Consumer Protections for Genomics and Precision Health

标题：“基因组学和精准健康的消费者保护” 项目概要/摘要（30行） 这个提议的R 01项目将解决多个领域、主题和问题， NHGRI for ELSI research.基因组学和精准健康方面的消费者保护（包括对 直接面向消费者的基因组检测、解读服务和产品;移动的医疗技术;以及数据 经纪人服务）的特点很差，很少得到研究关注。法律的和政策 研究集中在规范医疗器械和临床实验室的联邦机构，而不是 一个机构负责监督在线隐私，防止虚假广告，并监管不公平，去- 所有商业领域的优惠和反竞争贸易做法（即，联邦贸易委员会， FTC）。FTC对基因组学和精准健康的重要性越来越明显，因为医疗保健采用了电子医疗技术。 商业趋势，健康和消费品的定性区别是模糊的， “医学的超级化”。美国人正在经历前所未有的个人数据 基因组、健康记录和自我报告数据的聚合与智能手机的数据相关联， 可穿戴设备、家用显示器等。这种数据利用是否能实现 预期医学以及个人是否将利用该数据（例如，利用基因组和其他 在商业决策中使用健康信息或在医疗决策中使用非健康数据） 服务的定制、不可容忍的隐私侵犯或可容忍的妥协。一个坚定的理解 消费者保护政策对于理解基因隐私的真正风险至关重要，基因歧视， 数据本质主义和数据本质主义在生活的社会经验方面，不涉及受 《健康信息携带和责任法》以及遗传歧视的两个领域之外， 《基因信息非歧视法》已经禁止了这种行为。美国依靠A 隐私和数据保护的部门方法。没有对消费者保护进行深入的描述 联邦贸易委员会的政策（负责联邦贸易委员会法案）和国家推论（即，总检察长负责 “小FTC法案”）是经验ELSI研究进展的障碍（例如，遗传例外论研究 及其对公共政策态度的影响）和规范性ELSI研究（例如，新兴数据研究 不平等和公平政策的发展），并阻碍了评估联邦 全面的隐私法及其对基因组研究的影响。这个为期两年的项目的目标是 及时填补这一知识空白。本研究的平行目标是深入描述联邦（Aim 1)和国家（目标2）消费者保护在美国可用的基因组学和精确的健康。法律的和 政策研究方法将被用来确定、批判性地检查和描述消费者保护 联邦贸易委员会和总检察长在50个州、华盛顿特区和5个地区的执法活动， (1)DTC个人基因组服务和产品，（2）移动的健康应用程序，以及（3）数据代理服务。

TITLE: “Consumer Protections for Genomics and Precision Health” PROJECT SUMMARY/ABSTRACT (30 lines) This proposed R01 project would address multiple domains, topics, and issues explicitly prioritized by the NHGRI for ELSI research. Consumer protections for genomics and precision health (including regulation of direct-to-consumer genomic tests, interpretation services, and products; mobile health technologies; and data broker services) are poorly characterized and have received scant research attention. Legal and policy research has focused on federal agencies regulating medical devices and clinical laboratories rather than the one agency responsible for overseeing online privacy, preventing false advertising, and policing unfair, de- ceptive, and anti-competitive trade practices across all commerce areas (i.e., the Federal Trade Commission, FTC). The FTC's importance to genomics and precision health is becoming clearer, as healthcare adopts e- commerce trends, the qualitative distinction of health and consumer products is blurred, and warnings of the “uberization of medicine” are raised. Americans are experiencing unprecedented levels of personal data aggregation with genomic, health records, and self-reported data being linked with data from smartphones, wearables, home monitors, and more. It remains to be seen whether such data leveraging will achieve anticipatory medicine and whether individuals will view this data leveraging (e.g., use of genomic and other health information in commercial decisions or use of non-health data in medical decisions) as welcomed customization of services, reprehensible intrusion of privacy, or a tolerable compromise. A firm understanding of consumer protection policies is critical for appreciating the true risks of genetic privacy, genetic discrimin- ation, and data essentialism in aspects of the lived social experience not involving businesses bound by the Health Information Portability and Accountability Act and outside of the two areas in which genetic discrimin- ation has already been banned by the Genetic Information Nondiscrimination Act. The US relies upon a sectoral approach to privacy and data protection. Not having a deep characterization of consumer protection policies of the FTC (responsible for the FTC Act) and state corollaries (i.e., Attorneys General responsible for the “little FTC Acts”) is a barrier to progress in empirical ELSI research (e.g., study of genetic exceptionalism and its influence on attitudes toward public policy) and normative ELSI research (e.g., study of emerging data disparities and development of policies for fairness) and impedes efforts to evaluate proposals for a federal comprehensive privacy law and their implications for genomic research. The goal of this two-year project is to close this knowledge gap promptly. The parallel aims of this study are to deeply characterize the federal (Aim 1) and state (Aim 2) consumer protections available in the US for genomics and precision health. Legal and policy research methods will be used to identify, critically examine, and characterize consumer protection enforcement activities of the FTC and Attorneys General in the 50 states, DC, and five territories in matters of (1) DTC personal genomics services and products, (2) mobile health apps, and (3) data broker services.