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美国食品与药品管理局(FDA)对美国的远程医学管理不断出台一些新的政策。 FDA认为,远程医学是新兴的医学技术,直接关系到患者的健康,因此,必须加强管理。 首先在技术设备方面规定:应用于远程医学的所有硬件、软件均应得到FDA的认可。FDA在发表的一份白皮书中指出,用于远程医学的所有设备需要符合FDA下属的“仪器设备与放射线防保中心(CDRH)”的要求。目前这些要求正在标准化。凡是没经过充分技术评价的设备而用于远程医学活动是不合法的,对患者的利益有一定的风险。例如,在传输医学
The U.S. Food and Drug Administration (FDA) continues to introduce some new policies for the administration of telemedicine in the United States. FDA believes that telemedicine is an emerging medical technology that is directly related to the health of patients. Therefore, management must be strengthened. First of all, it is stipulated in the technical equipment that all hardware and software applied to telemedicine should be recognized by the FDA. The FDA stated in a published white paper that all devices used for telemedicine need to comply with the requirements of the FDA’s “Instrumentation and Radiological Protection Center (CDRH)”. These requirements are currently being standardized. It is illegal to use telemedicine activities for devices that have not been fully evaluated by the technology, and there are certain risks to the patients’ interests. For example, in the transmission of medicine