Danielle is a health care and life sciences attorney focused on transactions and regulatory compliance. She advises clients on sophisticated 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 also 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.
Danielle also advises clients on FDA regulatory and compliance matters, focusing on the regulations governing the approval, compliance, and marketing of drugs and medical devices. She supports clients in navigating the evolving landscape of FDA policies and guidance, offering tailored insights to address the complexities of the development and commercialization of new products. She also provides strategic counsel to FDA-regulated entities in transactions. Her clients include pharmaceutical companies, startups, and manufacturers.
Before joining Cozen O’Connor, Danielle was associate counsel at Penn Medicine Lancaster General Health (LGH) where she negotiated hospital contracts and counseled hospital leadership on HIPAA, fraud and abuse laws, governance, policy management, medical credentialing, governmental survey preparation and accreditation, and regulatory filings. She also provided counsel to the LGH Research Institute, including negotiating clinical trial sponsorship agreements and assisting with maintaining the institute's AAHRPP accreditation.
Danielle has many years of experience serving as a member of multiple Institutional Review Boards. In this role, she provided legal perspective on informed consent documents and clinical protocols, assisting with regulatory compliance, ethical standards, and risk mitigation.
Danielle earned her bachelor’s degree in political science from the University of Michigan and her law degree from Temple University Beasley School of Law. Danielle also holds a master’s degree in health policy from Thomas Jefferson University College of Population Health, and has completed graduate coursework in drug and device regulatory affairs through UC Berkeley.