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Clinical AI / Decision Support 4D Map
A. Clinical Problem & Target Definition
A. Clinical Problem & Target Definition
Intra-connections
Inter-connections
B. Data Strategy & Infrastructure
B. Data Strategy & Infrastructure
Intra-connections
Inter-connections
C. Model Development & Engineering
C. Model Development & Engineering
Intra-connections
Inter-connections
D. Preclinical & Clinical Evaluation
D. Preclinical & Clinical Evaluation
Intra-connections
Inter-connections
E. Regulatory Strategy & Submission
E. Regulatory Strategy & Submission
Intra-connections
Inter-connections
F. Clinical Integration & Deployment
F. Clinical Integration & Deployment
Intra-connections
Inter-connections
G. Post-Market Surveillance & Lifecycle Mgmt
G. Post-Market Surveillance & Lifecycle Mgmt
Intra-connections
Inter-connections
H. Reimbursement, Adoption & Ecosystem
H. Reimbursement, Adoption & Ecosystem
Intra-connections
Inter-connections
ALWAYS DEVICE PATHWAY - NO CDS EXEMPTION
Unmet clinical need
identification
Clinical workflow
analysis
📌 Intended use
definition
Indications for
use scoping
Patient population
specification
Literature &
evidence review
Existing AI/CDS
landscape scan
Clinical champion
identification
Stakeholder engagement
(clinicians, patients, IT)
Health system
leadership buy-in
Multidisciplinary
team assembly
Initial ethics review
IRB determination
(exempt vs. full)
Feasibility
assessment
Build vs. buy vs.
adapt decision
Clinical endpoint
selection
Health equity
impact assessment
Use case
prioritization
DICOM imaging data
export from PACS
HL7/FHIR structured
data from EHR
Claims & registry
data acquisition
Waveform/signal data
(ECG, EEG, CGM)
Genomic/multi-omic
data ingestion
Unstructured notes
extraction (NLP)
📌 Data use agreement
(DUA) execution
HIPAA compliance &
privacy review
De-identification &
privacy engineering
Safe harbor vs. expert
determination
Cohort definition &
selection criteria
Annotation workflow
design
Ground truth
establishment
Inter-rater reliability
measurement (kappa)
Train / validation /
test split strategy
Data representativeness
& bias audit
Multi-site data
collection logistics
📌 Datasheets for
Datasets documentation
Data pipeline
infrastructure (ETL)
Data versioning &
lineage tracking
Informed consent
(where applicable)
Synthetic data
generation
Data governance
committee review
Algorithm architecture
selection
CNN / vision model
(imaging AI)
Transformer / LLM
(clinical text)
Gradient-boosted trees
(tabular EHR)
Signal processing
model (waveforms)
Feature engineering
& selection
Training &
hyperparameter tuning
Internal validation
(hold-out set)
K-fold
cross-validation
Calibration assessment
(Brier score)
Explainability methods
(SHAP, Grad-CAM)
Uncertainty
quantification
Subgroup performance
analysis (demographics)
📌 IEC 62304 software
lifecycle documentation
Software architecture
& design docs
Version control &
reproducibility (MLOps)
🏁 GMLP alignment
self-assessment
📌 Model Card creation
(FDA format)
Unit & integration
testing
Software bill of
materials (SBOM)
Foundation model
fine-tuning
External validation
(independent sites)
Temporal validation
(train past, test future)
Silent/shadow
prospective deployment
MRMC reader study
design (imaging AI)
Standalone
performance testing
Assistive (human+AI)
performance testing
Autonomous
performance testing
Enriched vs. prevalence
study design
Ground truth
adjudication process
Fairness & health
equity audit
Robustness & stress
testing (domain shift)
Adversarial input
testing
Cybersecurity
threat modeling
Usability & human
factors (IEC 62366)
Clinical study
protocol design
Sample size &
power analysis
Comparator arm
selection
Formal clinical
trial needed?
📌 ISO 14971
risk analysis
Edge case & failure
mode analysis
Site-specific
calibration testing
Is this Software as a
Medical Device (SaMD)?
CDS Criterion 1:
NOT image/signal analysis
IMAGE / SIGNAL AI
ALWAYS FAILS CRITERION 1
Ultrasound, CT, MRI, X-ray,
pathology, retinal, dermoscopy,
ECG, EEG, CGM, continuous signals
CDS Criterion 2: Displays/
analyzes medical information
CDS Criterion 3:
Recommendation to HCP
Single recommendation:
enforcement discretion only (2026)
Risk scores: enforcement
discretion (non-acute only)
Time-critical predictions:
EXCLUDED from discretion
CDS Criterion 4: HCP can
review basis independently
🏁 All 4 criteria met:
Non-Device CDS (exempt)
Enforcement discretion
zone (2026 guidance)
📌 DEVICE PATHWAY
ENTRY
IMDRF SaMD risk
categorization (I-IV)
Risk classification:
Class I / II / III
Predicate device
identification
📌 510(k) pathway
(with predicate)
📌 De Novo pathway
(no predicate, low-mod)
📌 PMA pathway
(Class III, high risk)
Breakthrough Device
designation request
Pre-Submission meeting
request (Q-Sub)
Pre-Sub interaction
& FDA feedback
Device description
& architecture
Intended use &
indications for use
Data management
plan documentation
Model description
& training details
Performance validation
data package
Human factors
data package
Cybersecurity
documentation
Labeling &
Model Card
📌 PCCP: Description
of Modifications
📌 PCCP: Modification
Protocol
📌 PCCP: Impact
Assessment
FDA substantive
review
Additional information
(AI) request
Advisory panel review
(if applicable)
📌 Clearance / Authorization
/ Approval
Not Substantially
Equivalent / Denial
QMSR 21 CFR 820
quality system (ISO 13485)
General Wellness pathway
(non-invasive wearables)
EHR integration
(FHIR APIs for CDS)
PACS/DICOM integration
(imaging AI)
LIS integration
(laboratory AI)
Legacy HL7 v2
interface development
API design &
interoperability testing
IT security review &
infrastructure provisioning
Clinical workflow
redesign & embedding
Alert & notification
design (CDS)
Results display
design (imaging AI)
Clinician & staff
training program
Pilot site
selection criteria
Institutional AI governance
committee review
Go / No-Go
decision
Small-scale pilot
deployment
Prospective impact
assessment (pilot)
Clinician feedback
collection & iteration
Workflow adjustment
based on real use
📌 ONC HTI-1 FAVES
criteria compliance
Source attribute
transparency (HTI-1)
Institutional
scaling decision
Multi-site
rollout
Change management
program
Patient communication
& consent
Real-world performance
monitoring
Site-specific
performance tracking
Data drift
detection
Concept drift
detection
Input data quality
monitoring
Bias monitoring &
health equity tracking
📌 MedWatch MDR
reporting (devices)
Voluntary adverse event
reporting (non-device)
User feedback &
complaint tracking
Automated performance
dashboards
Model retraining
trigger assessment
PCCP-governed
modification
New submission
required?
Updated labeling
& Model Card
Post-market
surveillance studies
Site-specific revalidation
after updates
Cybersecurity patch
management
Annual performance
reporting
De-implementation &
retirement decision
Algorithmvigilance
program
CPT / HCPCS code
identification
AMA CPT application
process
Radiology AI CPT codes
(e.g., 0689T-0694T)
Payer evidence
requirements
CMS coverage
decision pathway
Commercial payer
policy development
Value-based &
outcomes contracting
Health economic outcomes
research (HEOR)
Guideline & society
recommendation
Clinical adoption &
trust dynamics
Automation bias
management
Patient engagement
strategy
Evidence generation
(real-world deployment)
Publication &
dissemination strategy
Competitive landscape
& market analysis
Generative AI &
foundation models
Federated learning &
privacy-preserving AI
EU AI Act compliance
assessment
State AI legislation
(CO, CA, etc.)
Liability & malpractice
framework evolution
🏁 URAC Health Care AI
Accreditation (2 tracks)
🏁 CTA ANSI/CTA-2135
Predictive Health AI Std
🏁 Joint Commission AI
Guidance (cert planned 2026)
AHA AI Assessment
Program (cardio)
🏁 NIST AI RMF 1.0
alignment
ISO/IEC 42001 AI
management system
IEEE clinical
AI standards
🏁 New problem
identification
LEGEND
Activity
Milestone / Deliverable
Decision Point
Optional / Conditional
Recent Regulatory Change (2024-2026)
Image/Signal AI: Always Device Pathway
🏁
Milestone (deliverable)
📌
FDA-required — cannot be skipped
Primary flow
Feedback loop
Governance / conditional
Sources: FDA TPLC (2025 draft),
FDA CDS (2026), PCCP (Aug 2025),
GMLP, NIST AI RMF 1.0, NAM,
Duke, ONC HTI-1, URAC, JC, CTA-2135
DISCLAIMER: Reference visualization for educational purposes only. Not legal, regulatory, or medical advice. Consult qualified professionals. Modeled on NCATS 4D Maps (ncats.nih.gov). CC BY-SA 4.0