23andMe and the FDA clearance - Discover Magazine (blog)

As they say, read all about it. I’m rather ambivalent. 23andMe has a business rationale to go in this direction, so I don’t begrudge them their decision. The problem, at least from a legal perspective, is that they’re providing medical advice at least implicitly. And I think this medical direction is really where the big money is in any case. There’s no angle standing on principle.

But, I still believe that on a deep level regulatory agencies don’t “get it.” Our own genotype and genome is going to be a cheap commodity in the next few years. Services like Promethease will proliferate to provide people open source information. Is openSNP going to the FDA anytime soon? The main reason that firms like 23andMe will go through regulatory hurdles is that they are, or aim to be, legitimate public entities. In other words this is an artifact of our institutions. Mind you, 23andMe et al. will probably always have slicker user interfaces, and there’s some value in that. But that doesn’t entail FDA oversight, does it?

The shift toward automation and computation are real ones, and I have a difficult time how seeing regulation developed in the 20th century is going to be relevant. There is a doctor shortage in this country. The number of graduates from medical schools is not keeping up with population growth, or a shift toward a population which consumes more health care. For regulatory reasons professionals like nurses can’t provide all the services that a full M.D. can, and I see no expectation that the medical professionals of the USA will welcome more competitors. So technology is the way to go in increasing productivity. If doctors don’t go into general practice because there’s no money in that, perhaps there’ll be an app for that?

I’m not imagining some magic bull algorithm. Rather, I’m assuming that the quantified self and more powerful artificial diagnostics will be able to take care a lot of the “low hanging fruit.” Personal genomics is part of this, though obviously not the totality of it.