Kyle Faget is a Boston-based partner and a health care and life sciences lawyer with Foley & Lardner LLP and is the co-chair of the Health Care & Life Sciences Sector's Medical Device Area of Focus and the former co-chair of Foley's Health Care Practice Group. Prior to joining the firm, she held in-house positions at pre-commercial and commercial stage pharmaceutical and medical device companies. Kyle advises life sciences companies, telemedicine and digital health companies, academic medical centers, physician practices, and consultants on a range of business, legal, and regulatory issues. She helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act (FDCA), the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the AdvaMed Code and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, manufacturing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements. Telemedicine, Telehealth, and Digital Health "Kyle has been a pleasure to work with and very helpful. She is very knowledgeable of key areas critical to our work and always communicates with compassion, kindness, and thoughtfulness." "Kyle is an incredible attorney. She is smart, sophisticated, and responsive. She really understands the healthcare industry." "Foley is the premier firm for telehealth counsel." "A market leader in telemedicine issues." "This is the Dream Team." - Chambers USA: America's Leading Business Lawyers (2020, 2021, 2022) Kyle was recognized by Chambers USA: America's Leading Lawyers for Business for her work in the practice area of Healthcare in 2022. Kyle works with start-up and established entrepreneurs to create direct-to-consumer medical services using synchronous and asynchronous telemedicine offerings. She advises on strategic models for care delivery and revenue streams, state-by-state telemedicine modalities and practice standards, contracting with laboratories and pharmacies, and e-commerce issues. Kyle also assists digital health innovators understand and navigate the FDA regulatory landscape. Kyle has married her years of experience counseling pharmaceutical and medical device companies on their brick-and-mortar clinical trial programs with her telehealth practice to offer cutting-edge decentralized clinical trial advice. Clinical Research, Clinical Trials and Life Sciences Kyle has extensive experience drafting and negotiating agreements with and for contract research organizations and site management organizations. She regularly drafts and negotiates clinical trial agreements, informed consents and other clinical development agreements on behalf of institutions and pharmaceutical and medical device clients. Kyle also advises clients on how to leverage and operationalize decentralized clinical trials. Kyle has also drafted and negotiated a broad swath of operational agreements for her pharmaceutical and medical device clients, including manufacturing agreements, distribution agreements, master services agreements, commercial agreements, and material transfer agreements. "Kyle is at the top of our collective list for quality of advice, depth of understanding and knowledge of the industry, responsiveness, and just plain reliability." - Chambers USA: America's Leading Business Lawyers (2020, 2021) FDA Regulatory Kyle regularly advises telehealth, pharmaceutical and medical device clients regarding advertising and promotion issues, including off-label promotion. She regularly assesses marketing materials directed toward health care providers and direct-to-consumer advertising campaigns for compliance with the Food, Drug and Cosmetic Act and FDA Guidance documents. Kyle also helps digital health clients navigate the FDA regulatory process when developing new digital health products. Corporate Compliance Kyle has assisted multiple pharmaceutical and medical device clients build and operationalize corporate compliance programs. She has also advised clients on compliance with Corporate Integrity Agreements (CIAs). Her work has included drafting compliance policies and regularly conducting sales force training. Kyle has also assisted a number of life sciences companies enter the U.S. market compliantly.