ONC Health IT Testing & Certification

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Overview

Leidos is honored to be authorized by the Office of the National Coordinator (ONC) for Health Information Technology, providing comprehensive pre-certification testing and post-certification reporting services. Our approach focuses on building long-term partnerships with health IT developers to support the successful achievement and continuous maintenance of their certified health IT products.

An Leidos ONC-ATL certificate indicates that your health IT meets the stringent criteria for technological capability, functionality, interoperability, and security set by the U.S. Department of Health and Human Services (HHS) to support various programs and initiatives.

The ONC Health IT Certification Program is an ongoing effort to drive innovation in the health IT field, with a primary goal of enhancing patient care and safety. It is also committed to providing care in an unbiased manner, ensuring convenient data delivery to patients, hospitals, clinicians, as well as all members of the patient's care team.

The program evolves annually, building on past rulemakings to improve interoperability for various health IT purposes. This evolution introduces new and enhanced certification criteria, standards, and implementation specifications to achieve these goals.

In January 2024, the ONC released HTI-1, the Final Rule titled Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. This rule reaffirmed ONC’s commitment to improving access, exchange, and use of electronic health information—laying the groundwork for greater interoperability and transparency in health IT.

Building on this foundation, HTI-2 introduces the Trusted Exchange Framework and Common Agreement (TEFCA), effective January 15, 2025. TEFCA establishes a nationwide framework for secure, trusted health data exchange, helping information follow patients wherever they receive care.

To further protect patient rights, HTI-3, effective in 2025, updates information blocking policies and introduces the Protecting Care Access Exception, focused on strengthening reproductive health privacy in alignment with HIPAA updates.

Together, HTI-1, HTI-2, and HTI-3 mark a critical evolution in the ONC Health IT Certification Program—driving secure, transparent, and patient-centered innovation across the healthcare ecosystem.

Our Capabilities

ONC Testing and Certification Services

• Testing Navigation Services: our team provides comprehensive support to our clients to determine readiness for testing based on their goals. 
• Official ONC Criteria Testing: through testing attestations, documentation evaultions, and live demonstrations tailored to our client’s specific scope to meet their unique business needs.
• Certification Navigation Services: our team assists our clients in becoming familiar with and beginning to prepare for the ongoing ONC Maintenance of Certification requirements.
• Ongoing ONC Certification Maintenance Services: 
  • Quarterly Adaptations and Updates requirements
  • Health IT updates including
    • Standards Version Advancement Process (SVAP)
  • Semi-Biannual Certification Attestation Reporting
  • Insights Condition Reporting 
  • Real World Testing (RWT)
  • Ongoing compliance and surveillance 

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Our Approach

We believe the testing and certification process should be a partnership for the life of our client’s health IT. Our team has an expansive testing, evaluation, certification and healthcare background employing proven methodologies and expertise to help optimize health IT testing and certification engagements with our clients.

We are one of a select few entities that is a trusted partner designated as an ONC Authorized Testing Laboratory (ONC-ATL) and ONC Authorized Certification Body (ONC-ACB), offering our clients a turnkey menu of support through the entire lifecycle of their testing and certification process.

Our ONC-ATL is accredited by the National Voluntary Laboratory Accreditation Program (NVLAP, Lab Code 200427-0), and our ONC-ACB is accredited by the ANSI National Accreditation Board (ANAB, Accreditation ID# 9043), ensuring alignment with ISO/IEC standards.

Information about our ONC Health IT Certification Program and evaluation and review procedures, rules and procedures for granting, for maintaining, for extending or reducing the scope of, for suspending, for withdrawing or for refusing certification; general information on the fees charged to applicants and to clients; description of the rights and duties of applicants and clients, including requirements, restrictions or limitations on the use of the Leidos ONC-ACB’s name or seal and the ONC Certified Health IT Certification mark and on the ways of referring to the certification granted; information about procedures for handling complaints and appeal and annual surveillance plan is available upon request.

For information on the means by which the Leidos ONC-ACB obtains financial support please visit: Leidos Financials.

Why Partner with Leidos

At Leidos, our team of Subject Matter Experts brings extensive experience in ONC Testing and Certification, software development, and healthcare regulatory compliance. Our deep understanding of ONC criteria, standards, and regulations allows us to develop tailored strategies for effective testing and certification that align with your specific needs and priorities. With our comprehensive expertise, we are your trusted partner in navigating the complexities of healthcare IT certification.

For further insights, read our latest 2024 Volume 2 White Paper, Elevating Healthcare Interoperability: The Next Chapter of ONC Health IT Certification.

At Leidos, our top priority is delivering services that precisely align with your unique requirements. This ensures that you acquire only what is truly essential for your business goals. This proven approach not only trims costs and timelines but also forms the bedrock of a lasting partnership.

 Meet the Health IT Team

Proven Success

With a legacy spanning more than two decades of demonstrated IT industry success, Leidos Accreditation Testing & Evaluation (AT&E) teams continue to reinforce our significant contributions as a frontrunner. We take immense pride in leading the industry not only in terms of volume but also in nurturing long-term partnerships, all while showcasing our widely recognized expertise. Our AT&E lab stands as a testament to our unwavering commitment to excellence, with a history of effectively certifying over 1,500 IT products across several diverse IT fields.

Notably, the year 2022 marked the inauguration of our ONC Health IT Certification Program – a pivotal stride that not only underscores our unwavering commitment to ensuring IT security and fostering innovation but also exemplifies our dynamic advocacy for the progress of health IT within the domain of the ONC Health IT Certification Program.

As a distinguished HIMSS North American Corporate Member Diamond, Leidos proudly embodies our unwavering commitment to reshaping the landscape of global health and wellness through information and technology. This steadfast dedication enriches our collaborations, fostering deeper connections. Moreover, our resolute advocacy for health IT standards and regulations plays a vital role in advancing patient safety and elevating the IT industry ecosystem to new heights.