In this episode, Casey Ross, National Technology Correspondent at Stat News, discusses his recently published report on FDA-approved AI-enabled tools. These are Software as a Medical Device (SaMD) tools that work as decision support tools to supply patients’ data to physicians and help them diagnose and treat the patients.

Data is the core ingredient that AI tools use. As per Casey, one of the major issues prevailing in the industry today is that there are inadequate disclosures on data sets used by many medical devices and algorithms approved by the FDA. To improve healthcare outcomes, transparency and disclosure in date sets must be the central agenda in the future. He further states that the pace of innovation, development, and building process of AI tools is outrunning the FDA and other regulators’ ability to stay on top of AI innovations. Take a listen.