Fecal transplants are not a topic healthcare technology gurus would normally be expected to think about much, if at all. But the way the Food and Drug Administration is dealing with the somewhat cringe-inducing technique could have implications for how it's addressing innovations in health IT as well.
There's one group of transplanters, called OpenBiome, which is acting as a bank for donors that it screens. The issue is that FDA considers the transplants a drug. Technically, that means OpenBiome is probably operating outside the law, except that the FDA has invoked its “enforcement discretion powers” in the matter, a recent New Yorker article explains.
The phrase should become increasingly familiar to FDA watchers. The agency has been announcing enforcement discretion over a wide swath of health IT.
The result is that a number of novelties that probably don't pass normal regulatory muster are being allowed to flourish. For example, one recent study showed that 14% of the top apps measuring blood pressure in the Google Play store for Android devices make claims that should be overseen by FDA.
It seems FDA has taken a light touch, at the moment, for informal, small-scale innovations. That's a trend to watch in 2015 and the future.
Follow Darius Tahir on Twitter: @dariustahir
