Regulation for the enforcement of federal health care provider conscience protection laws. Final rule

The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Section 245 of the Public Health Service Act, and the Weldon Amendment. These federal statutory health care provider conscience protections remain in effect.     

Standards for privacy of individually identifiable health information. Final rule

The Department of Health and Human Services ("HHS' or "Department') modifies certain standards in the Rule entitled "Standards for Privacy of Individually Identifiable Health Information' ("Privacy Rule'). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The purpose of these modifications is to maintain strong protections for the privacy of individually identifiable health information while clarifying certain of the Privacy Rule's provisions, addressing the unintended negative effects of the Privacy Rule on health care quality or access to health care, and relieving unintended administrative burdens created by the Privacy Rule.     

Altered states: state health privacy laws and the impact of the Federal Health Privacy Rule

Although the Federal Health Privacy Rule has evened out some of the inconsistencies between states' health privacy laws, gaps in protection still remain. Furthermore, the Federal Rule contains some lax standards for the disclosure of health information. State laws can play a vital role in filling these gaps and strengthening the protections afforded health information. By enacting legislation that has higher privacy-protective standards than the Federal Health Privacy Rule, states can play three important roles. First, because they can directly regulate entities that are beyond HHS's mandate, states can afford their citizens a broader degree of privacy protection than the Federal Health Privacy Rule. Second, by having state health privacy laws, states can enforce privacy protections at the local level. Finally, action by the states can positively influence health privacy policies at the federal level by raising the standard as to what constitutes sufficient privacy protection. High privacy protections imposed by states may serve as the standard for comprehensive federal legislation, if and when Congress reconsiders the issue. So far, states' reactions to the Federal Privacy Rule have been mixed. Only time will tell whether states will assume the mantle of leadership on health privacy or relinquish their role as the primary protectors of health information.     

Will EMTALA changes leave emergency patients dying on the hospital doorstep?

Despite charges that it is at times ambiguous and overly burdensome, the Emergency Medical Treatment and Labor Act (EMTALA) remains an important protection for patients, and a valuable instrument for enforcing public policy goals in the area of emergency healthcare services. The 250 Yard Rule is a small but crucial part of EMTALA, extending the statute's protections to emergency patients who have narrowly failed to reach the hospital's entrance. Following recent revisions to EMTALA's implementing regulations, some health-care law practitioners and senior federal regulators have opined that enforcement of the 250 Yard Rule will be dramatically curtailed. This Article explores the legal and public policy origins of the 250 Yard Rule and their continuing applicability in the current regulatory environment. The Article concludes that the regulatory basis for the 250 Yard Rule remains intact and that the legislative intent behind EMTALA, as well as ongoing public policy goals, dictate that the 250 Yard Rule be preserved.     

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.     

Trust,vulnerable populations,and genetic data sharing

Recent policies and proposed regulations, including the Notice of Proposed Rulemaking for the Common Rule and the 2014 NIH Genetic Data Sharing Policy, seek to improve research subject protections. Protections for subjects whose genetic data is shared are critical to reduce risks such as loss of confidentiality, stigma, and discrimination. In the article ‘It depends whose data are being shared: considerations for genomic data sharing policies’, Robinson et al. provide a response to our article, ‘The Growth and Gaps of Genetic Data Sharing Policies’. Robinson et al. highlight the importance of individual and group preferences. In this article, we extend the conversation on models for improving protections which will mitigate consequences for individuals and groups that are vulnerable to stigma and discrimination.     

Consumer managed care appeals: are the available procedural protections fundamentally fair?

Managed care incentives to reduce costs have also resulted in incentives to deny care. Anecdotes concerning managed care denials of care have led to a consumer outcry for protection either through the use of procedural due process or by the establishment of patient rights that would include appeal and grievance protections. This Article reviews the procedural protections of constitutional due process, the Consumer Due Process Protocol, and the Patient Bill of Rights. The Article then extensively discusses the availability of these procedural protections in various public and private forums. The discussion of public forums includes proposals contained in recent national legislative initiatives. The author then reviews relevant federal and state law, as well as Uniform Law proposals. Next, the Article analyzes the protections provided by accreditation agencies, dispute resolution organizations, professional organizations, and health insurers. Finally, the author recommends criteria to be used to determine whether a procedure is fundamentally fair.     

论民法上的注意义务

无论在英美法系还是在大陆法系,注意义务都是过失判定的基准。民法上的注意义务是义务主体谨慎地为自己一切行为(包括作为和不作为)的法律义务,其核心内容包括行为致害后果预见义务和行为致害后果避免义务。注意义务的产生依据包括制定法、技术规范、习惯和常理、合同或委托、在先行为。在注意义务的体系中,特别要重视以内容为标准的体系构成,还要理清作为注意义务与不作为注意义务,更要突出高度注意义务的地位。在注意义务存在冲突的情况下,其解决规则为依据注意义务的优先性。注意义务有着程度的差异,应当构建“注意程度标准人”以替代“合理人”。我国侵权行为立法应当明确规定注意义务。     

The shadow price of pluralism: the use of tax expenditures to subsidize hospital care in the United States

During the 1980s, and particularly during the past year, controversy has arisen over the propriety of the not-for-profit hospital's tax-exempt status. In addressing the issue, policy analysts and activists have focused attention on the comparative efficiency and effectiveness of not-for-profit and for-profit hospitals' provision of social benefit, variously conceived and quantified. We review the results of current research carried out within that focus and suggest that the findings are inconclusive and the focus misplaced. A more profitable avenue of inquiry would be to explore the extent to which the dominance of tax-subsidized not-for-profit hospitals is a societally preferred means of achieving the provision of a level of access to quality care that otherwise would require a large direct government subsidy.     

Confidentiality of genetic information in the workplace

This Article analyzes existing legal protections for the confidentiality of information collected through genetic screening or genetic monitoring in the workplace. It notes that there are a variety of protections, such as ethical codes for occupational physicians, statutes protecting health care information in the hands of the employers, and tort, contract and constitutional principles. It describes defenses to suits based on improper disclosure of medical information. The Article then analyzes legal bases for employee and third party access to the employee's genetic information. In response to gaps in existing legal protections, it suggests parameters for a model law protecting the confidentiality of genetic information collected in the workplace.     

行政法规范之违反与过失实行行为之认定——基于新过失论的阐释

讨论行政法规范之违反与过失实行行为之认定的关系,对于我国过失犯罪,特别是业务过失犯罪的认定,有重大意义。对此,应当从不同的过失犯构造理论出发,做体系性思考。立足于行为无价值的新过失论,将过失实行行为定义为违反结果回避义务,不仅能合理限制过失不法的范围,理论立场上也更为首尾一贯;而且通过注意义务的类型化,更能贯彻刑法的自由保障功能和法益保护功能。在新过失论的框架下,行政法规范上的义务和刑法上的注意义务在范围、性质上均有不同,但也存在相同之处:前者的危险防止义务是以定型的危险为前提而课予一般人的义务,后者则是以个案事态为前提而课予(处于行为人地位的)一般人的义务。违反不以避免构成要件结果为指向的行政法规范上的义务,并不构成对刑法上注意义务的违反。而违反以避免构成要件结果为指向的行政法规范上的义务,如果该义务对于个案中的结果回避是必要的或不足的,则构成对刑法上注意义务的违反;如果该义务对于个案中的结果回避是不必要的、可替代的,或者会起消极作用,则不违反刑法上的注意义务。     

Many Duties of Care--Or A Duty of Care? Notes from the Underground

In the course of attacking the idea that the concept of theduty of care can be dispensed with and replaced by a view ofnegligence that deals only with fault and causation, criticshave revived the notion that there are many duties of care.This article argues that the idea of many duties of care isunworkable, but that there is no need to revive such an ideato avoid falling into the view that the whole concept of theduty of care can be discarded. It argues instead for a unifiedview of the duty of care as a single duty. It also argues fora new analysis of negligence, facilitated by the one-duty view,which does see fault as central to negligence but which, insteadof discarding duty, sees arguments about duty as about whetherthe defendant should be permitted to act unreasonably. The articledefends the one-duty view and the new analysis of negligenceagainst the relational view of negligence and against chargesthat it is motivated by a desire for unity between English andFrench law, that it would be incompatible with the conventionaleconomic analysis of tort law (in the course of which it suggestsan economic analysis of the duty of care), and that, unlikethe no-duty view or the many-duties view, it fails to articulatea coherent view of the relationship between freedom and community.     

Beyond the property debate: animal welfare as a public good

Abstract

Animal protection is socially constructed through laws specifying which animals should be protected and how. Most jurisdictions codify animal abuse by specifying the legal protections granted to animals. While these vary between jurisdictions, western legal systems generally provide for better levels of animal protection by incorporating animal welfare and wildlife crime laws into criminal justice systems. UK legislation has long held that animal welfare is a public good, thus animals should be protected in the public interest. However, despite the protective provisions of animal protection laws they generally fall short of giving animals actual rights, protection exists only to the extent that animal and human interests coincide. Animals’ legal status as property dictates that much anti-animal abuse and wildlife crime legislation is about allowing animal exploitation commensurate with human interests. However, UK legislation in the form of the Animal Welfare Act 2006 subtly shifts this position in respect of domestic animals by imposing a duty of care towards companion animals. This paper argues that by requiring owners and responsible persons to give active consideration to the needs of individual companion animals, the Animal Welfare Act provides animals with a level of protection that amounts to a form of legal rights.     

Medicaid program; Medicaid managed care. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. In addition, this final rule expands on regulatory beneficiary protections provided to enrollees of prepaid health plans (PHPs) by requiring that PHPs comply with specified BBA requirements that would not otherwise apply to PHPs.     

Standards for privacy of individually identifiable health information. Office of the Assistant Secretary for Planning and Evaluation, DHHS. Final rule

This rule includes standards to protect the privacy of individually identifiable health information. The rules below, which apply to health plans, health care clearinghouses, and certain health care providers, present standards with respect to the rights of individuals who are the subjects of this information, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards will improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections will begin to address growing public concerns that advances in electronic technology and evolution in the health care industry are resulting, or may result in, a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

Why we need the independent sector: the behavior, law, and ethics of not-for-profit hospitals

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American Hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made, not-for-profit hospital behavior is consistent with the behavior required by law and morality. The moral argument, developed as a preliminary theory of not-for-profit ethics, also provides a potential reason to prefer not-for-profit hospitals. The findings provide a new justification for the not-for-profit tax exemption for hospitals, and also suggest new uses for ownership categories as regulatory tools.     

论雇主的保护照顾义务

雇主的保护照顾义务在我国学界未受到足够的重视,世界各国对其性质也有不同的认识,本文在梳理其各种认识的同时,分析了赋予雇主保护照顾义务的法理依据,阐述了雇主保护照顾义务的内容及违反义务的损害赔偿责任。     

TRICARE: changes included in the National Defense Authorization Act for Fiscal Year 2010; enhancement of transitional dental care for members of the Reserve Component on active duty for more than 30 days in support of a contingency operation. Final rule

The Department is publishing this final rule to implement section 703 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10). Specifically, that legislation amends the transitional health care dental benefits for Reserve Component members on active duty for more than 30 days in support of a contingency operation. The legislation entitles these Reserve Component members to dental care in the same manner as a member of the uniformed services on active duty for more than 30 days, thus providing care to the Reserve member in both military dental treatment facilities and authorized private sector dental care. This final rule does not eliminate any medical or dental care that is currently covered as transitional health care for the member.     

Standards for privacy of individually identifiable health information. Office of the Assistant Secretary for Planning and Evaluation, DHHS. Proposed rule

This rule proposes standards to protect the privacy of individually identifiable health information maintained or transmitted in connection with certain administrative and financial transactions. The rules proposed below, which would apply to health plans, health care clearinghouses, and certain health care providers, propose standards with respect to the rights individuals who are the subject of this information should have, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards would improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections would begin to address growing public concerns that advances in electronic technology in the health care industry are resulting, or may result, in a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule would implement the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.