Kyle Y. Faget advises a diverse client base – including life sciences companies, digital health platforms, virtual care providers, and academic medical centers – on regulatory, transactional, and compliance matters, with a focus on software as a medical device and artificial intelligence (AI) applications in healthcare. She has extensive experience in developing corporate compliance programs and regulatory strategies and provides guidance on US Food and Drug Administration (FDA) regulations for both established products and emerging technologies, including AI-enabled solutions.
Kyle counsels clients on the full spectrum of regulatory and compliance issues, including the Food, Drug, and Cosmetic Act; the False Claims Act; the Anti-Kickback Statute; and industry codes. She offers guidance on product marketing promotion compliance, assesses advertising materials and direct-to-consumer campaigns, and conducts sales-force training. She also oversees healthcare provider grants and charitable contributions and assesses research grants for healthcare professionals.
Kyle also advises on pharmacy supply chain contracting, laboratory and pharmacy relationships, and other healthcare service provider arrangements. She guides life sciences companies on market entry strategies and assists digital health innovators in navigating FDA requirements for emerging healthcare technologies. Her vast experience includes in-house positions at pre-commercial and commercial-stage pharmaceutical and medical device companies.
Kyle’s transactional experience encompasses pharmaceutical and medical device development and commercialization, including licensing agreements, manufacturing and distribution arrangements, collaboration agreements, clinical trial protocols, material transfer agreements, and healthcare professional engagement agreements.
Recognized for her deep experience in life sciences and healthcare law, Kyle is a prolific presenter and author. She frequently speaks at professional conferences and forums, developing topics in the context of her work and emerging technologies. She has published several articles in Health Care Law Today.
