Patient safety and quality improvement. Notice of proposed rulemaking

This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed "Patient safety work product" by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.     

Health economists' views of health policy

This article reports the views of a national survey of U.S. health economists on a series of questions ranging from mergers among health care providers to the profits of pharmaceutical manufacturers to fundamental health care reform. We find a high degree of agreement on issues of fact but considerable disagreement on issues that depend on values. Additional research may help to resolve some remaining disagreement about issues of fact but may do little to resolve disagreement over values. Results from this fall 2005 survey are compared with those from surveys conducted in 1989 and 1995.     

期货交易的若干法律问题

<正> 期货交易是商品经济高度发展的必然产物,其特有的套期保值功能、防止市场过度波动功能、节约商品流通费用功能以及促进公平竞争功能对于发展我国目前日益活跃的商品流通体制具有重要意义。近年来,我国的期货交易有了很大的发展,但是由于缺乏相应的立法,各地各行其事,使得期货交易处于无法可依的状态,且过度投机行为盛行。目前,加强期货交易的专门立法极为必要。本文意图对期货交易的若干法律问题进行探讨,以供立法者参考。 一、期货交易的法律性质问题     

高素质产业工人队伍建设发展的实践路径分析

中国制造的转型升级离不开一支高素质的产业工人队伍。改革开放以来,我国产业工人队伍伴随着经济社会的深刻变革而发展壮大,从业结构日趋多元,产业工人队伍素质提升面临诸多挑战,高素质技能人才比例不高的现实也客观制约了我国工业强国战略的实施。从世界工业强国成熟的发展经验来看,职业教育培训是培育高素质产业工人的制度路径。我国应充分借鉴这些有益经验,深化职业教育培训体制机制改革,加大资源投入,创新教育培训机制,提升产业工人队伍素质,进而为建设工业强国提供强有力支撑。     

China’s Experience in Legislation on Special Economic Zones

Since adoption of the policy of reform and opening up in 1978, China, in efforts to attract foreign investment and introduce advanced technologies into the country,