In December 2023, HHS released a major, very important rule about AI and Predictive Algorithms (broadly defined) in EHRs. See press release. See fact summary. See Federal Register. See PDF, 247pp (Dense!) here. Jump to pagea 1245-46 for an idea of what's in and what's out. (They're only able to give a probabiiltic, not a clean, answer when asked if the BMI algorithm is in and out. "Likely" not in, but don't pin us down...)
i can't do justice to the complexity of this rule, but the Mintz law firm can. Here is a go-to detailed article on the requirements:
VERY worth while reading. By attorney Pat Oullette. The actual 247 page rule is very dense, and in some parts, scary. Regarding overlap with FDA regulations for software and SAMD, they remark helpfully that if you've made it through FDA, you likely have much of the data required by THIS separate complex rule. But no guarantees.
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AI Corner.
While I can't recommend the Mintz article highly enough, and it's quite detailed, as an experiment I asked the AI resource Perplexity to summarize the rule, too.
https://brucedocumentblog.blogspot.com/2024/02/perplexity-and-hhs-onc-rule-on-ai.html
