美國HIPPA與歐盟GDPR條文解說訓練課程
In-person
Next: 21 Sep 2026
English
Identifier: 195085940
Course Overview
What you'll learn
課程大綱
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GDPR概述與基本原則
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資料保護管理與跨境資料傳輸要求
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個資外洩管理
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HIPAA立法背景與法規架構
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PHI與ePHI管理
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建立企業資料保護系統
特色效益
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了解GDPR與HIPAA之立法背景與監管目的
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理解GDPR與HIPAA之適用範圍及適用對象
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了解資料蒐集、使用、保存及刪除之法規要求
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建立醫療資料保護與資訊安全管理概念
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掌握資料外洩事件通報要求與處理流程
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參加全程課程者授予「上課證明」
Who This Course Is For
上課對象
- 醫療器材法規人員(RA)、品質管理系統人員(QA)、軟體品質保證人員(SQA)
- 醫療器材研發人員
- 資訊安全管理人員
- 臨床事務人員
- PMS與Vigilance管理人員
- Data Protection Officer(DPO)
About this course
隨著數位醫療、遠距醫療、AI醫療軟體（SaMD）、雲端醫療平台及智慧醫療器材快速發展，病患個人資料與健康資料的蒐集、傳輸、儲存及使用已成為全球監管機關高度關注的議題。
歐盟《一般資料保護規則》（GDPR）與美國《健康保險可攜與責任法案》（HIPAA）為目前全球最具影響力之個人資料與健康資訊保護法規。醫療器材製造商、醫療軟體開發商、醫療服務提供者及相關供應商，如涉及歐盟或美國市場，皆需了解並建立符合法規要求之資料保護管理機制。
本課程將深入解析GDPR與HIPAA的法規架構、核心要求、資料主體權利、資訊安全管理措施及資料外洩通報要求，並結合醫療器材產業實務案例，協助學員建立法規遵循能力與風險管理觀念。
課程原價：NTD16,000(含稅)；網路優惠價：NTD15,200(含稅)
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