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Standards Development
This document specifies a framework and general requirements for wearable technologies used in sleep monitoring and care. It establishes protocols and quality assurance criteria for ensuring the reliability, functional correctness, and consistency of sleep -related data from various sensors, devices and environments. This document is not cover the detailed definition and performance measurement of individual sleep stages.
These general requirements can be applied to all wearable sleep monitoring products and associated software used in home, travel, and clinical environments.
The accurate sleep monitoring and care can be achieved by the data collection processes and procedures covering the sleep cycle in daily life using various sleep monitoring devices. The use of this document facilitates cooperation, fosters exchange, and as sists in the harmonization of practices among wearable device manufacturers, sleep researchers, and other parties.
The purpose of this standard is to
• Ensure the quality, safety and effectiveness of wearable technologies for sleep monitoring and management.
• Establish common requirements for manufacturers, developers, sleep management professionals, and general users
• Promote interoperability between different sleep monitoring wearable devices and applications
• Support the use of reliable wearable technologies for different types of sleep monitoring and management
• Ensure user safety and data protection while encouraging innovation
• Set standards for appropriate use of wearable technologies for sleep monitoring and management
• Demonstrate the compatibility of wearable technologies with a wide range of devices and applications The need and justification for developing this standard is as follows
• Increasing need for integrated utilization of various wearable devices for sleep management
• The need to address public health and personal well-being concerns due to the increasing prevalence of sleep disorders and sleep problems
• The rapidly growing use of wearable technology for routine sleep monitoring and management
• Blurring lines between consumer and medical sleep monitoring wearable technology, requiring clearer standards
• Rapid growth and diversification of the sleep monitoring wearable technology market and need for regulation
• Need to ensure functional correctness and reliability of wearable sleep monitoring technologies
• Addressing concerns about data security, privacy, and ethical use of long -term sleep data collection
• Enabling effective integration of sleep monitoring wearable technologies with sleep management apps, smart home technologies, etc.
• Improve global market access by setting internationally consistent quality standards
• Increase consumer confidence and promote widespread adoption of wearable technologies for sleep health management
• Prevent misuse, abuse or over-reliance on wearable technologies for sleep monitoring and management
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