GALENOS 1-Auditor Biomedical Simulation, Open-Cohort & Regulatory Workbench
✓ 52/52 G1–G4 PASS ! S-SIGN: UNSIGNED (NULL) KR · 한국어
◈ 2026 KHIDI 1st Integrated Biomedical R&D Announcement (32 RFPs, 110p)

2026 KHIDI High-Ceiling 12-Track Biomedical R&D Command Matrix

Realigned around the 12 highest computational-ceiling RFPs in the 2026 KHIDI announcement. Combines first-principles ODE/ray-casting/FEP simulation (S-SIM), SHA-256-locked open human/biochemical cohorts (S-PUB), solver-free G1–G4 verification, and Zero-Physical-Custody external CRO bridging (S-EXT).

→ Open Priority Workbench (19-1 Rare Genomics) → Zero-Custody CRO & Clinical Bridge → 52-Gate Solver-Free Audit Vault

Live Audited Portfolio Telemetry

Solver-Free Verified
1-Auditor Mean Adoption Score
84.4 / 100
Up from ~25/100 in mixed APOSTOLUS v1
With Zero-Custody CRO & IRB
93.9 / 100
Peak 96 pts (19-1) · 95 pts (13-2 OB/GYN)
Real Open Cohort Benchmarks
11 / 12
ClinGen, MIMIC-IV, CTU-UHB, MIT-BIH, GEO, OASIS, D3R
Preserved Boundary & Hold Findings
36 Items
CRO Leads Advanced: 3/4
S-SYN
Synthetic Regression Fixture

Deterministic edge-case & adversarial fault-injection unit fixtures.

S-SIM
First-Principles Biophysical / Clinical Simulation

ODE/PDE hemodynamics, Beer-Lambert ray-casting, Zwanzig FEP cycles, and FHIR/DICOM state machines.

S-PUB
Locked Open Human Cohort Benchmark

SHA-256 pinned real human cohorts (ClinGen, Phenopackets, MIMIC-IV, CTU-UHB, MIT-BIH, GEO IPF, OASIS-2, ePillID, D3R GC4).

S-EXT
Zero-Physical-Custody CRO & Clinical IRB Gate

Drop-shipped ISO-17025/GLP CRO raw plate/PK ingestion & external M.D./IRB statutory validation.

S-SIGN
1-Auditor Cryptographic Sign-Off

Automated G1–G4 PASS never impersonates human sign-off; explicit principal signature required.

12-Track KHIDI Adoption & Verification Matrix (Click Any Track for 3-Pane Workbench)

Showing: 12 / 12
Wave · RFP Track & Biophysical / Cohort Architecture Ladder & TRL Audited Primary Metric (G3) Solo Score +CRO/IRB Audit & Statutory Gate
W1 · 19-1
p.104–106
Precision Rare-Disease Genomics SaMD
Joint Genotype × HPO Likelihood & ACMG-28 Rare-Disease Diagnostic CDSS
◈ S-PUB
TRL 3 → 5
100.00 %
Causal Gene+Variant Top-5 Diagnostic Recall (Noisy HPO + VCF) (n=240)
95% CI [98.42, 100.00] · vs Genome-Wide HPO Resnik IC Phenotype-Only Ranker (4,900 Genes, Noisy HPO) 56.67 %
89
v1: 31 pts
96
+CRO/IRB
✓ PASS
MFDS In-Vitro Diagnostic / Genomic SaMD Analytical Performance Dossier (IEC 62304 Class B/C)
W1 · 11-1 [3-2]
p.61–64
Cardiovascular Digital Twin
0D–1D Cardiopulmonary RK4 Hemodynamic Digital Twin & Counterfactual Therapy Engine
◈ S-PUB
TRL 3 → 5
0.8392 AUROC
Held-Out ICU Hypotensive Instability (MAP < 65 mmHg) Prediction AUROC (n=137)
95% CI [0.7604, 0.9145] · vs Early Window Static Shock-Index / Linear Windkessel Baseline 0.6536 AUROC
87
v1: New (Replaced Wet-Lab)
95
+CRO/IRB
✓ PASS
ASME V&V 40 Credibility Assessment for Computational Modeling in Medical Devices
W1 · 11-1 [1-2]
p.61–64
Musculoskeletal Radiographic Mensuration SaMD
3D Beer-Lambert CT→DRR Pose-Perturbed Radiographic Alignment & Cobb/HKA Mensuration
◈ S-PUB
TRL 3 → 5
0.9027 AUROC
Locked-Test Spinopelvic Sagittal Pathology (DH/SL vs Normal) AUROC (n=124)
95% CI [0.8488, 0.9473] · vs Single-Angle Radiographic Mensuration Baseline (Pelvic Incidence Only) 0.7374 AUROC
86
v1: New (Replaced Wet-Lab)
94
+CRO/IRB
✓ PASS
MFDS Orthopedic Radiological CADm / Mensuration SaMD Guideline (Sub-degree Repeatability)
W2 · 13-2
p.75–77
High-Risk Pregnancy & Intrapartum Fetal SaMD
Uteroplacental Oxygen Transport Simulator & Real 552-Delivery CTU-UHB Intrapartum CTG Predictor
◈ S-PUB
TRL 3 → 5
0.6376 AUROC
CTU-UHB Locked-Test Pre-Delivery Metabolic Distress AUROC (n=136)
95% CI [0.5265, 0.7391] · vs Maternal Age Alone Baseline 0.5076 AUROC
84
v1: New (Replaced Wet-Lab)
95
+CRO/IRB
✓ PASS
MFDS Obstetric Maternal-Fetal Monitoring SaMD Performance & IEC 62366-1 Usability Formative Test
W2 · 11-1 [3-6]
p.61–64
Wearable Patch ECG Risk SaMD
3D Cardiac Dipole Patch-ECG Simulator & Real 48-Record MIT-BIH Ambulatory Arrhythmia Detector
◈ S-PUB
TRL 3 → 5
0.9493 AUROC
MIT-BIH DS2 Patient-Disjoint Ventricular Ectopy Detection AUROC (n=330)
95% CI [0.9228, 0.9733] · vs Naive Fixed-RR (<600 ms) Threshold Baseline 0.8702 AUROC
85
v1: 26 pts
94
+CRO/IRB
✓ PASS
ANSI/AAMI EC57 Arrhythmia Algorithm Beat/Rhythm Reporting & MFDS Wearable ECG SaMD Review
W2 · 11-1 [6-1]
p.61–64
ICU Sepsis-ARDS Severity & Prognosis
Multi-Compartment Pulmonary V/Q Shunt Ventilator Twin & Real MIMIC-IV ICU Cohort Stratifier
◈ S-PUB
TRL 3 → 5
0.7442 AUROC
MIMIC-IV First-24h Subject-Locked ICU Deterioration AUROC (n=66)
95% CI [0.6057, 0.8615] · vs Single-Vital Admission Shock Index (HR/SBP) 0.6552 AUROC
85
v1: New (Replaced Wet-Lab)
93
+CRO/IRB
✓ PASS
KR CDI / HL7 FHIR ICU Vital-Sign Streaming Interoperability Conformance
W3 · 11-1 [3-1]
p.61–64
Aortic Dissection TEVAR Planning
Pulsatile Bifurcated True/False-Lumen Hemodynamic Solver & Virtual TEVAR Entry-Closure Planner
◈ S-SIM
TRL 3 → 5
0.8269 AUROC
Late Aortic Expansion Risk Stratification AUROC (Locked n=240) (n=240)
95% CI [0.7721, 0.8746] · vs Conventional Max Aortic Diameter >= 40 mm Guideline 0.5496 AUROC
84
v1: New (Replaced Wet-Lab)
94
+CRO/IRB
✓ PASS
4D-Flow Phase-Contrast MRI / CTA Centerline Concordance Benchmark
W3 · 11-1 [6-3]
p.61–64
IIP / IPF Multi-Omics & DP-Synth
Cross-Cohort IIP/IPF Lung Transcriptome Classifier (GSE32537 → GSE24206) & Privacy-Preserving Synth Engine
◈ S-PUB
TRL 3 → 5
0.9529 AUROC
Cross-Cohort Locked & External Lung Transcriptome AUROC (n=77) (n=77)
95% CI [0.8983, 0.9925] · vs Single-Locus MUC5B Transcript Expression Baseline 0.8701 AUROC
85
v1: 34 pts
93
+CRO/IRB
✓ PASS
KHIDI / PIPC Healthcare Pseudonymized & Synthetic Genomic Data Adequacy Review
W3 · 16-3
p.88–90
Dementia Longitudinal MRI & ARIA Risk
OASIS-2 373-Visit Longitudinal MRI Progression Ranker & T2*-GRE ARIA Scanner-Shift Simulator
◈ S-PUB
TRL 5 → 8 (Solo Ceiling TRL 5)
0.732 AUROC
Subject-Locked Longitudinal MRI Dementia Status AUROC (n=72 Visits / 31 Subjects) (n=72)
95% CI [0.6015, 0.8486] · vs Chronological Age-Only Clinical Baseline (Age-Matched Cohort) 0.5834 AUROC
80
v1: 27 pts
92
+CRO/IRB
✓ PASS
MFDS Pivotal Multi-Center Clinical Confirmation Trial Required for TRL 7–8 Commercial Approval
W4 · 18-3 [분야 2]
p.101–103
Wrong-Site / Wrong-Patient Surgical Prevention
FHIR × DICOM × Surgical Consent Cross-Reconciler Across 2,400 Fault-Injected Scenarios + Cholec80
◈ S-PUB
Hospital Safety System
97.58 %
Multi-Modal Surgical Error Detection Accuracy (n=2400)
95% CI [96.89, 98.13] · vs Surface String-Match & Unadjusted 24h Washout Baseline 58.58 %
84
v1: New (Replaced Wet-Lab)
94
+CRO/IRB
✓ PASS
Operating Room PACS / EMR / Barcode Wristband On-Premise Hospital Living-Lab Pilot
W4 · 18-2 [분야 2]
p.101–103
Automated Dispensing & MFDS DUR Audit
ePillID 3,728-Image 5-Fold Benchmark + Translucent Pouch Glare Simulator + Korean MFDS DUR Kernel
◈ S-PUB
Hospital Pharmacy Verification
99.69 %
Dispensing & MFDS DUR Hazard Interception Rate (n=320)
95% CI [98.25, 99.94] · vs Color-Shape Appearance-Only ATC Camera Baseline (No Imprint / No DUR) 87.19 %
82
v1: 30 pts
93
+CRO/IRB
✓ PASS
Korean ATC (Automated Tablet Dispensing & Packaging) Hardware Optical Rig Calibration
W4 · 5-1
p.35–37
Structure-Based AI Drug + Zero-Custody CRO
Real D3R GC4 BACE1/CatS Affinity Engine, Zwanzig FEP Cycle Closure & Zero-Physical-Custody CRO Bridge
◈ S-EXT
TRL 3 → 4
0.5033 r
D3R GC4 Out-of-Sample ΔG_bind Pearson Correlation (n=73) (n=73)
95% CI [0.2312, 0.711] · vs Molecular-Weight-Only Null Heuristic (-MW Across 73 Ligands) 0.047 r
82
v1: 25 pts
94
+CRO/IRB
✓ PASS
Fee-for-Service Dispatch to ISO-17025 / MFDS-GLP External CRO (Zero Sponsor Lab License Required)