USA – Providing context to AI/ML products may address explainability says FDA

Context is important when trying to address issues of transparency and explainability of artificial intelligence and machine learning products (AI/ML), according to a regulatory expert at the US Food and Drug Administration. Since many such products exist in a “black box,” providing context to the outputs may help ensure confidence in their results, he added.

As medical products companies race ahead to adopt AI/ML technology, FDA wants them to provide as much transparency about their product as possible in terms of how they make decisions and provide answers. The agency also wants the algorithms used by such products to be as explainable as possible to users, so they feel confident in their outputs…