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Healthcare AI Is Moving Fast.
Governance Has to Keep Up.

Healthcare organizations are deploying LLMs in clinical scribing, triage, diagnostic support, patient communication, and revenue cycle — without the governance infrastructure that should accompany them. Aggi Technologies and ARIA are built to close that gap.

NIST AI RMF HIPAA Native FDA CDS Guidance ISO 42001 Clinical LLM Deployments

A Lesson That Took Nineteen Years to Build On

In 2007, a Veterans Administration research grant worth $80 million was cancelled. Not because the science failed. Because the participating institutions — brilliant researchers at premier medical centers — could not share patient context data in a way that was simultaneously secure, HIPAA-compliant, and ethically defensible.

Dr. Golla was part of the team at UT Southwestern Medical Center trying to build the platform that could have made that research possible. The technology existed. The governance framework to use it safely did not.

"The governance infrastructure that should have arrived with the LLM deployment wave did not. We are building it now."

ARIA was built from that experience. Every question in ARIA's clinical assessment bank reflects a real gap that healthcare AI teams are navigating today — the same category of gap that ended $80 million in Gulf War Syndrome research nineteen years ago.

Healthcare AI

Healthcare AI Is Governing Without Infrastructure

The LLM deployment wave has outpaced the governance frameworks, tooling, and institutional knowledge that should accompany clinical AI deployments. Three failure patterns we see constantly.

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The RBAC Misconception
Role-based access control at the database layer does not protect against prompt injection at the LLM layer. Sending PHI to an external LLM API without a BAA is a HIPAA violation regardless of who has database access. RBAC is not an AI security strategy.
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The Vendor Compliance Myth
A Business Associate Agreement is a legal instrument, not a technical control. It does not validate that your vendor's model is not hallucinating medication dosages, drifting from its validated baseline, or processing PHI outside the scope of what you contracted.
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The One-Time Validation Gap
Most clinical AI systems were validated once — on clean data, before the vendor updated the underlying model. Every vendor model update is effectively a new system deployment requiring re-validation. Most organizations don't know when their vendor's model has changed.

ARIA — Built Specifically for This Problem

No other AI governance platform has native HIPAA modules, FDA CDS classification logic, or a question bank calibrated for clinical LLM deployments. ARIA was built from the ground up for this context.

  • Native HIPAA Assessment Module PHI flow mapping, BAA tracking, ePHI in LLM logs, breach notification readiness. Not a generic compliance checklist — clinical-specific questions about how PHI actually moves through LLM systems.
  • FDA CDS Classification Trigger Logic If your LLM may qualify as a regulated Clinical Decision Support device, ARIA flags it immediately — because deploying an uncleared medical device is a federal violation, not a compliance gap.
  • Dependency Graph — Gaps That Connect When a BAA is missing, ARIA surfaces every downstream PHI exposure. When EHR write-back lacks human review, it connects to FDA guidance and patient safety flags automatically.
  • 39 Critical Clinical Triggers Conditional logic built for healthcare — ED deployment, autonomous diagnostic recommendations, direct EHR write-back, patient-facing LLMs. The right escalations for the right clinical contexts.
  • Automated Bias Testing IBM AIF360, Microsoft Fairlearn, Aequitas — actual bias tests against your model outputs, disaggregated by age, race, sex, language, and payer type. Not a checkbox. A measurement.
  • Multi-Audience Reports CTO, CMO, Compliance Officer, Board — each formatted for their role. Executive summary for investor due diligence. Regulatory package for FDA or OCR review. Evidence-backed, audit-ready.
ARIA — Aggi Responsible Intelligence Assessor
Healthcare AI Governance
Platform
68 Clinical assessment questions
39 Critical trigger rules
4 NIST AI RMF functions
0 Other platforms with native HIPAA + FDA CDS
  • Free tier + professional plans — mid-market accessible
  • Platform subscription — your team runs it
  • Managed retainer — we run it for you monthly
  • Point-in-time assessment — fixed scope, 2 weeks
  • Platform fees and consulting fees are separate
Explore ARIA in Full Detail →

The Healthcare AI Organizations That Need This Most

Every enterprise governance platform ignores the market where clinical AI governance is most urgent. ARIA and Aggi Technologies are built for these organizations specifically.

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Healthcare AI Startups (Series A–C)
You've deployed an LLM in a clinical workflow. Enterprise customers are asking about your governance posture. Investors are asking about regulatory risk. You need a structured, evidence-backed answer — not a slide deck.
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Regional Health Systems
You're running 20–50 AI tools across clinical and administrative workflows. No unified governance framework. No single view of your AI risk posture across the organization. ARIA gives you one.
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Healthcare AI Vendors
Your clinical scribe, triage assistant, or diagnostic tool needs to demonstrate NIST AI RMF alignment and HIPAA compliance to every enterprise health system you sell to. ARIA generates that documentation.
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Compliance Officers & Legal Teams
You need audit-ready evidence that AI systems were formally assessed, findings were tracked, and remediation was documented. ARIA's tamper-evident audit log and export formats are built for exactly this.
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CTOs Without a Dedicated AI Governance Function
You don't have a Chief AI Officer, a dedicated compliance team, or the budget to build one. ARIA plus our managed retainer is your AI governance function — at a fraction of a full-time hire's cost.
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Boards and Healthcare Investors
You want evidence-based assurance that the AI systems in your portfolio are being governed responsibly. ARIA's executive summary and board report give you that — scored, trended, and defensible.

Every Framework That Matters in Healthcare AI

ARIA operationalizes the regulatory frameworks your clients, enterprise buyers, and compliance teams are already asking about — all in one platform.

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NIST AI RMF 1.0
All 4 functions — GOVERN, MAP, MEASURE, MANAGE. 68 questions calibrated for clinical LLM deployments.
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HIPAA
Privacy Rule, Security Rule, Breach Notification. PHI in LLM inference, training, logs, and caches. BAA tracking.
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FDA CDS Guidance
Automatic classification trigger. If your LLM may be a regulated medical device, ARIA tells you immediately.
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ISO 42001
AI Management System standard — increasingly required in enterprise healthcare procurement and international markets.
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OWASP LLM Top 10
Prompt injection, insecure output handling, training data poisoning — mapped to clinical deployment contexts.
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HIPAA Non-Discrimination (45 CFR 92)
Aequitas bias audit output maps directly to HIPAA non-discrimination documentation requirements.
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Automated Bias Testing
IBM AIF360, Fairlearn, Aequitas — actual bias metrics, not attestations. Disaggregated by demographic subgroup.
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HITRUST / SOC 2
Common in enterprise health system procurement requirements. Framework coverage in active development.

Ready to Govern Your Healthcare AI?

ARIA is accepting early access requests. Whether you want platform access, a managed retainer, or a point-in-time assessment — one conversation tells us what fits.