Comment from Arclio LLC
AnonymousSupportBusiness
Summary: Arclio LLC, the editor of the Proof of Insight (PoI) verification protocol, supports the pilot program but recommends that the FDA structure it around mechanically verifiable evidence rather than narrative audit logs. They argue for a distinction between process fidelity and analytical correctness, proposing a minimum evidence package that allows independent parties to verify AI-supported decisions.
Arclio LLC, editor of the open Proof of Insight verification protocol, respectfully submits the attached comment on Docket No. FDA-2026-N-4390.
Our central recommendation is that FDA build the pilot around evidence an independent party can mechanically verify, rather than narrative audit logs. This rests on one distinction the pilot's evaluation should adopt explicitly: FDA cannot certify that an AI-supported recommendation is correct, but with the right evidence format it can certify that the recommendation was produced as recorded, from the inputs, model, conditions, and reviews claimed. The attached comment develops this into a concrete minimum evidence package, a practical approach to closed-weight hosted models, mechanically checkable treatment of prespecification, negative findings, and independent review, and a recommendation that FDA make a public clinical-AI evidence profile a deliverable of the pilot.
We respond selectively, to the questions where verifiable evidence contributes most, and we do not ask FDA to endorse any particular protocol. The recommendation is the adoption of independently verifiable evidence obligations that any conforming format could satisfy.