Solutions

Connected Diagnostics:
From Test to Treatment, Seamlessly

Decentralized testing, AI-powered interpretation, and real-time results delivery — directly integrated with the care team wherever the patient is.

FDA-AlignedCLIA-CompliantTEFCA Ready21 CFR Part 11
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Test Anywhere

Mobile, home-based, and retail clinic testing — no hospital required.

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AI-Interpreted Results

ML models deliver diagnostic-grade interpretation directly from raw test data.

Instant Clinical Delivery

Results flow instantly to the ordering physician via FHIR R4.

How It Works

Six steps from physician order to structured clinical result — fully automated, fully compliant.

01

Order Test

Physician orders a test via FHIR-integrated EHR.

02

Distribute Kit

Smart logistics routes test kit to patient via Uber, FedEx, or DoorDash.

03

Patient Self-Tests

Patient tests at home or retail clinic with guided digital instructions.

04

Results Captured

Device captures and transmits data to HealthCloud in real time.

05

AI Interpretation

SignalPath ML engine interprets test data with >95% concordance.

06

Delivered to EHR

Structured FHIR Observation delivered to the ordering clinician.

Regulatory Framework

Every component of the diagnostics platform is built to comply with federal and clinical standards.

FDA / OpenCDx

Aligned with FDA Digital Diagnostics framework and OpenCDx submission guidance.

21 CFR Part 11

Electronic records and signatures fully compliant with audit trail requirements.

HIPAA / SOC 2

Patient data protection with enterprise-grade cloud security controls.

CLIA

Connected to a network of CLIA-certified lab partners for confirmatory testing.

What's Included

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Test Types

Rapid antigen, PCR, LFT, blood panels, STI, respiratory, and metabolic panels.

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Device Integration

Full integration with FDA-cleared diagnostic devices across all major categories.

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Lab Network

Connected to Quest, LabCorp, and national reference labs for confirmatory testing.

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AI Interpretation

SignalPath ML engine with >95% concordance to laboratory reference standards.

Architecture

Powered by SafeCDx

HealthCloud's decentralized diagnostics platform connects devices, labs, AI, and EHRs into a single compliant workflow.

1

Lab Network

Connect to decentralized CLIA-certified lab network

2

AI Interpretation

SignalPath ML engine interprets and validates results

3

Audit Trail

Full regulatory audit trail for 21 CFR Part 11 compliance

4

FHIR Delivery

Structured FHIR Observation delivered to EHR instantly

Ecosystem Integrations

Seamlessly integrates with EHRs, reference labs, and logistics networks via FHIR and TEFCA-aligned exchange.

EpicCernerAthenahealthQuest DiagnosticsLabCorpUber HealthFedExDoorDash
Unique Advantage

Built for Real-World Operations

Last-Mile Logistics

Integrates with Uber Health, DoorDash, FedEx, and UPS for specimen and device movement.

Return-to-Lab Workflows

Seamless coordination with reference labs for confirmatory and reflex testing.

Digital Chain of Custody

Track every step from test distribution to result delivery with immutable audit logs.

From Test Results to Intelligence

Patient-Level Graph

Every diagnostic result linked to a longitudinal patient record in the HealthCloud knowledge graph.

Population Insights

Aggregate data for public health surveillance, payer analytics, and outbreak detection.

AI Model Training

Fuel predictive models with real-world diagnostic data to continuously improve accuracy.

HIPAASOC 2TEFCAFDA-aligned21 CFR Part 11CLIA

Deploy connected diagnostics at national scale

From test to insight — fully integrated, compliant, and AI-powered.