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

技术的生物伦理、法律和人类学研究 (BLAST)

• 批准号: 10831226
• 负责人: Jennifer Kristin Wagner
• 金额: $ 20.05万
• 依托单位: PENNSYLVANIA STATE UNIVERSITY, THE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10831226
• 关键词: 3-Dimensional; Acceleration; Address; Adoption; Affect; Algorithms; Area; Artificial Intelligence; Artificial Organs; Artificial Pancreas; Artificial tissue; Attention; Bioethics; Biological Products; Biomedical Engineering; Biomedical Technology; Bionics; Classification; Complex; Computer software; Dangerousness; Data; Development; Devices; Disclosure; Disease; Educational Materials; Effectiveness; Emerging Technologies; Engineering; Ensure; Environment; Equity; Ethics; Europe; European; Eye; Food, Drug and Cosmetic Act; Foundations; Growth; Guidelines; Health; Health Personnel; Health Professional; Healthcare; Healthcare Systems; Heart; Hospitals; Human; Implant; Individual; Institutional Policy; Insulin-Dependent Diabetes Mellitus; Insurance Carriers; Intellectual Property; Internet; Interview; Justice; Knowledge; Language; Laws; Lawyers; Learning; Legal; Life Cycle Stages; Limb Prosthesis; Manufacturer; Marketing; Medical; Medical Device; Medicine; Modeling; Modernization; Operative Surgical Procedures; Organ; Patients; Pharmaceutical Preparations; Policy Maker; Privacy; Procedures; Process; Provider; Public Policy; Recommendation; Regulation; Regulatory Pathway; Research; Research Methodology; Risk; Robotics; Safety; Scientist; Solid; Surgeon; System; Technology; Thinking; Time; Translations; Update; World Health; bioprinting; cancer classification; clinical practice; comparative; data access; data privacy; deep learning; deep learning model; design; digital health; ethical, legal, and social implication; evidence base; functional improvement; health care delivery; health care settings; improved; informant; innovation; insight; interest; medical malpractice; member; new technology; novel; patient oriented; patient population; precision medicine; preference; privacy preservation; repaired; robotic system; standard of care; tool; trend; web site

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.

项目概要 努力将医学从反动的、反复试验的努力转变为前瞻性的、循证的 与此同时，被称为“精准医学”的努力已经进行了好几年。 还采取了促进以患者为中心的努力“学习医疗保健系统”（其中科学 研究为医疗保健的提供和医疗保健影响研究提供信息）并使医疗保健现代化 适用的道德、法律和监管框架，以加速生物医学创新。 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，例如 用于 1 型糖尿病的人工胰腺系统以及心脏等器官的生物打印）正在迅速发展。 然而，存在广泛的道德、法律和社会影响 (ELSI)，这些影响仍未得到充分审查，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（同时不存在不道德或非法的情况） 阻碍患者获取自己的健康信息或阻碍研究、开发和 充分发挥根据每个人的需求而定制的“混合搭配”生物医学技术的潜力 和偏好）。 在这个探索性项目中，我们寻求检查数据实践、数据隐私、数据访问和数据 正义问题（目标 1）；检查监管途径并确定监管差距（目标 2）； 与医疗保健领域三种技术的开发和使用相关的风险（目标 3）：机器人技术、仿生学和 为此，我们将依靠生物伦理学、法律和人类学的创新结合。 方法包括对科学家/工程师和律师进行关键知情人访谈、互联网研究 技术开发商网站披露、规范生物伦理学和比较法律研究（比较 美国和欧盟的监管框架），以及四个领域新兴判例法的法律研究： 产品 责任、医疗事故责任、组织责任、知识产权侵权。 方法可以识别三种技术之间的相似点和差异，并找出差距 感知的和实际的责任风险。 该项目的成功完成将提供重要的见解，不仅奠定了 为随后的实证和规范伦理、法律和社会影响奠定了坚实的实证基础（ELSI） 有关机器人、仿生学和生物打印的研究，但也提供了重要的见解，以告知 教育材料、工程标准、研究和临床实践的开发和完善 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 精准医疗中负责任的使用。