Mary Waller represents health care and life sciences companies on a variety of complex regulatory and compliance issues, including for M&A transactions and health care fraud and abuse litigation. She has represented hospitals, health systems, physician groups, pharmaceutical and medical device manufacturers, and established and emerging digital health companies.
Mary has advised clients on regulatory and compliance issues, including direct-to-consumer telemedicine, licensure, patient consent, remote supervision, e-prescribing, and health information privacy and security compliance under the Health Insurance Portability and Accountability Act (HIPAA). She has supported clients engaged in M&A and other strategic transactions, including home health and physician practice acquisitions and private equity investments, and has participated in structuring various management service agreements and other arrangements to provide professional, management, or administrative services. Her experience also includes defending health care clients in investigations and litigation relating to the False Claims Act, the federal Anti-Kickback Statute, and the Stark Law brought by federal agencies and qui tam whistleblowers.
On the life sciences side, Mary has provided regulatory advice on issues associated with clinical research and the regulation of drugs and devices by the Food and Drug Administration (FDA). She also provides support to clients engaged in life sciences M&A and other transactions, including due diligence.
Mary sits on the Steering Committee for the Fellowships at Auschwitz for the Study of Professional Ethics and is a member of the American Health Lawyers Association and the Illinois Association of Healthcare Attorneys. She maintains an active pro bono practice, including education advocacy and asylum cases.
- University of Michigan (J.D. December 2017); University of Southern California (B.A. in Cognitive Science and B.A. in Spanish, summa cum laude 2015; Phi Beta Kappa)