The tech industry has trumpeted the promise of wearable fitness and health devices to improve care by empowering patients with a critical resource: data. But turning a stream of information into predictions of outcomes isn’t an easy task. And there are still a number of significant obstacles before this sort of tech can get us to a point where, say, a Fitbit or Jawbone-like device can accurately assess someone’s risk of a heart attack.
Dr. Eric Topol, director of the Scripps Translational Science Institute; John Carlson, president of medical solutions at Flex (FLEX); Dr. David Rhew, chief medical officer and health care head at Samsung Electronics America; and Dr. Dave Albert, the founder and chief medical officer at AliveCor, were among the featured guests during a breakfast discussion at Fortune’s Brainstorm Health conference on Wednesday. And they grappled with the regulatory and technological obstacles to developing the kind of products and services that might tell someone that they’re at imminent risk of a catastrophic heart-related incident.
Part of the problem is that current technology available to consumers only picks up on heart rhythms. That can be useful from a personalized standpoint, but it’s not the same as actually predicting an arterial problem. And it certainly doesn’t give Americans all the information (and, more importantly, the medical context) that they need to make the right decisions about their medical care when it comes to anticipating a disastrous heart problem.
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“There’s no wearable that’s likely going to provide that,” said Topol. There’s just too much uncertainty and fluctuation among available consumer devices, which would have to go through the intensive Food and Drug Administration medical-device clearance process before they could actually provide more information to caregivers. The exact genetic and biological warning signs of a brewing heart attack also aren’t totally clear yet.
But Topol expressed hope that, regulatory snags aside, the technology will eventually get there — as long as firms can collect enough relevant data about the exact biological risk factors and warning signs for a heart attack or a stroke.
This presents its own problem, as Flex’s Carlson and AliveCor’s Albert pointed out. Creating a consumer product like Fitbit isn’t the same as developing an FDA-cleared medical device. The latter proposition is far more cumbersome and even more expensive.
Gaining FDA clearance “takes the development cycle from six months to three years,” said Carlson. Albert added that becoming an FDA-cleared device involves following a host of manufacturing rules that can gum up the works, and that there are legitimate risks to allowing this sort of tech (especially when it comes to things like “predicting” heart attacks) to run wild.
“There will always be false positives and false negatives,” said Albert. “And those results can influence patients behavior and incur, at the very least, a financial and emotional toll on them if they act on it.”