This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA Digital Health Center of Excellence advisor Aubrey Shick. They unpack what FDA’s latest moves signal for generative AI, digital health policy, and regulatory strategy. From Breakthrough designations for AI-powered recovery tools to TEMPO uncertainty and real-world FDA workflow challenges, this episode blends insider perspectives with real-time industry implications—plus a few jokes that hit a little too close to home.

Key Topics Covered

• Digital Health Center of Excellence: role, attrition, and impact 

• When software becomes a medical device (and why it’s still unclear) 

• Breakthrough designation for RecoveryAI (GenAI in regulated space) 

• FDA’s evolving approach to generative AI within existing frameworks 

• TEMPO program: timelines, submission variability, and policy implications 

• PMA approvals (including AI-enabled breast cancer detection) 

• FDA database limitations: transparency vs. discovery 

• AEMS (Adverse Event Monitoring System) rollout and implications 

• FDA’s internal AI tool (ELSA) and concerns around review transparency 

• Real-world challenges: reviewer workload, hiring, and infrastructure 

• Regulatory Accelerator and underutilized FDA resources for innovators