Billee Lightvoet Ward

Billee Lightvoet Ward is a highly experienced health care attorney with a career spanning over 25 years. She provides legal representation to individuals and corporate entities of all types with particular emphasis on health care providers and institutions, pharmaceutical and medical device companies, commercial product manufacturers and distributors, and private equity firms. Billee counsels clients in a variety of regulatory and product-related issues, contractual arrangements and transactional matters. She has extensive experience preparing corporate and other documents necessary for business operations; drafting and negotiating contracts; and providing counsel and education on regulatory issues relevant to business operations, purchase and sale transactions, and commercial products compliance.

Billee has expertise in a variety of federal and state health care laws including HIPAA and other laws governing information privacy and security; and the Stark Law, Anti-Kickback Statute, False Claims Act and other fraud and abuse laws. She regularly advises on corporate practice of medicine and dentistry laws relevant to private equity and other health care transactions, and provides health care diligence support for both buyer- and seller-side clients. She has over 20 years’ experience in human subjects research compliance and IRB operations, and helps commercial products clients with product classification, labeling, recalls, reporting, and general pre- and post-market FDA and CSPC compliance.

• Lead counsel to private equity client in purchase of multi-site IVF clinic
• Lead health care attorney for private equity dental service organization transaction involving multiple dental practices
• Lead counsel to physician practice in sale of assets to national health system
• Regulatory counsel and clinical trial contracting counsel to cardiac device company
• Regulatory counsel and clinical trial contracting counsel to international pharmaceutical company
• Counsel to renowned international cosmetics and skin care company in FDA compliance and product labeling review
• Counsel to numerous startup medical device companies in FDA product classification, pre-market strategy and post-market compliance
• Represented various personal protective equipment manufacturers and other COVID-related product manufacturers and distributors in navigating Emergency Use Authorizations and other FDA rules through course of COVID-19 pandemic
• Counsel to international FDA-regulated product manufacturer in product recall
• Counsel to international CSPC-regulated product distributor in product recall
• Compliance and contract counsel to numerous healthcare providers and large health systems

• Look Before You Leap – Early Determination of Product Classification and Regulatory Pathway for FDA-Regulated Products Healthcare Michigan, Volume 41, No. 4 April 2024
• Co-Presenter: The Regulatory Landscape for Cannabis Products in the U.S. and Canada – Is the Grass Greener on the Other Side? September 2022