Governance over the use of artificial intelligence in regulated environments such as healthcare has been developing in an almost arbitrary manner.
The U.S. Food and Drug Administration has taken the most definitive steps in its publication of the 2021 Artificial Intelligence and Machine Learning Software as a Medical Device Action Plan, which outlined the establishment of “practical oversight” of AI or ML-based Software as a Medical Device. However, the first draft guidance on proposing an approach to support iterative improvement wasn’t released for comment until spring 2023.
Other…
The U.S. Food and Drug Administration has taken the most definitive steps in its publication of the 2021 Artificial Intelligence and Machine Learning Software as a Medical Device Action Plan, which outlined the establishment of “practical oversight” of AI or ML-based Software as a Medical Device. However, the first draft guidance on proposing an approach to support iterative improvement wasn’t released for comment until spring 2023.
Other…
