Benefits
- Benefit
-
An area under the ROC curve of 0.81
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Intended. The validation applied the score retrospectively to stored data, and the score guided no care, so the sources report no realized benefit. [1]
Fully reviewed: supporting details for Status
Review date: 29 October 2026.
Sources: [1]
- Beneficiary groups
-
Organizations.
Awaiting review
- Beneficiaries
-
Unresolved
Not reviewedUnresolved
- Reach
-
Unresolved
Not reviewedUnresolved
- Distribution and access
-
Unresolved
Not reviewedUnresolved
- Duration
-
Unresolved
Not reviewedUnresolved
- Expected?
-
Yes
Awaiting review
- Costs and harms
-
Unresolved
Not reviewedUnresolved
AI system
- System
-
Sepsis ImmunoScore
Awaiting review
- Model
-
This is an explicit unresolved assignment: the sources on record do not settle this question.
Not reviewedUnresolved
- Release
-
Unresolved
Not reviewedUnresolved
- Provider
-
Unresolved
Not reviewedUnresolved
- Role
-
Unresolved
Not reviewedUnresolved
- Configuration
-
Unresolved
Not reviewedUnresolved
- Inputs and outputs
-
Unresolved
Not reviewedUnresolved
- Autonomy
-
Unresolved
Not reviewedUnresolved
- Workflow
-
The score used up to 22 inputs from the electronic health record, including a blood sample drawn within three hours of the first blood culture order. Risk thresholds were fixed before the validation study.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The study measured the accuracy of the score against physician adjudication. It did not compare care with and without the score.
Awaiting review
- AI contribution
-
Unresolved
Not reviewedUnresolved
Measurement
- Studies
-
Other. [1]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [1]
- Study design
-
Other. [1]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [1]
- Measurement
-
Retrospective study of prospectively collected data and samples; sepsis adjudicated by three physicians blinded to the score. [1]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [1]
- Setting and sample
-
746 patients with suspected sepsis at three US hospitals. [1]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [1]
- Measures
-
AUROC and sepsis rate by risk category. [1]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [1]
- Comparison
-
Physician adjudication of Sepsis-3. [1]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [1]
- Results
-
AUROC 0.81; sepsis 3.02% low to 69.70% very high. [1]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [1]
- Additional value from AI
-
Not isolated. [1]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [1]
- Limitations
-
Retrospective; same-site adjudicators; mechanical ventilation endpoint not met. [1]
Fully reviewed: supporting details for Limitations
Review date: 29 October 2026.
Sources: [1]
Money
- Kind of value
-
The kind of monetary value is unclear.
Not reviewedUnresolved
- Amount
-
The monetary value is not established.
Not reviewedUnresolved
- Currency and prices
-
The currency and price basis are unclear.
Not reviewedUnresolved
- Period and unit
-
The period and unit of the monetary estimate are unclear.
Not reviewedUnresolved
- Realization
-
Whether the monetary value was realized is unclear.
Not reviewedUnresolved
- Recipients and payers
-
The recipients and payers are unclear.
Not reviewedUnresolved
- Gross or net
-
Whether the monetary figure includes costs is unclear.
Not reviewedUnresolved
- Included costs
-
The costs included in the estimate are unclear.
Not reviewedUnresolved
- Comparison
-
The financial comparison is not established.
Not reviewedUnresolved
- Method
-
The method used to calculate monetary value is unclear.
Not reviewedUnresolved
- Return and payback
-
The return on investment or payback period is not established.
Not reviewedUnresolved
People and places
- Participants
-
Developer: Prenosis, Inc. Operator: Prenosis (retrospective validation on data from three US hospitals).
Awaiting review
- Jurisdictions
-
Benefit: Boston, Massachusetts; Chicago, Illinois; Royal Oak, Michigan,
United States. Developer: United States. Operator: United States.Awaiting review
- Ownership and control
-
Unresolved
Not reviewedUnresolved
- Dependencies
-
Unresolved
Not reviewedUnresolved
- Cross-border connections
-
Unresolved
Not reviewedUnresolved
- Geopolitical implications
-
The geopolitical implications are unclear.
Not reviewedUnresolved
Follow-up
- Conditions for replication
-
The patient is an adult with suspected sepsis and a blood culture ordered. Clinicians use the score with other findings and not as the sole basis for a decision.
Awaiting review
- Replication attempts
-
Unresolved
Not reviewedUnresolved
- Later findings
-
Unresolved
Not reviewedUnresolved
- Availability
-
Unresolved
Not reviewedUnresolved
- Institutional decision
-
A relevant institutional decision has not been established.
Not reviewedUnresolved
- Grounds
-
The grounds for an institutional decision are unclear.
Not reviewedUnresolved
- Action and result
-
The result of an institutional decision is not established.
Not reviewedUnresolved
- Success criterion
-
The criterion for a successful institutional decision is unclear.
Not reviewedUnresolved
Evidence
- Source numbers
-
AIBD-0626-source-0001
Awaiting review
- Citations
-
Numbered references below.
Awaiting review
- Language
-
Unresolved
Not reviewedUnresolved
- Source relationships
-
Independent
Awaiting review
- Original evidence
-
Unresolved
Not reviewedUnresolved
- Access and versions
-
Unresolved
Not reviewedUnresolved
- Supported findings
-
Unresolved
Not reviewedUnresolved
- Evidence links
-
Unresolved
Not reviewedUnresolved
- Evidence strength
-
Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report. [1]
Fully reviewed: supporting details for Evidence strength
Review date: 29 October 2026.
Sources: [1]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
Organizations.
Awaiting review
- Depth
-
The revised record no longer states this information.
Not reviewedUnresolved: supporting details for Depth
The record revision removed the mapped value.
- Reasons
-
Organizations: The risk categories were measured on retrospective data, and no hospital used the score to change care.
Awaiting review
- Observed or intended
-
Intended. The validation applied the score retrospectively to stored data, and the score guided no care, so the sources report no realized benefit. [1]
Fully reviewed: supporting details for Observed or intended
Review date: 29 October 2026.
Sources: [1]
- Rubric
-
Unresolved
Not reviewedUnresolved
- Assessor and date
-
Unresolved
Not reviewedUnresolved
- Alternative assessments
-
Unresolved
Not reviewedUnresolved
- Fill
-
Found by a regulator
Awaiting review
Entry details
- Kind
-
The case describes an evaluation or a study. A regulatory review of a validation study. [1]
Fully reviewed: supporting details for Kind
Review date: 29 October 2026.
Sources: [1]
- Related entries
-
Both records concern an AI model that flags hospital patients at risk of sepsis, and the hospital that relies on its alerts is the stakeholder in each.
Fully reviewed: supporting details for Related entries
Compared with the incidents in the AI Incident Database snapshot of 26 October 2026; a second reading confirmed that the incident concerns the same kind of system and stakeholder.
Sources: incidentdatabase.ai
- Field
-
Healthcare.
Awaiting review
- Purpose
-
The Sepsis ImmunoScore was built to identify patients at risk of having or developing sepsis within 24 hours. The measured risk stratification is that purpose.
Awaiting review
- Dates
-
Source published: 2 April 2024. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was tested in a laboratory. Retrospective validation on biobank samples and records; the score did not guide care. [1]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 88d1b88b8e1d…
Awaiting review: supporting details for Version
SHA-256 of the public case, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.
References
- Other identifiers
-
AI Incident Database: 1374.
Awaiting review
- Category mappings
-
Unresolved
Not reviewedUnresolved
- Citable summary
-
Unresolved
Not reviewedUnresolved
- Revisions
-
3 revisions. Latest: 29 October 2026.
Awaiting review
Sources
-
Regulatory document Independent author
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Sepsis ImmunoScore (DEN230036): decision summary. Granted 2024-04-02.
The ImmunoScore has demonstrated that an increase in risk score and category is correlated with the increased risk of sepsis.