"The Oura Ring has always had an influential clientele, but it's apparently now a popular accessory in Capitol Hill. Earlier this week, Politico ran a story about how the smart ring maker is lobbying legislators for less wearable regulation. Specifically, the article notes that Oura has floated the idea of creating a "digital health screener" classification for so-called low-risk wearable and health features that would be exempt from the Food and Drug Administration's clearance process."
"In it, Hale contends that wearables don't fit within the FDA's current regulatory framework, which broadly divides health tech into two categories: wellness and medical devices. He has a point. The line between wellness and medical devices isn't as clear as it ought to be. Wellness features are generally defined by the FDA as for educational or entertainment purposes. As such, they don't require oversight."
Oura has lobbied lawmakers to create a "digital health screener" classification that would exempt low-risk wearable and health features from FDA clearance. The proposal argues that the FDA's binary framework of wellness versus medical devices leaves many wearables in a regulatory gray area. Wellness features such as step counts, sleep quality, and resting heart rate are typically categorized as nonregulated educational or entertainment tools, while the medical device definition remains broad. That ambiguity complicates compliance, oversight, and consumer protections, indicating that clearer boundaries and enforcement resources may be as important as changing rules.
Read at The Verge
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