APPs是醫療器材嗎？從美國FDA對行動醫療應用程式的規範與管理談起

Are Applications Medical Devices? Take the Approach Taken by US Medical Device Regulator on Mobile Medical Applications as an Example

廖淑君

《科技法律透析》 24卷6期 (2012/06) Pp. 38-62

https://doi.org/10.7062/STLR.201206.0038

摘要

隨著行動通信科技的發展，以健康醫療照護為訴求的行動應用程式相繼問世與流通， 提昇人們進行自我健康管理與享受醫療照護服務的便利性。但是，這些程式如果設計不良或發生故障，也可能會帶來人體健康風險。為此，本文參酌美國醫療器材主管機關對行動醫療應用程式的管理途徑及作法，針對以健康或醫療為訴求之手機應用程式是否應受到管理及其管理方式進行討論。

關鍵字

行動應用程式 ； 醫療器材 ； 行動醫療應用程式

並列摘要

With the development of information communication teclmology, mobile medical or healthcare applications are developed and deployed by mobile device users to manage healthiness and fitness and take medical service. However, those applications may pose risk to human health if they cannot work well. Therefore, with consulting to the approach taken by US medical device regulator to regulate mobile medical applications, this study discuss whether and how mobile medical or healthcare applications shall be regulated as medical device.

並列關鍵字

Mobile applications ； medical devices ； mobile medical applications

參考文獻

U. S. FOOD AND DRUG ADMINISTRATION, FDA PROPOSES HEALTH "APP" GUIDELINES, July 19, 2011, http://www.fda.gov/ForConsumer/ConsumerUpdates/ucm263332.htm

資策會 FIND，2011年台灣行動應用軟體市場發展最新概況，2011/5/11，http://www.find.org.tw/find/home.aspx?page=many&id=286

資策會 FIND，App 帶來消費者生活與工作的多工型態：商業模式成為未來發展關鍵，2012/3/21，http://www.find.org.tw/find/home.aspx?page=many&id=313

Elisa Maldonado Holmertz, Developing a Mobile Medical App?, http://www.emergogroup.com/files/us-fda-mobile-apps-webinar-presentation-nov-2011.pdf (last visited on April 10, 2012)

U. S. FOOD AND DRUG ADMINISTRATION, FDA OUTLINES OVERSIGHT OF MOBILE MEDICAL APPLICATIONS, July 19, 2011, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm263340.htm