FDA关于移动医疗APP的几个问答

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What are mobile medical apps?移动医疗APP是什么

Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. 移动APP是运行在手机或者其它移动通信设备上的软件项目。他们可以是附在手机或其他通信设备上的辅助程序，或者是附属程序和软件的组合。

Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants.移动医疗APP满足医疗器械的定义，是受法规监管的医疗器械的附属程序或者将移动平台转化为受法规监管的医疗器械。消费者可以使用移动医疗APP和移动APP来管理自己的健康，例如监控自己热量摄取或者维持健康体重，例如National Institutes of Health’s LactMed app提供给奶妈们关于药品对于奶水和婴儿的影响。

Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient.其它APP是为了帮助医护人员改善和方便病人护理。例如REMM APP可以指导在诊断和治疗放射伤害。一些移动医疗APP可以诊断癌症或者心律异常，或者作为依赖胰岛素的高血糖患者的葡萄糖计。

How will the FDA regulate mobile medical apps?FDA将如何监管移动医疗APP

The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.  The guidance document (PDF - 269KB) provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C. FDA将采用与保证其它医疗器械安全和有效相同的基于风险的方法。

We encourage app developers to contact the FDA – as early as possible – if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.我们鼓励APP开发者联系FDA，尽量的早，如果他们有关于移动APP的问题，它的风险等级，以及是否要求上市前申请。

Mobile apps for which the FDA intends to exercise enforcement discretion FDA

可以执行自由裁量权的移动APP

For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:对于很多符合法规定义的设备的移动APP但对病人和消费者只有很小的风险，FDA将会执行强制的自由裁量权，并且不要求生产商递交批准前申报或者登记并列进FDA的清单。这种包括移动医疗APP：

·         Help patients/users self-manage their disease or condition without providing specific treatment suggestions;不会提供具体的治疗的建议；

·         Provide patients with simple tools to organize and track their health information;提供简单的工具组织并追踪他们的健康信息；

·         Provide easy access to information related to health conditions or treatments;提供能够接触关于健康状况或者治疗的信息；

·         Help patients document, show or communicate potential medical conditions to health care providers;帮助病人记录、展示或者沟通潜在的医学状态给护理人员；

·         Automate simple tasks for health care providers; or使护理人员的简单工作自动化；

Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.使病人或者服务者能够互动PHR或HER系统

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