clinical_ai_validate
Validates Clinical AI Card JSON documents against v0.1 schema, enforcing critical rules for autonomy, medical device classification, SaMD completeness, FDA clearance, PHI handling, and bias audit requirements.
Instructions
Validate a Clinical AI Card JSON document against the v0.1 schema. Enforces the headline rules: autonomy ⇔ medical device, SaMD completeness, FDA-clearance documentation, PHI ⇒ explicit HIPAA + BAA posture, and bias_audit_uri requirement for SaMD class II+ / autonomous / pre-authorization use.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| document_json | Yes | Clinical AI Card as inline JSON. |