• The Medical AI Assistant as Publication, Not Device - Why Peer-Reviewed, Open-Source AI Belongs in the Standard of Care

    Adrian Gropper, M.D.

    Abstract

    I define a medical artificial intelligence (AI) assistant (MAIA) as an open-weight generative reasoning model connected to a vector database indexing a patient�s health records, operated through an open-source chat interface by a physician as part of clinical practice. I argue that when a physician publishes a MAIA�s architecture, retrieval methodology, and validation results in a peer-reviewed journal, the published MAIA enters the medical literature as any other clinical methodology would. Physicians who subsequently adopt this methodology are not operating a medical device � they are practicing medicine informed by the published literature. This distinction has profound implications for the regulatory treatment of open-source medical AI and the evolution of the standard of care.