09/07/2026
The HTI-1 rule expanded the information certified health IT must make available about predictive decision-support tools. Its framework includes 31 source attributes for predictive interventions, covering areas such as intended use, training data, validation and risk management.
That is a major shift in how healthcare AI will be evaluated and communicated.
A product page saying an algorithm is “clinically validated” is no longer enough. Which population? Which setting? Which outcome? Which limitations?
The strongest healthcare AI companies will treat model transparency as part of product storytelling, not a compliance appendix.