我國電子病歷資訊系統法制之未來——以歐盟與韓國電子病歷系統相關法制為借鏡

The Future of Taiwan’s Electronic Medical Record (EMR) Information System Regulation: Learning from EMR-related Regulation and Measures of the European Union and Korea

我國「醫療機構電子病歷製作及管理辦法」於2022年歷經大幅度翻修，並已於同年7月18日正式發布施行，此次修正有多項政策上之重大開放，如開放醫療機構得委外建置電子病歷資訊系統、開放電子病歷得利用雲端服務等，而可能會帶來深遠之影響。惟本辦法為一框架性之規範，就電子病歷資訊系統之具體監管細節，目前仍在繼續發展中。本文藉由簡介歐盟與韓國對於電子病歷資訊系統之管制規範，特別聚焦於韓國「電子病歷系統認證」（EMRSystem Certification）方案，希望作為我國未來完善電子病歷資訊系統相關監管制度之參考。

In 2022, Taiwan's ''Regulations Governing the Creation and Management of Electronic Medical Records by Medical Institutions'' underwent significant revisions and became effective on July 18 of the same year. This amendment allows medical institutions to outsource the construction of electronic medical record (EMR) information systems and use cloud services, potentially leading to profound impacts. However, as a framework regulation, specific details on supervising EMR information systems are still evolving. This article introduces EMR-related regulations and measures of the European Union and Korea, particularly focusing on Korea's ''EMR System Certification'' program. It is hoped that this article could serve as a reference for developing a comprehensive regulatory system for EMR information systems in Taiwan.