Healthcare AI Governance

The AI in medicine
earns its trust here.

Amilieu is the governance layer for clinical AI — assessing, monitoring and regulating the systems that touch patient care, inside the environments where they actually operate.

Regulatory Alignment

Built to standards that healthcare already trusts.

TGA Aligned
NHMRC Guidance
ISO 42001
EU AI Act
WHO Framework
HIPAA Ready
ISO 13485
MDR Informed
Australian Privacy Principles
TGA Aligned
NHMRC Guidance
ISO 42001
EU AI Act
WHO Framework
HIPAA Ready
ISO 13485
MDR Informed
Australian Privacy Principles

The problem

Healthcare doesn't forgive mistakes.
Neither should AI.

AI is already writing into the patient record — triaging, diagnosing, discharging. Most of it has never been clinically assessed. No framework governs how it's deployed, monitored or retired when it drifts.

78%

of healthcare AI tools deploy without clinical-outcome validation.

1 in 4

models show measurable drift within twelve months.

0

jurisdictions currently mandate continuous AI monitoring in care.

/ indicative figures — Amilieu field research, 2025

The platform

Three disciplines.
One governance layer.

Amilieu's product is built for the reality of a hospital — clinical leads, risk committees, and AI vendors working from the same source of truth.

amilieu.io / governance

Governance Workflows

Manage compliance, approvals, change control

live

Checklists

10

Approvals

10

Change Req.

4

Eval plans

10

APP1110Approvals10Eval10+ Request

Evaluation plans

10 total · 2 running · 1 queued

Echo-Cardiac v3.2

Plan 6/6 · clinical envelope

Passed

Triage-ED-2

Plan 2/6 · cohort match

Running

Ambient Scribe v2.1

Plan 0/4 · awaiting sign-off

Queued

PathAI-Histology

Plan 12/12 · equity audit

Passed

Sepsis Early Warning v3.1

TGA SaMD class IIa · production

Approved

Chest X-ray Triage AI

TGA SaMD class IIa · production

Approved

Head CT Haemorrhage Triage

TGA SaMD class IIa · production

Approved

Stroke LVO Detection AI

TGA SaMD class IIa · shadow

Approved

Discharge Readiness Score

Pending lifecycle review

Pending
Avg review: 2.3 days · Median approval: 1.7 daysUpdated 12s ago

01 · Govern

A single console for every AI in the org

Policy, review cycles, accountable clinicians, risk tier, audit trail — all of it, for every system, in one place.

amilieu.io / registry / ambient-scribe

Ambient Scribe

Scribe Vendor A · v2026.04 · Ambient Documentation

HealthyProductionMedium riskSaMD exempt

Accuracy

98%

Accuracy

98%

vs baseline

Open alerts

1

0 critical

Open tasks

0

Nothing pending

Ingestion

12h

0.0% fail

Health1ActivityCompliance & Config

Recent activity

live · 24h

12:34Drift snapshot captured
12:18Sign-off received · D. Tyagi
11:52New cohort attached · 1,240 pts
11:30Compliance check passed

Hallucination rate

live · 30d

02 · Assess

Pre-deployment clinical assessment

Every model is validated against clinical outcomes, safety benchmarks and real-world performance data — before it writes into the record.

amilieu.io / dashboard

Good evening, Demo Admin

Hospital AI Surveillance & Compliance Platform

all audited

Active

10

Incidents

4

Reviews

8

Healthymedium

Ambient Scribe

Scribe Vendor A

98%

Healthyhigh

Chest X-ray Triage

Imaging Vendor A

93%

Healthymedium

Clinical NLP

NLP Vendor A

87%

Healthyhigh

Head CT Triage

Imaging Vendor B

92%

ops.ingest_failure

high

False-positive cluster · CT Scanner

slice.performance

high

Subgroup AUC drop · Head CT

drift.psi

high

PSI > 0.20 · time_since_admission

drift.psi

warn

Hallucination rate above threshold

calibration

warn

Brier score regression · Triage

2.3k events/min · 99.99% uptime · 1 in 7dSynced 12s ago

03 · Monitor

Drift, caught the day it starts

Continuous monitoring with clinical envelopes, not just statistical ones. We detect the moment a model stops behaving like the one you approved.

Where we govern

Every system, every site,
inside the real care environment.

Governance that travels from the boardroom to the bedside — across the full network of people AI in healthcare touches.

CliniciansPublic hospitalsPrivate networksRegulatorsAI vendorsResearchPatients

Care delivery

Public, private and tertiary networks where AI now writes into the clinical record.

Human accountability

Clinicians, executives and patients — every party with a stake in how AI behaves.

Oversight

Vendors, regulators and research institutions — the supply chain behind the systems.

The Amilieu directive

Intelligence that
strengthens human care.

Three commitments guide every framework we write, every assessment we run, and every deployment we approve.

01 / 03

Patient safety

Every AI that touches a patient is rigorously assessed before deployment and continuously after. Harm is not an acceptable emergent property.

02 / 03

Clinical trust

Clinicians must be able to inspect, question and override the systems they work alongside. Transparency is a governance requirement, not a feature.

03 / 03

Responsible innovation

Innovation without governance is risk transferred to the patient. We let healthcare adopt frontier AI with safety and compliance already inside.

Our principles

How we govern AI.

01/ 04

Evidence-based, not vendor-claimed

We validate AI on clinical outcomes and real-world performance. Vendor brochures are not evidence.

02/ 04

Governance that follows the lifecycle

Assessment, deployment, monitoring, retirement — one framework, one audit trail, one accountable clinician.

03/ 04

Built with clinicians, for clinicians

The console is designed for the people running the ward, not the lab. Governance should enhance workflow, never tax it.

04/ 04

Regulatory rigour as a baseline

TGA, NHMRC, EU AI Act, WHO guidance. We don't align with standards after the fact — we build from them.

Our founders

The minds behind
Amilieu.

Clinicians, technologists and regulators building the governance layer healthcare deserves.

JK

Joshua Kovoor

Co-founder & CEO

Read bio
AG

Aashray Gupta

Co-founder & COO

Read bio
GS

Gihwan Song

Co-founder & Chief Product Officer

Read bio
DT

Daksh Tyagi

Co-founder & Chief Partnerships Officer

Read bio

Frequently asked

Answers to the
hard questions.

Clinical governance, platform access, regulatory alignment, and everything else we get asked about.

Ask a different question

Amilieu is the governance layer for clinical AI. We assess, monitor and regulate the AI systems operating inside hospitals and health networks — and give clinicians, executives and regulators one source of truth for every system in the organisation.

Public and private hospitals, health networks, research institutions and AI vendors who need to deploy AI safely, prove it, and keep it safe over time.

Evidence, not brochures. We assess against clinical outcomes, cohort-matched safety benchmarks, regulatory requirements and real-world performance — with a written, auditable methodology.

Our frameworks are built from TGA, NHMRC, EU AI Act and WHO guidance, with technical conformance to ISO 42001 and ISO 13485 where applicable.

Q1 2026. Expressions of interest are open now — submit the form below and a member of the team will be in touch within two business days.

No. Amilieu is the operational layer that helps organisations meet — and exceed — what regulators require. We complement regulation; we don't replace it.

Begin

Deploy AI your clinicians
already trust.

From first assessment to ongoing governance — the confidence to innovate, with the evidence to defend it.

Register interest

Get on the
first cohort.

The first cohort of hospitals, networks and AI vendors will be onboarded directly with the founding team.

ADDRESS207 / 102 King Street
Newcastle NSW 2300

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