01/12/26 - Asymmetric FDA and CMS Enforcement, HeartLung Opportunistic Screening Clearance, MRM Health IND Approval

01/12/26 - Asymmetric FDA and CMS Enforcement, HeartLung Opportunistic Screening Clearance, MRM Health IND Approval

Episode description

This episode examines divergent federal regulatory frameworks creating asymmetric enforcement pressure across AI applications in healthcare, with the FDA reducing barriers for diagnostic tools while CMS and OIG increase scrutiny of AI-generated documentation and billing practices. Coverage includes HeartLung Corporation’s FDA clearance for multisystem opportunistic screening from existing chest CT workflows, MRM Health’s investigational new drug approval for a Phase 2B ulcerative colitis trial, and capital concentration data showing AI representing forty six percent of healthcare technology investment despite overall market contraction. The briefing details operational governance requirements for healthcare organizations navigating simultaneous deregulation in diagnostics and heightened compliance risk in revenue cycle applications.

No chapters are available for this episode.