CORE ANALYSIS
The Clinical Difference
Time-critical Decisions
Clinical environments require millisecond latency in governance. Standard post-
hoc auditing fails when decisions happen in trauma bays or ICUs. Lineage must
be captured at the point of inference, not reconciled days later.
Complex Data
Fragmentation
Bridging the gap between EHR
records, high-resolution Lab results,
and Imaging metadata. We unify
fragmented states into a single
verifiable truth.
Regulatory/Liability
Navigating FDA and HIPAA mandates
requires more than logs—it requires
evidence that stands up in a court of
law or a peer review board.
Why standard governance fails
Standard IT governance tools lack the semantic understanding of clinical context. They
see data packets; we see the patient's evolving physiological state and the doctor's
intent.
NO STATIC SNAPSHOTS
NO DECOUPLED AUDITS
REAL-TIME TRACEABILITY
CRYPTOGRAPHIC PROOF
FDA & SaMD Context
Ensuring compliance with Software as a Medical Device (SaMD) requirements through
continuous monitoring and real-world evidence.
PREDETERMINED CHANGE CONTROL PLANS (PCCP)
Our system tracks every model iteration against authorized
change plans, ensuring that self-learning algorithms remain
within the safety bounds established during regulatory
submission.
REAL-WORLD EVIDENCE COLLECTION
Capturing outcome lineage allows for the continuous loop of
clinical feedback, turning every decision into a verifiable
datapoint for future performance optimization.
AUDIT INTEGRITY
Verifiable Oversight
SYSTEM STATUS: [OPERATIONAL]
ACTIVE NODES: [142]
NOMINAL REVIEW
1.2s
Average time to approve. Indicates "rubber
stamping" without substantive engagement
with the underlying data.
SUBSTANTIVE REVIEW
48.5s
Engagement with lab results, imaging
windows, and justification notes indicates
active clinical oversight.
DISCREPANCY RATE
3.4%
Automated identification of clinician
overrides that diverged from model safety
guardrails.
Deploy Clinical Trust
Infrastructure
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workflow today.
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CLINICAL GOVERNANCE LAYER V2.4
Patient Safety Is an Accountability
Problem
Decision Lineage is the foundational infrastructure that makes clinical AI
governable. In high-stakes environments, "black box" is not an option. We
provide the cryptographic and technical evidence chain for every clinical
outcome.
Establish Provenance
Technical Docs
CASE STUDY: PLEXUS CLINICAL
Building Trust
Infrastructure First
Plexus Clinical reduced their deployment timeline by 60% by
embedding Decision Lineage at the architectural level. By
providing the FDA with a clear record of 'Inference-Time
Provenance', they moved from pilot to production without the
typical governance friction.
60%
Faster Deployment
100%
Audit Compliance
Prior Authorization
Accountability
A specialized module showing how policy evaluation layers verify clinical
criteria compliance in real-time. We don't just log the decision; we log the
policy that was active at the time of the request.
Policy Layer [v8.2] Verification Active
Clinical Criteria Cross-Reference: PASSED
Compliance Signature Hash: 0x82...BF3
Learned Intermediary & Oversight
Visualizing the clinician-in-the-loop record, capturing what the
clinician saw and their justification for overrides. In the event of a
dispute, the "learned intermediary" evidence chain is the most critical
asset for hospital liability defense.
Visual Context Capture
Logs exactly which UI elements and data metrics were visible to the
physician at the moment of override.
Justification Archiving
Cryptographically binds the clinician's note to the specific inference
token and model version.
The Data State Problem
A technical visualization of 'Inference-Time Provenance', capturing the EHR state at the exact
millisecond of decision, before the record changes. Most systems only see the current state; we see
the history that mattered.
EHR STATE (T0)
INFERENCE MOMENT
RECORD UPDATE (T1)
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