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Work item:
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F.781.2 (ex H.AI-SaMD-Req)
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Subject/title:
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Quality assessment requirements for artificial intelligence/machine learning-based software as a medical device
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Status:
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Approved on 2024-06-13 [Issued from previous study period]
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Approval process:
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AAP
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Type of work item:
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Recommendation
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Version:
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New
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Equivalent number:
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-
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Timing:
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-
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Liaison:
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-
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Supporting members:
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-
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Summary:
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With the advent of artificial intelligence/machine learning (AI/ML) and its strength in faster and more accurate disease detection and diagnosis, it is inspiring that more timely and widespread adoption of decision-making assistant (DMA) software as a medical device (DMA-SaMD) would benefit improving health for human beings. However, that does not mean the AI/ML-based DMA-SaMD for decision making is ready for the clinic, AI/ML technology can only be used with complete confidence if it has been quality controlled through a rigorous evaluation in a standardized way. The performance and usability shall be assessed under a reliable and rigorous evaluation with a robust method to substantiate AI/ML-based DMA-SaMD quality.
This Recommendation provides a requirement framework for the quality assessment with a perspective of lifecycle management for AI/ML-based DMA-SaMD. It describes the quality assessment principles and process in the life cycle of AI/ML-based DMA-SaMD, including requirement analysis, data collection, algorithm design, verification and validation, change control and other stages when using AI/ML technology to assist medical staff in making clinical decisions by providing suggestions on diagnostic and treatment activities.
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Comment:
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-
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Reference(s):
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Historic references:
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Contact(s):
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| ITU-T A.5 justification(s): |
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First registration in the WP:
2019-11-14 18:23:51
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Last update:
2024-05-06 13:17:36
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