Security, Compliance, & Certifications
BrainCheck is built for regulated healthcare environments and operates under formal security, privacy, and regulatory oversight.
FDA Regulation
BrainCheck Assess is an FDA Class II medical device.
As part of this designation:
- BrainCheck maintains an FDA-compliant quality system
- BrainCheck Assess undergoes FDA audits as required for Class II medical devices
- Development, validation, and change management processes follow FDA regulatory requirements
BrainCheck Assess is a Class II, 510(k)-exempt computerized cognitive assessment aid regulated by the FDA. It is indicated as an aid in the assessment of cognitive impairment and is not intended to be used as a standalone diagnostic tool. Refer to product labeling for full indications, limitations, and intended use.
HITRUST Certification
The BrainCheck Platform is HITRUST certified.
HITRUST certification confirms that BrainCheck’s security and privacy controls have been independently assessed and validated against a comprehensive healthcare security framework.
TX-RAMP Certification
BrainCheck’s cloud platform is TX-RAMP Level 2 certified, demonstrating compliance with the Texas Risk and Authorization Management Program (TX-RAMP), administered by the Texas Department of Information Resources (DIR).
TX-RAMP establishes standardized requirements for security assessment, authorization, and continuous monitoring of cloud services used by Texas state agencies to process confidential or regulated government data, and aligns with NIST SP 800-53 Moderate security controls.
HIPAA & Healthcare Compliance
BrainCheck supports HIPAA-compliant workflows and executes a Business Associate Agreement (BAA) with covered entities and eligible partners.
- Protected Health Information (PHI) is handled using role-based access controls
- Activity is logged to support auditability and compliance reviews
- Data retention and deletion can align with customer contractual requirements
Did you know?
Reading regularly can keep your mind engaged and healthy. Like a workout, but without the sweat.
