Committed to Ensuring Quality, Security, and Privacy in our Products

InsightRX is HITRUST certified, and HIPAA and GDPR compliant.

HITRUST certification offers a comprehensive and integrated framework for managing information security, particularly in healthcare, by harmonizing multiple standards and regulations into a single, unified approach.

GDPR compliance demonstrates a commitment to safeguarding personal data by adhering to the European Union’s stringent data privacy regulations. This framework ensures that organizations protect individual privacy rights and maintain transparent, secure data handling practices across all operations.

The InsightRX Nova^TM software conforms to internationally recognized regulations and quality standards for medical devices, including:

• ISO 13485 – QMS for medical devices
• ISO 14971 – Risk management for medical devices
• IEC 62304 – Medical device software lifecycle processes
• IEC 62366-1 – Usability engineering to reduce use-related risks
• IEC 82304-1 – Safety and security of health software products
• 21 CFR Part 11 – Trustworthy electronic records and signatures
• GxP – quality frameworks (GMP, GCP, GLP) across pharmaceuticals and devices

InsightRX Nova™ is self-certified as a Class I medical device under the EU MDD, carrying the CE mark valid in both the EU & UK.

CE marking confirms conformity with EU health, safety, and environmental protection standards, facilitating seamless access to the single market.

InsightRX is the first and only healthcare technology company to hold a US Patent (No. 11,075,010 B1) for our model improvement and retraining processes. Model optimization is based on distributed data acquisition and continuously refines dosing predictions using real-world data.