The FDA was able to supervise the majority of software used solely for clinical decision support ( CDS ) under the . That was in 2016. Six years later, the firm revised the strategy and issued guidance that made it more difficult for CDS software sellers to obtain these exemptions.  ,
The 2022 advice expressed concern about doctors who were pressed for time or unsure of their own decisions and who deferring to CDS recommendations. FDA advised at the time that whenever this incident develops, the program should be regulated as a device and subject to intraday review.  ,
In an opinion piece published Feb. 6 in JAMA Health Forum, a former FDA director argues the 2022 conditions is ripe for a re-think.  ,
According to , the FDA would govern CDS program “based on how the data analysis is presented to healthcare professionals rather than on how clinicians would use the data to inform their view.” In response to the goals of the 21st Century Cures Act and the policies advanced from 2017 to 2019, Gottlieb, MD writes.
AI tools that only inform or recommend clinicians—and make no attempt to robot diagnose conditions or strong treatments —” should not be subjected to intraday review”, he contends.  ,
Gottlieb concentrates particularly on artificial intelligence ( AI ) software that is designed to integrate with EMR systems. For software, he points out, you “generate perspectives that might otherwise go unnoticed by practitioners”.
He suggests that instead of regulating such applications as medical products, why wouldn’t the FDA permit EMR suppliers to promote these tools as long as they adhere to FDA standards for how the tools are created and validated?  ,
” ]B ] y drawing on real-world evidence of these systems in action in the post-market setting, the agency can verify that they genuinely enhance the quality of medical decision-making”, Gottlieb writes.  ,
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Almost any AI tool embedded in an EMR could fall under regulation if these tools are only classified as medical devices because they draw from various data sources or have scientific capabilities that are so detailed and clever that clinicians are likely to accept their analyses in full. EMR developers face the possibility of trying to circumvent regulatory uncertainty by omitting these features from their software. This could prevent clinicians from having access to AI tools that have the power to increase the quality and safety of medical care.
President Donald Trump appointed Gottlieb as head of the FDA in 2017 and he remained there until April 2019.  ,
Hear him out on AI-aided CDS <a href="https://jamanetwork.com/journals/jama-health-forum/fullarticle/2830189?resultClick=1″>here.