Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -

Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -

The wearable device market is emerging as a key player in big data and digital health. Worldwide sales of smart wearable devices are projected to become a $27 billion-plus market by 2022.And savvy businesses have noticed. Wearable devices are being developed for a broad range of convenient healthcare monitoring and preventive medicine functionalities, including motion trackers, vital signs measurement such as electrocardiograms (ECGs), and smart clothing. Many wearable devices are also integrating with telemedicine and telehealth to provide medical services, increasing the complexity of how these devices are regulated by the various agencies of the government. Key federal agencies that regulate wearable devices, their uses, distribution, and reimbursement include: the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), Office of Civil Rights (OCR), Consumer Product Safety Commission (CPSC), Centers for Medicare & Medicaid Services (CMS), and Office of Inspector General (OIG). Additionally, state governments may have similar or more restrictive laws than federal laws that regulate wearable devices and related services in the healthcare sector. Navigating these layered regulatory requirements both successfully and efficiently is critical to gaining a market advantage in this growing industry.