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Navigating the Ethical Complexities in Direct-to-Consumer Genetic Testing Through a Legal Lens

Author: Gurman Dhaliwal (gdhaliwa@ucsd.edu)

Table of Contents

Introduction

This project investigates the ethical complexities underlying direct-to-consumer genetic testing (DTC-GT) through a legal lens.

DTC-GT is a type of genetic testing that allows consumers to order genetic tests and receive results without the involvement of medical professionals. The results can include information about health, ancestry, and other characteristics.

The DTC-GT market has grown dramatically in popularity in recent years and it’s predicted to keep growing. The U.S. DTC-GT market size surpassed 3 billion USD and is expected to continue to grow at a compound annual growth rate of 25% from 2024 to 2030, according to a report by Grandview Research. This growth is further supported by the fact that nearly 100 million individuals have completed a DTC-GT. Amid this growth, recent data breaches have brought privacy concerns into the limelight.

There is no comprehensive federal initiative providing legal guidance in the United States, leaving states and companies to create patchwork. While ethical guidelines themselves could offer conceptual frameworks, legal regulations provide enforceable mechanisms that would protect consumer rights.

This paper aims to explore the current regulatory landscape, identify key ethical and legal challenges, and propose potential solutions to address these challenges in the rapidly evolving field of DTC-GT.

Existing Gaps in Regulation

U.S. Regulation

The patchwork of regulations and lack of comprehensive federal oversight in the United States creates significant challenges for ensuring consistent protection of consumer rights and privacy in DTC-GT. While some states have taken steps to address these issues, the inconsistency across states highlights the need for a more unified approach to regulation in this rapidly growing field.

Federal

While federal laws such as the Common Rule and HIPAA aim to protect individuals’ privacy, traditional methods for anonymization are difficult to apply due to the uniqueness of genetic data. HIPAA doesn’t apply to DTC-GT since there is no physician directly involved.

The three primary federal agencies responsible for genetic data are as follows:

  1. Center for Medicare and Medicaid Services (CMS) via the Clinical Laboratory Improvements Act (CLIA): The CLIA is primarily concerned with the analytical validation of testing but has no authority to assess the utility of the tests being performed or any ability to regulate the information DTC-GT companies have to convey to consumers.

  2. Federal Drug Administration (FDA): The FDA approves any diagnostic testing but doesn’t monitor any data storage techniques.

  3. Federal Trade Commission (FTC): The FTC is supposed to ensure DTC-GT companies don’t act deceptively and prevent them from misleading consumers. It endorses the NIST Privacy Framework and the Fair Information Practice Principles but lacks enforcement power.

Supreme Court

According to a Note from the Houston Law Review exploring the relation of DTC-GT and the Fourth Amendment, the Supreme Court and Legislature haven’t yet addressed whether genetic information through DTC-GT is protected by the Fourth Amendment (protections against unreasonable search and seizures, with an exception for law enforcement). The Article examines the decision in Carpenter v. United States and understands how the Supreme Court could address Fourth Amendment concerns in genetic testing. It concludes that either the Judiciary should choose not to extend the third-party doctrine to DTC-GT or abolish it entirely. Both options will do little for consumers’ privacy unless the Supreme Court determines that genetic information is protected under the Fourth Amendment.

It’s possible, but given the enormous leadership potential and exponentially growing market, it’s unlikely that the Supreme Court will arrive at such a decisive decision before these tests reach maturity.

UPHOLD Privacy Act

U.S. Senators Amy Klobuchar, Elizabeth Warren, and Mazie Hirono introduced legislation to expand protections for health data for consumers. It was introduced in the Senate in March 2023.

Link to the Bill

This bill restricts the collection, retention, use, and disclosure of personal health data by certain commercial entities (as well as individuals, nonprofits, and common carriers). The bill does not apply to health providers, insurance plans, or related busines