Posted by Michael Wonder on 24 Nov 2019
Lifecycle regulation of artificial intelligence and machine learning–based software devices in medicine
22 November 2019 - Artificial intelligence and machine learning (AI/ML) based technologies aim to improve patient care by uncovering new insights from the vast amount of data generated by an individual patient and by the collective experience of many patients.
Machine learning is an AI technique that trains software algorithms to learn from and act on new data to continuously improve performance.
In 2018, the US FDA cleared the first AI/ML-based software (a program for diabetic retinopathy) that provides screening decisions without needing clinician interpretation. Although such technologies hold promise, they also raise questions about their safety and effectiveness. In April 2019, the FDA announced that it was reviewing how to regulate AI/ML-based software. The distinctive characteristics of AI/ML-based software require a regulatory approach that spans the lifecycle of these technologies, allowing necessary steps to improve treatment while ensuring that the algorithm is safe.
