Create sop: Standard Operating Procedure for Vision-Based AI Form Filling in Prior Authorizations

SOPs/SOP-IT-001-Vision-Based-AI-Form-Filling-for-Prior-Authorizations.md

@@ -0,0 +1,114 @@
+---
+title: "Standard Operating Procedure for Vision-Based AI Form Filling in Prior Authorizations"
+author: ""
+date: 2026-01-20
+version: "1.0"
+status: "Draft"
+---
+
+## 1. Purpose
+This Standard Operating Procedure (SOP) defines the standardized process for using vision-based artificial intelligence (AI) systems to perform form filling for prior authorization submissions. The purpose is to ensure accuracy, data integrity, regulatory compliance, and consistent operational performance in accordance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485 requirements.
+
+## 2. Scope
+This SOP applies to all activities related to the use, validation, operation, monitoring, and maintenance of vision-based AI technologies used to extract, interpret, and populate prior authorization forms.
+
+*Specify departments, systems, and workflows covered by this SOP.*
+
+## 3. Audience
+The primary audience responsible for following this SOP includes:
+- Clinical Staff
+- Compliance Personnel
+
+## 4. Definitions
+| Term | Definition |
+|-----|------------|
+| Vision-Based AI | Artificial intelligence systems that use optical character recognition and computer vision to interpret visual data |
+| Prior Authorization | A requirement from a payer for approval before specific healthcare services are provided |
+| Data Integrity | Assurance that data is accurate, complete, and maintained throughout its lifecycle |
+
+## 5. Regulatory and Quality References
+| Regulation / Standard | Description |
+|-----------------------|-------------|
+| FDA 21 CFR Part 11 | Electronic Records and Electronic Signatures |
+| ISO 9001 | Quality Management Systems – Requirements |
+| ISO 13485 | Medical Devices – Quality Management Systems |
+| HIPAA | Health Insurance Portability and Accountability Act |
+
+## 6. Roles and Responsibilities
+| Role | Responsibility |
+|------|----------------|
+| Clinical Staff | Review AI-populated forms for clinical accuracy |
+| Compliance | Ensure adherence to regulatory and quality requirements |
+| IT / AI System Owner | Maintain system availability, security, and performance |
+| Quality Assurance | Oversight of validation, audits, and continuous improvement |
+
+## 7. Procedure
+### 7.1 System Access and Security
+- Ensure user access is role-based and authorized
+- Maintain audit trails in compliance with 21 CFR Part 11
+- Verify electronic signatures where applicable
+
+### 7.2 Input Document Handling
+- Confirm source documents are complete and legible
+- Validate document version and payer requirements
+- Upload documents according to defined workflow
+
+### 7.3 AI Form Filling Process
+- Initiate vision-based AI processing
+- Monitor AI extraction and field population
+- Flag low-confidence fields for manual review
+
+### 7.4 Human Review and Verification
+- Clinical Staff must review all AI-populated data
+- Correct errors identified during review
+- Document verification completion
+
+### 7.5 Submission and Record Retention
+- Submit completed prior authorization forms per payer guidelines
+- Archive records in validated electronic systems
+- Retain records according to organizational retention policy
+
+## 8. Validation and Change Management
+- Validate AI systems prior to production use
+- Document model updates, retraining, and configuration changes
+- Perform revalidation following significant changes
+
+*Describe validation protocol references and change control procedures.*
+
+## 9. Risk Management
+- Identify risks related to incorrect data extraction
+- Implement mitigation controls and monitoring
+- Review incidents and corrective actions
+
+## 10. Training Requirements
+- All users must complete initial and periodic training
+- Training records must be maintained
+- Competency assessments should be documented
+
+## 11. Monitoring, Auditing, and Continuous Improvement
+- Conduct periodic audits of AI performance and compliance
+- Track key performance indicators and error rates
+- Implement corrective and preventive actions as needed
+
+## 12. Documentation and Records
+| Record Type | Storage Location | Retention Period |
+|------------|------------------|------------------|
+| AI Output Logs | "" | "" |
+| Audit Trails | "" | "" |
+| Training Records | "" | "" |
+
+## 13. Deviations
+- Document any deviations from this SOP
+- Assess impact and implement corrective actions
+- Obtain approval for deviation closure
+
+## 14. Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2026-01-20 | Initial draft | "" |
+
+## 15. Approval Signatures
+| Name | Title | Signature | Date |
+|------|-------|-----------|------|
+| "" | "" | "" | "" |
+| "" | "" | "" | "" |