4 ms·

From the 23andme TOS: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Informati

by bcl 13y ago

From the 23andme TOS: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider." https://www.23andme.com/about/tos/ https://www.23andme.com/about/tos/

edmccard 13y ago
> From the 23andme TOS: > ... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results") In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims. [1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
Karunamon 13y ago
This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less. Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...
- wissler 13y ago
  In our era, it doesn't matter if two consenting parties agree, what matters is whether the judge or regulatory agency approves of the agreement.
  - hackinthebochs 13y ago
    Considering the fact that we know 99.9% of people blindly click through agreements, this is the way it should be. Companies should not be able to use the lack of careful reading of TOS/T&C to their benefit.
    - wissler 13y ago
      Considering the fact that we know 99.9% of people blindly click through agreements, this is the way it should be. This is just a bald-faced non-sequitur.
      - hackinthebochs 13y ago
        OK, Data, how about this: Should a company should be able to bury a clause in their ToS such as "by accepting this contract, you agree to forfeit to The Company your first born and every cent you ever make henceforth"? Of course not. People should be able to knowingly enter into whatever contract they want. The problem is that (as I cited elsewhere) information/effort/payoff asymmetries makes such a scenario ripe for exploitation. Therefore it follows that regulations should constrain what can reasonably appear in a contract. One should not have to parse 100 pages of legalese just to make sure they're not tacitly agreeing to indentured servitude for the rest of their lives. If this were not the case, it would be painfully easy for unscrupulous business to bury unsavory claims under mountains of incomprehensible legalese. What regulation does is balance the scales in favor of consumers. This does in fact follow from the fact that 99.9% of the public does not read and/or cannot comprehend every instance from the set of possible legal contracts.
        wissler 13y ago
bebop 13y ago
The TOS is perfectly valid. It is a solid document advising people to take any results up with a medial professional. The service tells people that the product is not a medical diagnosis, however the service does provide medical information. This clearly puts said service in the realm of the FDA. Therefor compliance should be sought. Really this goes for any company building medical services. Consulting someone on HIPAA compliance, as well as, FDA standards and practices is a must. Is this fair in this case? Who knows. It is irrelevant. Resistance is futile.

by bcl 13y ago

edmccard 13y ago

> From the 23andme TOS: > ... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results") In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims. [1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...

Karunamon 13y ago

This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less. Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...

wissler 13y ago
In our era, it doesn't matter if two consenting parties agree, what matters is whether the judge or regulatory agency approves of the agreement.
- hackinthebochs 13y ago
  Considering the fact that we know 99.9% of people blindly click through agreements, this is the way it should be. Companies should not be able to use the lack of careful reading of TOS/T&C to their benefit.
  - wissler 13y ago
    Considering the fact that we know 99.9% of people blindly click through agreements, this is the way it should be. This is just a bald-faced non-sequitur.
    - hackinthebochs 13y ago
      OK, Data, how about this: Should a company should be able to bury a clause in their ToS such as "by accepting this contract, you agree to forfeit to The Company your first born and every cent you ever make henceforth"? Of course not. People should be able to knowingly enter into whatever contract they want. The problem is that (as I cited elsewhere) information/effort/payoff asymmetries makes such a scenario ripe for exploitation. Therefore it follows that regulations should constrain what can reasonably appear in a contract. One should not have to parse 100 pages of legalese just to make sure they're not tacitly agreeing to indentured servitude for the rest of their lives. If this were not the case, it would be painfully easy for unscrupulous business to bury unsavory claims under mountains of incomprehensible legalese. What regulation does is balance the scales in favor of consumers. This does in fact follow from the fact that 99.9% of the public does not read and/or cannot comprehend every instance from the set of possible legal contracts.
      - wissler 13y ago

bebop 13y ago

The TOS is perfectly valid. It is a solid document advising people to take any results up with a medial professional. The service tells people that the product is not a medical diagnosis, however the service does provide medical information. This clearly puts said service in the realm of the FDA. Therefor compliance should be sought. Really this goes for any company building medical services. Consulting someone on HIPAA compliance, as well as, FDA standards and practices is a must. Is this fair in this case? Who knows. It is irrelevant. Resistance is futile.