Critical Medical Device Series: Part X Balancing Risk and Innovation: Fraud and Abuse Trends for MedTech

This session will provide an overview of the Federal Anti-Kickback Statute, focusing on emerging risks (and mitigation strategies) in the medical device industry. This includes exploring how to balance legal and compliance risks against the business rewards of innovation in an environment of ever-changing government enforcement priorities. We will review recent initiatives from OIG and DOJ, including important OIG Advisory Opinions and fraud alerts. The session will also highlight emerging compliance risks and opportunities driven by AI, such as data sharing, marketing automation, and patient engagement technologies.