Course Syllabus

Course Information：

Year-Semester	Course Number	Course Name	Phase	Credits	Hours	Required/Elective	Instructor	Class	Student NO.	Withdraw	Note
Fall Semester Year 2026	367164	Smart Healthcare Standards and Regulations	1	3.0	3	★	Chen, Shiang-Jiun	EECS(U)	7	0	大研合開

Course Plan：

Instructor	Chen, Shiang-Jiun　Office Hours
Email	annette@ntut.edu.tw
Last Updated	2026-09-07 10:20:54
Course Objective	本課程介紹主權AI於智慧醫療之應用場景與法規要求，涵蓋醫療器材法規架構、品質管理、風險管理、人因工程、互操作性、資料交換標準，以及AI法規、資安與隱私議題，協助學員建立智慧醫療系統開發與合規實務能力。 This course introduces the applications and regulatory requirements of Sovereign AI in smart healthcare. Topics include medical device regulatory frameworks, quality management, risk management, human factors engineering, interoperability, data exchange standards, and AI-related cybersecurity and privacy issues, helping learners build practical competence in smart healthcare development and compliance.
Course Schedule (Week 1-16)	wk1-wk4 課程導論與主權AI智慧醫療概念 醫療器材入門 醫療器材法規架構 品質管理系統概論 wk5-8 開發流程與設計控制 軟體與AI醫材開發標準 風險管理概論 人因工程與可用性 wk 9-12 風險與人因整合實務 互操作性概論 資料交換標準 互操作性實務應用 wk13-16 醫療器材入門 醫療器材法規架構 品質管理系統概論 開發流程與設計控制 軟體與AI醫材開發標準 風險管理概論 人因工程與可用性 風險與人因整合實務 互操作性概論 資料交換標準 互操作性實務應用 Wk 17: Remote Group Project Recording and Project Submission Wk 18: Peer Evaluation
Flexible Learning (Week 17-18)	Category ● 學生分組實作及討論(Student group practice and discussion) Content wk17: Remote Group Project Recording and Submission wk18: Peer Evaluation Hours 6 Learning Outcomes wk17: Group Project Video and Final Submission wk18: Peer Review Results and Evaluation Scores Assessment Percentage Week 17 – Remote Group Project Recording and Submission → Group Presentation (20%) Week 18 – Peer Evaluation → Course Participation (10%)
Evaluation and grading policy	Attendance & participate: 50% Team Project: 35% Presentation: 15%
Materials	All right reserved. Do not reproduce without permission. Foreign-language textbooks:No 《人工智慧基本法》、《個人資料保護法》、《資通安全管理法》及相關子法。 《醫療法》、《醫療器材管理法》及《醫療機構電子病歷製作及管理辦法》。 衛生福利部食品藥物管理署（TFDA）人工智慧／機器學習醫療器材軟體（AI/ML-Based SaMD）相關技術指引。 EU General Data Protection Regulation (GDPR) 與 EU Artificial Intelligence Act (EU AI Act)。 U.S. HIPAA/HITECH Act 及 FDA 醫療器材資安與 AI-enabled Medical Device 相關指引。 ISO/IEC 27001、ISO/IEC 27701、ISO/IEC 42001、ISO 14971、IEC 62304、IEC 81001-5-1 等資訊安全、AI 治理及醫療器材相關國際標準。 HL7 FHIR、SMART on FHIR、NIST Cybersecurity Framework (CSF) 與 NIST AI Risk Management Framework (AI RMF) 等技術規範與治理框架。
The access to curricular consultation	office hour Tues. 12:00-18:00 or by appointment office location: Hung-Yu Research Tech Building Room 1627 Announce will show on zuvio or ischool
Expanding teaching and resources	● 參與式創新教學 (Participatory & Innovative Teaching) 強調學生參與與產出，導入翻轉、PBL/專題、設計思考或遊戲化等策略。 Emphasizes student engagement and outcomes by adopting strategies such as Flipped Classroom, PBL (Problem/Project- Based Learning), Design Thinking, or Gamification. ● 數位科技融入 (Digital Technology Integration) 運用生成式AI、VR/AR、IoT、IRS等新興科技輔助教學與評量。 Utilizes emerging technologies such as Generative AI, VR/AR, IoT, and IRS (Interactive Response Systems) to facilitate teaching and assessment.
The course corresponds to the SDGs	SDG1：消除貧窮（No Poverty） SDG8：尊嚴就業與經濟發展（Decent Work and Economic Growth） SDG17：夥伴關係（Partnerships for the Goals）
Does the course incorporate AI	● 鼓勵學生使用生成式AI工具（Encourage students to use generative AI tools）
Note