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Blur

A SaaS platform for de-identifying patient data in clinical trials using NLP and simulations to ensure privacy, compliance, and data usability.

Solution by Instem
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Overview

Blur is a standalone SaaS platform designed to de-identify patient information from clinical trials. It employs role assignments, natural language processing, and risk simulations to ensure privacy and regulatory compliance while maintaining high data usability. Its purpose is to remove risk by adhering to defensible privacy standards, thereby protecting patient privacy and ensuring compliance requirements are met.

Developed by Instem in partnership with pharmaceutical sponsors, Blur is tailored to scale anonymization and conduct quantitative risk assessments efficiently. It offers a suite of advanced tools within a user-friendly interface, addressing the need for safeguarding patient information, maintaining data integrity, and complying with strict regulatory demands. Without effective de-identification measures, researchers face potential regulatory penalties and loss of trust, which could compromise clinical trial success.

Blur addresses the complexities associated with regulatory requirements and large data volumes, which can render traditional de-identification methods slow and error-prone. Additionally, it counters the threat of cyberattacks by providing automated, compliant solutions that enhance data usability while reducing time and risk.

Key Benefits of Blur

  • Boosts Efficiency: Centralizes de-identification processes, allowing task management from a single interface and minimizing the need for switching between different tools.
  • Saves Time: Automates tasks such as the detection and redaction of patient health information, speeding up document preparation and regulatory submission processes.
  • Removes Risk: Uses automation and NLP to ensure sensitive information is well-protected. It offers robust user logs and documentation for easy auditability.
  • Improves Compliance: Compatible with global standards like Health Canada, US FDA, EMA, EU CTR, and GDPR, ensuring adherence to privacy laws.
  • Maintain Data Usability: Facilitates data transformation to ensure usability without compromising confidentiality.
  • Simplified Collaboration: Offers role assignment to simplify task distribution and ensure accountability within teams.

Core Features/Modules

Blur provides an advanced toolkit of modules for privacy and compliance that extend beyond simple de-identification.

Blur Data

Efficiently removes or masks PHI in clinical datasets to comply with HIPAA, GDPR, and international regulations, achieving effective de-identification.

Blur Risk

Conducts simulation-based risk scoring to determine the safest and most data-preserving anonymization methods, enabling quick, informed decisions.

Blur CSR

Utilizes NLP to anonymize Clinical Study Reports for regulatory submission, simplifying the process and reducing associated stress.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Clinical & TrialsQuality & Compliance
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Tag(s)
Quality & Compliance ManagementClinical Trials Management