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Health matrix (Cleveland, Ohio : 1991)最新文献

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FDA preemption of drug and device labeling: who should decide what goes on a drug label? FDA对药品和器械标签的优先权:谁应该决定药品标签上的内容?
Tamsen Valoir, Shubha Ghosh

The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.

去年,最高法院裁决了一个对消费者健康和安全至关重要的问题。2009年4月,最高法院裁定,食品药品监督管理局对药品的广泛监管并没有优先于一项州法律的主张,即在标签上附加警告是保证药品合理安全使用的必要条件。因此,各州——甚至法院和陪审团——现在都可以自由地对药品标签应该写什么进行投票。这与医疗器械形成了直接对比,在医疗器械方面,联邦法规明确规定,州法规优先于州法规。本文讨论了基本的优先原则和药物,并探讨了医疗保健行业中支持和反对优先政策的政策后果。
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引用次数: 0
A veil of tax exemption?: A proposal for the continuation of federal tax-exempt status for "nonprofit" hospitals. 免税的面纱?:关于继续给予“非营利性”医院联邦免税地位的提案。
Jeremy J Schirra
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引用次数: 0
Where are all the citizen suits?: the failure of safe drinking water enforcement in the United States. 公民诉讼都到哪里去了?美国安全饮用水执法的失败。
Christine L Rideout
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引用次数: 0
Hidden truth: The perils and protection of off-label drug and medical device promotion. 隐藏的真相:超说明书药品和医疗器械推广的危险与保护。
Gregory Conko
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引用次数: 0
A public health perspective on health care reform. 从公共卫生角度看卫生保健改革。
Micah L Berman
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引用次数: 0
Medical liability and health care reform. 医疗责任和医疗改革。
Leonard J Nelson, Michael A Morrisey, David J Becker

We examine the impact of the Affordable Care Act (ACA) on medical liability and the controversy over whether federal medical reform including a damages cap could make a useful contribution to health care reform. By providing guaranteed access to health care insurance at community rates, the ACA could reduce the problem of under-compensation resulting from damages caps. However, it may also exacerbate the problem of under-claiming in the malpractice system, thereby reducing incentives to invest in loss prevention activities. Shifting losses from liability insurers to health insurers could further undermine the already weak deterrent effect of the medical liability system. Republicans in Congress and physician groups both pushed for the adoption of a federal damages cap as part of health care reform. Physician support for damages caps could be explained by concerns about the insurance cycle and the consequent instability of the market. Our own study presented here suggests that there is greater insurance market stability in states with caps on non-economic damages. Republicans in Congress argued that the enactment of damages caps would reduce aggregate health care costs. The Congressional Budget Office included savings from reduced health care utilization in its estimates of cost savings that would result from the enactment of a federal damages cap. But notwithstanding recent opinions offered by the CBO, it is not clear that caps will significantly reduce health care costs or that any savings will be passed on to consumers. The ACA included funding for state level demonstration projects for promising reforms such as offer and disclosure and health courts, but at this time the benefits of these reforms are also uncertain. There is a need for further studies on these issues.

我们研究了平价医疗法案(ACA)对医疗责任的影响,以及包括损害赔偿上限在内的联邦医疗改革是否能对医疗改革做出有益贡献的争议。通过保证以社区费率获得医疗保险,《平价医疗法案》可以减少因损害赔偿上限而导致的赔偿不足问题。然而,它也可能加剧医疗事故系统中索赔不足的问题,从而减少投资于预防损失活动的动机。将损失从责任保险公司转移到健康保险公司可能会进一步削弱医疗责任制度本已薄弱的威慑作用。国会中的共和党人和医生团体都推动将联邦损害赔偿上限作为医疗改革的一部分。医生对损害赔偿上限的支持可以用对保险周期和随之而来的市场不稳定的担忧来解释。我们自己在这里提出的研究表明,在对非经济损失设置上限的州,保险市场更稳定。国会共和党人认为,制定损害赔偿上限将降低医疗保健总成本。国会预算办公室(Congressional Budget Office)在估算联邦损害赔偿上限将带来的成本节约时,将减少医疗保健使用率所节省的成本包括在内。但是,尽管国会预算办公室最近提出了一些意见,但目前尚不清楚上限是否会显著降低医疗保健成本,或者是否会将节省的成本转嫁给消费者。《平价医疗法案》包括为一些有前景的改革提供州级示范项目资金,如报价和信息披露以及医疗法院,但目前这些改革的效益还不确定。有必要对这些问题进行进一步研究。
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引用次数: 0
Born by the woman, caught by the midwife: the case for legalizing direct-entry midwifery in all fifty states. 由女人生,由助产士抓:在所有50个州将直接进入助产合法化的案例。
Sarah Anne Stover
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引用次数: 0
Health related claims, the market for information, and the first amendment. 健康相关的索赔,市场信息,和第一修正案。
J Howard Beales
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引用次数: 0
Truth or consequences?: Commercial free speech vs. public health promotion (at the FDA). 真相还是后果?商业言论自由vs.公共健康促进(在FDA)。
Lars Noah
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引用次数: 0
Federal Trade Commission's authority to regulate marketing to children: deceptive vs. unfair rulemaking. 联邦贸易委员会监管儿童营销的权力:欺骗性与不公平的规则制定。
Jennifer L Pomeranz

Food and beverage marketing directed at children is of increasing concern to the public health and legal communities. The new administration at the Federal Trade Commission and abundant science on the topic make it a particularly opportune time for the government to reconsider regulating marketing directed at youth. This Article analyzes the Commission's authority to regulate food and beverage marketing directed at children under its jurisdiction over unfair and deceptive acts and practices to determine which avenue is most viable. The author finds that the Federal Trade Commission has the authority to regulate deceptive marketing practices directed at vulnerable populations. Although the Commission can issue individual orders, its remedial power to initiate rules would better address the pervasiveness of modern marketing practices. The Commission does not currently have the power to regulate unfair marketing to children; however, even if Congress reinstated this authority, the Commission's authority over deceptive marketing may be preferable to regulate these practices. Deceptive communications are not protected by the First Amendment and the deceptive standard matches the science associated with marketing to children. The Federal Trade Commission has the authority to initiate rulemaking in the realm of food and beverage marketing to children as deceptive communications in interstate commerce, in violation of the Federal Trade Commission Act. However, to effectuate this process, Congress would need to grant the Commission the authority to do so under the Administrative Procedures Act.

针对儿童的食品和饮料营销日益受到公共卫生界和法律界的关注。联邦贸易委员会(Federal Trade Commission)的新一届政府和有关这一主题的大量科学研究,使政府重新考虑对针对年轻人的营销进行监管成为一个特别合适的时机。本文分析了委员会对其管辖范围内针对儿童的不公平和欺骗行为和做法的食品和饮料营销进行监管的权力,以确定哪种途径是最可行的。发件人认为,联邦贸易委员会有权管制针对弱势群体的欺骗性营销行为。尽管委员会可以发布个别命令,但其启动规则的补救权力将更好地解决现代营销做法的普遍性。委员会目前没有权力管制针对儿童的不公平营销;然而,即使国会恢复了这一权力,委员会对欺骗性营销的权力可能更适合于监管这些做法。欺骗性通信不受第一修正案的保护,欺骗性标准符合与儿童营销相关的科学。联邦贸易委员会有权在违反《联邦贸易委员会法》的情况下,在向儿童推销食品和饮料作为州际贸易中的欺骗性通信的领域发起规则制定。然而,为了实现这一过程,国会需要根据《行政程序法》授予委员会这样做的权力。
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引用次数: 0
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Health matrix (Cleveland, Ohio : 1991)
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