隨著行動通信科技的發展，以健康醫療照護爲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。爲此，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，針對以健康或醫療爲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。

With the development of information communication technology, 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.