使用傳感器構(gòu)建智能手機(jī)醫(yī)療應(yīng)用程序插件

　　美國(guó)的FCC開始監(jiān)管可以將智能手機(jī)轉(zhuǎn)變?yōu)獒t(yī)療設(shè)備的應(yīng)用程序。本文著眼于這一舉動(dòng)的意義和如何使用新的傳感器打造智能手機(jī)附加的醫(yī)療應(yīng)用程序如心電圖或血壓測(cè)量壓力傳感器模擬前端。

　　美國(guó)的食品和藥物管理局一直在關(guān)注醫(yī)療應(yīng)用程序的問題以及如何管理它們。經(jīng)過兩年的協(xié)商，該機(jī)構(gòu)已經(jīng)發(fā)布了醫(yī)療應(yīng)用程序開發(fā)的新規(guī)則，并將規(guī)范那些應(yīng)用于硬件的應(yīng)用程序。

　　據(jù)research2guidance月份發(fā)表的一份報(bào)告，對(duì)移動(dòng)醫(yī)療應(yīng)用市場(chǎng)將達(dá)到2017美元260億。目前，在主要應(yīng)用商店中大約有97000個(gè)移動(dòng)健康應(yīng)用程序。

　　關(guān)于這些應(yīng)用程序如何在美國(guó)各機(jī)構(gòu)之間進(jìn)行監(jiān)管，一直存在著激烈的爭(zhēng)論。健康信息技術(shù)（HIT）的國(guó)家協(xié)調(diào)委員會(huì)辦公室（ONC）已要求FDA目前的監(jiān)管框架內(nèi)的工作來幫助移動(dòng)醫(yī)療技術(shù)的創(chuàng)新而不是改革現(xiàn)行法規(guī)。

　　At the same time， the US Federal Communication Commission （FCC） also has a role to play in regulating devices with wireless connections. The ONC‘s report was specifically called for by the 2012 FDA Safety and Innovation Act to look at a strategy and recommendations for an appropriate risk-based Health IT regulatory framework that would include mobile medical applications and promotes innovation， protects patient safety， and avoids regulatory duplication.

　　The new FDA rules mean the vast majority of apps will not be regulated， but the focus is on making sure that devices do not harm the patients if they do not work properly. It is this type of system， combining hardware and the app， which the FDA now regards as a medical device， and this can change the conformance requirements for such device developers