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Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more