Liability in the delivery of personalized medicine: driver, impediment, or both?

描述(由申请者提供)：个性化医学(PM)有可能在未来十年改变医学和医疗保健系统。一个被忽视的变量将在PM的实施中发挥重要作用，那就是潜在的法律责任。医生是PM的关键把关人，他们承担责任的风险最大。目前， 关于PM测试在临床护理中的使用，有很大的不确定性、分歧和迅速的变化。正是在这一不确定和变化的时期，责任的潜力最大，因此，对这些问题的交集进行全面的法律研究和分析的必要性是最迫切的。这个拟议的项目试图通过提供法律理论、经验和政策研究来填补对PM责任风险的理解空白 关于PM责任的风险、影响和可能的政策方法。这个项目的结果可以帮助更好地理解和预测项目管理的未来进程，并确定可能可用的关键法律和政策杠杆，以确保责任在项目管理的实施中发挥有益而不是有害的作用这个项目有五个主要目标。该项目将对医生的潜在责任进行全面调查和分析，首先审查将为责任提供法律框架的适用索赔、辩护和学说，这些本身目前正在经历重大变化。其次，我们将评估对医生的潜在责任风险，方法是将 通过四个可能的PM案例研究中的事实模式和证据，以及通过评估采用以前的医疗技术和实践的责任教训，进行理论分析。第三，我们将研究责任对医生、患者以及PM的更广泛采用、可用性和实施可能产生的影响第四，我们将识别和评估可以用来更好地管理PM领域风险和不确定性的政策工具。最后，我们将通过一个面向三个关键利益相关者群体的外联计划来传达我们项目的结果和影响：(I)医生和医学教育工作者；(Ii)患者团体和倡导者；以及(Iii)法律从业人员(包括法官)。在PM推广的这个关键时刻，在普遍责任形成之前，全面研究和广泛提供与PM相关的医生责任风险和相关因素的最佳信息和预测是非常重要和有用的 公共卫生相关性：个性化医疗(PM)的出现有可能极大地影响和改善患者护理，因为它提供了更好的测试、更好的药物和总体更好的健康结果的机会。医生法律责任风险的增加最终将影响PM领域将采用和拒绝哪些技术，塑造相关的护理标准，决定公共卫生结果，并影响PM技术的获得和最终受益者--患者--接受的护理。与PM责任风险相关的更好的理解、沟通和政策干预有助于确保责任对PM的吸收和实施具有有益而不是有害的影响。

DESCRIPTION (provided by applicant): Personalized medicine (PM) has the potential to transform medicine and the health care system over the next decade. An overlooked variable that will play an important role in the implementation of PM is the potential for legal liability. Physicians, a key gatekeeper in the uptake of PM, are at the greatest risk of liability. Currently, there is great uncertainty, disagreement and rapid change with regard to the use of PM tests in clinical care. It is during this period of uncertainty and change where the potential for liabilityis at its greatest and thus the need for comprehensive legal research and analysis of the intersection of these issues is most pressing. This proposed project seeks to fill the gap in the understanding of PM liability risks by providing legal doctrinal, empirical, and policy research on the risks, impacts and possible policy approaches with regard to PM liability. The results of this project can help to better understand and predict the future course of PM and to identify the key legal and policy levers that may be available to ensure that liability plays a beneficial rather thn detrimental role in the implementation of PM. This project has five primary objectives. This project will provide a comprehensive investigation and analysis of potential liability to physicians, first by examining the applicable claims, defenses and doctrines that will, provide the legal framework for liability, and which themselves are currently undergoing important changes. Second, we will evaluate the potential risks of liability to physicians by integrating the doctrinal analysis with the fact patterns and evidence in four likely PM case studies, as well as by evaluating liability lessons from the uptake of previous medical technologies and practices. Third, we will examine the likely impact liability will have on physicians, patients, and the broader adoption, availability and implementation of PM. Fourth, we will identify and evaluate policy tools that can be used to better manage risks and uncertainties in the PM arena. Finally, we will communicate the findings and implications of our project through an outreach program targeting three key stakeholder groups: (i) physicians and medical educators; (ii) patient groups and advocates; and (iii) legal practitioners (including judges). At this critical juncture in the rollout of PM, before widespread liability has taken hold, it is very important and useful to comprehensively study and make widely available the best information and projections of the risks and relevant factors for physician liability relating to PM. PUBLIC HEALTH RELEVANCE: The advent of personalized medicine (PM) has the potential to greatly impact and improve patient care by providing the opportunity for better tests, better drugs, and overall better health outcomes. The increased risk of legal liability for physicians wil ultimately influence which technologies will be adopted and rejected in the PM space, shape the relevant standard of care, dictate public health outcomes, and affect access to PM technologies and the care that the ultimate beneficiary, the patient, receives. Better understanding, communication and policy interventions relating to PM liability risks can help to ensure that liability has a beneficial rather than detrimental impact on PM uptake and implementation.