手機測皮膚癌、血壓？－－談美國行動健康應用程式（mHealth app）發展與法制趨勢

Using your smart phones to detect melanoma or measure blood pressure? - the latest developments and regulatory schemes regarding mobile health in the United States

運用資通訊技術於健康的電子健康（eHealth），已被世界健康組織（WHO）列作定期檢視項目；83%會員國更已致力推動行動健康（mHealth）。依最新調查顯示，於主要行動平台上架的行動健康應用程式（mobile health applications, mHealth app）已近26萬個，至2020年市場規模可達310億美元。然而，mHealth app是否屬於醫療器材？應適用哪些法令規範？對於多數為科技創新而非傳統健康照護產業背景的mHealth app業者來說，確屬攸關後續發展的議題。本文以美國立法例切入，首先檢視近兩年聯邦貿易委員會（FTC）就偵測黑色素瘤、量測心跳血壓兩款mHealth app的案例，繼而分析食品藥物管理局（FDA）指引與FTC mHealth app線上版指引工具的規範架構；最後，本文檢視我國在醫用軟體管理與個人資料保護相關法令最新發展，進而建議為建構可預見性高、遵法成本低的mHealth app法制架構，宜納入以下考量：以終端使用者區分設計規範架構，並考慮跨國規範議題；使業者簡單判分「是否屬於醫療器材」與「是否與如何適用其他法令」；兼顧「科技創新」與「健康」需求。

As electronic health (eHealth) has played a key role on the WHO agenda, 83% of WHO member states have implemented mobile health (mHealth) policies. The latest survey shows that the total number of mobile health applications (mHealth apps) on main mobile platforms has reached 260,000 and its market value is estimated to reach 31 billion USD by 2020. Since the majority of mHealth app publishers are technology companies or app developers rather than traditional healthcare industries, however, uncertainty about whether mHealth apps should be regulated as medical devices and governed by other laws and regulations might hinder their growth and development. The aim of this paper was to investigate the latest Federal Trade Commission (FTC) cases regarding the use of mHealth apps to detect melanoma and measure blood pressure. It also examined the Federal Drug Administration's (FDA) guidance and the FTC's interactive web tool to determine the regulatory approaches taken in the United States. In Taiwan, the TFDA issued medical software guidelines in 2015 and the highly controversial Article 6 of the Personal Information Protection Act regarding health information came into effect in March, 2016. To encourage the development of mHealth apps in Taiwan, we suggest the following: set up rules for end-users with different backgrounds and solve cross-border problems; help developers decide easily if regulations for medical devices apply, as well as how they comply with other laws and regulations; strike the perfect balance between innovation and health.