Apple’s keynote this week produced a lot of hype-worthy news, the way such Apple announcements often do. Laptops with no ports! Wearables with five-figure price tags! And who could forget the claims that the iPhone is now going to transform medical research? The keynote seemed to imply that iPhones, and ResearchKit, would transform our smartphones into medical tricorders, ready and able to diagnose Parkinson’s disease or atherosclerosis at the tap of a screen. Not so fast.
As much as Silicon Valley likes to think of itself as a force for good, disrupting this and pivoting that, it sometimes forgets that there’s a wider world out there. And when it comes to using devices in the practice of medicine, that world contains three very important letters: FDA. That’s right, the US Food and Drug Administration, which Congress has empowered to regulate the marketing and research uses of medical devices.
Oddly, not once in any of the announcement of ResearchKit did we see mention of premarket approval, or 510k submission, or even investigational device exemptions. Which is odd, because several of the uses touted in the announcement aren’t going to be possible without getting the FDA to say yes.