以國際法規趨勢審視台灣電子病歷之法律環境

An international comparative study of the legal environment of electronic medical records

醫療資訊的電子化為全球趨勢，除了對醫療照護的品質有所提升，同時使其相關資料之管理更為便利。因醫療資訊電子化具諸多優點，世界先進國家紛紛就技術、法律、制度等方面積極推動其應用。如何在保障醫療資訊所有者之個人隱私下，又方便醫療資訊之流通以提升醫療品質，成為醫務管理之一大課題。本研究分析全球電子病歷法規發展趨勢與我國現行法規之差異後，建議放寬時戳的規定，中央主管機關只需要進行簽章系統的認證，同時建議增訂「病歷電子化複製本」的概念，擴大醫療法及管理辦法之適用範圍，使現存之醫療資訊得應病人要求進行電子傳輸。

The digitalization of medical information is a global trend. In addition to the convenience of data management, this trend can also elevate healthcare quality. Due to all these advantages, most countries have tried to promote its utilization via changes in technology, laws and systems etc. How to protect privacy and at the same time promote the use of electronic medical records (EMRs) has become a major issue in healthcare management. This study aims at comparing the relevant legal frameworks worldwide and making tentative suggestions to improve Taiwanese legal environment in this regard. The conclusions include the government should focus on the certification of systems, not on the authorization of each transaction, and regulations should be revised to permit the release and electronic transmissions of existing electronic files in the healthcare industry.