Building Trust in Healthcare AI
Hospitals and regulators don’t buy metrics. They buy trust.
We help you turn performance into evidence that decision-makers believe in.Our physician-led team has evaluated hundreds of AI and digital health products and created frameworks used by hospitals, regulators, and investors.
We believe that healthcare AI must be evaluated through the lens of clinical practice, not just technical metrics. Our mission is to ensure new AI technologies enhance rather than complicate patient care by providing rigorous, clinically-grounded validation services.
Validation Builder: Turn testing into trust. Validation plans that show safety, effectiveness, and workflow fit — moving you beyond claims to evidence.
Regulatory Readiness: Lay the foundation for SaMD and CE. Risk files, evidence strategies, and monitoring protocols that let regulators move quickly and confidently.
Clinical Timeline Creation: Quickly reconstruct patient journeys to show how and where AI intersects with care, surfacing workflow gaps, safety issues, and hazard scenarios.
Physician Validation: Independent benchmarking, annotation, and review from practicing clinicians to build credibility with buyers and regulators
We partner with healthcare AI companies across the full growth journey, helping them build the trust needed to move from pilots to scale with confidence.
Early Stage companies preparing for pilots
Scaling vendors entering new markets or fundraising
Established vendors for regulatory or entreprise review
Governance Expertise: Trusted leader in healthcare AI oversight, with frameworks shaped by experience at RAND and aligned with FDA, EU AI Act, ISO, and NIST.
Proven Track Record: Hundreds of AI and digital health products evaluated, giving us unmatched insight into what hospitals, investors, and regulators expect.
Clinical Foundations: Physician-led team with Stanford, UCSF, and OHSU training, plus 20 years of frontline practice in patient safety and quality.
Our team combines deep clinical experience with technical expertise in AI evaluation. We understand both the complexities of clinical practice and the technical nuances of AI systems. This unique perspective allows us to provide evaluations that matter to healthcare organizations, clinicians, and ultimately patients.
Our founder, Dr. Sarah Gebauer, brings a unique perspective to healthcare AI evaluation, combining active clinical practice with deep expertise in artificial intelligence and system evaluation. As a practicing anesthesiologist and AI evaluation expert, she understands firsthand how new technologies impact clinical workflows and patient care.
After graduating from Stanford Medical School, Dr. Gebauer recognized the growing need for clinically-grounded AI evaluation. She completed additional training in Clinical Informatics and developed expertise in AI system evaluation methodologies, particularly focusing on safety, clinical relevance, and real-world utility.
Contact us at sarah (at) validaraheath.com to learn how we can help ensure your healthcare AI tools meet the highest standards of clinical safety and utility.
