Allison Shuren co-chairs the Life Sciences and Healthcare Regulatory Practice and advises a wide range of health care clients on regulatory, compliance, enforcement, and legislative matters. Her clients include large international manufacturers of medical devices, pharmaceuticals, biologics, emerging companies with early stage concepts, hospitals and integrated health networks, ambulatory surgery centers, diagnostic testing facilities, clinical laboratories, dialysis centers physicians, physician practice management companies, and developers of mobile and digital health technology. A primary focus of Ms. Shuren's practice is compliance with health regulatory requirements, especially the healthcare fraud and abuse laws. She counsels on complex referral arrangements as well as sales and marketing programs, including discounts and rebates, represents clients in government investigations and qui tam actions involving False Claims Act, Anti-Kickback Statute, Stark Law, and health care fraud allegations. She regularly interacts with the US Department of Health and Human Services Office of Inspector General, the US Department of Justice, and the Centers for Medicare and Medicaid Services. She also leads internal compliance investigations and regulatory due diligence related acquisitions and investments. Ms. Shuren's goal is to be a trusted advisor who helps clients meet legal requirements while achieving success in a competitive healthcare marketplace.
Before she began her legal career, Ms. Shuren was a practicing critical care pediatric nurse practitioner concentrating in pediatric cardiovascular disease and neonatal pediatric surgery. She has served as a principal investigator as well as a research coordinator for clinical trials involving pharmaceutical and medical device products. During her clinical career, she helped spearhead the development of an outcomes management and clinical pathway program.
FDA Law (2017)
- JD, University of Michigan Law School, 1998
- MSN, Nursing, University of Florida, 1994
- BSN, Nursing, Salem State College, 1987, cum laude
- District of Columbia
Member, American Health Lawyers Association
Member, American Bar Association’s health law section
Former adjunct faculty member, University of Maryland undergraduate and graduate schools of nursing