Allison Shuren co-chairs the Life Sciences & Healthcare Regulatory practice and advises a wide range of healthcare and life science clients on regulatory, compliance, and enforcement. She is a trusted advisor for international manufacturers of medical devices, pharmaceuticals, biologics and diagnostics as well as emerging companies with early-stage innovations, developers of virtual and digital health technology, private equity funds and the their portfolio companies, and broad range of providers of healthcare services, including ambulatory surgery centers, remote monitoring and diagnostic testing facilities, clinical laboratories, dialysis centers, physician group practices, virtual health networks, and physician practice management companies. A primary focus of Allison’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. She also 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 U.S. Department of Health and Human Services Office of Inspector General, the U.S. Department of Justice, and the Centers for Medicare & Medicaid Services. She also leads internal compliance investigations and regulatory due diligence related acquisitions and investments.
Before she began her legal career, Allison 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.
"Life Science Star"—Regulatory (2012–2016)
Health Care Law (2016-2023)
- J.D., University of Michigan Law School, 1998
- M.S.N., Nursing, University of Florida, 1994
- B.S.N., 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, University of Maryland undergraduate and graduate schools of nursing