Introduction

Legal Regulation of Smart Finance and Smart Healthcare is the sixth monograph in the series published by the Artificial Intelligence Law International Research Foundation, focusing on the legal and regulatory issues surrounding "Smart Finance" and "Smart Healthcare." In the realm of smart finance, the book discusses decentralized financial risks and supervision, as well as the dilemmas posed by virtual assets. In the realm of smart healthcare, it explores emerging challenges such as telemedicine, AI medical devices, and the protection of smart healthcare data and personal information. Bringing together the research achievements of scholars and experts from both sides of the strait on these critical legal and regulatory topics, this book is an unmissable read for anyone researching AI law!

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Table of Contents

CEO’s Preface / Chang Li-Ching

【Smart Finance】

Artificial Intelligence and Virtual Asset Applications: Controversies and Regulatory Analysis / Lin Meng-Hsiang

  • I. Prologue / 4

  • II. Application Boundaries and Regulatory Reflections on Artificial Intelligence / 4

  • III. Application Boundaries and Regulatory Reflections on Virtual Assets / 33

  • IV. Conclusion and Suggestions / 49

Transaction Risks and Supervision of Stablecoins / Hsu Pei-Ling

  • I. Introduction / 53

  • II. Types and Transaction Scenarios of Stablecoins / 55

  • III. Transaction Risks of Stablecoins / 59

  • IV. Singapore's Regulation of Stablecoins / 64

  • V. The EU's Regulatory Framework for Stablecoins—MiCA / 69

  • VI. Conclusion / 80

A Study on the Regulatory Approaches to Virtual Currencies / Hsu Yu-Ting

  • I. Foreword / 84

  • II. Concepts and Risks of Virtual Currencies / 84

  • III. Choosing Regulatory Approaches for Virtual Currencies / 90

  • IV. Current Status and Suggestions for Virtual Currency Regulation in Taiwan / 94

  • V. Conclusion / 99

International Transfer of Personal Data in Taiwan's FinTech Industry—Insights from Meta's €1.2 Billion Fine by the EU / Chu Yi-Hsuan

  • I. International Transfer of Personal Data under GDPR / 104

  • II. Taiwan's Environment for the International Transfer of Personal Data in FinTech: Not Yet Meeting GDPR Adequacy Decisions / 112

  • III. Compliance Framework and Practical Limits of Enterprises Adopting SCCs / 117

  • IV. Directions for Government Reference / 123

  • V. Summary / 132

The Positioning of Digital Currency in Criminal Law / Wang Cheng-Chia

  • I. Foreword / 136

  • II. The Development of "Digital Currency" and Criminal Law Issues / 137

  • III. The Criminal Law Positioning of Digital Currency under its Payment Function / 145

  • IV. Conclusion / 151

Decentralized Finance Risks and Virtual Asset Regulatory Challenges—Drawing on FATF Guidance / Cheng Ting-Hsien, Kung Ying-Pin

  • I. Foreword / 155

  • II. Development Status, Risks, and Legal Relations of Decentralized Finance / 158

  • III. Compilation of Disputed Cases and Legal Analysis Related to Decentralized Finance / 168

  • IV. Current Status of Global Regulation on Decentralized Finance and Virtual Assets / 177

  • V. Explanation of the Definitional Scope of FATF's Virtual Asset Regulatory Guidance and Applicability Concerns / 188

  • VI. Conclusion / 193

【Smart Healthcare】

Secondary Use and Compatibility Test—Observing the Development of EU and German Legal Systems / Liao Wei-Min

  • I. Secondary Use: Concept and Application / 198

  • II. Current Status in the EU: The New Legal System of the Compatibility Test (Kompatibilitätstest) / 200

  • III. Application Practice in German Law / 211

  • IV. Purpose Compatibility Legal System, Paradigm Shift of the Purpose Limitation Principle, and Medical Data Governance—In Lieu of a Conclusion / 217

  • Appendix: GDPR Article 6 Lawfulness of Processing / 221

Privacy Protection in the Use of Smart Healthcare Data—A Perspective from the U.S. Legal System / Shih Chia-Li

  • I. The Impact of AI Technology Applied in Smart Healthcare on Personal Medical Data Privacy / 225

  • II. Protection of Medical Information by the U.S. Health Insurance Portability and Accountability Act (HIPAA) / 227

  • III. The U.S. Federal Trade Commission (FTC) Privacy by Design Model / 235

  • IV. The Algorithmic Accountability Act of 2022 / 237

  • V. Summary / 238

Clinical Application of Medical Big Data and Personal Data Protection / Tseng Yun-Jung

  • I. Foreword / 240

  • II. The Connotation and Application of Medical Big Data / 242

  • III. Ethical Considerations in the Use of Medical Big Data / 255

  • IV. Comparative Legal Observation and Reference for Medical Big Data Regulations / 264

  • V. Regulations and Review of the Use of Medical Big Data in Taiwan / 273

  • VI. Conclusion / 281

Regulations and Practices of Telemedicine in Germany and Japan—And Lessons for Taiwan / Chang Li-Ching

  • I. Foreword / 286

  • II. Regulations and Practices of Telemedicine in Germany / 290

  • III. Regulations and Practices of Telemedicine in Japan / 310

  • IV. Comparison of Key Telemedicine Regulations in Germany and Japan / 320

  • V. Lessons from German and Japanese Telemedicine for Taiwan / 323

  • VI. Conclusion and Suggestions / 336

Administrative Supervision and Crime Prevention of Smart Medical Devices—A Comparison between Taiwan and U.S. Legal Systems / Wang Chi-Hsuan, Yeh Hui-Chen

  • I. Foreword / 344

  • II. Identification of Smart Medical Devices in Taiwan and the U.S. / 346

  • III. Administrative Supervision of Smart Medical Devices in Taiwan and the U.S. / 355

  • IV. Crime Prevention of Smart Medical Devices in Taiwan and the U.S. / 372

  • V. Conclusion / 380

(Note: The following chapters are presented in both English and Chinese in the original text; the structure below reflects this dual presentation).

Legal Regulatory Framework for Medical AI in China / Su Jiang

  • I. Introduction / 384

  • II. The Background and Application Scenarios of the Medical AI / 386

  • III. Registration and Supervision of Medical Artificial Intelligence Products / 390

  • IV. Data and Privacy Protection of Medical AI / 394

  • V. Medical AI and Product Liability, Medical Damage Liability / 408

  • VI. Medical AI and Intellectual Property Rights / 417

  • VII. Conclusion / 421

The Legal Regulatory Framework for Medical AI in China (Chinese Translation Version) / Jiang Su

  • I. The Background and Application Scenarios of the Rise of Medical AI / 425

  • II. Registration and Supervision of Medical Artificial Intelligence Products / 427

  • III. Data and Privacy Protection of Medical AI / 430

  • IV. Medical AI and Product Liability, Medical Damage Liability / 438

  • V. Medical AI and Intellectual Property Rights / 443

  • VI. Conclusion / 446

New Trends in Legislation and Regulations for eHealth Devices in Taiwan / Chen-Chi Wu

  • I. Introduction / 448

  • II. Special Considerations for eHealth Devices in Legal Regulations / 450

  • III. Current Legislation and Regulations for eHealth Devices in Taiwan / 463

  • IV. Conclusion / 479

New Trends in Legislation and Regulations for eHealth Devices in Taiwan (Chinese Translation Version) / Wu Chen-Chi

  • I. Foreword / 484

  • II. Characteristics and Potential Risks of Smart Medical Devices / 485

  • III. Special Considerations for the Regulation of Smart Medical Devices in Legal Norms / 493

  • IV. Current Legal Norms and Regulatory Status of Smart Medical Devices in Taiwan / 502

  • V. Conclusion / 515

Author Biographies

Author Biographies (Listed in order of articles)

  • Lin Meng-Hsiang: Associate Professor and Chair, Department of FinTech Application / Director, Master Program in FinTech, School of Financial Technology, Ming Chuan University

  • Hsu Pei-Ling: Associate Professor and Director, Graduate Institute of Technology Finance, CTBC Business School

  • Hsu Yu-Ting: Assistant Professor, Department of Ocean and Border Management, National Quemoy University

  • Chu Yi-Hsuan: Senior Legal Counsel, Hon Hai Precision Industry Co., Ltd. (Foxconn)

  • Wang Cheng-Chia: Professor, Department of Law, National Chung Cheng University

  • Cheng Ting-Hsien: Associate Professor and Director, Graduate Institute of Industrial Economics, National Central University

  • Kung Ying-Pin: Master's Student, Graduate Institute of Industrial Economics, National Central University / Attorney-at-Law (Taiwan)

  • Liao Wei-Min: Full-time Associate Professor, Department of Law, National Chung Hsing University

  • Shih Chia-Li: Partner, Bruce Stone LLP (USA)

  • Tseng Yun-Jung: Attending Physician, Emergency Department, China Medical University Hospital

  • Chang Li-Ching: Chair Professor, Department of Law, Shih Chien University / CEO, Artificial Intelligence Law International Research Foundation

  • Wang Chi-Hsuan: Associate Professor, Department of Law, Chinese Culture University / Deputy CEO, Artificial Intelligence Law International Research Foundation

  • Yeh Hui-Chen: Ph.D. Student, College of Law, National University of Kaohsiung

  • Jiang Su: Professor, Law School, Peking University

  • Wu Chen-Chi: Professor, Department of Otolaryngology, College of Medicine, National Taiwan University

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