HealthcareFairness-aware classification or prediction with human-facing transparency controlsearly-to-mid stage; fda is formalizing expectations and explicitly seeking comment on adequacy for emerging technologies such as generative ai.

Bias and transparency management workflow for AI-enabled medical devices

Before and after launch, the device maker checks whether the AI is fair, explains important information to users, and watches for problems that could hurt certain patient groups.

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EHR + Narrative ADE Detection Engine for Signal Triage

4 use cases in this application

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Source

https://www.fda.gov/news-events/press-announcements/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices