TITLE: ?Consumer Protections for Personal Genomics and Precision Health? PROJECT SUMMARY/ABSTRACT (30 lines) This proposed R01 project would address multiple domains, topics, and issues that have been explicitly prioritized by the NHGRI for ELSI research. Consumer protections for personal genomics and precision health (including regulation of direct-to-consumer genomic products and services; mobile health technologies; and data broker services) are poorly characterized and have received scant research attention. Legal and policy research has focused on the federal agencies regulating medical devices and clinical laboratories rather than the agency responsible for overseeing online privacy, preventing false advertising, and policing unfair, deceptive, and anti-competitive trade practices across all commerce (i.e., the Federal Trade Commission, FTC). The FTC's importance to personal 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 this data leveraging will achieve anticipatory medicine and whether individuals will view this data leveraging (e.g., use of genomic 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 discrimination, 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 discrimination 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., the Attorneys General responsible for the ?little FTC Acts?) is a barrier to progress in both 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 resolve this problem. The specific parallel aims of this study are to deeply characterize the federal (Aim 1) and state (Aim 2) consumer protections available in the United States for personal genomics and precision health. Legal and policy research methods will be used to identify, critically examine, and characterize the 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.
Consumer protections are of rising importance to the sustainability of personal genomics industry and the realization of precision health, yet the extent of consumer protections available from the Federal Trade Commission (the primary federal agency in the United States responsible for ensuring online privacy and data security beyond medical settings and for the prevention of unfair and deceptive trade practices of companies that might not be governed by HIPAA) are poorly characterized and have received surprisingly little ELSI research attention. This foundational knowledge is necessary for responsible policymaking; for legal epidemiology; for empirical ELSI research to better understand privacy, data protection, and nondiscrimination policies (and the influence of genetic exceptionalism and data essentialism on those policies); and for normative ELSI research that would develop policies to promote fairness and social justice (e.g., by adequately addressing the potential public health risks of emerging vulnerable populations of ?data rich? and ?data poor? individuals). To resolve this serious problem, this project aims to characterize the federal as well as state consumer protections for personal genomics and precision health through legal and policy research methods to identify and analyze the activities of the Federal Trade Commission and state Attorneys General in matters of direct-to-consumer personal genomic services and products; mobile health apps; and data broker services.
