AI hallucinations are the central unsolved problem for deploying language models in regulated industries: medical devices, clinical decision support, and drug development. This session presents the hypothesis that standard LLMs hallucinate because of an architectural gap. They hold no internal state they must remain consistent with, so output is statistical pattern matching rather than a constrained read against a model of self, history, or relationship. The session walks through an architecturally-governed AI substrate whose hormone state, scar memory, and trust lattice function as inspectable reasoning artifacts, and examines the regulatory implications for ALCOA+ audit trails, Predetermined Change Control Plans, and the FDA De Novo pathway for Class II AI-enabled Software as a Medical Device. It closes by opening a broader question this room is uniquely positioned to answer: what kind of validation should AI require before we trust it with regulated decisions?
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Marjorie McCubbins
