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AI Products
Intended Use
Patient Population
Inputs and Outputs
Performance Evidence
Safety and Limitations
Bias / Fairness
Human Factors / Workflow
Security / Privacy
Regulatory / Deployment
Company Name
Product Name
Product Version
Product URL
Product Summary
AI / Model Type
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Product Status
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Foundation Model
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Release Date
Primary intended use
Intended users
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Deployment settings
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Clinical workflow
What should the user do after receiving the output?
Out-of-scope uses
Adult, pediatric, or both?
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Age range
Clinical conditions or population
Geographic restrictions
Populations not evaluated, or where performance is uncertain
Input information types
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Where does input data come from at runtime?
How does the product receive data?
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EHRs you currently integrate with
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Output type
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Describe the output a user sees
Is the output intended to influence a clinical decision?
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Data used to develop or train the model
Has the product's performance been evaluated?
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Known limitations
Known failure modes
When should users not rely on the AI?
Current safeguards
Is human review of the output required?
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Your assessment of clinical risk level
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Have safety or reliability been tested?
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Has performance been evaluated across patient subgroups?
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Populations with uncertain or insufficient evaluation
What do you do to reduce bias?
How is the output presented to the user?
Can users override, reject, or modify the output?
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What happens when the AI cannot produce an output?
Has it been evaluated inside the intended clinical workflow?
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How do users understand, question, or give feedback on outputs?
Does the product process PHI?
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Does it process other PII?
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Does it store patient data?
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Encryption at rest?
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Encryption in transit?
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Role-based access controls?
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Audit logging?
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Certifications and attestations
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Subject to regulatory oversight?
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Current deployment status
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Where is the product available?
Does your product already support FHIR R4?
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How is the model maintained and updated?
How is performance monitored after deployment?
Funding source
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Stakeholders consulted during development
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Third-party components or data
Peer-reviewed publications
Clinical trial registration
Reimbursement status
Patient consent or disclosure