Our team at the Duke Institute for Health Innovation published the first AI product label in healthcare in March 2020 in Nature Digital Medicine. The manuscript describing the ‘Model Facts’ label and the initial example for the Sepsis Watch model are available here. The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule cited the DIHI Model Facts label multiple times, and we are thrilled to see our work shape federal regulation of AI in healthcare.

We have updated the original ‘Model Facts’ label to include a few additional fields to account for HTI-1 compliance.  Starting on January 1, 2025, AI products distributed by electronic health records (EHR) vendors must disclose 31 source attributes. The full list of attributes is available on page 2 of this document.

We are providing an updated template under a Creative Commons Attribution 4.0 license. Similar to before, anyone can adapt and distribute the label for any purpose, including commercial purposes. We only ask that you give the DIHI team credit for the use of the Model Facts label and cite the source, which we consider our original manuscript from March 2020. The Creative Commons Attribution 4.0 license allows you to:

• Share: copy and redistribute the material in any medium or format for any purpose, even commercially.
• Adapt: remix, transform, and build upon the material for any purpose, even commercially.

To download the template or an example of the completed template for the DIHI Sepsis Watch™ solution, click on the respective buttons below.

Download Model Facts label template view example label