Compliance

IO seeks to achieve compliance in all HIPAA, HITRUST, and SOC2 environments. All patient data is encrypted while in transit or at rest. To ensure Insight Optics properly protects data, we utilize procedures that we believe meet certification standards for IEC 62304 and ISO 27001. For more information, see our Terms of Use or Privacy Policy.

Classification

Insight Optics worked with two consulting groups to analyze what FDA regulations govern the OptoView System™. The resulting recommendation was that the OptoView™ product is classified as a Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.