VinBrain's Commitment to Global Quality and Multi-Layered Data Security

At VinBrain, we place the highest priority on quality, safety, and data privacy throughout the development and deployment of our DrAid™ platform, now used in nearly 200 hospitals worldwide. By adhering to rigorous global standards for quality management and regulatory compliance, we demonstrate our commitment to earning international recognition and fostering trust among hundreds of customers, partners, and thousands of users. 

1. Quality Commitment

FDA Clearance 

On September 2, 2022, VinBrain received the US Food and Drug Administration (FDA) clearance for DrAid™ Radiology V1. This is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pneumothorax. 

The AI algorithm is FDA 510(K) cleared and apt for the US market. DrAid™ Radiology V1 offers radiologists outstanding advantages: 

• Automatically identifies suspected pneumothorax  

• Notifies PACS (Picture Archiving and Communication System) of the presence of pneumothorax in the scan  

• AI accuracy exceeding 95% 

• AUC > 96% 

This event brought Vietnam into the Top 6 countries (USA, UK, Israel, Australia, Korea, and Vietnam) with an FDA-cleared AI product for chest X-ray cases with features suggestive of pneumothorax. 

ISO Certifications 

• ISO 13485:2016: Since 2022, VinBrain has maintained the ISO 13485:2016 certification, underscoring our commitment to global standards for quality management systems in the medical device industry. This certification verifies that VinBrain’s processes, design, and development of medical devices meet international safety and effectiveness standards. 

• ISO 9001:2015: VinBrain also holds the ISO 9001:2015 certification for quality management in in the following scope: 

1. Research, develop, produce and sell artificial intelligence (AI) software - DrAid™ to aid in the detection of image such as X-Ray, CT, MRI, and other similar images in the health sector 
2. Provide hardware integrated with DrAid™ to aid in the detection of image such as X-Ray, CT, MRI, and other similar images in the health sector 
3. DrAid™ Enterprise Data Solution, AI solution for Medical Data Management 

2. Personal Data Security Commitment: HIPAA Compliance

The Health Insurance Portability and Accountability Act (HIPAA), passed in 1996 by the U.S. government, outlines stringent rules for the security and privacy of medical data, including access, authentication, storage, auditing, and transfer of electronic medical records (EMRs). DrAid™ leverages the Microsoft Azure platform, ensuring full HIPAA compliance, allowing patients to control their health data while guaranteeing the highest levels of privacy and security. 

3. Protected Data Communication Commitment: Adherence to Global Standards

DrAid™ integrates the HL7 FHIR (Fast Healthcare Interoperability Resources) standard for data security and follows advanced encryption and authentication protocols to ensure that only authorized individuals can access patient information. FHIR ensures data is accurately understood between senders and recipients, maintaining data integrity throughout the transmission process. 

Achieving these prestigious certifications and global standards not only highlights VinBrain's relentless efforts in delivering top-tier quality and security but also instills confidence in our partners and customers, particularly in the sensitive field of healthcare.