Given the transformations taking place at every level in healthcare, it is no surprise that the 2017 SXSW Interactive Conference has a big spotlight on the industry. One superstar in the spotlight this year is wearables. The accelerator pitches during SXSW include ones for wearables designed to improve prenatal care and early breast cancer detection, and there is even a presentation on brain wearables to detect stress, improve focus, and even to let you play video games with your brain. That’s right, brain wearables that help you focus and let you play video games.
The health tech industry has clearly moved way beyond tracking your steps, sleep cycle, and heart rate, but that does not mean the importance of those more basic consumer wearables is diminished—far from it according to an academic researcher speaking at SXSW. Indeed, more than 250,000 research studies are based on consumer wearables data. But if consumer wearables are to have a meaningful impact on academic research (and therefore on health and healthcare) the data must be accurate, or at least more accurate than they are today.
Of course it’s not realistic to think that consumer wearables will reach the accuracy levels of clinical grade medical devices. Why should they? In January 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “General Wellness: Policy for Low Risk Devices,” announcing that the FDA does not intend to regular low-risk general wellness devices. (“Low-risk” means the product makes only general wellness claims and does not present inherent risks to a user’s safety; and “general wellness” means the product is one intended to maintain a healthy lifestyle or promote healthy activity but does not make reference to diseases or conditions, unless it is well understood that health living with a certain disease or condition.)
In other words, the marketplace carrot is there (the more accurate the data presumably the better the marketplace status and lower risk of consumer lawsuits), but the stick (FDA regulation) is not. One middle ground, suggested by the academic researcher, would be for the industry players to at least agree on the methodologies and protocol for measuring accuracy. Whether the industry players would be willing to do such a thing, even indirectly, remains to be seen, but the potential is there for all of those steps and sleep cycle collections to have a truly meaningful impact on research, health, and the direction of healthcare.