McDermott Will & Schulte, a global law firm

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.

Jayda Greco works at the intersection of healthcare regulatory, privacy and compliance, product counseling and marketing law, with particular emphasis on digital health products and services. Often working cross-functionally with stakeholders in sales, finance, marketing and product, Jayda is adept at devising creative and practical legal solutions for digital health initiatives to meet business objectives.

Jayda has a solid background in product development and the protection of intellectual property, gained from her years as in-house counsel for a national virtual care company, where she advised cross-functional groups of product managers and engineers on the creation and implementation of new features and functionality within iOS, Android and web platforms, as well as the risks and liabilities of proposed commercial models and transactions. She has a keen understanding of the Federal Trade Commission (FTC) Act, trademark, copyright and state consumer protection and marketing laws related to medical services and pharmaceuticals. She provides guidance on collateral and social media influencer campaigns, as well as drafting internal guidance and training on key issues to help her client maximize their marketing success while remaining in compliance with the complex healthcare and life sciences marketing and advertising regulations.

Jayda advises healthcare clients on compliance with HIPAA, CCPA as well as state and data breach laws where they converge with corporate transactions. She is a Certified Information Privacy Professional/United States (CIPP/US). Jayda also evaluates new business opportunities for her clients, examining health regulatory, privacy implications and similar concerns within the healthcare and consumer technology landscape at the federal and state level.