Practice Areas
Legal, regulatory and compliance counsel for healthcare companies operating in the United States and growing abroad.
Our clients are healthcare companies changing how care is delivered: medical device manufacturers and distributors, providers of clinical and B2B services, and businesses bringing new technologies into their offerings. We help them operate within a regulatory framework that keeps changing, in the United States and in the markets where they do business.
We advise on healthcare fraud and abuse laws, including the Anti-Kickback Statute, the Stark Law and the False Claims Act; on the structuring of clinical and B2B services; on HIPAA; and on emerging rules governing the use of artificial intelligence in healthcare.
We help clients enter or expand in Latin America and other regions by assessing how local legislation affects their products and services, including the registration, modification, renewal and transfer of health product registrations. Where local counsel is required, we coordinate the work and remain the client's single point of contact.
We draft, negotiate and review distribution, HCP, placement, consignment, clinical trial and B2B services agreements, and advise manufacturers on the most efficient legal structure for distributing their products abroad while identifying and addressing regulatory, legal and compliance risks.
We advise on anti-bribery, the FCPA, anti-money laundering and fraud prevention, and on the compliance programs that manage these risks across jurisdictions.