完善医疗制度 缓和医患关系

随着社会的发展,医疗纠纷数量日趋增多,成为卫生部门、医院、医生的最大难题,是继医疗改革之后的又一备受社会各界关注的热门话题,医患关系成为社会最不和谐的声音。医患关系紧张、医疗纠纷增多与我国目前相关制度、法规不健全有极大的关系。本文探讨通过建全相关制度、法规以缓和医患矛盾的问题,试图寻找合理处理医疗纠纷的办法。     

FDA regulation of medical software

Currently the FDA is reviewing its policy on the regulation of computer software in the medical arena. Healthcare practitioners hope that the FDA will take the least possible regulatory action required by law to fulfill its public health responsibility and will take into account the unique status of the ever-changing software industry. Innovations in telemedicine and medical informatics have yielded significant improvements in the quality and cost of healthcare, and the imposition of cumbersome regulatory requirements on the medical software industry would slow the development and introduction of medical software products.     

The regulation of cognitive enhancement devices: extending the medical model

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.     

Ethical, professional and legal regulation of medical practice

Moral or ethical codes of practice represent one of the oldest forms of medical regulation. Legislation such as the Medical Practice Act 1992 (NSW) enables regulatory bodies to create codes of practice for medical practitioners. Such codes can become an important aspect of disciplinary proceedings by providing the yardstick against which practitioners' conduct is evaluated. An important aspect of the New South Wales Board's Code of Professional Conduct 2005 is the obligation for doctors to report adverse events which reflect on the performance or conduct of colleagues. This is part of an increasing impetus to report adverse events in the interest of public safety. In the long- term this is a constructive development as it is likely to lead to improvements in identification of risks and hazards and thereby to result in better service provision and community health.     

Paths toward reclamation: therapeutic jurisprudence and the regulation of medical practitioners

Much about what used to be termed "disciplinary" investigations and hearings is being revisited in the modern era. Therapeutic jurisprudence enables informed and sensitive awareness to potentially therapeutic and counter-therapeutic effects of both investigations and hearings conducted by medical regulatory authorities. This article analyses key aspects of authorities' processes from the perspective of notifiers/complainants and practitioners. Using developments at the Victorian Medical Practitioners Board as a base, it addresses issues of both investigative procedures and decision-making at formal and informal hearings, as well as the ramifications of re-hearings for the integrity of peer review informed regulation. It argues that where reclamation of practitioners is possible (namely where impropriety is not of the most serious order), there is much that is constructive about a focus upon enhancement of performance and competence levels, rather than the traditional preoccupation with whether registered status needs to be affected as a result of practitioner conduct.     

Child Support Enforcement program; medical support. Final regulation

This regulation revises Federal requirements for establishing and enforcing medical support obligations in Child Support Enforcement (CSE) program cases receiving services under title IV-D of the Social Security Act (the Act). The changes: require that all support orders in the IV-D program address medical support; redefine reasonable-cost health insurance; require health insurance to be accessible, as defined by the State; and make conforming changes to the Federal interstate, substantial compliance audit, and State self-assessment requirements.     

Hospital care and medical services in non-VA facilities--VA. Final rule and regulation

Department of Veterans Affairs (VA) is amending regulations which pertain to the authorization for contract non-VA hospital care and medical services for veterans. The Veterans Health Care Act of 1992 provides that veterans with a total disability permanent in nature from a service-connected disability may be authorized contract non-VA hospital care and medical services. Contract care may be authorized only if the VA facility is not capable of furnishing the care required, or is not capable of furnishing economical care or services because of geographical inaccessibility. This amendment will make the regulations consistent with the law.     

Practitioner fraud and abuse in medical benefit programs: government regulation and professional white-collar crime

Physicians who defraud and abuse medical benefit programs provide a unique group of lawbreakers for scientific study. They could be considered to epitomize white collar criminals given their exceedingly high socioeconomic status and power as a professional group. Using official reports and documents, as well as interviews with enforcement and program personnel at both state and federal levels, this study examines the problem of physician fraud and abuse in Medicare and Medicaid. Major areas relevant to understanding this phenomenon and its control are presented and policy implications of present knowledge in the area are discussed.     

从医疗纠纷案例反思医学人文关怀

近年来,我国的医疗纠纷呈不断上升趋势,暴力伤医事件愈演愈烈,究其原因有各种各样的因素,其中对病人的人文关怀缺乏是主要原因之一。本文试图从一些典型医疗纠纷案例入手,从医学人文关怀视角剖析其纠纷发生的原因,提出在当前医疗环境中只有重视人文关怀才能改善医患关系,减少医疗纠纷,构建和谐社会。     

Forensic medical assessment of the validity of medical risk

The notions of an unfavorable outcome as accepted in medical practice as well as those of defected medical care and of iatrogeny are presented in the paper alongside with examples from forensic medical practice. An algorithm is suggested for the thanatogenetic analysis applicable to detection and evaluation of the cause-and-effect relations between the therapeutic-and-diagnostic measures, on the one hand, and the above outcome, on the other hand. Risk criteria are substantiated with reference to medical practice. Finally, a objective assessment scheme is suggested to confirm that the diagnostic and treatment tools, related with a higher risk, were justifiable.     

The art of regulation and the regulation of ART: the impact of regulation on research and clinical practice

How a society regulates Assisted Reproduction Technologies (ART) depends on cultural context. The challenge for the regulatory regime is to balance protection for patients and society with freedom for medico-scientific creativity. Neither an exclusively market-regulated nor a peer-regulated approach is realistic politically, or desirable socially, ethically and legally. Legitimate social issues that go beyond the exclusive expertise of doctors and scientists or market choice by patients need to be accommodated within the regulatory regime. Within this context, four key issues are discussed: the lack of a shared social ethic that helps the needs of the community to be balanced against those of its individual members; the negative impact of intrusive external regulation on scientists and doctors; the requirement for doctors and scientists to review their professional structures reflectively and critically if they are to be entrusted with peer-regulation; and the desirability of constructive dialogue between regulators and regulated rather than the use of coercion and criminal sanctions.     

论医疗技术规范在认定医疗过失中的作用

医疗过失是医疗事故和医疗侵权认定的重要要件,这可以从分析《医疗事故处理条例》中的相关内容得出结论。《医疗事故处理条例》第2条规定:本条例所称医疗事故,是指医疗机构及其医务人员在医疗活动中,违反医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规,过失造成患者人身损害的事故。