Clinical Documentation Engine
Transforms clinical notes into compliant documentation ensuring 100% regulatory adherence
The Challenge
Clinical documentation was inconsistent, creating compliance risks and audit findings. Clinicians spent hours manually structuring notes to meet FDA and ICH-GCP requirements.
The existing template-based process didn't fit real clinical work patterns. Staff would document in their preferred format, then spend hours reformatting for compliance.
Audits revealed documentation gaps that could jeopardize regulatory approval. The stakes couldn't be higher.
“Every hour our clinicians spend on paperwork is an hour they're not spending with patients.”
Our Solution
We built an AI-powered documentation assistant that takes freeform clinical notes and transforms them into compliant, structured documents.
The system flags missing information, suggests standard phrasing, and ensures all regulatory requirements are met without changing how clinicians actually work.
Real-time compliance checking catches issues before they become audit findings.
- Freeform note to structured document conversion
- Real-time compliance checking against FDA/ICH-GCP
- Missing information detection and prompting
- Standard terminology suggestions
- Audit trail for all document transformations
Implementation
Technical Approach
- Claude API with healthcare-specific fine-tuning
- HIPAA-compliant infrastructure on AWS
- React frontend integrated with existing EHR
- MongoDB for document versioning and audit trails
- Role-based access control for compliance
Change Management
- Pilot program with volunteer clinicians
- Iterative feedback incorporation
- Training sessions on AI-assisted documentation
- Champion network to support adoption
Results & Impact
- Clinicians document naturally, system handles compliance
- Zero compliance-related audit findings since deployment
- Documentation quality scores improved across all metrics
- Staff satisfaction with documentation process dramatically improved
