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.     

Medicare and Medicaid programs; recognition of the Joint Commission on Accreditation of Healthcare Organizations standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. As a result of this recognition, HHAs accredited by JCAHO are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which JCAHO must comply to maintain Medicare and Medicaid recognition of its HHA accreditation program.     

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Procedures for disclosure or production of information under the Freedom of Information Act; amendments--Consumer Product Safety Commission. Final Rule

The Electronic Freedom of Information Act Amendments of 1996, which amend the Freedom of Information Act, are designed to make government documents more accessible to the public in electronic form. The amendments are also intended to expedite and streamline the process by which agencies disclose information generally. In this notice, the Commission amends its Freedom of Information Act regulations to comply with the requirements of the new statute.     

Accreditation and the state of North Carolina: The revitalization of national standards

From the mid to late 70s, the Academy of Criminal Justice Sciences (ACJS) developed a process for accrediting post-secondary criminal justice education programs. The academy gave form to the program by developing guidelines and a complex organizational network. However, the program did not reach fruition for a variety of economic and political reasons and it is doubtful that the Academy will attempt to resurrect the program soon. Even though the accreditation movement was abandoned on the national level, the North Carolina Association of Criminal Justice Educators (NCACJE) decided to implement the program and stepped into a very lengthy and political process.     

Cybersecurity,safety and robots: Strengthening the link between cybersecurity and safety in the context of care robots

This paper addresses the interplay between robots, cybersecurity, and safety from a European legal perspective, a topic under-explored by current technical and legal literature. The legal framework, together with technical standards, is a necessary parameter for the production and deployment of robots. However, European law does not regulate robots as such, and there exist multiple and overlapping legal requirements focusing on specific contexts, such as product safety and medical devices. Besides, the recently enacted European Cybersecurity Act establishes a cybersecurity certification framework, which could be used to define cybersecurity requirements for robots, although concrete cyber-physical implementation requirements are not yet prescribed. In this article, we illustrate cybersecurity challenges and their subsequent safety implications with the concrete example of care robots. These robots interact in close, direct contact with children, elderly, and persons with disabilities, and a malfunctioning or cybersecurity threat may affect the health and well-being of these people. Moreover, care robots may process vast amounts of data, including health and behavioral data, which are especially sensitive in the healthcare domain. Security vulnerabilities in robots thus raise significant concerns, not only for manufacturers and programmers, but also for those who interact with them, especially in sensitive applications such as healthcare. While the latest European policymaking efforts on robot regulation acknowledge the importance of cybersecurity, many details, and their impact on user safety have not yet been addressed in depth. Our contribution aims to answer the question whether the current European legal framework is prepared to address cyber and physical risks from care robots and ensure safe human–robot interactions in such a sensitive context. Cybersecurity and physical product safety legal requirements are governed separately in a dual regulatory framework, presenting a challenge in governing uniformly and adequately cyber-physical systems such as care robots. We conceptualize and discuss the challenges of regulating cyber-physical systems’ security with the current dual framework, particularly the lack of mandatory certifications. We conclude that policymakers need to consider cybersecurity as an indissociable aspect of safety to ensure robots are truly safe to use.     

海上保险代位追偿权制度的构建标准与若干争议问题

针对海上保险代位追偿案件中的诸多争议,从分析代位追偿制度的法理基础与法律属性的角度人手,探寻构建海上保险代位追偿制度的相关标准,并以此为指引,解决若干争议问题,以实现代位追偿制度之本意与目的.     

Creating problems as part of the "solution": the JCAHO Sentinel Event Policy, legal issues, and patient safety

The recently reported number of patient deaths attributable to medical errors is staggering. In response to this crisis, the Joint Commission on Accreditation of Healthcare Organizations ("JCAHO") proposed its Sentinel Event Policy. The policy mandates self-reporting by hospitals accredited by the JCAHO. This Article argues that the JCAHO's policy shows an inattention to the legal realities of discovery and absence of immunity. Until the JCAHO addresses these issues, self-reporting will have limited success. This Article suggests that to promote patient safety, self-regulatory reports should go to a neutral, nonsanctioning third party, an approach adopted from aviation's highly successful reporting system.     

残疾标准制定与实施中的基本问题研究 ——以《人体损伤致残程度分级》为例

《人体损伤致残程度分级》的制定凝聚了一代法医临床司法鉴定理论界和实务界专家的心血,它的实施能够规范和统一我国的残疾鉴定标准.与现行的其他同类标准相比,《伤残分级》对于残疾情形覆盖更加全面、分级更加合理,更便于实践操作.但是《伤残分级》的点、线、面结构特点也使得其存在无法穷尽所有损伤情形、易忽视损伤相对性等问题.笔者主要从《伤残分级》点、线、面的结构特点为视角对《伤残分级》进行了一些研究,并为实践中更好的适用《伤残分级》提出建议.     

Variability and Similarity of Gait as Evaluated by Joint Angles: Implications for Forensic Gait Analysis

Closed‐circuit television (CCTV) footage is used in criminal investigations to compare perpetrators with suspects. Usually, incomplete gait cycles are collected, making evidential gait analysis challenging. This study aimed to analyze the discriminatory power of joint angles throughout a gait cycle. Six sets from 12 men were collected. For each man, a variability range VR (mean ± 1SD) of a specific joint angle at a specific time point (a gait cycle was 100 time points) was calculated. In turn, each individual was compared with the 11 others, and whenever 1 of these 11 had a value within this individual's VR, it counted as positive. By adding the positives throughout the gait cycle, we created simple bar graphs; tall bars indicated a small discriminatory power, short bars indicated a larger one. The highest discriminatory power was at time points 60–80 in the gait cycle. We show how our data can assess gait data from an actual case.     

The use of enzymatic hydrolysis for isolation of barbituric acid derivatives from blood (as exemplified by phenobarbital and barbamyl)

Modern isolation techniques by direct extraction with organic solvents or after protein precipitation by various sedimenting or salting-out agents are characterized by low efficiency and do not permit to liberate derivatives of barbituric acid from their complexes with blood proteins. The use of enzymatic hydrolysis makes it possible to break bonds between barbiturates and protein and thereby improve the efficiency of isolation. We performed enzymatic hydrolysis of the model phenobarbital-blood and barbamyl-blood complexes with the use of trypsin, pepsin, chymotrypsin, and papain. The degree of phenobarbital extraction with trypsin and barbamyl was estimated at 62.1 +/- 1.2% and 75.1 +/- 1.6% respectively; in other words, it was 32.7 +/- 1.0% and 51.1 +/- 1.0% higher than that achieved by traditional methods. Certain validation characteristics of the new method are presented.     

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.     

Shaping the Spiderweb: Towards the Concept of Joint Commission Through Another Person Under the Rome Statute and Jurisprudence of the International Criminal Court

This article argues that the concept of joint commission through another person has a central place in the co-perpetration architecture of the Rome Statute and jurisprudence of the International Criminal Court. The concept of joint commission through another person envisages a commission of a crime by two or more individuals through one or more subordinated persons. Even though the concept of joint commission through another person does not expressly derive from the Article 25(3)(a) of the Rome Statute of the ICC, this article argues that an individual can be held responsible as a co-perpetrator of a crime committed jointly with another individual through subordinated individuals if he or she has joint control over the crime because of his/her essential contribution to the commission of the crime.     

《违反欧共体反托拉斯规则的损害赔偿诉讼白皮书》释评——以具体制度分析为中心

2008年4月2日,欧盟委员会通过的《违反欧共体反托拉斯规则的损害赔偿诉讼白皮书》提供了一系列建议措施,以确保竞争违法行为的受害人所遭受的损失可以通过真正有效的机制获得充分赔偿。白皮书将对欧盟成员国的反托拉斯损害赔偿实践产生重大影响。     

放射性废物管理的国际法制度--《乏燃料管理安全和放射性废物管理安全联合公约》的视角

放射性废物管理是当今世界面临的一个重要问题。本文试图从国际法的角度,联系可持续发展理论,对迄今为止有关放射性废物管理方面最重要的全球性公约——《乏燃料管理安全和放射性废物管理安全联合公约》进行介绍和分析,并在此基础上就完善国际放射性废物管理法律制度提出建议。     

A dose of reality: assessing the Federal Trade Commission/Department of Justice report in an uninsured, underserved, and vulnerable population context

Despite the size of their report, the Federal Trade Commission and Department of Justice pay virtually no attention to tens of millions of uninsured and underinsured persons. By focusing on an increasingly rarified group of health care customers--healthy, affluent, and highly insured--the report takes on an untethered quality, with only the slightest tip of the hat to its own limitations. Furthermore, the report overstates the extent of legal constraints on the market, in particular, the degree to which the market is free to select its customers and tailor its goods and services to the best risks. By miscasting the legal context of the American health care system, the report ultimately undermines much of its potential value.