Ibex Medical Analytics Achieves HITRUST Certification Demonstrating the Highest Level of Information Protection Assurance

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Nov 14, 2023, 07:00 ET

The HITRUST Certification Validates Ibex's Commitment to Strong Cybersecurity and Meeting Key Regulations to Protect Sensitive Data

BOSTON, Nov. 14, 2023 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced it has earned certified status by HITRUST for information security.

HITRUST Risk-based, 2-year (r2) Certified status demonstrates that Ibex and Galen™, its AI-powered pathology platform, have met demanding regulatory compliance and industry-defined requirements and is appropriately managing risk. This achievement places Ibex in an elite group of organizations worldwide that have earned this certification. By including federal and state regulations, standards, and frameworks, and incorporating a risk-based approach, the HITRUST Assurance Program helps organizations address security and data protection challenges through a comprehensive and flexible framework of prescriptive and scalable security controls.

"With the largest number of live customer sites in the market, our AI technology supports pathologists in laboratories and hospitals around the world," said Dr. Yael Liebes-Peer, VP of Regulatory Affairs and Quality Assurance at Ibex Medical Analytics. "Ibex places privacy and cybersecurity at the forefront, putting a strong emphasis on safeguarding patient information in its product development and during the clinical use of Galen. We are therefore honored to add HITRUST Certification to Ibex's existing quality certifications, which already include Cyber Essentials Plus, ISO 27001 and ISO 13485, among others. This achievement showcases our dedication to delivering innovative tools that adhere to the most rigorous data and information security standards for our customers and their patients."

Liron Pantanowitz, MD, Chair of Pathology at the University of Pittsburgh Medical Center (UPMC) stated, "As a world renowned healthcare provider, recognized for our commitment to excellence, UPMC uses HITRUST-certified technologies to ensure the utmost level of information security. This certification provides us the assurance we look for to ensure data is managed correctly."

The HITRUST Certification will support Ibex's customer and digital pathology deployments around the world. Galen is the first and most widely deployed AI-powered platform in pathology, used globally as part of everyday clinical practice at laboratories, hospitals and health systems. The platform supports pathologists in the diagnosis of cancer in various tissue types. Galen helps improve diagnostic accuracy, reduce turnaround time and optimize workflows, and demonstrated outstanding outcomes across multiple clinical studies ^1,2,3,4,5.

"HITRUST Certification is globally recognized as validation that information security and privacy controls are effective and compliant with various regulations," said Jeremy Huval, Chief Innovation Officer, HITRUST. "HITRUST Certification is considered the gold standard because of the comprehensiveness and applicability of the control requirements, depth of the assurance process, and level of oversight that ensures accuracy. Individually, each element exceeds most other programs, and collectively they make HITRUST Certification the most comprehensive, transparent, consistent, and highest quality assessment available."

About Ibex Medical Analytics

Ibex Medical Analytics is transforming cancer diagnostics with world-leading clinical grade AI-powered solutions for pathology. Empowering physicians and supporting pathologists, Ibex is on a mission to provide accurate, timely and personalized cancer diagnosis for every patient. Ibex's Galen™ is the first and most widely deployed AI-powered platform in pathology. Pathologists worldwide use Galen™ as part of their everyday routine to improve the accuracy of cancer diagnosis, implement comprehensive quality control measures, reduce turnaround times and boost productivity with more efficient workflows. For additional company information, please visit https://ibex-ai.com/and follow us on LinkedIn and X.

The Galen™ platform includes solutions which are for Research Use Only (RUO) in the United States and not cleared by the FDA. Multiple Galen solutions are CE marked (IVDD and IVDR) and registered with the UK MHRA. For more information, including indication for use and regulatory approval in other countries, contact Ibex Medical Analytics.

Ibex Media Contact
Nechama Rosengarten
FINN Partners
[email protected]

[1] Pantanowitz et al., An artificial intelligence algorithm for prostate cancer diagnosis in whole slide images of core needle biopsies: a blinded clinical validation and deployment study, THE LANCET Digital Health Aug 2020
[2] Sandbank et al., Validation and real-world clinical application of an artificial intelligence algorithm for breast cancer detection in biopsies; npj Breast Cancer 8, 129 (2022)
[3] Comperat et al., Clinical Level AI-Based Solution for Primary Diagnosis and Reporting of Prostate Biopsies in Routine Use: A Prospective Reader Study, European Congress of Pathology 2021
[4] Raoux et al., Novel AI-Based Solution for Supporting Primary Diagnosis of Prostate Cancer Increases the Accuracy and Efficiency of Reporting in Clinical Routine, USCAP 2021
[5] Sandbank et al., Validation and Clinical Deployment of an AI-Based Solution for Detection of Gastric Adenocarcinoma and Helicobacter pylori in Gastric Biopsies, USCAP 2022

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SOURCE Ibex Medical Analytics