The American journal of medicine
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Despite the rapid growth of wearables as a consumer technology sector and a growing evidence base supporting their use, they have been slow to be adopted by the health system into clinical care. As regulatory, reimbursement, and technical barriers recede, a persistent challenge remains how to make wearable data actionable for clinicians-transforming disconnected grains of wearable data into meaningful clinical "pearls". In order to bridge this adoption gap, wearable data must become visible, interpretable, and actionable for the clinician. We showcase emerging trends and best practices that illustrate these 3 pillars, and offer some recommendations on how the ecosystem can move forward.
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The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices. ⋯ There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced to potentially costly, nonbeneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.