Part 3/7:
The pivotal concern lies in the FDA's current stance on AI tools in EMRs. The agency suggests that AI applications providing comprehensive and timely medical insights could be classified as medical devices. This contrasts with the intent of the 21st Century Cures Act passed in 2016, which aimed to facilitate clinical decision support software that empowers rather than replaces physician judgment. This evolving guidance could significantly curtail the incorporation of AI tools in everyday medical practice, potentially stifling innovation.