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.
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:
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
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.
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.
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