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 was designed to be an iterative process to promote innovation in the healthcare technology ecosystem to deliver improved information, more conveniently, to patients and clinicians. Since the program’s inception in 2010, the program has issued four editions. With the introduction of each new edition, the program furthers this objective.

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 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.

The 2015 Edition Cures Act Update also modified some of the existing 2015 Edition Health IT Certification criteria. The changes focus on but are not limited to standards and new processes.
 

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Our Approach

We believe that 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 Test 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 2015 Edition and 2015 Cure Update scheme evaluation procedures, rules and procedures for granting, for maintaining, for extending or reducing the scope of, for suspending, for withdrawing or for refusing certification is available upon request.

Our Capabilities

Testing and Certification Services

• Testing Navigation Services: our team provides comprehension 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
  • Real World Testing (RWT)
  • Standards Updates for Cures Edition compliance
  • Standards Version Advancement Process (SVAP)
  • Biannual Certification Attestation Reporting
  • Ongoing compliance and surveillance 
  • Product updates including

Why Partner with Leidos

Our Subject Matter Experts intimately understand which standards apply to your product, how to meet the required criteria, and how those requirements fit together. Our personnel combine evaluation expertise with programmatic experience, allowing Leidos to provide a single source for all of your testing and certification needs, decreasing overall cost and timelines, and building a long-term partnership.

Proven Success

Building on 20 years of industry experience, Leidos continues our successful contribution through our AT&E Lab as an industry volume leader. Our AT&E labs has certified more than 1,000 IT products across several disciplines.