Lumanity Becomes First Life Sciences Value Demonstration Partner to Achieve ISO 42001 Certification, Setting a New Standard for Responsible AI in Life Sciences

February 17, 2026

Morristown, NJ -- As artificial intelligence transforms the future of medicine, Lumanity has become the first life sciences commercialization partner to earn ISO 42001 certification, the global standard for Artificial Intelligence Management Systems (AIMS). This achievement cements Lumanity’s role as the industry benchmark for safe, transparent and expert-directed AI across the life sciences value chain.

ISO 42001 certification recognizes organizations that design or operationalize AI systems with rigorous governance, ethical oversight, and transparent risk management.

Lumanity’s disciplined, high-integrity approach to AI, embodied by its Expert-Directed Applied Intelligence (EDAI) platform, integrates human expertise, robust data standards, and ethical controls across evidence generation, commercialization and market access. This platform ensures that every AI-enabled solution is grounded in scientific and clinical context, aligning with the highest international standards.

The ISO audit awarded Lumanity “Best Practice” recognition for its exemplary, organization-wide approach to aligning AI systems with business and scientific objectives.

“Achieving ISO 42001 certification is a powerful validation of the standards we hold ourselves to,” said Jon Williams, Chief Executive Officer at Lumanity. “AI is transforming biopharma, but only those who invest in responsible, transparent, and expert-guided systems will deliver real, lasting value. This certification reinforces to our clients, partners and teams that Lumanity is leading the industry in applying AI with integrity, safety and scientific rigor.”

ISO 42001 certification is independent assurance that AI-enabled solutions meet the highest global standards for safety, transparency and ethical governance. These global standards ensure faster, lower-risk pathways to market for breakthrough therapies, confident navigation of evolving regulatory requirements and AI-powered insights grounded in real scientific and clinical expertise. ISO 42001 governance also ensures advanced technology delivers meaningful, measurable impact across the life sciences value chain.

“In healthcare, AI must be safe, transparent, and grounded in real scientific and clinical context. As medicine development becomes more complex, our clients need a partner who can operationalize advanced technology responsibly,” said Anthony Guethert, Chief Technology Officer at Lumanity. “This isn’t a time for a “wait and see” approach; thoughtful governance is essential to meet new regulatory requirements while harnessing technology’s true potential.”

For more information on how Lumanity’s leadership in AI and technology innovation in life sciences visit https://lumanity.com/technology-and-ai/.