# Consumer Protections for Genomics and Precision Health

> **NIH NIH R01** · GEISINGER CLINIC · 2020 · $399,957

## Abstract

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 genomic...

## Key facts

- **NIH application ID:** 9943719
- **Project number:** 1R01HG011051-01
- **Recipient organization:** GEISINGER CLINIC
- **Principal Investigator:** Jennifer Kristin Wagner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $399,957
- **Award type:** 1
- **Project period:** 2020-09-18 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9943719

## Citation

> US National Institutes of Health, RePORTER application 9943719, Consumer Protections for Genomics and Precision Health (1R01HG011051-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9943719. Licensed CC0.

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