GENERAL INFORMATION
Plan Report ID Number: 20241011ait
Developer Name: AiTmed Inc.
Product Name(s): AiTmed Telehealth System
Version Number(s): 2.0
Certified Health IT Product List (CHPL) ID(s): 15.05.05.3128.AITM.01.00.0.221201
Developer Real World Testing Plan Page URL: https://www.aitmed.com/onc-certification-and-costs
JUSTIFICATION FOR REAL WORLD TESTING APPROACH
Overall Testing Approach
To ensure compliance with 170.315(b)(10) Electronic Health Information (EHI) Export standards, we designed a Real World Testing Plan that assesses AiTmed Telehealth System's EHI export functionality across single-patient and multi-patient database exports in actual clinical environments. This testing approach is intended to validate the system’s interoperability, accuracy, and reliability when performing EHI exports for various clinical use cases, ensuring efficient and compliant data sharing across different settings. Our goal is to showcase AiTmed Telehealth System’s interoperability capabilities and demonstrate its ongoing functionality in a production environment to support the needs of clinicians and administrative users.​
Specific Methodology Outline
1.Single-Patient EHI Export: This measure tests a user’s ability to export all EHI for a single patient independently without developer support. The exported file must include all relevant patient data, adhere to the computable format requirements, and provide a publicly accessible link to the file format specifications. Our system will monitor export speed, data completeness, and file accessibility, verifying that all requirements of computable and human-readable formats are met.
2.Multi-Patient Database Export: This measure assesses whether the system can export comprehensive EHI for multiple patients simultaneously. This functionality is vital for data management and research applications, requiring a complete, computable data format with standardized file structure and syntax to ensure accuracy and consistency across patient data records.
3.User Authorization Control: To ensure data security, only authorized users can perform EHI exports. Testing will confirm that specific permission settings reliably limit EHI export functions to designated users, preventing unauthorized data access and protecting sensitive patient information.
Data Collection and Utilization
1.Data Collection: Throughout testing, data on export success rates, error rates, and export times will be collected to evaluate the system’s reliability under varied real-world conditions. Each export event will log timestamps, user ID, status, and success or failure, and we will analyze system and audit logs to ensure data integrity.
2.Data Use: Collected data will inform quality assurance reports, allowing us to continuously refine the EHI export functionality. Error causes, such as those related to user action, will be identified and used to improve user training, thereby enhancing future success rates for EHI exports.
Rationale and Certification Compliance
1.Compliance: This testing approach meets certification standard 170.315(b)(10), demonstrating that users can export a patient’s EHI independently at any time, as is essential for care coordination, transfers, and remote care scenarios.
2.Interoperability: This design verifies EHI export functionality across various clinical settings, showing AiTmed Telehealth System’s value in supporting data interoperability and effective real-world use, consistent with ONC's Cures Act interoperability requirements.
3.Adaptability Across Settings: The testing spans single-patient and multi-patient export functionalities suitable for diverse healthcare environments, such as primary care and specialty clinics, ensuring that AiTmed Telehealth System supports needs from urgent care to chronic care management.
Expected Outcomes
1.Single-Patient Export: We anticipate a success rate of over 99% for single-patient exports, with exports completed within five seconds and all files meeting the computable and readable requirements.
2.Multi-Patient Export: The system is expected to maintain stability under concurrent multi-user requests, ensuring 100% data completeness and alignment with structured data standards.
3.Authorization Control: Real-time monitoring will confirm that only authorized users access the EHI export feature, with unauthorized access attempts kept below 0.1%.
Testing Environment and Conditions
Testing will cover multiple environments, including emergency departments, internal medicine clinic, and specialty clinics, to ensure a comprehensive understanding of system performance in different settings.
Conclusion
This Real World Testing Plan is designed to rigorously assess AiTmed Telehealth System’s compliance with 170.315(b)(10) and ensure its export capabilities meet the highest standards of interoperability, security, and usability across diverse clinical settings.
STANDARDS VERSION ADVANCEMENT PROCESS (SVAP) STANDARDS UPDATES
The AiTmed Telehealth System product does not use any voluntary SVAP standards.
MEASUREMENT(S)/METRIC(S) USED IN OVERALL APPROACH