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

个性化医疗（PM）有可能在未来十年内改变医学和医疗保健系统。一个被忽视的变量，将发挥重要作用，在实施PM是潜在的法律的责任。医生，在吸收PM的关键守门人，是在责任的最大风险。目前， 关于PM测试在临床护理中的使用存在很大的不确定性、不一致性和快速变化。正是在这一不确定和变化的时期，责任的可能性最大，因此，对这些问题的交叉点进行全面的法律的研究和分析的必要性最为紧迫。该项目旨在通过提供以下法律的理论、经验和政策研究，填补对PM责任风险理解的差距： 风险，影响和可能的政策方针方面的PM责任。该项目的结果可以帮助更好地理解和预测PM的未来进程，并确定可能可用的关键法律的和政策杠杆，以确保责任在PM的实施中发挥有益而不是有害的作用。该项目有五个主要目标。该项目将提供一个全面的调查和分析的潜在责任的医生，首先通过检查适用的索赔，辩护和学说，将提供法律的框架的责任，目前正在经历重要的变化。其次，我们将通过整合 理论分析与事实模式和证据在四个可能的PM案例研究，以及通过评估责任的教训，从吸收以前的医疗技术和做法。第三，我们将研究责任可能对医生、患者以及PM的更广泛采用、可用性和实施产生的影响。第四，我们将确定和评估可用于更好地管理PM竞技场风险和不确定性的政策工具。最后，我们将通过针对三个关键利益相关者群体的外展计划传达我们项目的发现和影响：（i）医生和医学教育工作者;（ii）患者群体和倡导者;（iii）法律的从业人员（包括法官）。在推出PM的关键时刻，在广泛的责任已经站稳脚跟之前，全面研究并广泛提供与PM相关的医生责任的风险和相关因素的最佳信息和预测是非常重要和有用的。

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.