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.
Will 23andMe sign a business associate agreement (BAA)?
No, 23andMe will not sign a business associate agreement, and therefore is not HIPAA compliant.
What does 23andMe’s privacy policy cover?
23andMe is governed by state-level consumer privacy laws such as:
- California Consumer Privacy Act (CCPA)
- Colorado Privacy Act (CPA)
- Utah Consumer Privacy Act (UCPA)
- Connecticut Data Privacy Act (CTDPA)
- Virginia Consumer Data Protection Act (VCDPA)
Their Privacy Statement outlines how personal and genetic data may be used, shared, or transferred, including in the event of a sale or bankruptcy.
What does 23andMe’s privacy policy exclude?
23andMe is not bound by HIPAA’s protections for PHI.
This means:
- No HIPAA breach notifications
- No right of access under HIPAA
- No restrictions on data sale or transfer under HIPAA
Conclusion
23andMe does not sign a BAA and is therefore not HIPAA compliant.
Learn more: HIPAA Compliant Email: The Definitive Guide
FAQS
What is a business associate agreement?
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.
What is HIPAA?
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.
Who does HIPAA apply to?
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.
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