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Aye, that'd be my idea, too. It's abhorrent to suggest that people
should be locked out of their own genomes, but it's irresponsible to
suggest that someone should be allowed to tell *others* what their
genetic fate is without any responsibility for the consequences.
Data is not diagnosis; I can tell someone "you look pale, you might be
anaemic", and that's not a diagnosis, it's merely data; particularly
if suffixed with "you should see a doctor/qualified nutritionist". If I
offer a service where people send me selfies and I tell them whether or
not they *are* anaemic, then I (in a hypothetical scenario where I'm
under their auspices) deserve the FDA's ire.
On Thu, 28 Nov 2013 17:31:35 -0700
"Daniel C." <dcrookston@gmail.com> wrote:
> On Thu, Nov 28, 2013 at 4:05 PM, Jeswin <phillyj101@gmail.com> wrote:
>
> > I thought the whole hullabaloo was the fact they were interpreting
> > the data. Sure, you need accurate sequence reads but don't you
> > cross a certain regulatory line when you start interpreting the
> > data? Doesn't it then become a medical device like a glucose meter?
> > I think the FDA sees potential for misuse. Didn't they start to
> > regulate smartphone app makers who started to venture into the
> > medical device area?
>
>
> That was my impression as well, though I didn't read the letters
> myself. If 23andMe wants to give people their genetic data and let
> them analyze it themselves, that would probably be fine. But if you
> start telling people that they have genes that predispose them to a
> certain disease, they may take action based on that and suddenly
> 23andMe is providing a medical diagnosis.
>
> I saw the other thread where some people were upset that the FDA
> would do such a thing, and while I am generally a fan of freedom of
> information I can also see the argument against 23andMe giving people
> this kind of information about themselves without the proper context
> or responsibility.
>
> -Dan
>
Re: [DIYbio] Text of 23andme email
4:43 PM |
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