Drew Douglas-Steele helps health care and life sciences organizations understand the various regulatory and compliance considerations at play so that they can minimize risk while ensuring compliance with applicable laws and regulations. Clients appreciate that Drew keeps them well informed of new legal and regulatory developments in the rapidly changing health care world, and provides nuanced and detailed analyses of how such developments may impact their business operations. Drew has worked with academic medical centers, pharmaceutical and medical device companies, nonprofit and for-profit health care systems, hospitals, and physician practices on these multifaceted health care regulatory and transactional issues.
- Advises clients on compliance with requirements under the Common Rule; FDA requirements for clinical investigations; and federal, state, and international data protection and privacy laws, including HIPAA and GDPR, and Stark and Anti-Kickback Laws.
- Drafts and negotiates various agreements, including industry-sponsored and investigator-initiated clinical trial agreements, material transfer agreements, and medical device purchase, sale, and maintenance and service agreements.
- Reviews and revises institutional policies and procedures to identify and manage individual and institutional conflicts of interest.
- Advises clients on state and federal laws governing stem cell and fetal tissue research, state change-of-ownership and licensing requirements, and telehealth and teledentistry regulations.
- Provides advice on the various legal issues at play during strategic affiliations, mergers and acquisitions, and joint ventures.
Before joining Epstein Becker Green, Drew was a health care attorney at a New England regional law firm and started her career at an international law firm. She received her Juris Doctor from Duke University School of Law, where she served as Co-President of the Health Law Society and as Technology Editor of the Duke Journal of Gender Law & Policy.