Patient information on drug therapy. A problem of medical malpractice law: between product safety and user safety

Medicinal products are associated with risks as well as potential therapeutic benefits. This is reflected by the legal requirements for patient information on drug therapy which can be differentiated into general product information, regulated by pharmaceutical (i. e. product safety) law, and individual patient information on the treatment with the product, which is subject to medical malpractice law. The physician's duty to inform the patient comprises therapeutic information as well as information required for informed consent. Therapeutic information intends to empower the patient to comply with the requirements of treatment and to protect him/her against preventable danger and risk; it is part of the medical treatment, aimed at the individual patient and his/her personal situation. Information required for informed consent enables the patient to a self-determined decision on the treatment offered; it can be divided into information on the course of treatment and risk information. Product information and treatment information complement each other; the former should be the basis of individual information on the concrete treatment, provided by the physician in a mandatory oral conversation with the patient. Product information cannot replace the physician's individual information about the treatment.     

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2003 and inclusion of registered nurses in the personnel provision of the critical access hospital emergency services requirement for frontier areas and remote locations. Final rule with comment period

This final rule with comment period refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. In addition, as required by statute, we are announcing the physician fee schedule update for CY 2003. The update to the physician fee schedule occurs as a result of a calculation methodology specified by law. That law required the Department to set annual updates based in part on estimates of several factors. Although subsequent after-the-fact data indicate that actual increases were different to some degree from earlier estimates, the law does not permit those estimates to be revised. A subsequent law required estimates to be revised for FY 2000 and beyond. Although we have exhaustively examined opportunities for a different interpretation of law that would allow us to correct the flaw in the formula administratively, current law does not permit such an interpretation. Accordingly, without Congressional action to address the current legal framework, the Department is compelled to announce herein a physician fee schedule update for CY 2003 of -4.4 percent. Because the Department would adopt a change in the formula that determines the physician update if the law permitted it, we have examined how proper adjustments to past data could result in a positive update. The Department believes that revisions of estimates used to establish the sustainable growth rates (SGR) for fiscal years (FY) 1998 and 1999 and Medicare volume performance standards (MVPS) for 1990-1996 would, under present calculations, result in a positive update. The Department intends to work closely with Congress to develop legislation that could permit a positive update, and hopes that such legislation can be passed before the negative update takes effect. Because the Department wishes to change the update promptly in the event that Congress provides the Department legal authority to do so, we are requesting comments regarding how physician fee schedule rates could and should be recalculated prospectively in the event that Congress provides the Department with legal authority to revise estimates used to establish the sustainable growth rates (SGR) and for 1998 and 1999 and the NVPS for 1990-1996. The other policy changes concern: the pricing of the technical component for positron emission tomography (PET) scans, Medicare qualifications for clinical nurse specialists, a process to add or delete services to the definition of telehealth, the definition for ZZZ global periods, global period for surface radiation, and an endoscopic base for urology codes. In addition, this rule updates the codes subject to physician self-referral prohibitions. We are expanding the definition of a screening fecal-occult blood test and are modifying our regulations to expand coverage for additional colorectal cancer screening tests through our national coverage determination process. We also make revisions to the sustainable growth rate, the anesthesia conversion factor, and the work values for some gastroenterologic services. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule also clarifies the enrollment of physical and occupational therapists as therapists in private practice and clarifies the policy regarding services and supplies incident to a physician's professional services. In addition, this final rule discusses physical and occupational therapy payment caps and makes technical changes to the definition of outpatient rehabilitation services. In addition, we are finalizing the calendar year (CY) 2002 interim RVUs and are issuing interim RVUs for new and revised procedure codes for calendar year (CY) 2003. As required by the statute, we are announcing that the physician fee schedule update for CY 2003 is -4.4 percent, the initial estimate of the sustainable growth rate for CY 2003 is 7.6 percent, and the conversion factor for CY 2003 is $34.5920. This final rule will also allow registered nurses (RNs) to provide emergency care in certain critical access hospitals (CAHs) in frontier areas (an area with fewer than six residents per square mile) or remote locations (locations designated in a State's rural health plan that we have approved.) This policy applies if the State, following consultation with the State Boards of Medicine and Nursing, and in accordance with State law, requests that RNs be included, along with a doctor of medicine or osteopathy, a physician's assistant, or a nurse practitioner with training or experience in emergency care, as personnel authorized to provide emergency services in CAHs in frontier areas or remote locations.     

Trial and Error at the End of Life--No Harm Done?

English law gives the competent patient the right to refuselife-saving medical treatment, either contemporaneously or inan advance directive, and a physician commits a battery whentreating a patient who validly refused treatment. However, withregard to the details of a physician's liability, many questionsremain unanswered, and it is not at all clear under what circumstancesa patient's tort action for unwanted life-saving treatment willsucceed, and what remedies would be available to the patient.The article suggests that a physician should be liable in batteryfor administering life-saving treatment, even if he/she haddoubts about the validity of the patient's treatment refusal,unless a defence of reasonable mistake can be established. Furthermore,in case of a battery which resulted in keeping the patient alive,the patient should not only be able to claim nominal damages,but general and special damages, including mental and physicalpain and suffering caused by the prolongation of the patient'slife, should equally be available.     

司法鉴定人出庭质证能力优化的路径选择

近年来,随着法治意识的逐渐深入,社会公众对于鉴定意见的认知亦趋于理性,申请鉴定人出庭的频次大幅提升。与此同时,由于鉴定意见具有较高的证据价值,往往能左右司法裁判,因此,其在出庭过程中也将越来越多地受到来自诉讼各方的质疑与挑战,对鉴定人的出庭能力提出了新要求。为更好地维护原本客观的鉴定意见能够最终被法官所采信,应尽快开展鉴定人出庭能力专项培训,以模拟法庭、＂以老带新＂的形式培养鉴定人的法庭技巧。     

The Department of Health and Human Services issues proposed regulations on physician incentive payments by hospitals

Hospitals tempted to operate their own physician incentive plans are reminded that, under OBRA 1986, they are precluded from paying physician incentives of any kind to reduce or limit Medicare or Medicaid covered services. In light of the proposed regulations and the guidance of the preamble, hospitals should review their incentive plans to determine whether physicians providing direct patient care are receiving prohibited payments. Further, supervising physicians who are receiving incentives for certain hospital departments may not influence direct care over patients served by those departments, even through other physicians. Some risk may also exist if incentives are based on a formula that considers patients of the supervising physician's medical group. Finally, it may be useful to develop a utilization and quality of care review program specifically designed to assure that patient undertreatment does not occur as a result of any supervising physician incentive program.     

解读新《刑事诉讼法》 推进司法鉴定制度建设

新《刑事诉讼法》对司法鉴定制度做了如下修改：纠正了＂鉴定结论＂不准确的提法,还原了司法鉴定之本质;删除了＂人身伤害的重新鉴定或者精神病医学鉴定由省级人民政府指定医院进行＂的规定,理顺了司法鉴定体制;明确了鉴定人应当出庭作证的范围,确立了鉴定意见的传闻排除规则;增强了鉴定人参与诉讼的权利保护;增设了专家辅助人制度,使鉴定意见的质证程序有望实质化。这些修改是司法鉴定程序立法的重大进步,然而鉴定人权利保障体系尚有待健全。     

Sexual abuse by psychotherapists: the call for a uniform criminal statute.

Recent surveys show an alarming rate of sexual exploitation of patients by psychotherapists. As such conduct often falls outside the scope of rape, which allows a defense of consent, the psychotherapist is not prosecuted. Although all sexual contact between therapist and patient is prohibited by codes of professional ethics, the licensing boards that enforce these codes do not possess adequate power to deter this behavior. Further, professional review boards have absolutely no authority over unlicensed therapists who sexually abuse their patients. As a result, licensed therapists who have been censured in one state may practice as unlicensed therapists in another state and continue to sexually abuse patients. The only effective deterrent would be a uniform statute, adopted in all states, criminalizing this specific abuse of the unique therapist-patient relationship. Such a statute should include unlicensed therapists as potential offenders and consent to sexual contact should not be a defense. The statute also should provide for enhanced efforts to inform and protect victims. This Note first examines six of the nine criminal statutes that currently exist in order to show the full range of provisions presently in force to deter this conduct. This Note then proposes model provisions for a uniform statute.     

Sampson v. state of Alaska: in the Supreme Court of the state of Alaska

HELD: The Alaska Constitution's guarantees of privacy and liberty do not afford terminally ill persons the right to a physician's assistance in committing suicide and Alaska's statute prohibiting suicide assistance does not violate their right of equal protection.     

Attitudes and beliefs about domestic violence: results of a public opinion survey: I. Definitions of domestic violence, criminal domestic violence, and prevalence

This study reports analyses and findings from a public opinion survey designed to explore beliefs about domestic violence (DV)-what it is, when it is against the law, and how prevalent it is. The project interviewed 1,200 residents from six New York communities. The analyses reveal substantial firsthand and secondhand experience with DV and strong consensus that acts of physical aggression should be labeled as DV, but substantially less certainty about the illegality of the abusive behaviors. Overall, the respondents were less inclined to define women's aggressive behavior in pejorative or unlawful terms than men's. Respondents believed that DV was common in their communities, and that it affected a significant minority of couples. Multivariate analyses provide little support for conventional wisdom about the impact of socioeconomic background on tolerance for or knowledge about DV, although gender, generation, and secondhand familiarity with DV incidents play a role in opinions and beliefs.     

The HIV-infected health care provider. Doe v. Attorney General of the United States

Doe demonstrates that once an employer enters into a relationship with an individual and thereafter determines that he or she may be disabled, the employer has the right to ask the individual questions about the possible disability when those questions are relevant to assessing his or her qualifications for continuing on the job. In fact, once a health care provider is on notice that an employee's or physician's disability may render the employee or physician no longer qualified, thereby potentially endangering patients, the provider is required to determine whether the person is qualified for the job. In these sensitive matters, employers must draw a fine line between unreasonably following up on every rumor on the one hand, and on the other hand investigating reliable information when there may indeed be a direct threat to patients.     

论专家辅助人意见——以刑事辩护为视角的分析

我国2012年新《刑事诉讼法》首次设立了专家辅助人制度，对鉴定意见的质证提供了技术上的支持，对于刑事辩护来说意义重大。从证据法的角度看来，专家辅助人意见具有言词证据、意见证据、弹劾证据的多重属性，因此意见的内容应围绕鉴定意见中的专门性问题，并结合《刑事诉讼法》及相关司法解释对鉴定意见的审查判断规则来提出；而法庭对于鉴定意见的审查也应从准入资格与可靠性两方面进行，以免专家辅助人意见替代鉴定意见来主导审判。     

裁判文书援引学说的基本原理与规则建构

学说的内容实质正当性及其约束法官自由裁量空间的外观进而增强裁判可接受性的功能,是裁判文书援引学说的基本原理,也是建构援引规则的出发点。学说根据其竞争力可以分为通说、主流说、少数说,法官既可以援引通说也可以援引非通说;援引非通说应当成为援引的主流。法官在援引学说时应尽量采用对话技术,尤其是在援引通说时应尽量避免对学说进行大篇幅的“复制与粘贴”;应尽量援引不同体裁的代表性作品以体现学说的数量优势外观。学者姓名承担了标识学术产品的质量担保功能、“商誉”功能与司法修辞功能,学说出处具有定位学者学说发展脉络等功能,援引学说须注明姓名与出处。裁判文书援引学术作品实质上是法官“购买”学术产品的行为,它将刺激处于供给侧的学者主动生产实务所需的产品,继而促成学术与实务的良性互动。最高人民法院可以考虑出台有关裁判文书援引学说的具体规则指引。     

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2006 and certain provisions related to the Competitive Acquisitions Program of outpatient drugs and biologicals under Part B. Final rule with comment

This rule addresses Medicare Part B payment policy, including the physician fee schedule that are applicable for calendar year (CY) 2006; and finalizes certain provisions of the interim final rule to implement the Competitive Acquisition Program (CAP) for Part B Drugs. It also revises Medicare Part B payment and related policies regarding: Physician work; practice expense (PE) and malpractice relative value units (RVUs); Medicare telehealth services; multiple diagnostic imaging procedures; covered outpatient drugs and biologicals; supplemental payments to Federally Qualified Health Centers (FQHCs); renal dialysis services; coverage for glaucoma screening services; National Coverage Decision (NCD) timeframes; and physician referrals for nuclear medicine services and supplies to health care entities with which they have financial relationships. In addition, the rule finalizes the interim RVUs for CY 2005 and issues interim RVUs for new and revised procedure codes for CY 2006. This rule also updates the codes subject to the physician self-referral prohibition and discusses payment policies relating to teaching anesthesia services, therapy caps, private contracts and opt-out, and chiropractic and oncology demonstrations. As required by the statute, it also announces that the physician fee schedule update for CY 2006 is -4.4 percent, the initial estimate for the sustainable growth rate for CY 2006 is 1.7 percent and the conversion factor for CY 2006 is $36.1770.     

Knowledge transfer to emerging markets via consulting projects

In recent years, development agencies (DAs) have focused their activities on consulting projects rather than on financing turnkey projects when assisting emerging markets. The main reason is that the implementation of consulting projects is likely to be connected with an intensive knowledge transfer from developed to emerging markets. Training of local employees and cooperation with local firms are necessary elements to make the transfer effective. The empirical statistics shows training and cooperation to be more frequent in consulting projects financed by DAs as compared to commercial projects. According to theory and experience, training should be included in projects in the least developed host countries, whereas local cooperation should be more frequent, the higher is the development level of the host country. However, DAs do not follow these rules of thumb in a convincing way. A policy implication of the paper is therefore that DAs should better organize and plan the contents of their consulting projects.

判决与民意——兼比较考察中美法官如何对待民意

职业主义要求法官像法律家那样思维,但是按照民主主义的要求,法官应该像民众那样思维,判决应当符合民意。在中国,传统法官采用平民化、大众式的思维方式,力求判决能够体现民众的意愿。这种传统一直延续到现代中国。而在法律职业发达的美国,法官在对民意的问题上既强调限制又强调开放,具有两面性。中美在判决与民意问题上的共性与差异具有一定的启示意义。     

Roe v. Wade and the lesson of the pre-Roe case law

The attempt is made in this discussion to demonstrate that the Supreme Court in deciding the Roe v. Wade case should not have decided an abortion case when it did and that the opinion was almost destined to be bad in that the Court could find no persuasive rationale in the pre-Roe cases for each of the points in its decision. In 1973 political forces were actively debating abortion. Abortions had been prohibited by most states, except to save a woman's life, since the 19th century. In the 5 years immediately preceding Roe, 13 states had revised their statutes to resemble the Model Penal Code's provisions, which permitted abortions if the pregnancy threatened the woman's life, if it would gravely impair her physical or mental health, if it resulted from rape or incest, or if the child would be born with grave physical or mental defects. 4 states had removed all restrictions on the permissible reasons for seeking an abortion before a pregnancy passed specified lengths. In short, in many states the political process had yet to decide on abortion, but Roe's rejection of Texas's statute voided almost every other state's statutes as well. Between 1970 and 1972, a flurry of constitutional challenges hit the courts. 3 years was hardly sufficient time for the judicial system to evolve sound analysis for such an emotionally charged issue as abortion. The Court could justifiably have allowed the dispute to simmer longer in the lower courts. There is some indication that a sounder case law might evolved if given time, but that was prevented by Roe. The Court could not find a rationale in 1973, but it decided anyway, suggesting a legislative rather than a judicial process.     

知识产权诉讼中技术调查官制度的若干问题研究——以技术调查意见为视角

技术调查官制度是审理知识产权案件中查明技术事实的重要制度.技术调查官根据法官的指令参与诉讼审理的全过程并对查明的技术事实出具技术调查意见.由于我国的现行规定存在局限性,导致技术调查意见在司法实践的适用过程中出现诸多问题,比如适用范围的界定不清、适用程序中是否公开以及具体适用方式等问题.为了有效规范技术调查意见的具体适用...     

Consumer beliefs and health plan performance: it's not whether you are in an HMO but whether you think you are

Surveys that rate how persons enrolled in HMOs and other types of health coverage feel about their health care are used to bolster claims that HMOs provide inferior quality care, providing justification for patient protection legislation. This research illustrates that the conventional wisdom regarding inferior care in HMOs may color how people assess their health care in surveys, resulting in survey findings biased toward showing HMOs provide inferior care and reinforcing existing stereotypes. Using merged data from the Community Tracking Study Household and Insurance Followback surveys, we identify privately insured persons who correctly and incorrectly know what kind of health plan they are covered by. Nearly a quarter misidentified their type of health coverage. Differences between responses by HMO and non-HMO enrollees to questions covering satisfaction with health care and physician choice, the quality of the last physician's visit, and patient trust in their physician shrink or disappear when we control for beliefs about what type of plan they are covered by. Results suggest that researchers and policy makers should be cautious about using consumer surveys to assess the relative quality of care provided under different types of health insurance.     

MUDDLING THROUGH THE MURKY WATERS OF TROXEL

A critical case in the area of third-party visitation rights was decided by the U. S. Supreme Court in July 2000 ( Troxel v. Granville ). A plurality in this case held that a Washington grandparent visitation statute was not facially unconstitutional but was as applied to the facts of that case. The author discusses the varying opinions of the Supreme Court justices in the Troxel decision. Next, he analyzes the plurality opinion to determine the appropriate standard of review in grandparent visitation cases. Following is a consideration of how the decision will affect other state grandparent visitation legislation. Examining these issues, the author concludes that future third-party visitation cases will be decided on a fact-specific, case-by-case basis.