Application of regulatory handbrake to 23andMe offers cautionary tale to Silicon Valley

Apple Watch--Courtesy of Apple

Observers tipped the arrival of Apple's ($AAPL) long-awaited Watch to bring the worlds of health and tech closer than ever, but this week's announcement was notably light on medical uses. The failure to even mention HealthKit in the presentation has sparked discussion of Silicon Valley's wariness of healthcare regulators in the wake of 23andMe's run-in with the FDA.

As the highest-profile company among the early health players in Silicon Valley, the experience of 23andMe is being observed closely. Associated Press reports sales have fallen 50% since November--when the FDA sent its warning letter--slowing the company's advance toward its goal of building a database of one million genetic profiles. To recover, 23andMe has hired four executives with healthcare backgrounds and begun working to gain FDA clearance for its tests.

The 23andMe case is seen as being indicative of a broader clash between Silicon Valley and Washington. "This is a culture war. Silicon Valley is used to just bringing their products straight to the market and any regulatory scheme that involves scrutiny and delay is alien to them," regulatory consultant Steve Grossman said. Reuters reports Apple may have deliberately avoided talking up Watch's medical applications to keep the FDA off its back.

Of course, Apple's silence has done little to quell speculation about how Watch could be used in medical research and healthcare. Discussions center on applications for the infrared and visible-light LEDs--plus photodiode sensors--that allow Watch to track health metrics. While the device has fewer sensors than early reports suggested, the use of infrared and visible-light sensors appears tailored to quell the doubts many in research and healthcare have about the accuracy of self-tracking devices.

"Somebody did some deep research on that and invested a lot of money in it. The sensors in the Watch might be good for wellness apps because they focus on measuring something so precisely," Neurotechnology Industry Organization founder and CEO Zack Lynch told VentureBeat.

- read the 23andMe interview
- and the AP's other article
- check out Reuters' piece
- here's the VentureBeat feature

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