What SAFE Health Systems does

SAFE Health Systems, Inc. is a private connected care diagnostics platform company founded in 2020 and headquartered between Scottsdale, AZ and Fairfax, VA. The company builds a cloud-native, microservices-based platform (Spring Boot, gRPC) that unifies at-home diagnostic testing, AI-powered test interpretation, telehealth, prescription fulfillment, and clinical data exchange under open standards including HL7 FHIR, LOINC, SNOMED CT, ICD, RxNorm, and UMLS. Its core products include the Connected Care Platform, Connected Diagnostics with a patent-pending Rapid Diagnostic Test (RDT) CV/ML reader, OpenCDx (an open-source connected diagnostics framework co-developed with the FDA to establish a national remote diagnostic infrastructure), a Test-to-Treat consumer pathway, Remote Care Experiences built on exclusive Mayo Digital Protocols, and a Decentralized Clinical Trials (DCT) module with AI-powered consent and remote proctoring.

The company monetizes via multiple streams: subscription platform fees for enterprise healthcare deployments, recurring white-label/OEM licensing for test manufacturers embedding the platform under their own brand, decentralized clinical trial services for pharma and biotech sponsors, transaction-based per-test scanning fees, and distribution/fulfillment fees from pharmacy partners and direct-to-consumer logistics. Go-to-market is sales-led, with "Request a Demo" CTAs across the website targeting test manufacturers, healthcare enterprises, government and public health agencies, health plans, self-insured employers, and telehealth providers. Additional reach comes through developer relations (OpenCDx GitHub and HL7 FHIR Connectathons), channel partnerships (pharmacy and fulfillment networks), and an OEM/white-label embedded model for diagnostics manufacturers. Strategic anchors include Mayo Clinic (collaboration, equity investment, and exclusive clinical protocols), an FDA partnership for the OpenCDx national framework, ARPA-H Investor Catalyst Hub Spoke Network membership, and BioLabs International for forensic vertical expansion.

Name

SAFE Health Systems

Legal name

Safe Health Systems, Inc.

Website

https://safehealthsystems.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

51–100 employees

Short description

SAFE Health Systems is a private connected care diagnostics platform that unifies at-home testing, AI-powered rapid test interpretation, telehealth, and prescription fulfillment for test manufacturers, healthcare enterprises, decentralized clinical trial sponsors, and government agencies.

Ownership category

akta.pro rank

Product category

Connected Diagnostics Platform

NAICS

Medical and Diagnostic Laboratories (62151), Home Health Care Services (621610), All Other Outpatient Care Centers (621498)

SIC

Services-Prepackaged Software (7372), Services-Testing Laboratories (8734), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

At-Home Lab Testing & Diagnostics-Integrated Virtual Care (HLALAAAE)

akta.pro secondary industries

Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Prescription-Based Digital Clinics (Condition-Specific Rx Programs) (HLALAAAD), Hospital-at-Home & Acute-at-Home Remote Monitoring (step-down, escalation workflows) (HLALAFAH)

Keywords

• Connected diagnostics
• Decentralized clinical trials
• Telehealth platform
• Test-to-treat
• Healthcare interoperability

Headquarters

HQ city

Scottsdale

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain

Revenue model

1. Platform SaaS/Subscription: Connected Care Diagnostics Platform sold to healthcare enterprises, test manufacturers, government agencies, and health plans. Likely subscription-based with white-label options for test manufacturers.
2. White-Label Licensing: Test manufacturers license the platform to embed connected diagnostics under their own brand with no development lift required, generating recurring licensing revenue.
3. Decentralized Clinical Trials (DCT) Services: Platform services for clinical trial sponsors including consent management, remote proctoring, test kit logistics, and real-time data capture. Revenue from clinical study support and regulatory compliance features.
4. Transaction/Per-Test Fees: Per-test scanning and result interpretation fees through AI-powered RDT reader technology. Transaction-based revenue model for diagnostic test processing.
5. Distribution & Fulfillment Services: On-demand test kit distribution through pharmacies, fulfillment partners, and direct-to-home delivery. Logistics and fulfillment fees for test kit delivery.

Go-to-market motion4 records

Distribution channels4 records

Marketing channels6 records

Core offering

SAFE Health Systems operates a Connected Care Diagnostics Platform that combines at-home diagnostic testing, AI-powered result interpretation, telehealth, and prescription fulfillment into a unified software stack. The platform enables test manufacturers, healthcare enterprises, government agencies, and clinical trial sponsors to deliver decentralized care, with modules spanning Connected Diagnostics, Decentralized Clinical Trials (DCT), Test-to-Treat, Remote Experiences, and the FDA-partnered OpenCDx open-source framework.

Product overview

SAFE Health Systems operates as a Connected Care Diagnostics Platform offering a unified platform-plus-modules architecture. The core Connected Care Platform enables decentralized care models through five integrated modules: Connected Diagnostics (integrated at-home testing with patent-pending RDT scanning), Decentralized Clinical Trials (remote trial management with AI consent and proctoring), Test-to-Treat (end-to-end testing to treatment pathways), Remote Experiences (telehealth and care management), and OpenCDx (FDA-partnered open standards framework). Supporting features include the Rapid Diagnostic Test Reader (AI-powered CV/ML image analysis), Population Health Management tools, the HealthCheck mobile App, and white-label solutions for test manufacturers. All offerings are built on open standards including HL7 FHIR, with interoperability across Epic, Cerner, Quest, and LabCorp systems.

Differentiator

Problem solved

Functional benefit

Brands

• OpenCDx: Industry's first open-source, standards-based Connected Diagnostics platform designed to support national healthcare infrastructure, public health surveillance, and remote patient care.
• DCT (Decentralized Clinical Trials)
• Test-to-Treat

Products and services

• Connected Care Platform Unified cloud-native platform enabling healthcare enterprises, test manufacturers, and government agencies to deploy decentralized care models. Powers connected diagnostics, clinical data exchange, care automation, distribution logistics, and remote care experiences through five integrated modules on open standards (HL7 FHIR, LOINC, SNOMED CT).
• OpenCDx Open-source, standards-based Connected Diagnostics platform developed in partnership with the FDA. Facilitates standards-based diagnostic data capture, harmonization, and transmission between disparate healthcare systems using HL7 Analysis Normal Form (ANF). Includes Form Builder and Analytical Data Repository (ADR) modules.
• Decentralized Clinical Trials (DCT) Platform Platform enabling pharmaceutical and biotech sponsors to run decentralized clinical trials with AI-powered identity verification, remote consent, live video proctoring of specimen collection, real-time data capture, automated test-kit logistics, and regulatory compliance. Claims up to 50% cost reduction and 3x faster patient recruitment.
• Test-to-Treat End-to-end workflow combining at-home test ordering, AI-powered test scanning and result interpretation, telehealth consultation, and prescription fulfillment to connected pharmacies. Enables consumers and providers to complete testing-to-treatment pathways without in-person visits.
• Powder Tracer App AI-powered forensic companion application built on SAFE Health's diagnostic platform for government agencies and forensic professionals including fire departments, border patrol, ICE, police, and correctional facilities. Provides AI-based precise analysis and secure evidence-based data storage for forensic testing workflows.
• HealthCheck Mobile App Mobile consumer application providing telehealth services, biometric login, camera-based diagnostic test scanning, GPS location services for finding nearby lab facilities, and secure data storage. Powers the consumer-facing side of the Test-to-Treat workflow.
• White-Label Connected Diagnostics Solution White-label OEM offering for in-vitro diagnostic test manufacturers, enabling them to launch connected diagnostics under their own brand with customizable care workflows, instant experience updates, real-world usage tracking, and EHR integration without any internal development effort.

Quantifiable outcome

• 16% patient engagement (2x industry average)
• +4 more outcomes

Named customers3 records

Segments7 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration10 records

AI capability9 records

Feature6 records

Partnerships

Twelve partnerships are on record, tiered notable and core.

• BioLabs International LLCnotableStrategic or Co-development Partner · 18 December 2024Partnership to launch Powder Tracer forensic test and Powder Tracer App 'Made in the USA.' AI-powered forensic companion application for government agencies and forensic professionals including fire departments, border patrol, ICE, police, and correctional facilities. Safe Health's diagnostic platform capabilities applied to forensics.
• ARPA-H Investor Catalyst (IC) Hub Spoke NetworkcoreStrategic or Co-development Partner · 2 December 2024Joined ARPA-H's IC Hub Spoke Network, a groundbreaking initiative backed by the Advanced Research Projects Agency for Health. Network unites organizations from private, public, and nonprofit sectors enabling collaboration for real-world impact. Provides access to industry leaders, researchers, and innovators for partnerships and knowledge exchange.
• Mayo CliniccoreStrategic or Co-development PartnerDeep collaboration with Mayo Clinic including exclusive access to Mayo Digital Protocols for care automation. Mayo Clinic is backing Safe Health and invested in the platform for delivering low-acuity care in the home. Joint development of connected care platform for primary and complex care modernization.
• FDA / HHScoreStrategic or Co-development PartnerFDA partnership to establish OpenCDx - a national remote diagnostic framework and standards-based connected diagnostics platform. Funded by federal contract. FDA/HHS collaboration on Analytical Data Repository (ADR) development. OpenCDx created to accelerate implementation and adoption of connected diagnostics capabilities.
• Epic (EHR Integration)notableTechnology or IntegrationCross-sector integration with Epic electronic health records system as part of OpenCDx platform interoperability.
• Cerner (EHR Integration)notableTechnology or IntegrationCross-sector integration with Cerner electronic health records system as part of OpenCDx platform interoperability.
• Quest DiagnosticsnotableTechnology or IntegrationIntegration with Quest Diagnostics lab systems as part of OpenCDx cross-sector integration ecosystem.
• LabCorpnotableTechnology or IntegrationIntegration with LabCorp laboratory systems as part of OpenCDx cross-sector integration ecosystem.
• CDCnotableTechnology or IntegrationAgency integration with CDC for public health reporting and surveillance capabilities within OpenCDx platform.
• CMSnotableTechnology or IntegrationAgency integration with CMS for healthcare data standards and regulatory alignment within OpenCDx platform.
• Pharmacy Fulfillment PartnersnotableChannel Partner/ Reseller/ DistributorDistribution network of pharmacy partners enabling on-demand test kit fulfillment and prescription delivery capabilities.
• LaunchDxnotableStrategic or Co-development PartnerRelated company for clinical studies support, providing streamlined workflows, real-world data capture, and FDA-ready support for test manufacturers.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Teladoc Health: Largest U.S. telehealth incumbent offering virtual care across primary, chronic, and mental health — broad competitor in the virtual care ecosystem where SAFE's platform integrates.
• Amwell: Enterprise telehealth platform serving health systems and health plans with virtual care infrastructure — competing broadly for the same healthcare enterprise customers SAFE targets.

Direct peers

• Ro: D2C telehealth platform offering virtual care, at-home diagnostics, and pharmacy fulfillment across multiple conditions — comparable virtual-first integrated care model.
• Medable: Decentralized clinical trial platform offering eCOA, eConsent, telehealth, and remote data capture — directly competes with SAFE's DCT module for pharma and biotech sponsors.
• LetsGetChecked: End-to-end at-home diagnostics platform combining test kits, telehealth consultations, and prescription fulfillment — competes head-to-head with SAFE's test-to-treat workflow.
• Cue Health: Connected diagnostics company with a connected rapid molecular test reader and integrated telehealth — directly comparable in hardware-enabled connected diagnostics for home and enterprise use.
• ixlayer: B2B diagnostic testing platform powering at-home and direct-to-consumer lab testing for health systems and payers — a close horizontal analog to SAFE's white-label platform model.
• Everlywell: Direct-to-consumer at-home lab testing platform with integrated telehealth and treatment pathways — closely mirrors SAFE's test-to-treat model, though Everlywell is consumer-first rather than a B2B platform.
• Hims & Hers Health: D2C telehealth platform integrating virtual consultations, prescription fulfillment, and at-home testing — overlaps with SAFE's test-to-treat value proposition for consumer health.

Emerging players

• BioIQ: Connected diagnostics and at-home testing platform focused on employers and health plans — overlaps with SAFE's self-insured employer and health plan segments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SAFE Health Systems