论文部分内容阅读
随着大数据、传感器及网络信息技术的发展,基于采集、传输、分析人体生理参数检测的可穿戴设备系统应运而生,并应用在移动医疗的方方面面。在带给人们诸如疾病早期预防、历史数据对比分析辅助诊断等方面便利外,也同时带入了设备对人们造成的电能、热能、生物相容性、数据安全及隐私泄露等方面的危害。本文重点介绍可穿戴设备的发展现状、设备参考的标准、临床评价及风险控制方面的内容,引导生产企业开发符合国家法规及标准的产品。在实现健康管理、慢性病生理参数监测等模式下,达成符合预防医学意义的社会利益和经济利益。
With the development of big data, sensor and network information technology, wearable device systems based on the collection, transmission and analysis of human physiological parameters have emerged and are applied in all aspects of mobile medical treatment. In addition to bringing people convenience such as early prevention of disease and auxiliary diagnosis of historical data comparative analysis, it also brings harm to people in terms of electrical energy, thermal energy, biocompatibility, data security and privacy leak caused by the device. This article focuses on the development of wearable devices, equipment reference standards, clinical evaluation and risk control aspects, to guide manufacturers to develop products in line with national laws and standards and standards. In the realization of health management, chronic disease physiological parameters monitoring and other modes, to achieve a sense of social and economic benefits in line with preventive medicine.