Danielle E Sapega

Practice Areas

Danielle advises clients on transactions in nuanced health care sectors, assisting with due diligence, pre- and post-transaction compliance, licensing, regulatory filings, risk mitigation, and operational transition issues. She regularly counsels clients on technical federal and state health law matters, including fraud and abuse, privacy and data breach incidents, Medicare and Medicaid reimbursement-related issues and audits, corporate practice of medicine and fee-splitting prohibitions, and general corporate compliance. Danielle is considered go-to counsel for compliance, training, and advice on HIPAA. She also advises clients on FDA regulatory and compliance matters, with a particular focus on medical devices and digital health technologies, including questions around classification, premarket requirements, marketing and promotion, and ongoing regulatory obligations.

Education