In 2021, the FDA held a Virtual Public Workshop that promoted transparency principles and concluded that users should be provided ready access to clear, relevant information about AI products. It is in this spirit that we created the Transparent-AI program to afford potential buyers and users of AI such transparency — how an algorithm under consideration was trained, indications for use, validation and verification details.

Benefits of joining Transparent-AI:

  • It is FREE and open to all manufacturers.
  • Your organization will achieve a higher level of credibility.
  • Manufacturers who provide the necessary data elements will receive the Transparent-AI badge on their products.
  • Help drive a better understanding of how products may work within local workflows, populations and equipment environments.

What Is Transparent-AI Comprised Of?

Transparent-AI is a voluntary program that consists of a set of data elements which will be solicited from all imaging AI manufacturers who currently have an FDA-cleared product in the U.S. market. The transparency content will be posted on AI Central and include data that fall within the following general categories: Model Identification, Characteristics, Indications for Use, Performance, Training Details and Limitations. Examples of data elements include intended user, age range, scanner manufacturer and scanner models used in stand-alone performance. We plan to include the Instructions for Use (IFU) for each product, an FDA-required document that already contains much of the discrete data referenced above.

For the full list of data elements, please see the Transparent-AI Data Dictionary attached in the appendix.

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