The joint guidance issued by the FDA, Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency marks a significant step towards achieving transparency in artificial intelligence-enabled medical devices. The document updates and builds on principles outlined in 2021, providing a comprehensive framework for healthcare AI developers and marketers to ensure transparency in machine learning-enabled medical devices (MLMDs). The guidance defines transparency in MLMDs as “the degree to which appropriate information about a MLMD… is clearly communicated to relevant audiences.” It emphasizes the importance of considering the full range of ramifications for patient safety and population health, and provides six questions to help conduct pre-deployment probes. The guidance also highlights the benefits of transparency, including building fluency and efficiency in the use of MLMDs, fostering trust and confidence in the technology, and encouraging adoption and access to beneficial technologies. Overall, this guidance is a crucial step towards ensuring that medical devices are safe, effective, and trustworthy.
AI Transparency in Medical Devices – A New Era
The transparent and consistent presentation of information, including known gaps in information, can have many benefits.
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