June 3, 2019. Artificial Intelligence/Machine Learning (AI/ML)-based software device that incorporates special computer techniques (algorithms) capable of detecting relevant medical patterns from large amounts of data. These very sophisticated pattern recognition capabilities (AI/ML) have broad potential healthcare applications, including making recommendations to healthcare providers and patients about the diagnosis, prognosis, treatment, or prevention of disease.1 The complexity, scalability, and broad scope of these new technologies thus raise important issues regarding their safety and effectiveness as it pertains to patients’ health.
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