Digital Health
A 0.99 AUROC can still be a translational non-starter. Retrospective accuracy is one axis of four — and because the axes multiply, excellence on the one everybody optimizes cannot carry a product into clinical use.
AI Clinical Validation & Digital Biomarkers
- DOSSIER55 pp · 15 figures. How cardiology, neurology and oncology AI fail for the same structural reasons.
- WORKBOOK18 sheets. 132 audited claims; trackers for the FDA device count, PCCP, EMA qualifications.
- AUDIT92 / 100, release-ready. Every citation re-verified live, zero retractions.
- HYPOTHESES12 falsifiable, dated, each connecting ≥2 domains.
Exactly what's inside AI Clinical Validation & Digital Biomarkers.
The full research-report table of contents and every one of the 18 tables in the evidence workbook — the real structure of what you license, not a teaser.
- Executive Summary
- Scope and Evidence Integrity Statement
- Decision Snapshot Overview
- Buyer Decision Cheat Sheet
- Source Quality Dashboard
- The Four Axis Translation Model
- Cross Domain Convergence Map
- Evidence Maturity Matrix and Category Comparison
- Key Findings
- Quantitative Evidence
- Mechanistic Insights and Failure Modes
- Domain Deep Dives Cardiology Neurology Oncology
- Prospective Evidence Standards and Minimal Viable Designs
- Non Obvious Early Pipeline Ai Opportunities
- Second Order Effects and Non Obvious Predictions
- Testable Hypotheses
- Most Valuable Next Studies
- Regulatory and Evidence Standards Pathway
- Commercial Market Access and Payer Strategy
- Strategic Recommendations
- Limitations
- Final Judgment
- Expert Review and Validation Note
- Appendix Methodology Glossary and Evidence Layers
- References
Workbook Guide
An orientation to the workbook — its scope, how the claim counts reconcile, and the audit posture.
In this dossier: AI-Enabled Translational Validation & Digital Biomarkers Evidence Workbook
Claim Ledger
Every factual claim in the report, independently re-verified against its primary source, each carrying a support verdict and a recalibrated evidence grade.
In this dossier: all 131 audited claims (59 customer-facing + 72 excluded); independent verdicts & grades
Evidence Table
The full registry of cited sources — PMIDs, NCTs and DOIs — with metadata, resolved live against the primary record.
In this dossier: final curated, independently-verified reference set (100 sources)
Source-Support Verdicts
The verbatim source excerpt behind each claim, with an independent verdict on whether the source actually supports it.
In this dossier: Independent Source-Support Verdicts — own read of full text (verbatim excerpt + location)
Source Quality Summary
A reconciled view of source quality across the evidence base, with the grading rationale.
In this dossier: independent re-grade vs source artifact
Category Scorecard
Programs or modalities scored on the framework's axes — a structured, side-by-side comparison (expert, ordinal, non-evidentiary).
In this dossier: Category / Platform Scorecard — digital-biomarker categories x four axes (ordinal/fenced)
Therapeutic-Area Scorecard
Programs or modalities scored on the framework's axes — a structured, side-by-side comparison (expert, ordinal, non-evidentiary).
In this dossier: Area Scorecard — read through the four axes
V-U-E-D Scorecard
Programs or modalities scored on the framework's axes — a structured, side-by-side comparison (expert, ordinal, non-evidentiary).
In this dossier: Validity-Utility-Evidentiary-Deployment Scorecard — the controlling frame
Figure Source Map
The provenance of every figure — its underlying data and how it was produced.
In this dossier: every figure mapped to claim IDs, source IDs, and limitation labels
Figure Attempt Ledger (Internal
The provenance of every figure — its underlying data and how it was produced.
In this dossier: Figure Attempt Ledger (Internal QA) — render provenance & status; all 15 rendered, none pending
Hypotheses Ledger
The forward-looking, falsifiable hypotheses — each with a predicted readout and an explicit disconfirming test.
In this dossier: 12 non-obvious, falsifiable, current hypotheses (original 5 re-validated + 7 new)
Most Valuable Next Studies
The highest-leverage experiments to run next, prioritized — a ready-made research agenda.
In this dossier: 8 fundable, falsifiable validation programs
Early-Pipeline AI Opportunities
A structured table within the evidence workbook.
In this dossier: Pipeline AI Opportunities — deploy AI earlier to manufacture prospective evidence
Regulatory Tracker
Regulatory designations and pathways relevant to each program — noting that a designation is never an approval.
In this dossier: Regulatory & Evidence-Standards Tracker (SaMD/510(k)/PCCP/GMLP/RWE/qualifications)
Trial Registry Tracker
A structured tracker of the programs, signals and evidence in this dimension of the analysis.
In this dossier: Trial / Registry Tracker — every NCT opened & verified (ClinicalTrials.gov v2)
Verification & Search Log
A dated log of the verification searches run — the audit trail behind the evidence.
In this dossier: independent re-assessment + fresh searches (queries, dates, outcomes)
Excluded Claims
Every claim we considered and removed, with the reason — showing the work, including what didn't make the cut.
In this dossier: disposition of all 72 (20 recovered + 52 remain excluded)
Salvage Ledger
Claims recovered from the excluded set after deeper verification.
In this dossier: reuse / improve / replace decisions vs the original report
Click any table to see what it is.
Different buyers live in different tabs.
Click a buyer to see exactly what they get.
Every claim resolves to a primary source.
This dossier ships with its independent diligence audit. Evidence is labelled Established / Inferred / Hypothesis. A surrogate is never equated with outcome; a designation is never an approval.
Zemi Research publishes independent, pre-packaged research reports delivered as digital downloads (PDF + spreadsheet). These are information products — not medical, clinical, investment, legal, or professional advice; not a consulting, advisory, or regulated service; and they create no professional-client relationship. Provided for general informational use by industry professionals.