AI in Healthcare June 17, 2024
AI transparency in medical devices is achievable and imperative, according to new guidance jointly promoted by the FDA, Health Canada and the U.K.’s Medicines and Healthcare products Regulatory Agency.
Issued June 13, the document updates and builds on principles the three bodies outlined in 2021.
The guidance defines transparency in “MLMDs”—for machine learning-enabled medical devices—as “the degree to which appropriate information about a MLMD … is clearly communicated to relevant audiences.”
The guidance asks healthcare AI developers and marketers to consider their technology’s full range of ramifications for patient safety and, by extension, population health. It lays out six questions to help conduct these pre-deployment probes.
Q. To whom is MLMD transparency relevant?
A. Transparency is relevant to those who...
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