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

title, author, date, version, status

title	author	date	version	status
Standard Operating Procedure for Vision-Based AI Form Filling in Prior Authorizations		2026-01-20	1.0	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
""	""	""	""
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