# SaMD-Avoid Technical-Legal Positioning - PappAI

> Why PappAI is not a Software as a Medical Device (SaMD): architectural controls and regulatory rationale.

Source: https://pappai.it/en/samd-positioning

## Executive summary

PappAI is designed as professional nutritional and organisational support software: it does not formulate diagnoses, does not perform automated clinical screening, and does not prescribe therapies. This document sets out the technical and legal controls that support this classification.

## Declared intended use

- Operational support to the nutritionist in managing patient care pathways.
- Improvement of patient adherence and care continuity.
- Support for the creation and updating of nutritional plans.

## Architectural controls

- Model governance: runtime pin on gemini-2.5-flash.
- Controlled local fallback: rule-based-fallback.
- Mandatory regulatory notice on all AI outputs.
- Data minimisation on AI payloads.
- Full audit trail on all AI operations.
- Rate limiting, alerting, and operational monitoring.

## Non-SaMD classification rationale

- No therapeutic automation based on diagnosis.
- No automatic diagnosis: AI outputs are informational insights only.
- Mandatory human-in-the-loop on every clinical decision.
- Non-diagnostic framing enforced in prompts, outputs, and UI.

## Residual risks and mitigations

- Semantic drift toward clinical claims: lexical guardrails and regression tests.
- Improper use by the professional: mandatory documentation and disclaimers.
- Uncontrolled model changes: version pinning and blocking CI checks.