What question did this study set out to answer?

The aim is to evaluate a Sovereign Intelligence Operating System for managing special category patient data securely during clinical trials.

July 4, 2026Open Access

Sovereign AI for Pharmaceutical Clinical Trials

Key Points

The aim is to evaluate a Sovereign Intelligence Operating System for managing special category patient data securely during clinical trials.
Utilized an air-gapped hardware system operated by the sponsor to ensure data privacy.
Implemented a post-quantum Open Audit Record for offline verification of AI actions.
The proposed system prevents unlawful sending of special category patient data to public cloud AI.
The offline verifiable audit record provides decades of regulatory compliance assurance.

Abstract

Clinical development cannot lawfully send special category patient data to public cloud AI. Mickai runs entirely on the sponsor's own air-gapped hardware, with a post-quantum Open Audit Record a regulator can verify offline for decades.Originally published at https://mickai.co.uk/articles/pharma-clinical-trials. Mickai is a Sovereign Intelligence Operating System; the Open Audit Record signs every artificial intelligence action before it executes, post-quantum and offline-verifiable. Mickai LTD (Companies House 17166618).

Read Full Paperexternally

اسأل الذكاء الاصطناعي

Bookmark

View Full Paper