包括戒指、智慧手表和手腕带在内的可穿戴装置，正被 Samsung Electronics Co.、Apple Inc.、Fitbit、Garmin Ltd.、Google、Whoop Inc. 和 Oura 等公司研究，用于预测健康事件。去年这个市场规模估计已超过 900 亿美元。Whoop 在 3 月募资 5.75 亿美元后，估值达到 101 亿美元；而 Oura 去年 9 月募资 8.75 亿美元后，估值约为 110 亿美元。Oura 在 5 月新增了一项功能，可监测避孕和某些老化症状；同时，Samsung Health 正在努力侦测失智症，并计划在未来几个月推出一款 AI 个人健康伙伴。
业界的目标是最早在心脏病发作前 15 分钟，甚至某些情况下提前数年发出警示，但专家表示，预测的门槛远高于单纯搜集资料。疑虑包括过度追踪、频繁换医生、穿戴焦虑、不必要的检测、HIPAA 保护的缺口，以及资料外泄。FDA 仍未放宽禁止可穿戴装置诊断疾病或确认医疗状况的规定；同时，Oura 正在推动一项新的美国分类，让可穿戴装置在无需经过医疗器材所要求的漫长审批流程下，就能提醒使用者潜在的健康问题。
Haley Billey, 31, bought a $450 Oura Ring to track fertility, but it arrived the day after she learned she was pregnant. Months of worrisome readings on energy and stress led her to seek a professional opinion, and the cause turned out to be Hashimoto’s disease, an autoimmune disorder. She is now sharing data with Oura Health Oy as it tries to detect signs of hypertension and build an artificial intelligence model to predict events like heart attacks and strokes years before they happen.
Wearables such as rings, smartwatches, and wrist bands are being studied by companies including Samsung Electronics Co., Apple Inc., Fitbit, Garmin Ltd., Google, Whoop Inc., and Oura for predicting health events. The market size was estimated last year at over $90 billion. Whoop was valued at $10.1 billion in March after raising $575 million, and Oura was valued at about $11 billion after raising $875 million last September. Oura added a feature in May to monitor birth control and some symptoms of aging, while Samsung Health is working to detect dementia and plans to roll out an AI personal health companion in the next several months.
The goal in the industry is to warn of heart attacks as little as 15 minutes before and in some cases years ahead of time, but experts say the bar for prediction is much higher than data gathering. Concerns include obsessive tracking, doctor shopping, wearable anxiety, unnecessary testing, gaps in HIPAA protection, and data breaches. The FDA still has not loosened rules barring wearables from diagnosing diseases or confirming medical conditions, while Oura is advocating for a new US classification that would let wearables alert users to potential health issues without the lengthy clearance process required for medical devices.