicine: a case study of antenatal corticosteroids

This article argues that liability for negligent medical treatment should be predicated upon a standard of care reflecting what is medically and scientifically reasonable. Legal science (jurisprudence) and medical science (evidence-based medicine) should be reconciled to improve patient care and outcomes. The use of antenatal corticosteroids in obstetrics during the 1990s illustrates how most jurisprudence for setting the standard of care for treatment is ill equipped to meet the fundamental aims of tort law. The proliferation of evidence-based medical practice provides a unique opportunity for the law to encourage best medical practice when setting the standard of care for treatment. It is argued that, eventually, the law should recognise clinical practice guidelines as the prima facie standard of care for treatment. This will provide legal certainty, appropriate medical practitioner accountability, and ultimately improve patient care and outcomes.     

National health insurance and the new health occupations: nurse practitioners and physicians' assistants

This article considers a number of issues which might arise in formulating policy for new health occupations. Its particular focus is on nurse practitioners and physicians' assistants and their treatment under potential national health insurance arrangements. The development and expansion of these occupations are described, as is the evidence on their performance with respect to the quality of medical care provided, the impact on the cost of such care, and changes in access to care. We then discuss several issues which might arise in the context of national health insurance legislation, including reimbursement rates and methods, certification and licensure, training subsidies, deployment incentives, and compatibility with an increased supply of physicians.     

Between the Scylla and Charybdis: physicians and the clash of liability standards and cost cutting goals within accountable care organizations

This article seeks to examine the conflict between non-cost-conscious medical malpractice liability standards and health care cost cutting measures within the context of Accountable Care Organizations ("ACOs") under the new health care reform law. This article begins by providing an overview of the high level of health care spending within the United States health care system in order to provide a context for better understanding policymakers' push for cost cutting measures, including ACOs. This article then examines the tension between cost containment efforts and medical liability standards through an examination of the "stuck in the middle" mentality that physicians face when they are forced to meet both liability standards that do not take into account cost concerns and cost cutting standards imposed by or through managed care organizations, pay-for-performance programs and consumer-driven healthcare. This article then introduces the concept of the ACO and describes elements of the ACOs envisioned under the new health care reform legislation. This article concludes by examining and analyzing whether and how ACOs will exacerbate the cost containment/liability standard tension, and how that tension may impact the effectiveness of ACOs.     

The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research

This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.     

Telemedicine and the law

The delivery of medical services through the use of modern technology is proving of significant benefit, particularly in remote communities where transportation of patients and medical practitioners is problematic. Technical systems supporting telemedicine-based consultations have been available for some years and more recently diagnostic services such as pathology and radiology have embraced this new technology. While teleradiology and telepathology allow medical services to be delivered across vast distances from highly populated areas to regions of low population density, the same technology can also deliver services across national and international boundaries. Where the patient and medical practitioner are located in different jurisdictions, issues arise regarding the regulation of medical service provision and this has an impact on the registration of medical practitioners, mutual recognition of training and specialisation and the administration of medical service provision. The increasing specialisation of medical practice and manpower shortages in key practice areas would suggest that there will be ongoing expansion of telemedicine services in the years to come. This will require greater standardisation of medical education, together with an improvement in arrangements for mutual recognition of medical practitioners across national boundaries.     

The ethics of managed care: a dose of realism

This article examines the ethics of medical practice under managed care from a pragmatic perspective that gives physicians more useful guidance than existing ethical statements. The article begins by stating the authors' starting premises and framework for constructing a realistic set of ethical principles: namely, that bedside rationing in some form is permissible; that medical ethics derive from physicians' role as healers; that actual agreements usually trump hypothetical ones; that ethical statements are primarily aspirational, not regulatory; and that preserving patient trust is the primary objective. The authors then articulate the following concrete ethical guides: financial incentives should influence physicians to maximize the health of the group of patients under their care; physicians should not enter into incentive arrangements that they would be embarrassed to describe accurately to their patients or that are not in common use in the market; physicians should treat each patient impartially, without regard to source of payment, and in a manner consistent with the physician's own treatment style; if physicians depart from this ideal, they must tell their patients honestly; and it is desirable, although not mandatory, to differentiate medical treatment recommendations from insurance coverage decisions by clearly assigning authority over these different roles and by having physicians to advocate for recommended treatment that is not covered.     

Administering Entitlement: Governance,Public Health Care,and the Early American State

This article explores the federal marine hospitals of the early republic, the first public health care system in US history. Beginning in 1798, the federal government collected twenty cents per month from mariners' wages and used this revenue to subsidize medical care for sick and disabled merchant mariners. Previous studies have traced links between marine hospitals and modern public policy. By studying governance from the bottom up, this article takes a different approach. I argue that jurists, physicians, and officials' regulation of sailors' entitlement to public health care facilitated and reflected a transformation of national authority. Between 1798 and 1816, sailors' entitlement was a local matter, based on the traditional paternalist understandings of maritime laborers as social dependents. By 1836, though, the federal Treasury redefined entitlement around a newly calculus of productivity: only the productive were entitled to care at the marine hospitals. This story about governance, federal law, and political economy in the early United States suggests that the early American state was a more vibrant participant in the market and society than has been previously understood.     

Assessing the risk of recidivism in physicians with histories of sexual misconduct

Physicians who engage in sexual conduct with patients usually cause serious harm and have a high rate of recidivism. Although offending physicians may lose their privilege to practice, they have the right to appeal for restoration of the license. Yet medical licensing board members do not currently have any clear standards by which to predict whether a given physician is likely to abuse again. Using New York as a paradigm, this paper offers practical, clinically based guidelines for assessing the risk of restoring an offending physician's license. These guidelines are derived from psychoanalytic theories of character, the insights of therapists who have worked with abusive physicians, and the psychiatric model of assessing dangerousness. Recognizing character patterns and psychological vulnerabilities of physicians with histories of sexual misconduct will help board members identify those who are at high risk of abusing again if their licenses are restored.     

The form and context of federalism: meanings for health care financing

This article examines the meaning of federalism for health care financing (HCF) and is based on two considerations. First, federal institutions are embedded in their national context and interact with them. The design and performance of HCF policy will be influenced by contexts, the workings of the federal institutions, and the interactions of these institutions with different elements of the context. This article unravels these influences. Second, there is no unique model of federalism, and so we have to specify the particular form to which we refer. The examination of the influence of federalism and its context on HCF policy is facilitated by using a transnational comparative approach, and this article examines four mature federations: the United States, Australia, Canada, and Germany. The relatively poor performance of the U.S. HCF system seems associated with the fact that it operates in a context markedly less benign than those of the other national HCF systems. Heterogeneity of context appears also to have contributed to important differences between the United States and the other countries in the design of HCF policies. An analysis of how federalism works in practice suggests that, while U.S. federalism may be overall less favorable to the development of well-functioning HCF policies, the inferior performance of these policies is to be principally attributed to context.     

The national residency exchange: a proposal to restore primary care in an age of microspecialization

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America's approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with improvement in health outcomes, disease prevention, cost effectiveness, and coordination of care. This Article highlights provisions in the PPACA that impact primary care physicians. Finally, this Article proposes the creation of a universal primary care loan repayment program and a national residency exchange designed to alleviate the U.S. primary care crisis by facilitating optimal distribution of resident physicians in each medical specialty based on community need.     

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.     

Unwarranted variations in the quality of health care: can the law help medicine provide a remedy/remedies?

This Article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed consent to assure that patient preferences are respected in choice of treatment; we suggest that the law adopt a standard of informed patient choice in which patients are invited, not merely to consent to a recommended treatment, but to choose the treatment that best advances their preferences. In the case of supply-sensitive care, we suggest that physicians who seek to adopt more conservative patterns of practice be protected under the "respectable minority" or "two schools of thought" doctrine.     

FDA regulation of medical software

Currently the FDA is reviewing its policy on the regulation of computer software in the medical arena. Healthcare practitioners hope that the FDA will take the least possible regulatory action required by law to fulfill its public health responsibility and will take into account the unique status of the ever-changing software industry. Innovations in telemedicine and medical informatics have yielded significant improvements in the quality and cost of healthcare, and the imposition of cumbersome regulatory requirements on the medical software industry would slow the development and introduction of medical software products.     

中医医疗机构不良执业行为及防范措施调查分析

为了解和掌握东城区中医医疗机构的执业现状,探讨如何规范中医医疗机构的执业行为,为下一步制定中医药发展综合改革政策提供参考,东城区卫生监督所编制了《东城区中医医疗机构依法执业调查表》,对东城区103家中医医疗机构进行了问卷调查。调查结果显示：参与调查的东城区103家中医医疗机构有34家存在使用异地执业医师、设立网站未经审核、医疗废物暂时贮存时间超过2天等不良执业行为。经数据分析,中医医院不良执业行为的发生率比诊所高且具有统计学意义。针对上述问题笔者提出应针对中医医疗机构实施分级管理,加强对中医医疗机构依法执业的培训,卫生监督部门应加大执法力度,建立官方权威中医宣传平台等防范措施,以促进中医医疗机构依法执业及中医行业的健康发展。     

Ethical issues in managed care: can the traditional physician-patient relationship be preserved in the era of managed care or should it be replaced by a group ethic?

Over the last decade managed care has become the dominant form of health care delivery, because it has reduced the cost of health care; however, it has also created serious conflicts of interest for physicians and has threatened the integrity of the traditional physician-patient relationship. In this Article, Dr. Grochowski argues that the efficiencies created by managed care are one time savings and will not in the long run reduce the rate of rise of health care expenditures without a concomitant plan to ration health care. He explores the traditional physician-patient relationship and concludes: a) that while rationing of health care is inevitable, physicians must not ration care at the bedside; b) that physicians must be advocates for their patients; c) that physicians must avoid conflicts of interest whenever possible; d) that physicians must put the needs of the patient before their own self-interests; and e) that physicians must act in ways to promote trust in their relationship with patients.     

Ireland and medical research with minors: some medico-legal aspects

The practice of medical research with minors in Ireland consist of practices pertaining to therapeutic and non-therapeutic medical research. Clinical trials (a category of therapeutic research), is governed by legislation. However, any other therapeutic research (non-clinical trials research) and non-therapeutic research, e.g. observational medical research such as a longitudinal study of children or non-therapeutic research such as blood sample collection for analysis of cause of disease, are unregulated by legislation. This, article will outline and describe some of the medico-legal issues involved in both types of research and will comment on matters such as what national law exists, how the directive on good clinical practice has been implemented, what guidelines, if any, exist.     

论我国医疗损害责任制度的修改与完善——以《民法典·侵权责任编草案(三审稿)》的规定为视角

我国正在起草和制定的《民法典·侵权责任编草案(三审稿)》修订和完善了医疗损害责任的部分规则,使医疗损害责任规则体系更具有科学性和可操作性。为了满足司法实践的需要,保持法律规范的先进性和前瞻性,有必要完善知情同意规则、规定医疗技术损害责任的认定标准和考虑的因素、多个医疗机构的损害责任、误诊损害责任、医师外出会诊损害责任、完善医疗产品责任、远程医疗损害责任、医疗机会丧失损害责任、医疗管理损害责任以及医疗损害限额赔偿责任等方面的法律规则。我国立法机关应当利用制定民法典的契机,采纳司法实务界和学术界提出的有效解决医疗损害责任纠纷的建议,修改和完善《侵权责任法》确立的医疗损害责任制度,构建科学的医疗损害责任法律体系,为健康中国战略目标的实现提供法律保障。     

Electronic fetal monitoring: physician liability and informed consent

Electronic fetal monitoring (EFM) has been criticized as ineffective, unsafe and costly. Despite existing controversy regarding the risks involved in using EFM, this monitoring procedure continues to be widely employed. In many jurisdictions, in fact, the use of EFM during labor may be considered the customary practice. This Article analyzes the medical and legal issues arising from a physician's use of or failure to use EFM. The Author argues that EFM subjects the mother and the fetus to risks which may be avoided if auscultation, a less intrusive monitoring technique, is employed. The "customary practice" standard of care, the ordinary negligence standard of care, and the "best judgment" and "duty to keep abreast" standards of care are compared and applied to the physician's decision to use EFM. The Author contends that physicians who employ auscultation may not be liable for failing to use EFM; however, physicians who use EFM despite the evidence of its risks may be liable for failing to "keep abreast" or to use their "best judgment" or for negligence. Finally, the Author contends that both physicians and their patients are best protected when the physician elicits the mother's informed consent to employ a particular monitoring technique during labor.