Gottlieb: FDA’s CDSS Guidance Could Hamstring AI Integration Into EMRs

Scott Gottlieb -- who led FDA under President Donald Trump’s first administration -- is raising concerns that the agency’s 2022 guidance on clinical decision support software (CDSS) could restrict efforts to directly embed artificial intelligence tools capable of analyzing data to generate clinical insights into electronic medical records. He is calling for a return to CDSS policies from his tenure as FDA commissioner when AI tools within such records were generally not regulated as medical devices. AI within EMRs has...