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Introduction to the Right to Procreate and Assisted Reproductive Technologies 生殖权利和辅助生殖技术导论
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.49
I. Cohen, E. Jackson
{"title":"Introduction to the Right to Procreate and Assisted Reproductive Technologies","authors":"I. Cohen, E. Jackson","doi":"10.1093/oxfordhb/9780190846756.013.49","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.49","url":null,"abstract":"This chapter briefly discusses the right to procreate and related technological assistance. The right to procreate is one of the most important personal rights, and it has received widespread recognition under the law. Yet its protections can be tenuous for many people, particularly those who are poor and those who need assisted reproductive technologies (ARTs) to have children. This chapter highlights the complications arising from the right to procreate with technological assistance. Of all the areas of health law and bioethics, this may be the one with the largest disagreements across countries. On whether (and under what conditions) to permit surrogacy, anonymous gamete donation, pre-embryo disposition agreements, and posthumous reproduction, to name but a few examples, there are sharp divergences among, and even within, countries (in the United States, much of this is committed to state not federal law).","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"122 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123141445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Regulating Medical Devices in the United States 在美国监管医疗器械
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.59
Patricia J. Zettler, Erika Lietzan
{"title":"Regulating Medical Devices in the United States","authors":"Patricia J. Zettler, Erika Lietzan","doi":"10.1093/oxfordhb/9780190846756.013.59","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.59","url":null,"abstract":"This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115643730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Introduction to Fraud and Abuse Law 欺诈和滥用法概论
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.65
Tracey Elliott, J. Krause
{"title":"Introduction to Fraud and Abuse Law","authors":"Tracey Elliott, J. Krause","doi":"10.1093/oxfordhb/9780190846756.013.65","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.65","url":null,"abstract":"This chapter focuses on healthcare fraud and the range of legal solutions provided to address fraud in the United States and Europe on a federal level. It provides key examples of the range of approaches to healthcare fraud that are adopted within Europe. It also analyzes the manner in which healthcare systems in the United States and Europe are funded and organized, considering that fraud is dynamic and dependent on the mechanisms for funding in the relevant system. This chapter reviews the issue of what qualifies as healthcare fraud, and it considers both the definitional problem and the interplay between the moral and ethical content of fraud and legal definitions of fraudulent conduct. It discusses operational issues in the identification, prevention, and punishment of healthcare fraud in the United States and Europe.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125479809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Right to Avoid Procreation and the Regulation of Pregnancy 避免生育的权利与怀孕的调节
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.53
J. Herrmann, Elizabeth Sepper
{"title":"The Right to Avoid Procreation and the Regulation of Pregnancy","authors":"J. Herrmann, Elizabeth Sepper","doi":"10.1093/oxfordhb/9780190846756.013.53","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.53","url":null,"abstract":"This chapter considers the right to avoid procreation and the regulation of pregnancy from an American perspective. In the United States, the right to avoid procreation finds protection in constitutional and statutory law. The Supreme Court’s decisions to recognize contraception and abortion as constitutional rights have permitted generations of women a measure of reproductive freedom. However, the constitutionalization of contraception, and abortion in particular, has brought to the fore deeper contestation about the moral (and legal) status of the fetus, women’s place in society, and the meaning of motherhood. These same issues play out in decisions about the protection and regulation of women during their pregnancies. Within the framework of Supreme Court precedent, the fifty states have adopted varying approaches to the right to abortion. The trend, however, has inclined toward greater restrictions in a growing number of states. At the same time, the current Court seems likely to dilute or reject the right to abortion, with consequences for contraception, protections for pregnant women at work, and criminal intervention during pregnancy.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134368015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Introduction to Public Health Law 公共卫生法导论
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.61
W. Parmet, Markus Frischhut, Amandine Garde, B. Toebes
{"title":"Introduction to Public Health Law","authors":"W. Parmet, Markus Frischhut, Amandine Garde, B. Toebes","doi":"10.1093/oxfordhb/9780190846756.013.61","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.61","url":null,"abstract":"This chapter provides an overview of public health law. In contrast to healthcare law, public health law seeks to protect health at a broad population, as opposed to an individual patient, level. The field of public health emphasizes prevention and health promotion, as opposed to the treatment of disease. The chapter looks at three critical areas of public health law: communicable disease control, the control of noncommunicable diseases, and efforts to address the social determinants of health. While the United States and Europe face broadly similar questions, the answers given often differ. In part, this is because the European Union is for the most part a supranational organization, while the United States is a more integrated, albeit federal, nation state. In addition, important distinctions between the legal traditions and the value given to individual liberty versus the public good provide a focus of the comparison between the US and European approaches to public health.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114678161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Introduction to Access to Healthcare 医疗保健概论
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.46
A. Exter, M. Hall, Allison K. Hoffman, K. Syrett
{"title":"Introduction to Access to Healthcare","authors":"A. Exter, M. Hall, Allison K. Hoffman, K. Syrett","doi":"10.1093/oxfordhb/9780190846756.013.46","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.46","url":null,"abstract":"This chapter demonstrates how the comparison between Europe and the United States reveals two very different approaches to dealing with the fundamental question of access to healthcare. Here, ‘access to care’ consists of both availability and affordability. Affordability is determined by how a country helps people to pay for care, including by means of healthcare coverage that entitles or enables a patient to access affordable care. Coverage is commonly provided by some type of insurance that pays for the costs of treatment. But care can be arranged and paid for more directly, without insurance, through a program that simply operates facilities or clinics serving an eligible population, as in the United Kingdom. Typically, these direct-access programs are run by government, but they may also be privately operated, as for instance the free clinics and ‘safety net’ hospitals that serve the uninsured in the United States.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114772145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Healthcare Fraud and Abuse in Europe 欧洲的医疗保健欺诈和滥用
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.7
Tracey Elliott
{"title":"Healthcare Fraud and Abuse in Europe","authors":"Tracey Elliott","doi":"10.1093/oxfordhb/9780190846756.013.7","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.7","url":null,"abstract":"This chapter explores the significant problem of healthcare fraud in Europe, which in the UK alone is estimated at £1.27 billion a year or more than 30% of the European Union healthcare budgets. It emphasizes the difficulties of identifying the predominant “European approach” on the ethical, definitional, and operational challenges that make healthcare fraud difficult to define, identify, police, and prevent. It also describes different healthcare fraud problems in European countries that vary in historical, cultural, and political circumstances. This chapter discusses the significance of how European states manage the financing of their healthcare systems and payment of healthcare professionals as it affects the forms of abusive conduct that might occur. It also mentions the UK, Ireland, Italy, Spain, Portugal, and the Nordic Countries as states vulnerable to procurement corruption as stated by Transparency International.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131079224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Fraud and Abuse Law in the United States 美国的欺诈和滥用法
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.6
J. Krause
{"title":"Fraud and Abuse Law in the United States","authors":"J. Krause","doi":"10.1093/oxfordhb/9780190846756.013.6","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.6","url":null,"abstract":"This chapter focuses on healthcare fraud, which remains a significant problem in the United States despite years of increased fraud enforcement. It describes the US federal government's anti–fraud activities, which include expanding the range and severity of laws targeting healthcare fraud. It also points out the role played by the United States' lack of a centralized, universal program of health insurance, which causes healthcare to be paid for by a variety of public, private, and hybrid sources. This chapter mentions the strategy of capitation as the strictest mechanism for managing care, in which a primary care physician receives a fixed per–patient payment in return for meeting the patient's healthcare needs during a set period of time. It also looks at changes made to Medicare reimbursement under the Patient Protection and Affordable Care Act (ACA) that reward providers for the “value” rather than the volume of services provided.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114534620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
US Law Relating to Noncommunicable Diseases 美国有关非传染性疾病的法律
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.62
W. Parmet
{"title":"US Law Relating to Noncommunicable Diseases","authors":"W. Parmet","doi":"10.1093/oxfordhb/9780190846756.013.62","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.62","url":null,"abstract":"This chapter examines US laws that seek to reduce the prevalence of noncommunicable diseases (NCDs) by targeting the sale, marketing, or use of the products with which they are associated. It reviews some of the broad debates that have helped shape the US response to NCDs, such as concerns about paternalism, individual responsibility, and the appropriate role for law regarding noncommunicable health threats. It also examines the allocation of authority between US jurisdictions to address NCDs. This chapter provides an overview of key US laws and policies that relate to tobacco, unhealthy foods, firearms, and opioids. It tackles the roles of the regulation of commercial speech and the First Amendment's protection for speech on reducing the threat of NCDs.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122082029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient Autonomy, Capacity, and Consent 病人的自主、能力和同意
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.52
M. Donnelly, J. Berg
{"title":"Patient Autonomy, Capacity, and Consent","authors":"M. Donnelly, J. Berg","doi":"10.1093/oxfordhb/9780190846756.013.52","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.52","url":null,"abstract":"This chapter discusses patient autonomy, capacity, and consent involving children. It first provides a general overview of children’s rights with respect to making medical decisions in both the United States and Europe. The chapter then discusses the best interests standard (which is usually applied in cases of minors) and how to consider capacity in the context of children. In the discussions of European approaches, the chapter covers relevant international and regional human rights law. The jurisdiction of England and Wales are used as examples. The chapter also provides a general overview of US state approaches and federal law. The chapter concludes by noting some new areas of medical decision-making which challenge the traditional models.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"9 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129217848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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