Shihang Lee is an attorney with strengths in the healthcare sector, specializing in healthcare data, pharmaceutical and medical regulations, and biotech consulting.

Mr.Lee's work focuses on minimizing legal risks in healthcare research and establishing a legal foundation for data utilization. He provides advice on regulatory issues concerning clinical trials, medical records utilization, pseudonymization, MyData, and artificial intelligence, where laws such as the Medical Services Act, the Bioethics and Safety Act, and the Personal Information Protection Act intersect.

Based on his experience at the Ministry of Food and Drug Safety, Mr.Lee counsels on regulatory compliance, as well as administrative and criminal investigations for pharmaceuticals, medical devices, in vitro diagnostic devices, cosmetics, food and health functional foods, and digital medical products. His expertise covers business licensing and product approvals, advertising and labeling, quality and GMP compliance, and Sunshine Act reporting.

Additionally, leveraging his biotechnology expertise and strong startup network, Mr.Lee effectively analyzes the regulatory risks of new business models and pipelines for biotech and digital health companies, supporting investment and growth strategy development.