Fairfax, VA – SAFE Health Systems is proud to announce the release of OpenCDx, the industry’s first open-source, standards-based Connected Diagnostics platform designed to support national healthcare infrastructure, public health surveillance, and remote patient care. Built on real-world deployment, OpenCDx represents a major milestone in the transformation of digital health innovation and regulatory science. At SAFE Health, we believe advancing public health is a shared responsibility, and we feel a strong obligation to contribute meaningful tools that empower the broader healthcare ecosystem to innovate, collaborate, and deliver better outcomes for all.

Funded by a federal contract to SAFE Health, this release aligns with the government’s strategic objective to modernize healthcare delivery, expand access, and strengthen national emergency preparedness. OpenCDx was developed to enable accurate, secure, and seamless capture, exchange, and analysis of diagnostic data across consumer apps, providers, and public health systems.

“OpenCDx marks a major shift from proprietary diagnostics to a collaborative, open-source, and standards-compliant foundation,” said Jeff Miller, Technology Specialst at SAFE Health Systems. “By releasing the SAFE Clinical Data Repository and core CDx infrastructure to the public, we’re empowering the healthcare ecosystem to build faster, integrate better, and scale securely.”

Built for the Future of Connected Health

OpenCDx is a modular, cloud-native, and interoperable platform architected with the complexities of real-world health delivery in mind:

• Microservices-based design using Spring Boot and gRPC

• Open standards including HL7 FHIR, LOINC, SNOMED CT, ICD, RxNorm, and UMLS

• Cross-sector integrations with EHRs like Epic and Cerner, lab systems like Quest and LabCorp, and agencies like CDC, FDA, and CMS

• Zero-trust security with blockchain-backed audit logs, federated identity, and patient-controlled consent management

• Device ecosystem support for FDA-regulated over-the-counter (OTC) and point-of-care (POC) diagnostics with UID tracking

• Full regulatory alignment with HIPAA, GDPR, 21 CFR Part 11, and HiTrust

• Built-in support for HL7 Analysis Normal Form (ANF) to normalize clinical observations for longitudinal care and advanced analytics

Designed to Bridge Gaps in Telehealth, Public Health, and Research

The OpenCDx platform addresses longstanding gaps in diagnostics, especially for underserved and remote populations. From automated interpretation of rapid diagnostic tests (RDTs) on smartphones to population-scale disease surveillance, OpenCDx brings connected care to where it’s most needed.

Use cases supported by OpenCDx include:

• Remote test-to-treat models integrated with telehealth and pharmacy services

• Clinical research enablement through decentralized trial data collection

• Real-time public health reporting and epidemiological insights

• SMART HealthCard support for insurance and digital wallets

• ADR integration for secure, scalable data access

• ANF-coded observations powering AI and decision support

Empowering the Ecosystem

OpenCDx isn’t just a system, it’s an ecosystem. SAFE Health has laid the foundation for an OpenCDx Working Group and a potential membership model to support a trusted, standards-aligned ecosystem that accelerates diagnostic innovation, reduces regulatory burden, and improves outcomes at scale.

“The future of healthcare lies in ecosystems, not silos,” added Mark Laurent, Senior Director of Technical Delivery at SAFE Health Systems. “With OpenCDx, we’re enabling seamless collaboration across the care continuum while integration with ADR and use of ANF ensures the data is structured, computable, and ready for AI-driven decision making.”

Get Started with OpenCDx

Developers, health IT teams, researchers, and digital health companies can access documentation, code, and deployment guides at:
https://github.com/opencdx/opencdx

About SAFE Health Systems

SAFE Health Systems is a digital health platform company based in Fairfax County, VA. It partners with agencies such as the FDA and leading academic medical centers to deliver scalable, secure, and standards-compliant solutions in diagnostics, remote patient care, and clinical interoperability. SAFE’s solutions power next-generation connected diagnostics and clinical data exchange using open standards like FHIR, ANF, and CDx Spec, while ensuring compatibility with national platforms like ADR.