Digital Health June 20, 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices focusing on transparency.
The guidance on the transparency of machine learning medical devices, published on 13 June 2024, was jointly established by MHRA, the US Food and Drug Administration (FDA) and Health Canada to ensure that information is communicated clearly and is relevant to its intended audience.
It builds on 10 guiding principles for good learning practice, published by the three organisations in 2021.
According to the MHRA guidance: “These guiding principles are intended as considerations when adopting and advancing good transparency practices.
“Continued engagement on this topic can help inform the collaborative development, implementation and iteration of good transparency practices and consensus...
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