Review your Draft

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
Large language model
Product Status
Dev
Foundation Model
Third-party API
Release Date
Primary intended use
Intended users
Nurses
Physicians
Deployment settings
Emergency department
Inpatient
Clinical workflow
What should the user do after receiving the output?
Out-of-scope uses
Adult, pediatric, or both?
Adult
Age range
Clinical conditions or population
Geographic restrictions
Populations not evaluated, or where performance is uncertain
Input information types
Demographics
Vitals
Clinical notes
Where does input data come from at runtime?
How does the product receive data?
FHIR R4 API
SMART on FHIR app
EHRs you currently integrate with
Epic
Oracle Health (Cerner)
Output type
Risk score
Recommendation
Describe the output a user sees
Is the output intended to influence a clinical decision?
Supports a clinician who makes the decision
Data used to develop or train the model
Has the product's performance been evaluated?
Yes, using clinical data
Evaluation type
Retrospective
External
What was the evaluation trying to show?
Primary metrics and results
How should these results be interpreted?
Comparator or baseline
Dataset description
Sample size
Evaluation population
Evaluation setting
Link to supporting evidence
Known limitations
Known failure modes
When should users not rely on the AI?
Current safeguards
Is human review of the output required?
Always
Your assessment of clinical risk level
Moderate
Basis for that assessment
Have safety or reliability been tested?
Yes
What did the safety testing try to show?
Safety and reliability results
Test type
Testing data description
Interpretation
Link to supporting evidence
Has performance been evaluated across patient subgroups?
Yes
Groups evaluated
Age
Sex
Race / ethnicity
Subgroup metrics and results
What did you find?
Testing data description
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?
Accept, reject or modify
What happens when the AI cannot produce an output?
Has it been evaluated inside the intended clinical workflow?
Yes
Describe the workflow evaluation
How do users understand, question, or give feedback on outputs?
Does the product process PHI?
Yes
Does it process other PII?
Yes
Does it store patient data?
No
Encryption at rest?
Yes
Encryption in transit?
Yes
Role-based access controls?
Yes
Audit logging?
Yes
Certifications and attestations
SOC 2 Type 2
ISO 27001
HIPAA security risk assessment
Subject to regulatory oversight?
Yes
Regulatory pathway
FDA 510(k)
Status
Cleared / authorized
Device classification
Clearance / authorization identifier
Clearance date
Current deployment status
Pilot
Where is the product available?
Does your product already support FHIR R4?
Yes
How is the model maintained and updated?
How is performance monitored after deployment?
Funding source
Self-funded
Stakeholders consulted during development
Nurses
Physicians
Health system leaders
Third-party components or data
Peer-reviewed publications
Clinical trial registration
Reimbursement status
Patient consent or disclosure