Consumer Protections for Genomics and Precision Health

标题：《基因组学与精准健康的消费者保护》 项目摘要/摘要(30行) 这个建议的R01项目将解决多个领域、主题和问题，这些领域、主题和问题由 NHGRI用于ELSI研究。消费者对基因组学和精确健康的保护(包括监管 直接面向消费者的基因组测试、解释服务和产品；移动健康技术；以及数据 经纪服务)的特点很差，几乎没有得到研究关注。法律和政策 研究的重点是监管医疗设备和临床实验室的联邦机构，而不是 一个负责监督在线隐私、防止虚假广告和监管不公平的机构，去- 所有商业领域的概念性和反竞争贸易做法(即联邦贸易委员会， 联邦贸易委员会)。随着医疗保健采用电子技术，联邦贸易委员会对基因组学和精确医疗的重要性正变得越来越明显。 商业趋势，保健品和消费品的质量区别模糊，警告 “医学的Uber化”被提了出来。美国人正在经历前所未有的个人数据水平 通过将基因组、健康记录和自我报告数据与来自智能手机的数据链接起来进行聚合， 可穿戴设备、家庭监视器等。这种数据杠杆是否会实现，还有待观察 预见性医学以及个人是否会利用(例如，使用基因组和其他 商业决策中的健康信息或医疗决策中使用非健康数据)受到欢迎 定制服务、应受谴责的侵犯隐私行为或可容忍的妥协。坚定的认识 消费者保护政策对于认识到基因隐私的真正风险至关重要，基因识别- 生活社会体验方面的数据本质主义，不涉及受 《卫生信息可携带性和责任法》以及基因区分的两个领域之外- 《遗传信息非歧视法案》已经禁止了这种行为。美国依赖于一个 对隐私和数据保护采取部门办法。没有对消费者保护有深入的描述 联邦贸易委员会的政策(负责联邦贸易委员会法案)和州推论(即，总检察长负责 《小联邦贸易委员会法案》)是经验ELSI研究(例如，遗传例外论研究)取得进展的障碍 及其对公共政策态度的影响)和规范性ELSI研究(例如，对新兴数据的研究 公平政策的差异和发展)，并阻碍了评估联邦政府提案的努力 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 迅速弥合这一知识鸿沟。这项研究的平行目标是深入描述联邦(AIM)的特征 1)和州(AIM 2)在美国为基因组学和精确健康提供的消费者保护。法律和 将使用政策研究方法来识别、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、哥伦比亚特区和五个地区的执法活动 (1)DTC个人基因组学服务和产品，(2)移动健康应用程序，(3)数据经纪人服务。

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.