Clinical AI Evidence Infrastructure

The decision recordAI made invisible.

When clinicians work alongside diagnostic AI, the medical record captures neither the AI's recommendation nor the reasoning behind agreement or override. Evidify creates the structured, tamper-evident evidence that doesn't exist today.

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evidify_export_SES-mmfc2zfa.zip
▸ evidence packageVERIFIED
events.jsonl818 EVENTS
decision_trajectories.json
double_bind_records.json
derived_metrics.csv
compliance_manifest.json
data_quality_index.jsonDQI: 99/100
▸ analysis/
imrmc_raw.csv
run.py
▸ notarization/
timestamp.tsrRFC 3161
28 files · 867 KBchain integrity: PASS · 818/818 links
Patent Pending · U.S. App. No. 63/987,880
Academic Validation Active
AMIA 2026 Submitted

The Problem

950+ FDA-cleared AI devices.
Zero documentation standard.

Diagnostic AI is being integrated into clinical decisions at scale. When an adverse outcome involves AI, the medical record cannot reconstruct what happened.

01

The silent record

When a radiologist reads with AI assistance, the medical record does not capture whether they saw the AI output, agreed with it, overrode it, or why. The decision sequence is invisible.

02

The double bind

Clinicians face potential liability for following an incorrect AI recommendation and for overriding a correct one. No documentation standard exists to create a defensible record for either scenario.

03

The regulatory gap

The EU AI Act mandates human oversight documentation for high-risk AI systems, with enforcement timelines approaching. ACR has called for payment structures recognizing AI review workload. No compliance-ready evidence infrastructure exists.

The Approach

Gate-enforced sequential disclosure

Every phase of the clinician-AI interaction is architecturally enforced, cryptographically recorded, and exported as a self-contained evidence package.

STEP 01

Independent assessment first

The clinician's diagnostic impression is captured and cryptographically locked before any AI output is released. AI findings are withheld by the server until the independent assessment is verified — the data does not exist on the network path until commitment is proven.

Server-side AI withholding · SHA-256 hash lock · Proof of commitment before release
STEP 02

Controlled disclosure with comprehension

AI recommendations appear through a gate-enforced protocol with error rate transparency and calibrated comprehension verification before the clinician decides.

FDR/FOR disclosure · Numeric comprehension estimation · Calibrated confidence
STEP 03

Documented override or agreement

When the final decision differs from AI, structured reason codes and rationale create a defensible record. Automation bias patterns are classified automatically.

Structured reason codes · Bias classification · Override direction tracking
STEP 04

Tamper-evident evidence package

Every session produces a self-contained export with dual-verified hash chain, server-side AI release proof, decision trajectories, compliance mapping, and RFC 3161 trusted timestamps.

Self-contained verifier · iMRMC-compatible · Server-side proof chain

What It Produces

Every session generates a complete evidence package

Research-grade behavioral data, automatic bias classification, and regulatory compliance mapping — from every participant, every session.

Evidence Package Contents28 files · 867 KB · Self-contained verification
Research

Decision Trajectories

Automatic bias pattern classification per case with millisecond phase timing.

Capitulation · Partial anchoring · Resistance
Legal

Double Bind Records

Four-pillar accountability: independent judgment, AI considered, deliberate decision, tamper evidence.

Oversight → provable accountability
Integrity

Cryptographic Audit Trail

Dual-verified SHA-256 hash chain: client-side and server-side chains computed independently. RFC 3161 trusted timestamps. Self-contained verifier runs without platform access.

818 events · Dual chain verification · Third-party verifiable
Compliance

Regulatory Mapping

Automatic mapping to HIPAA, EU AI Act, GDPR, and 21 CFR Part 11.

Generated automatically per session
Analysis

iMRMC Export

FDA-compatible multi-reader multi-case statistical analysis files.

iMRMC + RJafroc compatible
Quality

Data Quality Index

Automatic per-case scoring for read time, deliberation, and protocol compliance.

99/100 mean DQI in validation
Methods

Reproducibility Package

Methods snapshot, analysis script, codebook, and protocol validation.

Python analysis script included
Design

Counterbalancing

Latin Square assignment, washout enforcement, case queue management.

5-condition · 50-case · Multi-reader

Who It's For

Two audiences. One evidence gap.

Whether you're studying clinician-AI interaction or managing the liability it creates, the fundamental problem is the same.

FOR RESEARCH

Principal investigators running reader studies

  • Browser-based remote reader study execution — no installation required
  • Built-in Latin Square counterbalancing and configurable washout enforcement
  • Automatic automation bias pattern classification with behavioral timing
  • iMRMC and RJafroc-compatible export for standard MRMC analysis
  • IRB-ready data security with embedded informed consent
FOR RISK & COMPLIANCE

Insurers, risk managers, and compliance teams

  • Structured evidence proving clinicians made accountable decisions
  • Tamper-evident packages with independent timestamp verification
  • Automatic compliance mapping to HIPAA, EU AI Act, and 21 CFR Part 11
  • Override and agreement documentation with structured reason codes
  • Audit trail exceeding 21 CFR Part 11 electronic records requirements

Get in Touch

Let's talk about your use case

Evidify is in active academic validation with a research university partner. If you're working on clinical AI evidence standards, documentation infrastructure, or clinician-AI interaction research, I'd welcome a conversation.

Currently partnering with select institutions for clinical validation.

Start a Conversation or reach me directly at [email protected]
Joshua M. Henderson, Ph.D.Founder, Evidify LLCEast Orange, NJ