Security & Regulatory Compliance

InsightRX is committed to ensuring the security, privacy and quality of our software and services.

Security & Privacy

The InsightRX platform is hosted on HITRUST and SOC2 certified infrastructure, and is HIPAA and GDPR compliant.


The InsightRX NovaTM software conforms to ISO13485, IEC 62304, ISO 14971, ISO 14155, IEC 62366-1, 21 CFR Part 11, and GxP.

CE Marked

The InsightRX NovaTM software is a self-certified CE Mark Class I medical device for availability in the EU and the UK under the MDD.