Summary
Updates the original Model Facts label with fields intended to support disclosure of the 31 source attributes required by the HTI-1 final rule for predictive decision support interventions distributed through certified health IT.
Healthcare Implications
Developers and health systems can use the template to document intended use, development and validation data, performance, fairness, limitations, update practices, and other source attributes in a consistent product label that supports procurement, implementation, clinician understanding, and HTI-1-aligned transparency.