Mario specializes in the intersection of technology and healthcare, focusing on the FDA's oversight of artificial intelligence, Medicare's reimbursement for health technologies, the integration of AI in clinical practices, mental health chatbots, and consumer wearable devices. Additionally, he co-writes the STAT Health Tech newsletter, which is distributed for free twice a week. You can contact Mario through Signal at mariojoze.13.
The Food and Drug Administration is currently working on a strategy to regulate medical devices that incorporate generative artificial intelligence.
According to Rick Abramson, the director of the FDA's Digital Health Center of Excellence, the agency will publish documents detailing its policies on this emerging technology.
In a conversation with STAT, Abramson stated, "Our aim is to establish formal policy guidance. The ecosystem is seeking clarity, and we intend to provide that. In addition to general guidance on generative AI, the ecosystem can also anticipate specialized advice on specific topics of interest or complexity within this realm."



