Benefits
- Benefit
-
Hepatocellular ballooning (0.563 against 0.414)
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Reported benefit
Awaiting review
- 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
-
AIM-NASH (Artificial Intelligence-Based Measurement of NASH histology; also called AIM-MASH)
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
-
Slides were scanned on the Aperio AT2 scanner. A trained liver pathologist reviewed every AI score and could reject it. The model was locked before validation.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The validation compared AI-assisted reads with unassisted individual pathologist reads of the same 1,481 cases against the same expert panel.
Awaiting review
- AI contribution
-
The validation compared AI-assisted reads with unassisted individual pathologist reads of the same 1,481 cases against the same expert panel.
Awaiting review
Measurement
- Studies
-
Controlled observational. [2]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [2]
- Study design
-
Controlled observational. [2]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [2]
- Measurement
-
Weighted kappa of AI-assisted reads and of individual manual reads against panels of two expert pathologists with a tiebreaker. [2]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [2]
- Setting and sample
-
1,481 cases from four completed MASH trials (three phase 2 and one phase 3). [2]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [2]
- Measures
-
Weighted kappa against the consensus panel. [2]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [2]
- Comparison
-
Individual manual reads of the same cases. [2]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [2]
- Results
-
Lobular inflammation 0.419 against 0.297; ballooning 0.563 against 0.414; steatosis and fibrosis similar. [2]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [2]
- Additional value from AI
-
Weighted kappa higher by 0.12 to 0.15 for inflammation and ballooning. [2]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [2]
- Limitations
-
Clinical meaning of the gains questioned by CHMP; locked model and one scanner model; study funded by PathAI and drug companies. [2]
Fully reviewed: supporting details for Limitations
Review date: 29 October 2026.
Sources: [2]
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: PathAI. Operator: PathAI with sponsors of MASH drug trials (validation on archived biopsies from trials of obeticholic acid, pegbelfermin and semaglutide).
Awaiting review
- Jurisdictions
-
Benefit: Multinational MASH clinical trials (central pathology reading). 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
-
Users run the locked version of the tool on slides from the same scanner model. Major changes to the model come with new validation.
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-0652-source-0001–0003
Awaiting review
- Citations
-
Numbered references below.
Awaiting review
- Language
-
Unresolved
Not reviewedUnresolved
- Source relationships
-
Independent, Developer
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, one independent press release and the makers' peer-reviewed study. The cited evidence includes no independent study or report. [1] [2] [3]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
Organizations.
Awaiting review
- Depth
-
Organizations: 2.
Awaiting review
- Reasons
-
Organizations: Weighted kappa against the expert panel rose from 0.297 to 0.419 for lobular inflammation and from 0.414 to 0.563 for ballooning in 1,481 cases.
Awaiting review
- Observed or intended
-
Unresolved
Not reviewedUnresolved
- 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 regulator's qualification of a validated method. [2]
Fully reviewed: supporting details for Kind
Review date: 29 October 2026.
Sources: [2]
- Related entries
-
No incident in the AI Incident Database snapshot of 26 October 2026 concerns the same kind of system harming the same kind of stakeholder.
Partly reviewedUnresolved: supporting details for Related entries
Compared with the incidents in the AI Incident Database snapshot of 26 October 2026.
- Field
-
Drug development / pathology.
Awaiting review
- Purpose
-
AIM-NASH was built to help trial pathologists score MASH biopsies with less variability. More accurate and consistent scoring is that purpose.
Awaiting review
- Dates
-
Source information as of: June 2023. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was tested in a laboratory. The validation re-read archived biopsy slides from completed trials. [2]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [2]
- Version
-
SHA-256: 26ea130afba6…
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
-
Unresolved
Not reviewedUnresolved
- Category mappings
-
Unresolved
Not reviewedUnresolved
- Citable summary
-
Unresolved
Not reviewedUnresolved
- Revisions
-
1 revision. Latest: 29 October 2026.
Awaiting review
Sources
-
Peer-reviewed study Developer
Pulaski H, Harrison SA, Mehta SS, et al. Clinical validation of an AI-based pathology tool for scoring of metabolic dysfunction-associated steatohepatitis. Nature Medicine. 2025;31:315-322. Published online 4 November 2024.
the difference in WK for AI assisted and GT compared to mean WK for IMR and GT for hepatocellular ballooning was 0.15 (95% CI, 0.11-0.19; non-inferiority P < 0.0001) and for lobular inflammation was 0.12 (95% CI, 0.08-0.17; non-inferiority P < 0.0001)
-
Regulatory document Independent author
European Medicines Agency, Committee for Medicinal Products for Human Use. Qualification opinion for Artificial Intelligence-Based Measurement of Non-alcoholic Steatohepatitis Histology in Liver Biopsies to Determine Disease Activity in NASH/MASH Clinical Trials. Adopted 27 February 2025 (EMADOC-1700519818-1761332 Corr.1).
The Applicant concludes that the accuracy analysis demonstrated that the AI-assisted scores were superior to the manual pathologist scoring for lobular inflammation and hepatocellular ballooning and non-inferior for steatosis and fibrosis. Secondary and exploratory analysis also demonstrated improved accuracy of the AI-assisted scoring compared to manual pathologist evaluation. This overall conclusion is endorsed, but some questions on clinical meaningfulness on comparison to literature reports remain.
-
Press release Independent author
European Medicines Agency. EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples. 20 March 2025.
The evidence submitted to CHMP shows that AIM-NASH biopsy readings, verified by one expert pathologist, can reliably determine MASH disease activity with less variability than the current standard used in clinical trials