About Staff
Yi currently serve as a Deputy Legal Researcher in the Biomedicine and Health Policy Division. My work focuses on designing and implementing biomedical regulatory projects in the areas of market access, innovation facilitation, and reimbursement in the United States, the United Kingdom, and Singapore. I specialize in legal and policy analysis concerning advanced medical devices, digital/AI health, and public health policy.
．LL.M., National Chengchi University, Institute of Law and Inter-Discipline. (Expected)
．M.S., National Taiwan University, Institute of Environmental health.
．B.S., Taipei Medical University, Department of Public Health.
．Institute for Information Industry / Science & Technology Law Institute/ Associate Legal Researcher (Sep 18, 2023 - )
．Centers for Disease Control, Ministry of Health and Welfare / Bio-medical Laboratory Technician(Nov, 2018- Sep, 2019, Sep, 2021- Dec, 2022)
．Health Promotion Administration, Ministry of Health and Welfare/ Administration Staff (Jan- Oct, 2018)
Thesis
．Yi Liu, Bench scale study for assessment of DBPs formation from human endogenous organic precursors, (Jan, 2018) (unpublished M.D. dissertation, National Taiwan University).
Article
．Yi, Liu, A Concise Analysis of U.S. Regulatory Strategies for AI/ML Medical Device Software, Science and Technology Law Review, 36(4), 84-92 (2024).
．Yi, Liu, The U.S. FDA’s Center for Devices and Radiological Health Releases FY2024 Medical Device Guidances, STLI Quarterly Newsletter (January 2024).
．Yi, Liu, The U.K. Government Announces Its “Future Regulations Implementation” Plan for Medical Devices, STLI Quarterly Newsletter (May 2024).
．Yi, Liu, Brazil Adopts Normative Instruction No. 290 to Expedite Market Entry for Medical Devices Already Approved by International Regulators, Trade Insight Biweekly (Issue 646) (June 26, 2024).
．Yi, Liu, The U.K. Issues a Policy Draft on an International Recognition Framework for Medical Devices to Ease Post-Brexit Shortages, Biotechlaw (November 5, 2024).
．Yi, Liu, The U.K. Department for Science, Innovation and Technology Releases the “AI Opportunity Action Plan” , AnkeCare (March 7, 2025).
．Yi, Liu, Pain Points in Home-Based Care (Part I): Interoperability, Service Trade-offs, and the Ongoing Need to Establish Quality and Standards, AnkeCare (June 26, 2025).
．Yi, Liu, IMDRF Proposes (March 2025) a Draft “Operations Manual for the Medical Device Regulatory Reliance Program” to Promote International Regulatory Convergence and Product Mobility, STLI Quarterly Newsletter (July 2025).
．Yi, Liu, The U.K. Launches an “AI Medical Device Regulatory Sandbox” to Address the Regulatory Challenges Facing AI-Enabled Medical Devices (Part I), NCKU Medical Device and Technology Innovation Newsletter (Issue 19) (August, 2025).
Keynote Speech
．Yi, Liu, International Regulatory Trends in Medical Device Software, National Union of Medical Device Commercial Associations — Foundational Training on Smart Medical Device Product Development (August 29, 2024).
．Yi, Liu, International Regulatory Trends for AI-Enabled Medical Devices and Digital Health, Compliance Seminar on Advanced Medical Technology Products (July 11, 2025).
．ISO/IEC 27001:2022 Lead Auditor
．ISO/IEC 42001:2023 Lead Auditor