ABSTRACT

The phrase "wearable" denotes the ability of a gadget to be sustained by either the wearer's body or clothes. Phones now come with sensors like gyroscopes, accelerometers, microphones, and cameras, as well as the computing ability to evaluate the data generated by these sensors thanks to technological breakthroughs. Moreover, Bluetooth and other short-range radio technologies have improved battery life, allowing the development of smaller devices with data logging and action-triggering capabilities. These wearables and apps can be used for health and fitness as well as "mHealth" services that may eventually include applications in medicine and healthcare. Health-conscious individuals all over the world are widely utilizing these devices. As a result, information about their existence, functions, usages, and benefits is progressively spreading among the general public. However, these devices tend to be more accessible to those belonging to affluent societies who can afford their procurement and use. The wearable gadget industry is anticipated to grow, more individuals will have access to cutting-edge technologies. There may still be a safety coverage gap, though, because wearables-related rules and standards are still being defined. Customers may be unduly exposed to wearable gadget dangers as a result of this gap. The regulatory framework for medical devices is described in this article, along with an outline of its main requirements, limitations, evaluation parameters, and considerations in respect of wearables. Keywords: Wearable device, Healthcare industry, Medical Image Storage Device, Evaluation
Publication date: 01/09/2024

https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8276.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.9.8276