Consumer Protections for Genomics and Precision Health

Project: Research project

Project Details


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.
Effective start/end date9/1/218/31/22


  • National Human Genome Research Institute: $384,271.00


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