無紙化醫院之法律挑戰【一百期特別企劃】 試閱
The Legal Challenges of Paperless Hospitals
無紙化醫院旨在提升行政效率、促進數據流通及支持智慧醫療,但實施過程中面臨資料完整性、隱私保護、數據權屬及法律責任等挑戰。我國法規對病歷的定義仍停留於紙本概念,未能涵蓋多樣化電子數據,導致保護模式與技術需求脫節,且對病歷安全性及流通規範的應對不足。
印尼「第24號衛生部長規定」提供了重要啟示,其明確病歷內容歸病人所有,文件由醫療機構負責,資料流通需病人同意或符合特定例外,同時要求醫療機構電子化並設立資安及備份標準。該法規擴大適用範圍至健康相關服務單位,展現全面性與彈性,值得我國參考以完善無紙化醫院的法規建設。
The implementation of paperless hospitals aims to enhance administrative efficiency, facilitate data circulation, and support smart healthcare. However, it faces challenges related to data integrity, privacy protection, data ownership, and legal responsibilities. Current regulations in Taiwan still define medical records based on traditional paper formats, failing to encompass diverse electronic data, which results in a misalignment between protection measures and technological needs. Additionally, there is insufficient regulation addressing the security and flow of medical records.
Indonesia’s MOH Regulation No. 24 of 2022 offers valuable insights. It clearly establishes that the content of medical records belongs to the patient, while the documents themselves are owned by healthcare institutions. Data circulation requires patient consent or must meet specific exceptions. Furthermore, the regulation mandates the digitization of medical records and sets standards for cybersecurity and data backups. By expanding its scope to include health-related service units, it demonstrates a comprehensive and flexible legislative approach. Taiwan can draw on this example to improve the regulatory framework for implementing paperless hospitals.
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