What You Should Know:
– Gesund.ai, the clinical AI validation company, today announced the open sourcing of a comprehensive library of evaluation methodologies and frameworks to help developers and users address AI performance and potential bias across patient cohorts for the FDA-regulated AI solutions on the market.
– As part of its mission to standardize AI validation, Gesund.ai is also announcing it has joined the Coalition for Health AI, after partnering with public and private industry groups like CancerX, the NIST AI Safety Institute Consortium, VALID AI and the American Heart Association.
Gesund: Pioneering AI Assurance in Healthcare with Open-Source Validation Tools
Gesund is the world’s first AI assurance platform dedicated to advancing clinical-grade AI solutions for healthcare. It offers industry-leading, independent third-party validation for medical AI used by pharmaceutical and medical device companies. Supported by leading investors such as Merck, McKesson, Northpond, and 500, Gesund orchestrates the entire AI/ML lifecycle through a no-code environment, seamlessly integrating models, data, and experts. Its AI-native platform can be deployed on-premises, in air-gapped environments, or in the cloud, enabling rapid collaboration with healthcare providers and board-certified physicians.
– Navigating Bias and Regulatory Evolution: Screening clinical AI for bias is uniquely challenging due to the evolving regulatory landscape. By 2025, healthcare providers and payors—not just AI developers—will share the responsibility of preventing discrimination caused by clinical algorithms.
– Bridging Gaps with Gesund Validate: Although the FDA provides guidelines for clinical AI performance, no universal platform exists for physicians or developers to conduct independent assessments. Gesund has spent years developing a comprehensive clinical AI validation suite used across diverse healthcare settings. Now, it has launched Gesund Validate, an open-source tool accessible to healthcare, AI, and industry professionals at this LINK.
– Key Features of Gesund Validate:
– Coverage Across Clinical AI Domains: Designed for AI solutions like radiology, it supports unstructured multimodal data using “expert-in-the-loop” workflows and diverse computer vision tasks.
– Bias Detection and Mitigation: Identifies performance disparities across patient demographics (e.g., age, gender, race) using integrated fairness and bias mitigation frameworks.
– FDA-Aligned and Customizable: While aligned with FDA standards, it can be adapted to specific hospital needs and evolving regulations.
Gesund’s open-source initiative follows a period of rapid expansion, marked by recognition in the **CB Insights AI 100** and new partnerships with public and private clinical AI organizations. It has also expanded its real-world data partnerships, now collaborating with the Institute for Better Health (IBH) at Trillium Health Partners (THP), a leading health system in Toronto. This expansion reinforces Gesund’s commitment to providing robust and transparent AI validation for safer healthcare outcomes.
“One goal of open sourcing this library is to rally communities together to update, improve and expand standards and methodologies as the field evolves,” said Dr. Enes Hosgor, CEO and founder of Gesund.ai. “No one company can or should do it alone.”
