Developers of medical devices that use machine learning should be mindful of the four W’s and one H – who, what, why, when and how – when developing data transparency policies.
That’s the main takeaway of a new set of guiding principles developed by regulators in the US, UK, and Canada. The new guidelines build on a 2021 collaboration between Health Canada, the US Food and Drug Administration, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) that identified 10 guiding principles for good machine learning practice
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