Security and Regulatory Compliance
Committed to Ensuring Quality Security, and Privacy in our Products
Globally recognized certifications support our mission to deliver precision dosing software that healthcare providers, IT teams, and regulators can all trust.
Secure, Compliant, Validated
Trusted frameworks for safeguarding healthcare data and meeting regulatory requirements

Security and Privacy
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.

Quality Standards
The InsightRX NovaTM 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

EU & UK Compliance
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.

Patented Processes
InsightRX is the first and only healthcare technology company to hold a US patent (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.
Additional Information
Learn more about our products and services:
Utilize the Gold-Standard in Bayesian MIPD
Individualize therapy with Bayesian dosing support that adapts to each patient. InsightRX Nova clinical decision software helps you personalize doses at the point of care, reaching therapeutic targets faster and helping clinicians proactively reduce adverse drug events.
Integrate Seamlessly with Existing Clinical Systems
Eliminate transcription errors and reduce manual calculation burden. InsightRX Nova integrates securely with leading EHRs and clinical surveillance tools, delivering precision dosing decision support exactly where and when clinicians need it.