Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more. Allyson’s healthcare regulatory work ranges from clinical bioethics and informed consent issues to counseling on compliance with U.S. federal fraud, waste, and abuse laws such as the Anti-Kickback Statute, Stark Law, Sunshine Act, and their state law equivalents, as well as HIPAA, state healthcare privacy laws, change of ownership and state licensing requirements for various healthcare and healthcare adjacent entities.