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The Genetics Laws in the United States and What They Mean For You

The Genetics Laws in the United States and What They Mean For You

22.DEC.2023

Written by Dani Roche

Reviewed by Wendi Gill, CGC

It’s common to wonder if participating in genetics research or even undergoing genetic testing will cause you to be discriminated against based on your genetics. 

In the United States, a framework of laws and regulations governs the use of genetic information at both the state and federal levels. In this article, we will cover: 

  • The key legislation to know

  • The LetsGetChecked privacy policy

The key legislation to know

Since the completion of the Human Genome Project in the early 2000s, the genetic landscape in the United States has undergone significant changes. The project’s successful mapping of the entire human genome opened new opportunities in understanding genetics but also raised concerns about the use of genetic information [1]. In response to this, the U.S. government crafted legislation to protect individuals from genetic discrimination and to regulate the field of genetic research. 

The Genetic Information Nondiscrimination Act (GINA)

One of the critical legislations addressing concerns in genetic research is the Genetic Information Nondiscrimination Act (or GINA for short), which was signed into law in 2008. The legislation is designed to prevent discrimination based on genetic information in both employment and health insurance [2]. 

GINA marked a crucial step forward in protecting individuals from the potential misuse of their genetic information, helping to foster public trust in genetic research and testing. It prohibits:

  • Employers from using genetic information to make decisions about hiring, promotion, or job assignments

  • Health insurers from using genetic information to deny coverage or set premiums 

It's important to note that these protections do not encompass life insurance or disability matters. GINA exclusively safeguards residents of the United States. Additional information can be located at ginahelp.org.

The Affordable Care Act (ACA)

The Affordable Care Act (ACA) was signed into law in 2010. It brought significant changes to the healthcare landscape, including provisions related to genetic information [3]. 

This provision provides additional protection to individuals seeking genetic testing or undergoing genomic research. Under the ACA, health insurers are prohibited from:

  • Denying coverage or charging higher premiums based on pre-existing conditions, including genetic predispositions

The Health Insurance Portability and Accountability Act (HIPAA) and the Common Rule

Genetic research can often involve the collection and analysis of large datasets containing genetic information. Ensuring the privacy and confidentiality of this information is a critical aspect of genetic laws in the U.S.

Although not specifically designed for genetic information, The Health Insurance Portability and Accountability Act (HIPAA) of 1996, establishes the standard for protecting health information, including genetic data [4]. It includes:

  • Standards for protecting the privacy and security of health and genetic data

  • Gives individuals rights concerning their data, for example, to access or amend their data

  • Mandates national standards to protect sensitive health and genetic information from disclosure to third parties without patient knowledge or authorization, except in very limited circumstances.

In addition to HIPAA, the Common Rule governs research involving individuals and plays a role in protecting the privacy of genetic research participants. Researchers must adhere to informed consent procedures, disclosing the purpose of the study, potential risks, and how genetic information will be handled [5]. 

The Federal Trade Commission (FTC) 

The Federal Trade Commission (FTC) plays a role in regulating direct-to-consumer genetic testing, ensuring that they adhere to the truth-in-advertising standards and provide accurate information to consumers. Organizations involved in healthcare and genetic testing must be transparent and truthful about their practices, for example concerning how they use or disclose health and genetic data they collect.

State legislation

Various U.S. state privacy laws are in place to protect individual’s personal data and grant rights to individuals about the collection, use, and disclosure of their data by businesses. This could include a right to receive a privacy notice detailing an organization’s privacy and security practices, such as:

  • What data they collect

  • How it is used, shared, and secured. 

Individuals also have privacy rights under these state privacy laws, such as:

  • Withdraw consent from activities involving personal data

  • Request their data be deleted

  • Learn more about the third parties who may receive their data and what is shared with such parties.  

Several states have also introduced privacy legislation that specifically addresses a range of healthcare issues, including standards for protecting biometric identifiers and health data. This includes genetic data, requirements to collect consent for certain activities involving health information, and other health data-specific privacy rights.

The LetsGetChecked privacy policy

Keeping your data private and secure is important to us. We use appropriate technical and organizational measures to ensure the security and confidentiality of your information and only share your information where required to deliver our products and services or where we have a legal basis to do so, such as with your consent. 

For further information about our privacy and security practices, please see our online privacy policy. Additionally, Washington state residents can review our Washington Consumer Health Data Privacy Policy.

References

1. National Human Genome Institute. The Human Genome Project. Online: Genome.gov 2. National Human Genome Institute. Genetic Information Nondiscrimination Act. Online: Genome.gov 3. National Library of Medicine. Genetic Information, Non-Discrimination, and Privacy Protections in Genetic Counseling Practice. Online: Ncbi.nlm.nih.gov 4. National Library of Medicine. What guidance does HIPAA offer to providers considering familial risk notification and cascade genetic testing? Online: Ncbi.nlm.nih.gov 5. National Library of Medicine. Revised Common Rule Changes to the Consent Process and Consent Form. Online: Ncbi.nlm.nih.gov