Regulatory & Compliance

As a medical imaging leader for more than 30 years, Novarad meets or exceeds the following industry standards in its products, solutions, and processes:

• DICOM
• HL7
• HIPAA and HITECH
• ISO 13485 (for over 10 years)
• ISO 27001
• MDSAP
• FDA Cleared for preoperative use K190929
• FDA Cleared for intraoperative stereotactic spine K220146
• FDA Pending for intraoperative cranial and neck
  

Our data centers meet the following standards:

Data Security Details:

• Data is AE256 encrypted at rest in the Novarad Object Storage
• Data is encrypted in transit using https
• Tls 1.2 protocol
• Over 40Bn images are managed on Novarad systems worldwide
• Disaster Recovery of all offsite storage included

FDA Clearance

Novarad is currently in the process of having VisAR cleared for brain and spinal operative use.  OpenSight, the predecessor of VisAR, was the first AR surgical navigation system to receive FDA clearance for pre-operative use. 

HIPAA Compliance

Novarad Corporation is dedicated to helping our customers ensure the confidentiality, integrity, and availability of their electronic health information. Novarad makes every effort to conduct our business in compliance with the privacy and security standards set forth in the Health Insurance Portability and Accountability (HIPAA) Act of 1996, the Health Information Technology for Economic and Clinical Health (HITECH) ACT of 2009, and all other applicable information security standards as required by law. 

Certificates 

DICOM Conformance Statement