Top 5 Life Sciences Regulatory & Policy Updates
This newsletter summarizes the top five recent regulatory updates and policy changes impacting the U.S. life sciences and healthcare industries. 1. New State Laws Create a Patchwork of AI Regulation in Healthcare While U.S. Congress failed to pass a federal moratorium on Artificial Intelligence (AI) legislation, states are aggressively moving forward with new regulatory regimes, […]
Why Your PI Agreement Might Be a Ticking Time Bomb
When was the last time you read your Principal Investigator’s agreement cover to cover? For many clinical trial sites, the physician employment contract feels like a box-checking exercise. Draft it, sign it, file it away, and move on. But here’s the uncomfortable truth: These agreements are the foundation of your research program and the wrong […]
When Patient Assistance Becomes a Legal Minefield
For two decades, OIG guidance has warned that manufacturer-run Patient Assistance Programs are high-risk under the Anti-Kickback Statute. Directly covering Medicare co-pays for your own drug? Red flag. Funding a “charity” that only helps patients on your product? Still risky. The 2005 OIG Special Advisory Bulletin outlined safe harbors—donate only to truly independent charities, keep […]
