篇名

行動醫療軟體的上市前規範:美國經驗   免費試閱

並列篇名

The Premarket Regulation of Mobile Medical Software: The American Experience

作者
中文摘要

行動醫療軟體近年來發展迅速,同時為醫療的發展帶來風險與利益。如何在上市規範上,平衡行動健康市場發展的需求及對健康風險的控制是重要的課題。本文觀察美國規範的發展歷程與管理措施,發現其呈現逐步放寬、漸進釐清的模式。相較於臺灣,提供了較多的彈性空間,或許值得吾人參考。

英文摘要

Mobile medical software has developed rapidly in recent years which brought risks and benefits to the development of medical care. It has become an important issue about how to balance the development of the mobile health market and the control of health risks. This article observes the evolutionary process and management measures of American legal regime and finds that it presents a pattern of gradual relaxation and progressive clarify. Compared with Taiwan, the American model provides more flexibility and may be worthy of reference.

起訖頁

021-033

出版單位
DOI

10.3966/241553062019040030002  複製DOI  DOI查詢

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