SHOMA AI Health API

AI Compliance Summary for Hospitals & Clinics

Intended Purpose

SHOMA AI is an administrative support tool designed exclusively for authorised staff of hospitals and clinics. Its sole purpose is to reduce documentation and administrative workload by structuring and organising clinical documents.

Key Design Features

• Professional use only – patients have no access • Zero data retention – all clinical data is cancelled and permanently deleted immediately after the temporary report is generated • No storage of patient data, personal data or Protected Health Information (PHI) • No training of AI models on any customer or patient data • All final clinical decisions remain the sole responsibility of the licensed doctor

What the system does NOT do

• It does not provide medical advice • It does not provide diagnoses • It does not provide treatment recommendations • It does not function as clinical decision support • It is not intended as a medical device under the EU Medical Devices Regulation (MDR)

EU AI Act Positioning

The system is designed as a supportive administrative tool. It does not make autonomous medical decisions. Classification under the EU AI Act depends on the precise intended purpose and actual use. We maintain internal documentation of the system's design, limitations and risk assessment. We recommend that each hospital/clinic perform its own assessment in light of its specific deployment.

Data Protection

• Strict zero-retention architecture • GDPR-ready • HIPAA-compliant • Business Associate Agreements available

Transparency

Every AI-generated report clearly states that it is a temporary administrative output and that the treating doctor remains fully responsible for all clinical decisions.