Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms' Fit for Purpose for Safety Outcomes.

The ACE-IT supports a structured, transparent, and flexible approach for decision-makers to appraise whether electronic health record or medical claims-based algorithms for safety outcomes are FFP for a specific decision context. Reliability and validity testing using a larger sample of participants in other therapeutic areas and further modifications to reduce the time needed to complete the assessment are needed to fully evaluate its utility for regulatory decision-making.