Helping Clients Navigate and Thrive in a Rapidly Changing Regulatory Environment
In this watershed era for healthcare innovation and delivery, we work closely with industry leaders, pioneers and disrupters to help them navigate and thrive in a rapidly changing regulatory environment.
Fenwick’s healthcare regulatory team counsels digital health, healthcare and life sciences companies at all stages of growth on a wide range of regulatory and transactional matters. We help clients develop and implement optimal pathways to delivering best-in-class healthcare products and services, navigating healthcare regulatory and fraud and abuse issues at the state and federal level.
The healthcare regulatory group works closely with Fenwick’s market-leading corporate practice, providing sophisticated regulatory counsel on transactions including seed, venture capital and other financings, mergers and acquisitions and securities offerings. We also help structure and negotiate operating and services arrangements.
The team counsels companies on regulatory matters including:
- Healthcare fraud and abuse compliance and counseling, e.g., Federal Anti-Kickback Statute, Federal False Claims Act, Federal Stark law and state equivalents
- Emerging healthtech counseling, including digital health, state telehealth rules, online prescribing, licensing and scope-of-practice requirements
- Advising on structuring physician and other licensed healthcare provider practice management models, including corporate practice of medicine/licensed restrictions and fee-splitting rules
- Transactional matters involving health facilities, physician organizations and other healthcare providers, suppliers and life sciences companies
- Additional regulatory and transactional matters, including:
- Licensing regulatory compliance
- Government reimbursement compliance
- Integrated delivery systems, value-based models, care management and provider networks
- Healthcare fraud and white-collar investigation support
As technology continues to disrupt healthcare, our team combines up-to-the-minute regulatory knowledge and experience with a deep and dedicated understanding of our clients’ business and technologies, enabling us to provide clients with legal counsel and pragmatic solutions to help them compete in the global marketplace.”