Based on this groundbreaking de novo classification granted last month to Prenosis, the flag is up that any player in the AI scanning of electronic health records (EHR) space with the intent to predict, diagnose and/or risk stratify patients for sepsis should start working on a 510(k) clearance pre-market submission with FDA. Most notably Epic has operated in this space with the Epic Sepsis Model, so while Epic will be under particular scrutiny from the FDA in the coming weeks to months to submit their product for pre-market clearance, there are other companies using AI to scan EHRs to create sepsis risk scoring, and they too will be subject to pre-market clearance requirements now established by Prenosis. I wouldn’t expect much patience on the part of FDA for participants in this space to remove / disable product(s) from market that FDA feels should be regulated pending pre-market clearance. Eventually FTC notices and FDA warning letters will start to fly to those deemed in violation.
Epic could attempt with the resources at their disposal to dispute aspects of the September 2022 final guidance for Clinical Decision Support Software (CDSS), which called out a sepsis specifically as an example of a life-threatening condition that is FDA regulated as a device. Industry was shocked at the differences from the 2019 draft guidance for CDSS and the 2022 final and the general perception of overreach by FDA without proper consultation of the public and stakeholders. That said, Presnosis’ move to de novo proceedings was sensible as the FDA had made their intentions clear. The knock off effect of Prenosis’ de novo is now any AI company operating in the EHR space where they are giving risk scores for sepsis is marketing a FDA regulated, class II special control device, which gives no wiggle room to those who would try and argue they market a CDSS not subject to FDA regulation. FDA won’t allow a product deemed violative to market product while 510(k) submission is pending, instead it will be required to pull from market any sepsis related product offerings until 510(k) clearance. Similarly, the FDA will not allow companies to market a product they deem violative to engage in a CDSS dispute and continue to market product. Frankly, a CDSS dispute with FDA could very costly in time and money, with very uncertain outcomes.
I wouldn’t expect the coming FDA enforcement to stop with sepsis related products. CDSS final guidance called out “life-threatening” conditions, which could cover any number of situations companies are looking to address by analyzing patient specific EHR data to call out risks of patients heading into some type of critical deterioration. Astute participants in the AI space should heed the Prenosis de novo as a wake up call that they need to start de novo proceedings for any “life-threatening” conditions that they attempt to risk model based on EHR data run through AI models. Unfortunately some companies marketing these other risk modeling products for other life-threatening conditions also market sepsis related products, so unwanted attention from FTC/FDA due to sepsis related violations could spread to their other products being pulled from market until a de novo classification and / or 510(k) clearance is secured. The future of AI is bright with many exciting opportunities that will be transformative to healthcare, but when it comes to life-threatening conditions being predicted, diagnosed or otherwise risk scored by AI, the FDA has clearly signaled that they intend to regulate it.
