Organ Procurement and Transplantation Network--HRSA. Final rule with comment period

This document sets forth the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), which performs a variety of functions related to organ transplantation under contract with HHS. The document also offers a 60 day period for additional public comment. The rule will become effective 30 days following the close of the comment period. If the Department believes that additional time is required to review the comments, we will consider delaying the effective date. In combination with a new National Organ and Tissue Donation Initiative, this rule is intended to improve the effectiveness and equity of the Nation's transplantation system and to further the purposes of the National Organ Transplant Act of 1984, as amended. These purposes include: encouraging organ donation; developing an organ allocation system that functions as much as technologically feasible on a nationwide basis; providing the bases for effective Federal oversight of the OPTN (as well as for implementing related provisions in the Social Security Act); and, providing better information about transplantation to patients, families and health care providers.     

Rule‐Intermediaries in Action: How State and Business Stakeholders Influence the Meaning of Consumer Rights in Regulatory Governance Arrangements

The boundaries between public and private actors are increasingly blurred via regulatory governance arrangements and the contracting out of rights enforcement to private organizations. Regulation and governance scholars have not gained enough empirical leverage on how state actors, private organizations, and civil society groups influence the meaning of legal rules in regulatory governance arrangements that they participate in. Drawing from participant observation at consumer law conferences and interviews with stakeholders, my empirical data suggest that consumer rights and, in fact, consumer law, mean different things to different stakeholders tasked with adjudicating consumer rights. Rights afforded consumers who purchase warranties are now largely contingent on first using alternative dispute resolution structures, some created and operated by private organizations with soft state oversight and others run by stakeholders but with greater state oversight and involvement. Using new institutional sociology and regulatory governance theories, I find that stakeholders involved in overseeing and administering these dispute resolution systems filter the meaning of consumer rights through competing business and consumer logics. Because consumer laws mean different things to stakeholders tasked with adjudicating consumer rights, two different rights regimes simultaneously exist in this field. I conclude that how rule‐intermediaries administering private and state‐run dispute resolution systems conceptualize what consumer laws mean in action may have implications for regulatory governance and more broadly, consumers' access to justice.     

Organ Procurement and Transplantation Network. Health Resources and Services Administration, HHS. Final rule

This document sets forth improvements to the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), published in 1998. It reflects the advice of a panel convened by the National Academy of Science's Institute of Medicine, as called for in the Department's appropriation act for 1999. It also reflects comments on the 1998 rule and consultation with representatives of the organ transplantation community, as recommended in the same legislation; and it summarizes new transplant data developed in the period since enactment of the appropriations act.     

Organ Procurement and Transplantation Network; final rule revision of comment period and effective dates--HRSA. Extension of comment period and delay of effective date for the Organ Procurement and Transplantation Network

This document sets forth the revisions required by the Fiscal Year 1998 Supplemental Appropriations Act, Public Law 105-174, signed into law by the President on May 1, 1998. Section 4002 of that Act states that public comments on the Organ Procurement and Transplantation Network (OPTN) Final Rule are permitted until August 31, 1998, and that the OPTN rule will not become effective before October 1, 1998. This document is provided to notify the public about these provisions and to make corresponding changes to the regulation.     

Public Good, Private Protections: Competing Values in German Transplantation Law

Organ transplantation has become almost routine practice in many industrialized countries. Policy, ethical, and legal debates tend to center on fairness of allocation rules or alternatives to promote greater numbers of donations. There are also certain beliefs about the use of bodily materials that are often presumed to be homogenous across Euro–American societies. In Germany, however, the idea of using the bodies of some for the good of others, and the right to proclaim some bodies dead for large–scale medical and political purposes is highly charged. This is due to the historical context of medical experimentation, selection, and euthanasia under National Socialism, and the former East German socialist policies which intervened in the private lives and bodies of citizens. This article is based on an ethnography of organ procurement practices during the period when German policymakers struggled with writing a transplant law. Active public resistance revealed deep concern about state intervention in private matters and amplified the growing unrest over definitions of moral community in a changing, post–reunification society. The article shows how public disputes about health policy become a way through which societies deal with other social conflicts.     

商事登记法律性质辨析:法经济学的视角

商事登记制度的产生具有自发性、自觉性,商事登记规则的形成是商事交易的客观需要使然。法律作为一种规则体系必定是社会生活事实需要的产物和制度的体现,法律规范应该是对社会经济事实客观的"映照,"而非主观的"塑造"。因此,对商事登记法律性质的解释不应是学术的,而应是经济的。后现代结构方法主张视角多元主义,克服定式化思维。突破商事登记法律行为公私法性质定式的牢笼,探求其背后的经济本性,于实务更有裨益。     

Measuring the Economic Impact of University-Based Research

University research has propelled the United States into world-class leadership, but continuing that momentum in the 21st century requires major funding. Both the public and private sector have risen to meet that financial challenge through increased support of university-based research. Since 1995, New York Governor George E. Pataki and the New York Legislature have fostered the growth of high technology and biotechnology industries by investing more than $1 billion in superlative research laboratories and academic centers. However, with this increased outlay comes the demand for greater accountability. Both public and private stakeholders expect applied research to have economic impact through a unique combination of good science plus good business producing wealth and opportunity for all citizens. However, measuring the economic impact of university research proves difficult. This paper suggests a possible method for a public funding agency to quantify and tabulate research outputs such that economic impacts are reported as a percent return on investment or ROI. With this model, multiple stakeholders can evaluate divergent research technologies using a measurement that is familiar to scientists, business leaders, elected officials, and the public.     

性的自治与规制——在法律规则的视野下对性权利的一种解读

尽管人的进步是和性的解放关联在一起,但是法治意义上的性权利绝不是完全的性自治和性自由,性权利永远都是法律规则与制度下的权利,永远都是与性义务、性责任相对应的权利,它受制于社会规则,来源于社会合作。因此,性的法治是建立在自治基础上对性的法律控制。具体说,这种法律控制体现在婚姻形态的选择、国家对性资源的配置以及国家权力与私人力量的博弈等环节或过程中。     

明律“私充牙行埠头”条的创立及其适用

明律新创“私充牙行埠头”条,将牙行制确定为全国通行的一种法定制度,在市场管理中扮演着重要角色。该条的创立是对中国古代尤其是宋元以来市场交易中介行为进行总结继承和明初社会经济秩序要求“因事制律”的结果。该条在调整市场秩序的实践中发生了一定作用。明代官府通过控制市场交易中介组织来调整市场秩序的经验对清代的市场管理法制产生了重大影响。     

VA homeless providers grant and per diem program--VA. Final rule

We are, with changes, adopting as a final rule the provisions of an interim final rule promulgated pursuant to The Homeless Veterans Comprehensive Service Programs Act of 1992. The Act authorizes the Department of Veterans Affairs to assist public or nonprofit private entities in establishing new programs to furnish supportive services and supportive housing for homeless veterans through grants. The Act also authorizes VA to provide per diem payments, or in-kind assistance in lieu of per diem payments, to eligible entities that established programs after November 10, 1992 that provide supportive services or supportive housing for homeless veterans, or service centers providing supportive services. This rule contains criteria and requirements relating to the awarding of grants and relating to per diem payments. Accordingly, this rule is necessary so that grants can be awarded and per diem payments can be made.     

社会实在的规范性与公私法的界限——与徐国栋教授商榷民法的“公私法混合说”

民法的＂公私法混合说＂建立在＂强行法说＂基础之上,该理论通过区分任意性规范和强制性规范把私法的范围限于任意性规范。强行法说预设了一种缺少规范性的＂社会实在＂：一方面忽略了法律对社会实在的构造功能,没能看到强制性规范与私人领域的构成性关系;另一方面忽略了通过强制性规范所表达的私人自治的规范性要素,没能看到强制性规范与私人领域之间在合法性意义上的共生性。尽管公私法的划分问题具有可争议性,但强行法说因其对社会实在的理解存在偏差而无法成为一种妥当的公私法界限理论,民法的＂公私法混合说＂自然无法成立。     

Medicare and Medicaid programs; hospital conditions of participation; identification of potential organ, tissue, and eye donors and transplant hospitals' provision of transplant-related data--HCFA. Final rule

This final rule addresses only provisions relating to organ donation and transplantation. It imposes several requirements a hospital must meet that are designed to increase organ donation. One of these requirements is that a hospital must have an agreement with the Organ Procurement Organization (OPO) designated by the Secretary, under which the hospital will contact the OPO in a timely manner about individuals who die or whose death is imminent in the hospital. The OPO will then determine the individual's medical suitability for donation. As well, the hospital must have an agreement with at least one tissue bank and at least one eye bank to cooperative in the retrieval processing, preservation, storage, and distribution of tissue and eyes, as long as the agreement does not interfere with organ donation. The final rule requires a hospital to ensure, in collaboration with the OPO with which it has an agreement, that the family of every potential donor is informed of its opinion to donate organs or tissues or not to donate. Under the final rule, hospital must work with the OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of organs and tissues take place. In addition, transplant hospitals must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide, if requested, such data directly to the Department.     

欧洲统一市场的建立与对国家干预的规制

为了促进欧洲统一市场的建立,《欧共体条约》确定了竞争规则和自由流动规则,对成员国制定的不利于统一市场建立的政府干预措施,如授予公用企业独占权、给予国家援助、制定歧视性贸易措施、对私人破坏竞争的行为不作为等进行规制。在欧共体法院的有力保障下,这些规则在推动欧洲一体化进程中发挥了重要作用,特别是其中的竞争规则,因其具有中立、开放之品格而成为规范经济和政治关系、促进共同体市场建立的核心手段和"发动机"。     

Private Interests Seeking Punishment: Prosecution Brought by Private Individuals and Groups in Spain

This article centers on the study of the Spanish private prosecution system. It is an attempt to highlight both its theoretical potential and its practical dysfunctions. This type of lay participation in criminal matters is often seen as a way to strengthen democracy or to legitimate justice, opinions that the author rejects. Although private prosecution may work as a safety valve against the public prosecutor's inactivity, the introduction of private interests in the penal process may distort its true significance and function. Private prosecution can become a Trojan horse within the system.     

现代财政制度的法学审思

十八届三中全会提出建立“现代财政制度”,这是建立健全现代国家治理机制、实现长治久安的制度保障.传统财政制度重国家本位轻人民本位、重管理轻治理、重结果导向轻过程导向.而现代财政制度具有法治性、回应性、均衡性和公共性的品格,彰显对公共财产权的规范,进而实现对公共财产、私人财产的双重保障;其法律构造内含宪法规范、公共财产规范、分配规范和宏观调控规范四个维度.构建现代财政制度,应以点带面、循序渐进,现阶段应将改进预算制度、完善税收立法和建立事权与支出责任相适应的财政分权模式作为三大抓手.     

关于我国公安依法行政理念的构建

随着“依法治国,建设社会主义法治国家”理念的进一步深入人心,我国社会治理的方式和目标也正在从传统的人治向现代的法治变迁。而法治的核心是如何制约公权力和保护公民的私权利,使公职行为在法律规定的范围内行使。公安系统作为我国特殊的行政机关,其能否积极的依法行政直接关系到政府及其职能部门的社会形象和威信,所以我们在此探寻其行政法治的理论基础,并积极寻找具有实践意义的路径。     

The public interest dimension of the single market for data: Public undertakings as a model for regulating private data sharing

Data plays a crucial role for society. Accordingly, building a ‘single market for data’ by increasing the availability of public and private data ranks high on the EU policy agenda. But when advancing legal data sharing regimes, there is an inevitable need to balance public and private interests. While the European Commission continues to push for more binding rules on data sharing between private businesses, public undertakings are already covered by mandatory rules. Exploring how the law addresses their data offers valuable lessons on the reconciliation of market reasoning with the public interest. In particular, this article inquires into the recast Open Data and Public Sector Information Directive, the Data Governance Act, and different national rules which regulate access to and re-use of public undertakings' data. It identifies five striking characteristics and discusses their potential and limitations for regulating data sharing by private undertakings. The implications serve as a guidepost for advancing the wider debate on building a single market for data in the EU. Some of them are already reflected in the upcoming EU Data Act.     

Is there a rationale for regionalizing organ transplantation services?

This paper explores issues in the designation of centers to provide organ transplantation procedures and aftercare, a decision faced increasingly by policymakers, planners, and payers. As background for consideration of the regionalization of organ transplantation services, an array of models of regionalization of health services, ranging from full-scale vertical integration to market-enhancing information provision, is described. In the United States, regionalization has mainly followed the designation model within the certificate-of-need system; vertical integration has been adopted only in limited ways. Next, the authors' review of current approaches to the regionalization of organ transplantation centers by public and private payers indicates that designation of centers is increasing, although the empirical evidence concerning the classes of hospitals upon which designation decisions rest is weak. The authors then review the literature on the relationship between volumes and outcomes on surgical services with particular reference to organ transplantation, which on the whole suggests that a relationship between volumes and outcomes exists. Original empirical analysis of data on kidney transplants that were secured from the Health Care Financing Administration is then presented. The study of the effects of hospital and surgeon volumes on graft and patient survival and of the effect of volume on charges found no systematic influence of hospital or surgeon volumes on graft or patient survival. Some evidence that charges are lower for larger centers was found. The authors conclude that the evidence implies that using volume as the provider characteristic upon which to base designation of transplantation centers is problematic, at least for kidney transplants. Steps policymakers might take to ensure quality of transplantation services is discussed in the final section.     

Judicial Responses to Bright Line Rules in Social Security: In Search of Principle

This article considers judicial responses to the use of 'bright line' rules in social security law. It analyses, within the framework of judicial deference, the receptiveness of the judiciary to an argument by the executive that a rule is justified as being administratively convenient to operate. The article questions the proposition that the judiciary is at its most deferential when complex issues of socio-economic policy or resource allocation are raised in the context of social security law. A contrast is drawn between cases involving an issue of statutory interpretation and those applying a proportionality test. The article tests the presumption that a difference in approach should be discernable in these two situations. It concludes by criticising the courts for failing to articulate clearly the values at stake and by arguing for the need for greater transparency and a broader public debate concerning the use of bright line rules.     

The politics of managed competition: public abuse of the private interest

The doctrine of managed competition in health care sought to achieve the social goals of access and efficiency using market incentives and consumer choice rather than governmental regulation and public administration. In retrospect, it demanded too much from both the public and the private sectors. Rather than develop choice-supporting rules and institutions, the public sector has promoted process regulation and benefit mandates. The private health insurance sector has pursued short-term profitability rather than cooperate in the development of fair competition and informed consumer choice. Purchasers have subsidized inefficient insurance designs in order to exploit tax and regulatory loopholes and to retain an image of corporate paternalism. America's health care system suffers from the public abuse of private interests and the private abuse of the public interest.