Security & Regulatory

Committed to quality, security, and privacy across every product.

InsightRX meets the most rigorous security, quality, and regulatory standards in healthcare software. Every certification listed here is independently audited or publicly verifiable.
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Built to the standards that clinical software demands

Clinical dosing software occupies a unique position in the healthcare stack. It processes protected health information, informs clinical decisions at the bedside, operates in regulated environments including clinical trials, and must meet the expectations of hospital IT, pharmacy leadership, compliance officers, and international regulators simultaneously.

InsightRX addresses each of these dimensions with specific, independently audited certifications. The credentials below are not general software quality marks. They are the frameworks specifically designed for healthcare data security, medical device software development, and clinical regulatory compliance.

Security and Privacy

The frameworks governing how InsightRX protects patient data and health information across US and international deployments.

Standard   What it covers
r2 HITRUST Badge HITRUST certified Health Information Trust Alliance The most comprehensive security certification in healthcare IT, integrating requirements from HIPAA, NIST, ISO 27001, and other frameworks into a single audited standard. HITRUST certification is increasingly required by health systems as a condition of vendor approval.
GDPR GDPR compliant General Data Protection Regulation EU regulation governing the collection, processing, and storage of personal data for individuals in the European Union. Relevant for European health system deployments and life sciences customers running international clinical trials.

Software Quality Standards

The internationally recognized standards governing how InsightRX software is designed, developed, validated, and maintained as a medical device software product.

Standard   What it covers
ISO 13485 Medical Device Quality Management InsightRX conforms to ISO 13485, the international standard for quality management systems in the design, development, and production of medical devices. It requires documented and auditable processes across the full product lifecycle, from initial design through post-market surveillance.
IEC 62304 Medical Device Software Lifecycle InsightRX conforms to IEC 62304, the primary international standard for software lifecycle processes in medical devices. It governs how medical device software is developed, tested, and maintained, with specific requirements for risk-based software classification and traceability.
ISO 14971 Medical Device Risk Management InsightRX conforms to ISO 14971, the international standard for applying risk management throughout the medical device lifecycle. It requires systematic identification, evaluation, and mitigation of risks, including software-related hazards specific to clinical decision support contexts.
IEC 62366-1 Medical Device Usability Engineering InsightRX conforms to IEC 62366-1, the international standard for applying usability engineering to medical devices as it relates to safety. It requires a documented process for analyzing, specifying, and evaluating user interface design to assess and mitigate risks associated with use errors in clinical environments.
IEC 82304-1 Health Software Product Safety InsightRX conforms to IEC 82304-1, the international standard for safety and security requirements of health software products designed to operate on general computing platforms without dedicated hardware. It covers the full product lifecycle including design, development, validation, maintenance, and disposal.
21 CFR Part 11 FDA Electronic Records and Signatures InsightRX is compliant with 21 CFR Part 11, the FDA regulation establishing requirements for electronic records and signatures in regulated environments. Compliance is required for software used in FDA-regulated clinical trials and drug development workflows, including PK data collection and dosing records.

EU and UK Regulatory Clearance

Market authorization and regulatory clearance for clinical deployments in the European Union and United Kingdom.

Standard   What it covers
CE marking logo CE marking EU MDD Class I Medical Device InsightRX Nova is self-certified as a Class I medical device under the EU Medical Device Directive, carrying the CE mark valid in both the EU and UK. CE marking confirms conformity with applicable EU health, safety, and technical requirements, and is a prerequisite for placing medical device software on the EU market.

The only patented model optimization process in clinical dosing software

InsightRX is the first and only healthcare technology company to hold a US patent for pharmacology model optimization based on distributed data acquisition. The patent protects the core methodology by which patient data is aggregated across institutions and used to continuously retrain and validate pharmacokinetic models.

US Patent 11,075,010 B1

Pharmacology model optimization based on distributed data acquisition. Granted July 27, 2021.

View on Google Patents

Maximize therapeutic success with precision medicine.

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