SAFE Health Systems Inc.

What SAFE Health Systems Inc. does

SAFE Health Systems, Inc. is a digital health company that operates a Connected Care Diagnostics Platform enabling decentralized care models, remote diagnostics, and decentralized clinical trials (DCT). The platform integrates AI-powered consent and identity verification, remote proctoring, real-time data capture, automated last-mile logistics, and EHR interoperability into a single workflow. Core technology includes a patent-pending Rapid Diagnostic Test (RDT) computer vision/machine learning reader for automated interpretation of lateral flow assays, an OpenCDx diagnostic data standards framework co-developed with the FDA, and exclusive integration of Mayo Clinic Digital Protocols for care automation. Product modules span a DCT platform, at-home connected diagnostics with return-to-lab services, remote primary/complex care experiences, interoperability solutions, LaunchDx (a 510(k) clearance accelerator), and care automation tooling.

The company monetizes through a mix of recurring platform licensing/subscription revenue and usage-based fees tied to test kit logistics and distribution. It targets four primary customer segments: in-vitro diagnostic test manufacturers (particularly those pursuing OTC 510(k) clearance), healthcare enterprises modernizing patient pathways, telehealth providers expanding into remote diagnostics, and government health entities implementing national remote diagnostic frameworks. Go-to-market is enterprise field sales driven by direct demo requests and customized platform deployments; pricing is not publicly disclosed. The company is privately held, headquartered in Los Angeles, reports 101–250 employees, and was founded in 2020.

Strategically, SAFE Health positions itself as an ecosystem infrastructure layer for connected diagnostics rather than a single-product vendor. Its most distinctive assets are the formal FDA partnership for OpenCDx standards and the Mayo Clinic collaboration, both of which the company cites as clinical-validation and regulatory-alignment advantages. Quantified value claims include up to 50% reduction in DCT study costs and 3x faster patient recruitment versus traditional trials. The company has disclosed one funding round (November 2021, undisclosed amount, led by Three Bridges Private Capital with Particular Ventures) and provides no revenue figures.

Name

SAFE Health Systems Inc.

Legal name

Safe Health Systems, Inc.

Website

https://safehealth.me

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

101–250 employees

Short description

SAFE Health Systems operates a Connected Care Diagnostics Platform for decentralized clinical trials and remote diagnostics, developed in partnership with Mayo Clinic and the FDA. It serves test manufacturers, healthcare enterprises, telehealth providers, and government health entities via enterprise SaaS deployments.

Ownership category

akta.pro rank

Product category

Healthcare Technology Platform

NAICS

Medical and Diagnostic Laboratories (62151), Home Health Care Services (6216)

SIC

Services-Prepackaged Software (7372), Services-Health Services (8000)

akta.pro primary industry

Decentralized/Hybrid Trial Enablement (DCT) Platforms (HLACAOAL)

akta.pro secondary industries

Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Consent, Preference & Data Rights Management (incl. HIPAA/GDPR support) (HLACAIAG), Primary Care & General Medicine Virtual Care (HLALAAAA)

Keywords

• Connected diagnostics platform
• Decentralized clinical trials
• Remote patient monitoring
• Healthcare interoperability
• AI diagnostic testing

Headquarters

HQ city

Los Angeles

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Connected Diagnostics Platform: Platform licensing and subscription model providing access to decentralized clinical trial capabilities, AI-powered consent and proctoring, remote diagnostics, and interoperability solutions for healthcare enterprises and test manufacturers.
2. Test Kit Logistics and Distribution: Last-mile distribution and logistics services including study test kit delivery within 24 hours and Return-to-Lab (RTL) testing with pickup and delivery capabilities.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

SAFE Health Systems operates a Connected Care Diagnostics Platform that enables decentralized care models through AI-powered consent verification, remote proctoring, real-time data capture, and automated test kit logistics. The platform supports decentralized clinical trials (DCT), at-home diagnostic testing with a patent-pending AI rapid diagnostic test reader, EHR interoperability, and remote patient care experiences built on Mayo Clinic clinical protocols.

Product overview

SAFE Health Systems Inc. offers a Connected Care Diagnostics Platform with multiple integrated product modules including the Decentralized Clinical Trials (DCT) Platform, Connected Diagnostics, Remote Experiences, Interoperability Solutions, OpenCDx, Care Automation, and LaunchDx. The platform is developed in collaboration with Mayo Clinic and includes a patent-pending Rapid Diagnostic Test (RDT) Reader technology. The DCT Platform leverages AI for consent verification, remote proctoring, and real-time data capture, while the Connected Diagnostics module provides integrated at-home testing with return-to-lab capabilities. OpenCDx, developed in partnership with the FDA, establishes national remote diagnostic data standards.

Differentiator

Problem solved

Functional benefit

Brands

• OpenCDx: A national remote diagnostic framework established in partnership with FDA to accelerate implementation and adoption of connected diagnostics capabilities through standards-based diagnostic data capture and transmission.

Products and services

• Connected Care Diagnostics Platform
• Decentralized Clinical Trials (DCT) Platform
• OpenCDx
• Connected Diagnostics

Quantifiable outcome

• DCT platform cuts study costs by up to 50%
• +3 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered flagship, core and minor.

• Mayo ClinicflagshipStrategic or Co-development PartnerSAFE Health collaborates with Mayo Clinic on platform development, leveraging Mayo Clinic's clinical expertise and protocols. The company has exclusive access to Mayo Digital Protocols for care automation integrating clinical protocols. This collaboration positions SAFE Health as a trusted healthcare technology provider with industry-leading clinical validation.
• FDAcoreStrategic or Co-development PartnerSAFE Health has a formal partnership with the FDA to establish OpenCDx, a national remote diagnostic framework. This partnership creates foundational diagnostic data standards for connected diagnostics in the U.S. healthcare ecosystem, facilitating standards-based diagnostic data capture, harmonization, and transmission between disparate systems.
• LaunchDxminorOthersLaunchDx is referenced as a related platform under 'Our Impact' section, suggesting a commercial or referral relationship for test-to-treat and diagnostic launch services.

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Veeva Systems: Veeva's Vault Clinical Suite (EDC, ePRO, eConsent) and Vault CTMS serve global biopharma and is increasingly adding DCT functionality. It overlaps with SAFE's DCT platform at the enterprise sponsor layer with a much larger installed base.
• Oracle Clinical One: Oracle's Clinical One platform unifies EDC, RTSM, ePRO, and DCT capabilities within a broader life sciences portfolio. It is a broad incumbent that competes with SAFE's DCT offering for enterprise biopharma sponsors with large IT footprints.
• Roche / Genentech Digital Diagnostics: Roche Diagnostics is a global IVD manufacturer integrating digital readers, connectivity, and partner platforms (e.g., navify) for connected diagnostics. It is a broad incumbent whose regulatory and standards influence in diagnostics overlaps with SAFE's OpenCDx and RDT Reader efforts.

Direct peers

• ObvioHealth: ObvioHealth is a DCT-focused CRO with a mobile app for eConsent, ePRO, remote visits, and home health nursing. Its end-to-end DCT delivery model closely parallels SAFE's integrated software + in-home testing workflow.
• Castor: Castor provides an eClinical platform spanning EDC, eConsent, eCOA, and DCT functionality with strong API interoperability. It competes with SAFE's DCT and Interoperability modules, particularly for hybrid and decentralized trial deployments.
• Science 37: Science 37 (now part of Evidera/PPD) operates a DCT platform with patient recruitment, telemedicine visits, and in-home nurse networks. It is a direct peer in decentralized trial enablement and competing for the same sponsors moving trials outside traditional sites.
• Medable: Medable is the leading standalone decentralized clinical trial (DCT) platform, offering eCOA, eConsent, remote monitoring, and telehealth for trial participants. It directly overlaps with SAFE Health's DCT module and AI-powered consent/proctoring capabilities, serving the same test manufacturer and biopharma sponsor base.
• Signant Health: Signant Health specializes in clinical technology for eCOA, eConsent, patient engagement, and DCT logistics. It is a direct peer to SAFE's DCT platform, particularly for trials requiring connected diagnostics and patient-centric data capture.

Emerging players

• Curebase: Curebase offers a decentralized trial platform with virtual sites, eConsent, telehealth, and home health networks. It is an emerging peer that overlaps with SAFE's DCT and remote care experience offerings for sponsors moving to fully decentralized designs.
• Everlywell: Everlywell is a direct-to-consumer at-home diagnostics and telehealth platform with its own LFA-based test portfolio. It is comparable to SAFE's Connected Diagnostics module and at-home testing logistics, though it operates a consumer rather than sponsor-facing model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SAFEplatform

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors2 records

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 Inc.