Gaps in real-world monitoring limit the ability to assess how AI-enabled medical devices perform once deployed in care settings. Device behavior can change over time, vary across populations, and introduce risks that are not fully captured through premarket evaluation alone, creating uncertainty about real-world safety, effectiveness, and equity, and posing challenges for effective post-market oversight.

To address this gap, DiMe is conducting a policy-focused analysis examining how patient-generated health data (PGHD), alongside other forms of real-world data and evidence (RWD/E), can strengthen oversight of AI-enabled medical devices after deployment. This work centers patient experience and outcomes while helping regulatory decision-makers move from reactive oversight to earlier, evidence-informed intervention.

Through this effort, DiMe is working with Arnold Ventures to enable more transparent, accountable, and patient-centered oversight that amplifies patient voice and supports FDA and congressional efforts to ensure AI-enabled medical devices remain safe, effective, and equitable in real-world use.