Business View Magazine l October 2022

93 BUSINESS VIEW MAGAZINE VOLUME 9, ISSUE 10 WI LL A I ‘ REHUMANI ZE ’ HEALTHCARE? “FDA has made significant strides in developing policies that are appropriately tailored for software as a medical device (SaMD),” the U.S. FDA wrote in a 2019 discussion paper inviting industry comment. However, “the traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies… The highly iterative, autonomous, and adaptive nature of these tools requires a new, total product lifecycle regulatory approach.” In 2021, with the launch of the FDA’s AI/ML- based SaMD Action Plan, the federal agency announced that it “would expect a commitment from manufacturers on transparency and real- world performance monitoring for [AI/ML]- based software as a medical device, as well as periodic updates to the FDA on what changes were implemented as part of the approved pre-specifications and the algorithm change protocol.” Fortunately, Baird believes this won’t be as difficult as it sounds if the industry can first standardize how AI is designed for the healthcare environment. And this starts with risk management. AI, the Familiar In 2022, a small task force from the AAMI AI Committee published a new industry Consensus Report, AAMI CR34971:2022, which serves as a guideline for the application of ISO 14971 to artificial and machine learning. The document was reviewed by the full AI Committee and by risk analysis experts at the British Standards Institute before its launch. While just an indistinguishable string of letters and numbers for people unfamiliar with medical device management, ISO 14971 is the title of go-to guidance for the risk management of medical devices around the world. “The process is the same no matter what you’re doing. You need to plan, set risk-acceptability criteria, and