DEMONSTRATION ENVIRONMENT — All clinical scenarios, provider identities, and patient data are fictional. This software is not FDA-cleared and does not constitute medical advice. For illustration purposes only.

AI Governance for Healthcare. Mathematically Enforced.

Every clinical AI decision — provably compliant, cryptographically sealed, deterministically replayable. HIPAA, FDA SaMD, and EU AI Act from day one.

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Δtomic Rx Dr. Martinez · NPI DEMO-000000
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HIPAA FDA SaMD EU AI Act blake3://b7e2...0a2b

Two-thirds of physicians use AI daily. Most of it is ungoverned.

The gap between clinical AI adoption and institutional oversight is growing. Recent medical literature warns that governance frameworks built for specific tools cannot keep pace with general-purpose AI entering clinical workflows.

Shadow AI

Consumer AI tools used outside institutional oversight. Clinicians adopt whatever works — creating compliance blind spots that no audit can detect.

Compliance Gap

Governance designed for specific, approved tools fails when applied to general-purpose AI. The frameworks were not built for this.

Audit Black Hole

No provenance trail. No replay capability. When regulators ask what happened, all you have are log files and good intentions.

How It Works

Three steps between unmonitored AI and provable governance.

Step 1

Wrap

Deploy around any clinical AI — ambient documentation, diagnostic tools, clinical decision support. No changes to existing workflows.

Step 2

Govern

Every interaction is compliance-checked in real time against HIPAA, FDA SaMD, and EU AI Act requirements. Violations are caught before they reach the patient.

Step 3

Prove

A cryptographic provenance chain seals every decision. Deterministic replay lets you reconstruct any governance state, exactly, for any audit.

See It In Action

Try the full healthcare AI governance wrapper. Type clinical queries, trigger HIPAA violations, switch between specialties — everything is governed, sealed, and replayable.

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Compliance Coverage

Built-in support for the frameworks that matter in healthcare AI.

HIPAA Mapped

§164.312 Alignment

Audit controls, access logs, PHI safeguards — framework mapped

FDA SaMD Framework

Framework Mapped

Framework requirements mapped. Not FDA-cleared.

EU AI Act

Art. 9–15 (High-Risk)

Risk management, data governance, transparency, human oversight

SOC 2 Framework Mapped

Trust Services Criteria

Framework requirements mapped to Trust Services Criteria.

NIST AI RMF

GOVERN, MAP, MEASURE, MANAGE

Full function mapping with crosswalk to other frameworks

Framework requirements mapped. Independent verification recommended.

48
Patent Filings
1,026
Machine-Verified Proofs
8,106
Automated Tests
11
Industry Verticals

They audit. We prove.

The difference between governance theater and mathematical certainty.

Traditional Governance Δtomic Rx
Approach Heuristics and checklists Conservation law enforcement
Verification Statistical sampling Formal mathematical proof
Audit Trail Log files Cryptographic provenance chain
Replay Not possible Deterministic reconstruction
PHI Handling Policy-based controls Mathematically enforced isolation

Clinical Use Cases

Governance that works where clinical AI actually lives.

Clinical Decision Support

Governance for diagnostic AI recommendations. Every suggestion is compliance-checked, provenance-sealed, and replayable on demand.

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Ambient Documentation

HIPAA-compliant oversight of AI scribes. PHI is detected, sealed, and governed before it ever leaves the encounter.

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Pharmacy AI

Drug interaction governance with counterfactual replay. Reconstruct the exact reasoning behind any formulary decision.

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Ready to govern your clinical AI?

See how mathematically enforced compliance works in your environment. We will walk you through a live governance session with your workflows.

Request Demo

Or contact us at raf@atomictrust.ai