Kiyong Song is a corporate healthcare associate in the New York office of Kirkland & Ellis LLP, focusing on healthcare, life sciences, and privacy & security regulatory and transactional matters of healthcare and life sciences entities and investors. He regularly counsels clients with respect to business transactions including mergers, acquisitions, carve-outs and other strategic business deals.
Kiyong also counsels clients to strategically navigate the complex regulatory landscape impacting companies in the healthcare provider and life science space, including pharmaceutical and medical device manufacturers, contract development & manufacturing organizations (CDMOs), active pharmaceutical ingredient (API) suppliers, medical device manufacturers, advanced therapeutics developers, laboratories, pharmacies, mental health providers and digital health companies.
Kiyong evaluates U.S. Food & Drug Administration (FDA) compliance requirements for all aspects of drug, biologics and device product life cycle, including product development and clinical trials, product classification, manufacturing, regulatory inspections and product recalls. In counseling his clients, Kiyong also brings special counsel on wide range of federal and state healthcare regulatory matters such as HIPAA compliance, ONC 21st Century Cures Act Final Rule, FTC Health Breach Notification Rule, state consumer health data privacy and security, application of Artificial Intelligence (AI) or Machine Learning (ML), the federal policy for the protection of human subjects, corporate practice of medicine, and federal and state healthcare fraud and abuse laws such as the Anti-Kickback Statute and the Stark Law and other related regulatory matters.
Kiyong is also experienced in advising clients on healthcare and FDA regulatory issues in the context of commercial transactions, and regulatory disclosures and filings at both the federal and state levels.
