Shihang Lee is a legal expert specializing in healthcare regulation and data protection. He focuses on establishing integrated regulatory strategies for the digital transformation of the healthcare industry.

Global Research Data Privacy & AI Regulation: Shihang excels in resolving complex legal challenges at the intersection of medical, bioethics, and privacy laws. He is particularly recognized for his ability to navigate high-stakes regulatory uncertainties, supporting the development of robust data governance frameworks for global multi-center clinical trials, cross-border data transfers, and AI model training using Real-World Data (RWD).

Healthcare Regulatory & Crisis Management: Drawing on his experience at the Ministry of Food and Drug Safety (MFDS), Shihang provides practical, end-to-end solutions throughout the product life cycle – from business licensing and GXP compliance to labeling, advertising, and post-market surveillance. He has a proven track record in risk mitigation and crisis management, representing clients in significant administrative and criminal proceedings that impact business continuity.

Bio & Digital Product Commercialization Strategy: Leveraging his life sciences background and extensive secondment experience at multinational corporations, he bridges the gap between R&D and legal functions. He provides strategic counsel on the commercialization of digital health business models and innovative pipelines, ensuring they meet both global business objectives and local regulatory requirements.