主动健康数据采集设备管理属性界定的分析与思考

Analysis and Thinking on the Management Attribute Definition of Active Health Data Acquisition Equipment

主动健康数据采集设备在实现“全民健康”规划中发挥着重要作用,为了加强主动健康数据采集设备的监管,确保使用者的安全和健康,应充分借鉴美国和欧盟等发达国家的相关经验,重点解决好管理属性界定,明确监管政策,这也是落实国家规划、保障产业发展的迫切要求。主要针对主动健康数据采集设备的技术特点、监管中存在的问题和各国目前的属性界定政策等进行了分析。通过研究,认为在对主动健康数据采集设备进行属性界定时,除了依据其所宣称的预期用途外,还必须充分考虑其具体能够实现的目的、采集数据的可靠性以及配合使用的产品的具体情况,以更加科学合理地对主动健康数据采集设备进行属性界定,为该类设备的科学监管奠定基础。

Active health data acquisition equipment plays an important role in the realization of the“national health”plan.In order to strengthen the supervision of active health data acquisition equipment and ensure the safety and health of users,relevant experience of developed countries such as the United States and the European Union should be fully learned,focusing on the definition of management attributes and clear regulatory policies.This is also the implementation of the national plan,to ensure the industry development of urgent requirements.This paper mainly analyzes the technical characteristics of active health data acquisition equipment,the problems existing in regulation and the current attribute definition policies of various countries.Through the research,it is believed that in the attribute definition of the active health data acquisition equipment,in addition to the declared intended use,it is necessary to fully consider the specific purpose that can be realized,the reliability of the collected data and the specific situation of the products used together with the active health data acquisition equipment,so as to make the attribute definition of the active health data acquisition equipment more scientific and reasonable.Lay a foundation for the scientific supervision of this kind of equipment.