ONC Health IT Testing & Certification

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Overview

Leidos has partnered with the Office of the National Coordinator (ONC) for Health Information Technology. Our pre-certification testing and post-certification reporting services allow Health IT developers to achieve and maintain certification of their Health IT effectively through a long-term partnership approach. Becoming ONC Certified demonstrates your EHR software has met criteria conformance to the technological capability, functionality, interoperability, and security requirements adopted by the U.S. Department of Health and Human Services (HHS) to support their various programs.

The ONC Health IT Certification Program has been designed to be an iterative progression to promote innovation in the healthcare technology ecosystem to deliver improved information, more conveniently, to patients and clinicians.  The ONC HIT Program continues building on past rulemakings to facilitate greater interoperability for multiple clinical health information purposes and enable health information exchange through new and enhanced certification criteria, standards, and implementation specifications.

The ONC HIT Program published the most recent 2015 Edition Cures Act Update in 2020 through the 21^st Century Cures Act.  The update further supports seamless and secure access, exchange, and use of electronic health information. It also includes a provision requiring that patients have electronic access to all their electronic health information, structured or unstructured, at no cost to the patient.

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Our Capabilities

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 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 begin to prepare for the ongoing ONC requirements of Certification.
• Ongoing Certification Maintenance Services: 
  • Quarterly Adaptations and Updates requirements
  • Product updates including
    • Standards Version Advancement Process (SVAP)
    • Standards Updates for Cures Edition compliance
  • Biannual Certification Attestation Reporting
  • Real World Testing (RWT)
  • Ongoing compliance and surveillance 

Our Approach

We believe the testing and certification process should be a partnership for the life of our client’s health IT products. 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 (ATL) and ONC Authorized Certification Body (ACB), offering our clients a turnkey menu of support through the entire lifecycle of their testing and certification process.

Our ATL is accredited through the National Voluntary Laboratory Accreditation Program (NVLAP Lab Code 200427-0) and our ACB is accredited through the ANAB/ANSI program (Accreditation ID# 9043) ensuring our processes are consistent with ISO/IEC standards.

Information about our ONC Health IT Testing and Certification Program and 2015 Cure Update scheme 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 and 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

Our team of Subject Matter Experts holds a deep foundational comprehension of ONC criteria, standards, and regulations, drawing from experience in diverse fields including ONC Testing and Certification, software development and rollouts, and government regulatory prerequisites within the healthcare sector. This unique understanding of our clients enables us to excel in crafting effective strategies for testing and certification. With this extensive expertise and a profound grasp of clients' needs and priorities, Leidos is positioned to be your trusted source for comprehensive testing and certification solutions.

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.

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 1,000 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 exemplify 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.