Bioethical, Legal, and Anthropological Study of Technologies (BLAST)

项目摘要 努力将医学从一种反动的、试错的奋进转变为一种预期的、有证据的努力， 被称为“精确医学”的基于基础的奋进已经进行了几年。与此同时， 还努力促进以患者为中心的“学习型医疗保健系统”（其中科学 研究为医疗保健的提供信息，医疗保健影响研究），并使 适用的伦理、法律的和监管框架，以加速生物医学创新。小说 生物医学技术（包括人工智能驱动的机器人手术技术，仿生技术，如 用于1型糖尿病的人工胰腺系统，以及器官如心脏的生物打印）正在迅速发展。 然而，有一个广泛的道德，法律的，和社会影响（ELSI），仍然没有得到充分的审查，并呼吁 质疑现有的法律，法规和道德准则是否足以确保这些 技术是安全、有效、公平和保护隐私的（而不是不道德或非法的 阻碍患者获取自己的健康信息或妨碍研究、开发和 充分发挥“混合搭配”生物医学技术的潜力，满足每个人的需要 偏好）。 在这个探索性的项目中，我们试图研究数据实践，数据隐私，数据访问和数据 司法问题（目标1）;审查监管途径并找出监管差距（目标2）;以及审查赔偿责任 风险（目标3）与医疗保健中三种技术的开发和使用有关：机器人技术，仿生学， 生物打印要做到这一点，我们将依靠生物伦理学、法律的和人类学的创新组合。 包括与科学家/工程师和律师进行关键信息提供者访谈的方法， 技术开发者的网站披露、规范性生物伦理学和比较法律的研究（比较 美国和欧盟的监管框架），并在以下四个领域对新兴判例法进行法律的研究： 责任、医疗事故责任、组织责任和知识产权侵权。这 这种方法可以确定三种技术之间的相似性和差异，并确定 感知和实际责任风险。 该项目的成功完成将提供重要的见解，不仅将奠定一个 为随后的经验和规范伦理、法律的和社会影响奠定坚实的经验基础 关于机器人，仿生学和生物打印的研究，也提供了重要的见解， 开发和完善教育材料、工程标准、研究和临床实践 指导，以及机构和公共政策和程序，以帮助确保技术的道德和 在精准医疗中负责任地使用。

PROJECT SUMMARY Efforts to transform medicine from a reactionary, trial-and-error endeavor to an anticipatory, evidence- based endeavor referred to as “precision medicine” have been underway for several years. Concurrently, efforts also were undertaken to promote patient-centered “learning healthcare systems” (in which scientific research informs the delivery of healthcare and healthcare influences research) and to modernize the applicable ethical, legal, and regulatory frameworks in order to accelerate biomedical innovations. Novel biomedical technologies (including AI-driven robotic surgical technologies, bionic technologies such as the artificial pancreas systems for type 1 diabetes, and bioprinting of organs such as hearts) are advancing rapidly. Yet there are a wide range of ethical, legal, and social implications (ELSI) that remain under-examined and call into question whether existing laws, regulations, and ethical guidelines are adequate for ensuring that these technologies are safe, effective, equitable, and privacy-preserving (while not unethically or unlawfully obstructing patient access to their own health information or hampering the research, development, and realization of the full potential of “mix and match” biomedical technologies tailored to each individual's needs and preferences). In this exploratory project, we seek to examine the data practices, data privacy, data access, and data justice issues (Aim 1); examine regulatory pathways and identify regulatory gaps (Aim 2); and examine liability risks (Aim 3) related to the development and use of three technologies in healthcare: robotics, bionics, and bioprinting. To do so, we will rely upon an innovative combination of bioethical, legal, and anthropological approaches involving key informant interviews with scientists/engineers and lawyers, internet research of technology developers' website disclosures, normative bioethics and comparative legal research (comparing the US and EU regulatory frameworks), and legal research of emerging case law in four areas: products liability, medical malpractice liability, organizational liability, and intellectual property infringement. This approach could identify similarities and differences among the three technologies and also identify gaps in perceived and actual liability risks. The successful completion of this project would provide important insights that would not only lay a solid empirical foundation for subsequent empirical and normative ethical, legal, and social implications (ELSI) research regarding robotics, bionics, and bioprinting but also provide important insights to inform the development, and refinement of educational materials, engineering standards, research and clinical practice guidance, and institutional and public policies and procedures to help ensure the technologies' ethical and responsible use in precision medicine.