datosX Is Building the Validation Engine for Digital Health in the Age of AI
In a market moving at AI speed, evidence cannot take a year. StartUp Health community member Robin Roberts of datosX Digital Health Labs is transforming how digital health teams validate their solutions, delivering buyer-credible evidence and real market traction in months, not years.
The Challenge
For digital health and AI-powered solutions, validation is everything. Without credible evidence, innovators struggle to earn the trust of buyers, investors, and regulators, and even the strongest products can stall before they ever reach scale. The problem is that the traditional pathways for generating evidence often move at a very different pace than technology. Legacy CRO models can be slow, expensive, and operationally heavy, and they frequently separate validation from real-world adoption.
As Robin Roberts, CEO and Chairman of datosX Digital Health Labs, puts it plainly, “In a market moving at AI speed, evidence cannot take a year.”
Origin Story
datosX began as a solution to a problem that kept repeating at scale. Before founding datosX Digital Health Labs, Roberts spent nearly two decades at Novartis, where he ultimately became Chief Operating Officer and Co-founder of the Novartis Biome. While working at the intersection of pharma and digital health, he saw the same challenge arise again and again. Teams wanted to use promising digital health technologies in new clinical contexts, but the evidence to support those use cases rarely existed. Digital health companies could not afford to run endless studies, and large organizations were not built to execute digital health validation quickly or efficiently.
“We created what we called the Evidence Lab out of sheer necessity,” Roberts explains. “We needed a way to collect the right data, in the right setting, without spending years and enormous budgets doing it.”
After years of refinement and success inside Novartis, the model proved powerful enough to stand on its own. In October 2023, the Evidence Lab officially spun out as datosX Digital Health Labs.
Under the Hood
At its core, datosX operates a validation network designed to serve both sides of digital health adoption: the innovators building new solutions and the health systems deciding what to adopt.
On the health system side, datosX offers a structure that removes financial and operational friction. Health systems choose which studies to participate in, are reimbursed for execution costs, and retain access to all resulting data. This gives them the freedom to test more innovations, more often, and only in areas that match their priorities. “Once we had one or two health systems on board, the rest became easy,” Roberts says. “They realized it costs them nothing to participate, and they can only win from the data.”
That model has helped datosX build relationships with many of the world’s leading providers, including Kaiser Permanente, University of Michigan, Stanford Health, University of Texas, Columbia University, and Walgreens.
For digital health teams, datosX delivers an end-to-end validation engine. The company supports study design, protocol development, execution, analysis, clinical study reports, publications, and regulatory submissions. But the real differentiator is that validation is paired with real commercial opportunity. Studies run inside health systems that are actively evaluating whether the technology solves a real problem for their organization.
“The golden ticket for a digital health company,” Roberts explains, “is collecting regulatory-grade evidence while piloting your technology with a healthcare system that may become your next customer.”
The result is speed and efficiency that are difficult to achieve through traditional routes. Typical validation studies at datosX run 30–60% faster and can be completed at 8–10× lower cost than legacy CRO approaches. “What often takes CROs years,” Roberts says, “we can do in months.”
datosX also supports retrospective studies through an established network of real-world data partners, including BeekeeperAI, OMNY, and Dandelion, allowing clients to access high-quality data faster and more cost-effectively.
What Makes datosX Different
Unlike traditional CROs that rely on paid sites disconnected from adoption, datosX embeds validation directly inside health systems that may become long-term partners. Evidence generation becomes a pathway to market traction, not just a regulatory checkbox. By incorporating the voices of healthcare providers and patients into validation early, datosX helps ensure that the technologies advancing are the ones truly solving real-world problems.
“I wanted the end users involved from the beginning,” Roberts says. “Too often technologies are built in a silo and miss the mark. Working directly with health systems lets us make sure innovation actually serves patients and providers.”
What’s Next
datosX is now expanding beyond execution into intelligence with the rollout of EVIDIA, which stands for ‘Evidence and Validation Database powered by AI.’ EVIDIA transforms global digital health trial knowledge into a searchable, AI-driven system that helps teams design better studies, avoid past mistakes, strengthen regulatory strategies, and accelerate commercialization. Beta access is a near-term focus, with broader availability planned for the second half of 2026.
The long-term ambition is clear: datosX is building category-defining infrastructure for digital health evidence, pairing an execution and validation engine with a scalable intelligence layer that creates lasting competitive advantage.
The Takeaway
For innovators trying to earn trust and move faster, datosX delivers a simple message: stop waiting 18 months for proof. Validate in months, not years, and unlock pilots with tier-1 health systems while building regulatory-grade, buyer-credible evidence.
That mission is deeply aligned with the work of the StartUp Health community, which has worked with Roberts and the team since the earliest days of the Novartis Biome. As Roberts reflected during his conversation with StartUp Health co-founder Unity Stoakes, “From the very beginning, we knew we had to be part of this ecosystem.”
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Published: Jan 20, 2026
By Nicole Kinsey
