23andMe is a direct-to-consumer genetic testing company that provides ancestry reports, health risk assessments, and trait analyses based on DNA samples submitted by individuals. It operates independently of healthcare providers and does not require physician involvement.
With 23andMe, individuals can explore their genetic makeup, learn about inherited traits, and access health predisposition reports, all without clinical oversight or integration with healthcare systems.
Is 23andMe HIPAA compliant? No, based on our research, 23andMe is not HIPAA compliant.
No, 23andMe will not sign a business associate agreement, and therefore is not HIPAA compliant.
23andMe is governed by state-level consumer privacy laws such as:
Their Privacy Statement outlines how personal and genetic data may be used, shared, or transferred, including in the event of a sale or bankruptcy.
23andMe is not bound by HIPAA’s protections for PHI.
This means:
23andMe does not sign a BAA and is therefore not HIPAA compliant.
Learn more: HIPAA Compliant Email: The Definitive Guide
A business associate agreement (BAA) is a legally binding contract establishing a relationship between a covered entity under the Health Insurance Portability and Accountability Act (HIPAA) and its business associates. The purpose of this agreement is to ensure the proper protection of personal health information (PHI) as required by HIPAA regulations.
The Health Insurance Portability and Accountability Act (HIPAA) sets national standards for protecting the privacy and security of certain health information, known as protected health information (PHI).
HIPAA is designed to protect the privacy and security of individuals’ health information and to ensure that healthcare providers and insurers can securely exchange electronic health information. Violations of HIPAA can result in significant fines and penalties for covered entities.
HIPAA applies to covered entities, which include healthcare providers, health plans, and healthcare clearinghouses. It also applies to business associates of these covered entities. These are entities that perform certain functions or activities on behalf of the covered entity.