近年來，行動健康應用程式(mHealth Apps)產業迅速成長，為醫療與健康照護領域帶來許 多影響。此類應用程式範圍可分類為二，一為屬於醫療器材應受規範，二為非醫療器材不受 規範，兩者間的區分重點亦在於醫療行動應用程式與健康生活類應用程式之差異。在是否屬 於醫療器材判斷部份，參考美國FDA之行動醫療應用程式指導原則，以及歐盟以既有之指令 規範來解釋適用，皆以先判斷應用程式是否屬於醫療器材來進行規範。 在非醫療器材之部份，尤其為用於健康類別，易於市場上架，消費者取得容易，對公眾 健康產生影響層面較大，且變化快速，主管機關亦不及審查因應，因此，建議採取之規範立 場為強化業者自律規範，建立自主驗證制度來促進消費者權益的保護。再者，在部分具有欺罔消費者情形之應用程式，透過主管機關的處罰來建立一定的上市標準，此亦可提供業者上 市時參考做為借鏡。 本文探討國際規範趨勢，並提出建議說明，以做為未來產業發展之參考，同時亦做為我 國相關規範建立之建議。

The mobile health applications (apps) industry has exploded in the past years, which has a major impact on Healthcare system. The United Stated Food and Drug Administration (FDA) issued Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications on Sept. 25, 2013, and this document was updated on Feb. 9, 2015. The Guidance clarifies and outlines the FDA´s current thinking. FDA intends to apply its regulatory oversight to mHealth Apps which are medical devices. In Europe, similar to the regulation of FDA, mHealth Apps should adhere to the Medical Device Directive 93/42/EEC. mHealth Apps can be considered as medical devices if they provides a proper diagnostic or therapeutic purpose. Some mHealth Apps allow users to control over their own health and wellbeing, but many apps are developed without any clinician or expert input. Manufacturers and developers have rapid mHealth Apps innovation, and the authority will only require approval for a narrow scope of Apps, the mHealth Apps industry is better to regulate itself effectively. Moreover, the mHealth Apps may be covered by consumer protection laws to prevent from fraud and deception. This study discuss the regulations to the United Stated FDA and Europe of mHealth Apps, and make recommendation to industry and government for establish appropriate regulatory framework.