Don’t Trust Your Critical ONC Certification Compliance to Just Anyone
Trust the Experts at Drummond! Drummond Group has provided more ONC Health IT certifications than all other ACB’s combined.
The Leader in ONC Health IT Testing & Certification
Drummond Certified products show potential customers that your IT solutions are compliant with industry standards. Products tested and/or certified by Drummond can be used by eligible clinicians/providers and hospitals to qualify for the Center for Medicare and Medicaid Services (CMS) incentive payments.
As the leading ONC Authorized Certification Body (ONC-ACB) and Test Lab (ONC-ATL) within the Office of the National Coordinator Health IT Certification Program, Drummond specializes in working with healthcare information technology developers to test and certify their Health IT software for use by healthcare providers in regulatory programs.
Drummond has certified over 3,500 Health IT products, more than all other ACBs combined.
We’re ready to help you prepare for, and will guide you through, the ONC Health IT testing and certification process.
Resources
- Insights & Guidance
EPCS Market Survey
- Blog
Increased FHIR Adoption Requires a New Testing Strategy
- Events & Video
New State Regulations Mandate ONC Certification: How to Know If Your Software Is Affected
- Blog
ONC Certification is Not HIPAA Compliance: Why You Need Both
- Blog
How NIST Frameworks Build Regulatory Readiness and Resilience
- Blog
Why Poor AI Governance Is a Bottom-Line Risk for Healthcare
- News & Announcements
Pawscripts Becomes First Veterinary Prescribing Software to Earn Drummond Certification for EPCS
- Updates
Temporary Enforcement Pause on Most Insights Requirements
- Insights & Guidance
Penetration Testing Estimator
- Insights & Guidance
Securing AI: Creating Adoption-Ready Health IT Solutions
ONC Health IT Requirements
Drummond’s Health IT testing and certification services help you navigate complex ONC Health IT requirements including Real World Testing (RWT), adding or updating test criteria, and certifying new software applications to meet your own customers’ needs with integrity and confidence.
Drummond has enhanced several aspects of our program to improve user experience and certification process efficiency, including:
- Client Portal: An up-to-date knowledgebase, test proctor access, and ONC Health IT guidance.
- Flexible Testing Duration: Choose from half or full-day live testing.
- Transparent Pricing: Upfront and itemized pricing with no hidden fees.
Drummond's ATL and ACB Team
Discover the expertise behind Drummond’s ONC Health IT testing and certification success, the people of Drummond. Our ATL and ACB teams combine deep industry knowledge with a commitment to helping Health IT developers navigate complex compliance requirements. Our team’s expertise and client-focused approach have made Drummond the trusted leader in ONC Health IT Certification.
Approved Certification Body
Drummond’s ONC-Authorized Certification Body services ensure Health IT products meet and maintain ongoing ONC certification requirements. Our ACB services include:
- Certification Approval: Official ONC certification upon successful completion of testing.
- Real World Testing (RWT): Supporting compliance with annual RWT plans and reports.
- Standards Updates: Incorporating updates through the Standards Version Advancement Process (SVAP).
- Conditions & Maintenance of Certification: Ensuring reporting of compliance status twice per year.
- Quarterly Attestation: this required attestation process allows developers to attest to changes to certified functionality)
- Ongoing Compliance Monitoring: Working with developers to ensure and maintain certification integrity.
Approved Testing Lab
As an ONC-Authorized Testing Lab, Drummond evaluates Health IT products to ensure compliance with ONC’s Health IT Certification criteria. Our ATL services include:
- Criteria-Specific Testing: Validating system capabilities through ONC’s required test procedures.
- Live Demonstrations: Assessing functionality and interoperability in real-time scenarios.
- Attestation Testing: Verifying specific compliance statements as outlined by ONC requirements.
- Goal Oriented Testing Support: Providing guidance to help clients achieve their specific certification objectives.
Drummond’s ONC-ATL is accredited through the National Voluntary Laboratory Accreditation Program (NVLAP Lab Code 200979-0). Our ONC-ACB operates under accreditation through the ANAB/ANSI program (Accreditation ID# 1045). These accreditations ensure our processes align with ISO/IEC standards for quality and consistency.
FAQs
What is the ONC Health IT Certification Program?
The ONC Health IT Certification Program is a voluntary program established by the Assistant Secretary for Technology Policy (ASTP) (previously known as the Office of the National Coordinator for Health Information Technology or ONC) to certify health IT products. Certification ensures these products meet federal standards for health information security, data exchange interoperability, and software usability. Certification may be required for participation in some state or federal value-based care programs.
Why is ONC Health IT certification important?
ONC certification helps healthcare organizations and providers ensure that their health IT products meet government and industry-established standards for data security, interoperability, and functionality.
Read this article to learn more about why ONC Health IT certification is important.
Who needs ONC Health IT Certification?
Health IT developers who create electronic health record (EHR) systems, health information exchange (HIE) solutions, or other health IT products seeking to participate in federal or state programs requiring certified technology must obtain ONC certification.
What are the key components of the ONC Health IT Certification Program?
The program includes defined certification criteria, required conformance procedures, and ongoing conditions and maintenance of certification requirements to ensure certified products continue to meet compliance standards.
How does a health IT developer achieve ONC Health IT Certification?
To achieve certification, a health IT product must be tested by an ONC-Authorized Testing Laboratory (ONC-ATL) and then certified by an ONC-Authorized Certification Body (ONC-ACB).
What role do ONC-Authorized Certification Bodies (ONC-ACBs) play?
An ONC-ACB is a federally recognized accredited certification body responsible for certifying health IT products that have successfully passed testing by an ONC-ATL. ONC-ACBs also are responsible for working with developers to maintain ongoing compliance with all Conditions and Maintenance of Certification (CoC/MoC) requirements. They also oversee all product surveillance, including any complaints from healthcare organizations or providers.
Drummond has certified more Health IT systems than all other ONC-ACBs combined.
What is an ONC-Authorized Testing Laboratory (ONC-ATL)?
An ONC-ATL is a federally recognized accredited testing body that evaluates health IT products to ensure they meet conformity to ONC’s certification criteria before certification.
What are the testing requirements for ONC certification?
To obtain ONC Health IT Certification, health IT products must undergo rigorous testing to ensure their product can meet conformance standards as dictated by the latest certification criteria set by the Assistant Secretary for Technology Policy (ASTP) (previously known as Office of the National Coordinator for Health Information Technology or ONC). The criteria cover interoperability, security, usability, and clinical functionality to support healthcare data exchange and patient care.
Health IT developers do not need to test or certify every criterion available and are able to select the criteria that best serve the needs of their customers.
It is important to note that certification criteria are updated regularly—often annually—to reflect new regulatory requirements, advancements in health IT, and evolving interoperability standards. Health IT developers must stay informed of these changes and ensure their products remain compliant with the latest ONC standards.
To view the most up-to-date ONC certification criteria, visit the official ONC website – ONC Health IT Certification Criterion
Download the Drummond ONC Health IT Decision Guide for additional guidance on selecting testing and certification criteria.
How long does the ONC certification process take?
The timeline depends on the complexity of the health IT product, the readiness of the developer, and the testing results. Certification can take anywhere from a few weeks to several months.
How much does it cost to obtain ONC Health IT Certification?
Costs vary depending on the testing and certification body used and the scope of certification sought by the developer. Fees can include testing, certification, and potential retesting if the product does not initially meet all requirements.
What is the Certified Health IT Product List (CHPL)?
The Certified Health IT Product List (CHPL), pronounced chapel, is an official online database maintained by ASTP that lists all certified health IT products. Organizations can use CHPL to verify product certification status.
All certified ONC Health IT products can be found on the CHPL website.
All Drummond Certified ONC Health IT products can be found the Drummond website.
Where can I find a list of ONC-certified health IT products?
The Certified Health IT Product List (CHPL), pronounced chapel, is the official online database maintained by ASTP that lists all certified health IT products. Organizations can use CHPL to verify product certification status.
All certified ONC Health IT products can be found on the CHPL website.
All Drummond Certified ONC Health IT products can be found the Drummond website.
What is the process for maintaining ONC certification?
Maintaining ONC Health IT Certification involves ongoing compliance with the Assistant Secretary for Technology Policy’s (ASTP) (previously known as Office of the National Coordinator for Health Information Technology or ONC) standards.
Certified health IT developers must conduct annual Real World Testing to demonstrate the interoperability and functionality of their certified health IT in all product-supported real-world settings. This process includes:
- Developing a Real World Testing Plan: Health IT developers create a comprehensive plan outlining their testing approach and key metrics for the upcoming calendar year.
- Submitting the Plan: The Real World Testing plan must be submitted to the developer’s ONC-Authorized Certification Body (ONC-ACB) by their deadline that allows the ONC-ACB to publish it on the Certified Health IT Product List (CHPL) no later than December 15 of each calendar year.
- Conducting Testing: The developer must conduct their Real World Testing throughout the calendar year according to the plan approved by their ONC-ACB, assessing the certified health IT’s performance in real-world scenarios.
- Reporting Results: Developers must compile the outcomes of their Real World Testing and submit the results to their ONC-ACB by their deadline, enabling the ONC-ACB to publish these results on the CHPL no later than March 15 of the following calendar year.
This structured approach ensures that certified health IT products continue to meet ONC’s standards for interoperability and functionality in practical settings, thereby maintaining their certification status.
Other requirements for maintaining certification include bi-annual and quarterly attestations of continued conformance, health IT product updates to meet the latest interoperability standard updates, and responding to communications from your ONC-ACB.
What happens if a certified health IT product fails to meet ONC’s ongoing requirements?
If a certified product is found noncompliant during surveillance, it may be subject to corrective action. If issues are not resolved, the ONC-ACB or the ASTP may revoke the certification, requiring the developer to reapply.
Can ONC-certified health IT products lose their certification?
Yes. If a product fails to maintain certification or no longer meets ONC’s requirements, it may have its certification suspended or terminated by an ONC-ACB or the ASTP. Developers must address compliance issues to retain certification.
How does ONC certification support interoperability?
The program works with the health IT industry to establish technical and functional standards that ensure certified health IT products can securely exchange and interpret electronic health data across the entire healthcare ecosystem. Many of these standards are internationally recognized and implemented, allowing for interoperability across county, state, or federal borders.
How does ONC certification impact healthcare providers?
Healthcare providers using ONC-certified products can be confident that their health IT systems meet federally recognized standards for data security and privacy, system reliability and functionality, and data interoperability exchange. Using ONC-certified products also provides peace of mind for providers by providing a compliant process in cases of suspected non-conformity.
What are the consequences of using non-certified health IT products?
Healthcare providers using non-certified health IT may face interoperability challenges, security concerns, and limitations in participating in certain federal programs that require certified systems. Healthcare providers may also find they have additional burdens when meeting HIPAA compliance requirements, instead of relying on certified health IT products to assist in areas of technical security and privacy.
Does ONC certification apply only to electronic health record (EHR) systems?
No. While EHRs are a major focus, ONC certification applies to various health IT systems, including patient portals, health information exchanges (HIEs), and decision support tools. If your health IT product requests, captures, stores, exchanges, and/or transforms health data, you would likely benefit from interoperability provided by ONC Certification.
Where can I get more information about ONC Health IT Certification?
The ONC’s official website (https://www.healthit.gov) provides detailed resources, program updates, and certification criteria. You can also speak with a Drummond representative by using the CONTACT form below or requesting a FREE CONSULTATION.
Trust the Leaders in ONC Health IT Testing & Certification
Drummond’s proctors are ONC Health IT experts and are available to help you decide if ONC Health IT testing and certification is right for your organization.
Get Started Today
Fill in this form and a Drummond representative will contact you.
Why choose Drummond?
TRUST
There is a lot at stake. Our staff has deep experience in certification; we’re not cutting our teeth on your project. When you work with Drummond, you experience a team of highly skilled professionals that bring a code of honesty, empathy, and advocacy to each engagement. Our team will help you achieve compliance and certification and look for ways to help you pursue comprehensive compliance in the service of the greater good for your business.
QUALITY
We focus on quality from every angle. In many cases, our staff are the people who created the frameworks everyone else tests to. We bring an exclusive and proven methodology to each engagement and look for ways to improve and be more efficient at every step of the project. We take ownership and accountability of our work as we help you mitigate risk and achieve positive outcomes.
INTEGRITY
Ask any of our clients, they will tell you that the Drummond difference is its people. The people of Drummond listen carefully, and tailor solutions to your unique business and situation. Experience our team of highly skilled experts and proven methodologies and unique approach to help you achieve compliance for regulatory information security mandates. Our team will help you test critical applications for standards conformance and interoperability and gain certifications for your long-term success. Increase trust, gain expertise and experience our unique approach and attention to detail as we partner with you for your long-term success.