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The innovation team: innovate@pistoiaalliance projectenquiries@pistoiaalliance.org
The Problem
Unlike traditional diagnostics and medical devices, AI and ML systems have an ability to continuously learn based on exposure to new patients and data in clinical settings and hence their performance may vary over time. This represents a unique challenge to regulators. Multiple other issues may also be challenging: availability and use of data, public trust, algorithmic bias, accountability, transparency, reproducibility and explainability of AI algorithms. Recently both the European Commission and FDA have released draft AI ethics and regulatory guidelines in early 2019 (FDA Proposal April 2019).
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