Life science and health information technology businesses are simultaneously the most dynamic growth sectors of the healthcare industry and the most challenging from a regulatory compliance perspective. Nelson Hardiman has a depth of experience representing life science and health technology companies in business and regulatory matters, including Medicare, U.S. Food and Drug Administration (FDA), and HIPAA compliance. Our attorneys have successfully assisted life science and health technology businesses in a broad range of legal matters, including structuring of new business ventures, resolution of FDA investigations, and complying with research, labeling and marketing, and other requirements for products and services.
In the life sciences industry, our clients include medical device manufacturers and resellers, biotechnology companies developing new drugs, biologics, medical foods, and other therapies, and manufacturers and resellers of “nutraceutical,” “cosmeceuticals,” and supplements. We have deep experience in clinical research compliance. We advise and assist clients on all aspects of product development and regulatory approval, including issues relating to Medicare and third-party payor reimbursement. We have defended numerous investigations relating to compliance and fraud and abuse issues, and leverage that experience to help clients stay in compliance and develop safe practices in their operations, including marketing, and reimbursement.
In the health information technology industry, we have worked with many technology companies and telehealth providers. Nelson Hardiman attorneys have unparalleled experience developing compliant business models, and helping clients stay in compliance and grow their businesses safely. Clients count on Nelson Hardiman to ensure that their businesses are protected from risk in all aspects of federal and state law relating to their licensing, operations, and reimbursement.