---
title: Security & Regulatory
description: InsightRX is HITRUST CSF r2 certified, CE marked, and 21 CFR Part 11 compliant, conforming to ISO 13485, IEC 62304, and ISO 14971.
---
[](https://www.insight-rx.com/?hsLang=en)
- For Providers
- Solutions
- [MIPD for Providers Explore our full solution for Bayesian model-informed dosing](https://www.insight-rx.com/mipd?hsLang=en)
- [Future of Pharmacy Learn what's next for AI in health tech, and why architecture matters](https://www.insight-rx.com/future?hsLang=en)
- Products
- [InsightRX Nova Bayesian dosing (MIPD) app for bedside clinical decision support](https://www.insight-rx.com/provider/nova?hsLang=en)
- [InsightRX Apollo Real-time clinical analytics to measure outcomes](https://www.insight-rx.com/provider/apollo?hsLang=en)
- [Drug Modules Available medications for precision dosing apps](https://www.insight-rx.com/provider/drug-modules?hsLang=en)
- [For Life Sciences](https://www.insight-rx.com/life-sciences?hsLang=en)
- Overview
- [InsightRX for Life Sciences Explore our solution for biopharma and clinical trial use](https://www.insight-rx.com/life-sciences?hsLang=en)
- Products
- [Nova for Life Sciences Precision dosing app for clinical trial use](https://www.insight-rx.com/life-sciences/nova?hsLang=en)
- [Astra for Life Sciences AI-native environment for PK/PD modeling and simulation](https://www.insight-rx.com/life-sciences/astra?hsLang=en)
- Platform
- [Continuous Learning Patented process for model retraining and improvement](https://www.insight-rx.com/platform/continuous-learning?hsLang=en)
- [Integrations Platform interoperability setup with EHRs, EDCs, and more](https://www.insight-rx.com/platform/integrations?hsLang=en)
- [Security & Regulatory Standards for product development and release](https://www.insight-rx.com/platform/security-regulatory)
- [Success & Support Pharmacist-led training, onboarding, and education](https://www.insight-rx.com/platform/support?hsLang=en)
- Resources
- Science
- [Data Science Explore the science and learn more about our R&D](https://www.insight-rx.com/data-science?hsLang=en)
- [Scientific Publications Impactful research manuscripts with at least one InsightRX author](https://www.insight-rx.com/data-science/scientific-publications?hsLang=en)
- [How to Cite Using one of our apps? Follow this easy guide for citation in research](https://www.insight-rx.com/how-to-cite-insightrx-nova?hsLang=en)
- Explore
- [Success Stories Case studies from real InsightRX customers about their journey](https://www.insight-rx.com/success-stories?hsLang=en)
- [White Papers In-depth analysis and best practices for review and download](https://blog.insight-rx.com/resources/tag/white-papers?hsLang=en)
- [Pubs. Using InsightRX Review research that has used InsightRX applications](https://www.insight-rx.com/publications-using-insightrx-software?hsLang=en)
- [Blog](https://blog.insight-rx.com/resources?hsLang=en)
- [All Blog Posts Read the latest posts by our team of experts](https://blog.insight-rx.com/resources?hsLang=en)
- [Product Innovation The latest updates on our products, services, and science](https://blog.insight-rx.com/resources?section=product_innovation&hsLang=en)
- [Thought Leadership Posts from our team of experts on PK, MIPD, science, and more](https://blog.insight-rx.com/resources?section=thought_leadership&hsLang=en)
- Company
- About
- [About Us Our story, what drives us and why we're passionate about our work](https://www.insight-rx.com/about?hsLang=en)
- [Leadership Founders and team leaders who strive toward excellence in MIPD](https://www.insight-rx.com/leadership?hsLang=en)
- [Advisory Board Scientists and experts to ensure our collective success](https://www.insight-rx.com/advisory-board?hsLang=en)
- [Careers Interested in joining? View available openings here](https://www.insight-rx.com/careers?hsLang=en)
- [Customers Hear what others have to say about their experience](https://www.insight-rx.com/customers?hsLang=en)
- Press
- [All Stories InsightRX news, company updates, and more](https://blog.insight-rx.com/press-releases?hsLang=en)
- [Press Releases Announcements for events, partnerships, and company updates](https://blog.insight-rx.com/press-releases?section=press_releases&hsLang=en)
- [Media InsightRX in the news — digital, print, podcasts, and other outlets](https://blog.insight-rx.com/press-releases?section=media&hsLang=en)
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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.
1. [Home](https://www.insight-rx.com?hsLang=en)
2. Platform
3. Security & Regulatory
## 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 |
| --- | --- | --- |
|  | [HITRUST CSF r2 certified](https://hitrustalliance.net/) Health Information Trust Alliance | The most comprehensive security certification in healthcare IT, integrating HIPAA, NIST, ISO 27001, and other frameworks into a single audited standard. InsightRX holds HITRUST CSF certification at the risk-based two-year (r2) level, the framework's most rigorous tier. HITRUST certification is increasingly required by health systems as a condition of vendor approval. |
|  | [GDPR compliant](https://gdpr-info.eu/) 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](https://www.iso.org/iso-13485-medical-devices.html) 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](https://www.iso.org/standard/38421.html) 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](https://www.iso.org/standard/72704.html) 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](https://www.iso.org/standard/63179.html) 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](https://www.iso.org/standard/59543.html) 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](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/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](https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm) 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](https://patents.google.com/patent/US11075010B1/en)
## Explore more...
Every InsightRX product and capability is built to work together, supporting precision medicine at every stage.
### [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.](https://www.insight-rx.com/provider/nova?hsLang=en)
### [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.](https://www.insight-rx.com/platform/integrations?hsLang=en)
### [Leverage Fully-Validated Drug Modules Enhance dosing precision with InsightRX's extensive library of pharmacokinetic and pharmacodynamic drug modules, rigorously validated to support individualized therapy across diverse patient populations.](https://www.insight-rx.com/provider/drug-modules?hsLang=en)
Maximize therapeutic success
with precision medicine.
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#### What We Do
##### For Providers
- [Nova (Bayesian Dosing)](https://www.insight-rx.com/provider/nova?hsLang=en)
- [Apollo (Clinical Analytics)](https://www.insight-rx.com/provider/apollo?hsLang=en)
- [Drug Modules](https://www.insight-rx.com/provider/drug-modules?hsLang=en)
##### For Life Sciences
- [Nova (MIPD for Clinical Trials)](https://www.insight-rx.com/life-sciences/nova?hsLang=en)
- [Astra (AI-Powered Clin Pharm)](https://www.insight-rx.com/life-sciences/astra?hsLang=en)
- [Companion Applications](https://www.insight-rx.com/life-sciences/nova?hsLang=en#companion-applications)
#### How We Do It
##### Platform
- [Continuous Learning](https://www.insight-rx.com/platform/continuous-learning?hsLang=en)
- [Integrations](https://www.insight-rx.com/platform/integrations?hsLang=en)
- [Security & Regulatory](https://www.insight-rx.com/platform/security-regulatory)
- [Success & Support](https://www.insight-rx.com/platform/success-support?hsLang=en)
##### Science
- [Data Science](https://www.insight-rx.com/data-science?hsLang=en)
- [Scientific Publications](https://www.insight-rx.com/data-science/scientific-publications?hsLang=en)
#### Information
##### Resources
- [Success Stories](https://www.insight-rx.com/success-stories?hsLang=en)
- [White Papers](https://www.insight-rx.com/white-papers?hsLang=en)
- [Publications Using InsightRX](https://www.insight-rx.com/publications-using-insightrx-software?hsLang=en)
- [How to Cite InsightRX](https://www.insight-rx.com/how-to-cite-insightrx-nova?hsLang=en)
##### Blog
- [All Posts](https://blog.insight-rx.com/resources?hsLang=en)
- [Product Innovation](https://blog.insight-rx.com/resources?section=product_innovation&hsLang=en)
- [Thought Leadership](https://blog.insight-rx.com/resources?section=thought_leadership&hsLang=en)
#### About
- [Our Story](https://www.insight-rx.com/about?hsLang=en)
- [Leadership](https://www.insight-rx.com/leadership?hsLang=en)
- [Advisory Board](https://www.insight-rx.com/advisory-board?hsLang=en)
- [Our Customers](https://www.insight-rx.com/customers?hsLang=en)
- [Press Releases](https://blog.insight-rx.com/press-releases?section=press_releases&hsLang=en)
- [Media](https://blog.insight-rx.com/press-releases?section=media&hsLang=en)
- [Careers](https://www.insight-rx.com/careers?hsLang=en)
- [Contact](https://www.insight-rx.com/contact-us?hsLang=en)
---
InsightRX Nova is HITRUST CSF r2 certified, CE marked, and 21 CFR Part 11 compliant. Our quality management, risk management, software lifecycle, and usability engineering processes conform to ISO 13485, IEC 62304, ISO 14971, IEC 62366-1, and IEC 82304-1.
InsightRX Nova is not considered to be a medical device in the U.S. and has not been submitted to the U.S. Food and Drug Administration for review or clearance.
740-05000-REC-01 · 08/2025
---
[](https://www.insight-rx.com/?hsLang=en)
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#88083
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---
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