Under the ONC Health IT Certification Program, Health IT Developers are required to conduct
Real World Testing of their Certified Health IT
Year 2025
Background & Instructions
Under the ONC Health IT Certification Program (Program), Health IT Developers are required to conduct Real World Testing of their Certified Health IT (45 CFR 170.556 and 170.523(i)). The Office of the National Coordinator for Health Information Technology (ONC) issues Real World Testing resources to clarify Health IT Developers’ responsibilities for conducting Real World Testing, to identify topics and specific elements of Real World Testing that ONC considers a priority, and to assist Health IT Developers to develop their Real World Testing plans.
Health IT Developers have maximum flexibility to develop innovative plans and measures for Real World Testing. As developers are planning for how they will execute Real World Testing, they should consider the overall complexity of the workflows and use cases within the care settings in which they market their Certified Health IT to determine which approaches they will take.
This Real World Testing plan template was created to assist Health IT Developers in organizing the required information that must be submitted for each element in their Real World Testing plan. Health IT Developers must submit one plan for each year of Real World Testing (see resources listed below for specific timelines and due dates). ONC does not encourage updating plans outside the submission timeline and will not post updates on the Certified Health IT Product List (CHPL). If adjustments to approaches are made throughout Real World Testing, the Health IT Developer should reflect these adjustments in their Real World Testing results report. ONC would expect that the Real World Testing results report will include a description of these types of changes, the reasons for them, and how intended outcomes were more efficiently met as a result. This resource should be read and understood in conjunction with the following companion resources, which describe in detail many of the Program requirements referenced in this resource.
General Information
| Plan Report ID Number: | |
| Developer Name: | EDENLAB OÜ |
| Product Name(s): | Kodjin FHIR Server |
| Version Number(s): | Version 3 |
| Certified Health IT Product List (CHPL) ID(s): | 15.04.04.3148.Kodj.03.00.0.230330 |
| Developer Real World Testing Page URL: | https://kodjin.com/real-world-test-plan-2025/ |
Justification for Real World Testing Approach
Consistent with the ONC’s recommendation that “Real World Testing verify that deployed Certified Health IT continues to perform as intended by conducting and measuring observations of interoperability and data exchange”, this test plan focuses on capturing and documenting the number of instances that certified capability is successfully utilized in the real world. In instances where no evidence exists due to zero adoption of a certified capability or the inability to capture evidence of successful use for other reasons, we will demonstrate the required certified capability in a semi-controlled setting as close to a “real world” implementation as possible.
It is important to note that Real World Testing is only one component of the Health IT Certification program used to demonstrate compliance with the program requirements. Real World Testing should augment and support testing that was conducted prior to certification being granted. It is not intended to duplicate the methods or results previously demonstrated. Instead, this test plan was developed to demonstrate that the certified capabilities have been successfully deployed for providers to use at their discretion in live settings.
Kodjin FHIR Server doesn’t have narrow care settings, it can be used by any practices. All measures reasonably align with the §170.315(g)(10) and §170.315(b)(10) certification criterion.
Standards Updates (Including Standards Version Advancement Process-SVAP and USCDI) EDENLAB OÜ has not updated Kodjin FHIR Server to any new standards as part of SVAP or the
Cures Update criteria as of this date nor plan to prior to the execution of the 2025 Real World Test.
Care Settings
Kodjin FHIR Server doesn’t have narrow care settings, it can be used by any practices.
Measures Used In Overall Approach
For each measurement/metric we define next elements:
- ● Associated certification criteria
- ● Description of each measurement/metric
- ● Justification for each measurement/metric
- ● Expected Outcomes for each measurement/metric
MEASURE 1 – FHIR REST API Interactions by SMART on FHIR Applications
§170.315(g)(10) Standardized API for patient and population services
| Metric description | Criteria | Justification | Expected Outcomes |
| Count of FHIR API requests by SMART on FHIR applications and error rate | Using FHIR API by SMART on FHIR applications proves respond to requests for a single patient’s data according to the specification and (g)(10) requirements | Demonstrating the ability of Kodjin FHIR Server to respond on requests SMART on FHIR applications | It is expected that the FHIR API will be conformant to § 170.315(g)(10) with less than 1 percent error rate experienced by users |
MEASURE 2 – FHIR REST API Interactions utilizing bulk-export specification
§170.315(b)(10) Electronic Health Information Export
| Metric description | Criteria | Justification | Expected Outcomes |
| Count of EHI bulk export requests and error rate | Using bulk export (Single patient or Population) operation proves respond to requests for multiple patients’ data as a group according to the specification and (b)(10) requirements | Demonstrating the ability Kodjin FHIR Server module to respond on EHI-export requests | API calls are expected to be executed successfully, with an estimated benchmark of 99% success |
MEASURE 3 – Authentication flow with Patient Selection
§170.315(g)(7) Application Access – Patient Selection
| Metric description | Criteria | Justification | Expected Outcomes |
| Number of requests for a patient ID or token Number of requests that provided sufficient information to provide a valid response Number of follow-up requests made using the provided patient ID or token | This criterion requires the certified Health IT module to provide an API and supporting documentation that enables external applications to request a unique patient identifier from the certified Health IT module that can be used to request additional patient data | We intend to record the frequency that patient ID requests received by providers via API to demonstrate the certified capability is available and effective, regardless of the frequency it is used | Our expectation is there will be low utilization by providers with a high success rate without errors |
Schedule of Key Milestones
Develop a list of clients to assist with Real World Testing: Q1 2025
Preparation and scheduling testing with clients: Q2 2025
Collection of information as laid out by the plan: Q2 and Q3 2025
Real World Testing plan will be completed according to ONC and ONC-ACB requirements and expectations: Q4 2025
Document our 2024 test results: January 2025
Submit Real World Testing Report to ONC-ACB: February 2026
Attestation
This Real World Testing plan is complete with all required elements, including measures that address all certification criteria and care settings. All information in this plan is up to date and fully addresses the health IT developer’s Real World Testing requirements.
Authorized Representative Name: Eugene Yesakov
Authorized Representative Email: [email protected]
Authorized Representative Signature:
Date: 31/10/2024
