Tag Archives: GMLP

FDA AI Guidance and the Hard Part of Transparency

The least glamorous part of AI in radiology may turn out to be the most important: telling people what changed.

That sounds simple. It is not. A diagnostic AI tool may be trained on one dataset, validated on another, deployed inside a PACS or reporting workflow, monitored after release, and then updated when the model, threshold, input, interface, or intended environment changes. Somewhere in that chain, a radiologist is expected to decide whether to trust a box, a score, a contour, a triage flag, or a sentence.

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The FDA has an Idea, or 10, on Good Machine Learning Practice

Good machine learning practices goes beyond the chip

The U.S. FDA, Health Canada, and the UK’s MHRA have unveiled 10 guiding principles for Good Machine Learning Practice (GMLP) in developing AI/ML medical devices. These principles aim to ensure safety, efficacy, and quality in healthcare innovation. Key focuses include leveraging multi-disciplinary expertise, implementing good software and security practices, ensuring representative clinical study participants and data sets, maintaining independence between training and test data sets, and emphasizing the performance of the human-AI team. These guidelines also highlight the importance of clear user information, robust testing, and ongoing monitoring of deployed models to manage re-training risks and maintain performance.

Read the full GMLP draft on the FDA website.

1-Minute Summary

Here are the ten principles of GMLP.

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