Fierce Biotech June 14, 2024
The FDA is joining hands with regulators in Canada and the U.K. on policies to ensure transparency in the development of medical devices powered by machine learning.
Alongside Health Canada and the U.K. Medicines and Healthcare products Regulatory Agency, the trio in 2021 published a set of 10 best practices for applying artificial intelligence in patient care—with principles such as employing multi-disciplinary expertise in development, using diverse, representative datasets and adhering to common cybersecurity standards.
The new update underlines the importance of delivering transparency as well—not just for the health professionals who use the system, but also the patients who receive care, as well as administrators, payors and governing bodies.
That includes clearly communicating a product’s intended use and...
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