23andMe's genetic reports are not medical diagnoses and should not be used to make health or treatment decisions. Any reliance on the information provided is explicitly at your own risk.
This analysis describes what 23andMe's agreement states, permits, or reserves. It does not constitute a legal determination about enforceability. Regulatory applicability and practical outcomes may vary by jurisdiction, enforcement context, and individual circumstances. Read our methodology
This clause shifts significant responsibility to the user by stating that genetic results, including health-related reports, are not medical advice and cannot substitute for professional clinical evaluation. Users acting on genetic findings without professional guidance have no contractual recourse against 23andMe.
Interpretive note: The enforceability of the 'solely at your own risk' liability disclaimer varies materially by jurisdiction; in many of the countries served by this international version, consumer protection law may limit the extent to which this disclaimer can insulate 23andMe from liability for health-related information.
The updated Terms now apply only to users who live outside the United States, Canada, EEA, UK, and Switzerland, or who access the Services from outside those regions. US, Canadian, EEA, UK, and Swiss…
The updated Terms of Service now apply exclusively to users in the United States, narrowing the geographic scope from the prior version that addressed users in multiple regions. The terms now contain…
The updated terms now apply only to users who live outside or access services outside the United States, Canada, EEA, UK, and Switzerland. Previously, the terms applied to US-based users. The terms a…
If you receive a genetic result suggesting elevated risk for a health condition and make a medical decision based on that result, the terms state this is entirely at your own risk and that 23andMe does not warrant or guarantee any health-related information provided. This is a significant liability limitation that consumers relying on health reports should understand.
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"23andMe's Services are not intended to diagnose any condition or disease. The Services are not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication, how much of a medication you should take, or determine any treatment. Reliance on any information provided by 23andMe, 23andMe employees, others appearing on our website at the invitation of 23andMe, or other visitors to our website is solely at your own risk.— Excerpt from 23andMe's 23andMe Terms of Service
(1) REGULATORY LANDSCAPE: This provision is central to 23andMe's regulatory positioning as a non-clinical, research-and-educational service rather than an in vitro diagnostic device or clinical laboratory test subject to FDA oversight in the US or equivalent bodies internationally. The terms acknowledge that 23andMe is licensed as a clinical laboratory in California but is not universally licensed internationally for health-related genetic testing. Regulatory bodies in served jurisdictions, including Australia's TGA and equivalent national authorities, may independently assess whether the services constitute medical devices or clinical tests regardless of this contractual disclaimer. The FTC Act is relevant to the adequacy of disclosures and whether the disclaimer is sufficient to prevent consumer confusion about the health significance of results. (2) GOVERNANCE EXPOSURE: High. The tension between offering reports that discuss disease risk and carrier status while simultaneously disclaiming any diagnostic or medical function is a known area of regulatory scrutiny for direct-to-consumer genetic testing companies. The disclaimer that reliance is 'solely at your own risk' is a broad contractual liability waiver whose enforceability varies significantly by jurisdiction, particularly in consumer protection contexts where liability waivers for personal harm are often limited or void. (3) JURISDICTION FLAGS: In the EU, UK, Australia, and many other jurisdictions, contractual disclaimers that attempt to exclude liability for personal injury or that contradict mandatory consumer statutory rights may be unenforceable. Australia's Australian Consumer Law, for example, provides guarantees that cannot be excluded by contract. Singapore, New Zealand, and Canadian jurisdictions similarly have consumer protection frameworks that limit the enforceability of broad liability exclusions. (4) CONTRACT AND VENDOR IMPLICATIONS: Healthcare providers or employers seeking to use 23andMe results in a clinical or occupational context should note that the terms explicitly disclaim any clinical validity or medical utility for these purposes. The prohibition on employer use of the services as a user eligibility condition reinforces this boundary. (5) COMPLIANCE CONSIDERATIONS: Compliance teams should assess whether the disclaimer language is adequate under each served jurisdiction's consumer protection law and whether additional disclosures are required for health-related genetic reports. The statement that 'many of the genetic discoveries that we report have not been clinically validated' is a material disclosure that should be prominently surfaced at the point of purchase and result delivery, not only in the terms of service.
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This clause shifts significant responsibility to the user by stating that genetic results, including health-related reports, are not medical advice and cannot substitute for professional clinical evaluation. Users acting on genetic findings without professional guidance have no contractual recourse against 23andMe.
If you receive a genetic result suggesting elevated risk for a health condition and make a medical decision based on that result, the terms state this is entirely at your own risk and that 23andMe does not warrant or guarantee any health-related information provided. This is a significant liability limitation that consumers relying on health reports should understand.
No. ConductAtlas is an independent monitoring service. We are not affiliated with, endorsed by, or sponsored by 23andMe.