The 8 Standards
Our comprehensive framework evaluates healthcare AI products across eight critical dimensions to ensure safety, efficacy, and ethical deployment.
Set the standard
your AI will be measured by.
Regulatory Compliance and Safety
Adherence to global health regulations and rigorous safety protocols. We evaluate alignment with FDA, CE marking, HIPAA, and other relevant regulatory frameworks to ensure products meet the highest safety standards.
Integrability
Seamless interoperability and communication within existing clinical workflows. Products must demonstrate compatibility with EHR systems, HL7/FHIR standards, and real-world deployment environments.
Transparency
Clear interpretability, explainability, and traceability of AI decisions. Clinicians and patients must be able to understand how and why an AI system reaches its conclusions.
Clinical Outcomes
Measurable, positive impacts on patient health and care delivery. We assess whether the AI product demonstrably improves diagnosis, treatment, workflow efficiency, or patient outcomes.
Ethics
Strict bias monitoring and ensuring equitable accessibility for all patients. Products must demonstrate fairness across demographics and address potential disparities in AI-driven care.
Model and Clinical Validity
High fidelity and robust statistical validation of AI models in clinical settings. We evaluate training data quality, validation methodologies, and real-world performance metrics.
Human-in-the-Loop
Mandatory human oversight and optimized usability for healthcare professionals. AI must enhance clinical decision-making while keeping practitioners in control of patient care.
Operational Assurance
Ongoing value demonstration and comprehensive lifecycle stewardship. Products must show sustained reliability, maintainability, and continuous improvement over time.