Real World Testing Plan for Smile CDR  

 

This is the real world test plan for 2026 for the Smile CDR Product . It provides the real world test measurements and metrics that meet the intent and objectives of ONC’s Condition of Certification and Maintenance of Certification requirement for real world testing (§ 170.405 Real World Testing) to evaluate compliance with the certification criteria and interoperability of exchanging electronic health information (EHI) within the care and practice setting which it is targeted for use.  


This document provides the targeted testing measurements and metrics that Smile Digital Health will use to evaluate the Smile CDR product interoperability within typical production settings. For each measure, the associated testing methodology, ONC criteria, justification for measurement, and expected outcomes from the testing are presented.  

General Information

Plan Report ID Number:
Developer Name: Smile Digital Health
Product Name: Smile CDR
Version Number: 2025
Certified Health IT Product List (CHPL) ID(s): 15.04.04.3129.Smil.24.03.0.250414  
Developer Real World Testing Plan Page URL: https://www.smiledigitalhealth.com/cdr-real-world-test    

Justification for Real World Testing 

Real World Testing is intended to verify that deployed Certified Health IT continues to perform as intended by demonstrating that certified capability for interoperability and data exchange is successfully utilized in the real world. The Smile CDR product has broad use cases and it can be used by many clinical settings practices. All measures reasonably align with the §170.315(g)(7), §170.315(g)(10) and §170.315(b)(10) certification criteria.  

Developer 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: James Agnew  
Authorized Representative Email: compliance@smiledigitalhealth.com  
Authorized Representative Phone: +1 (877) 537 3343  
Authorized Representative Signature: James Agnew  
DATE: October 28, 2025  

Timeline and Milestones for Real World Testing 2026

  •  2026-Q1: Draft test plan. Identify and allocate resources for RWT activities.. 

  • 2026-Q2.Execute draft test plan and capture results for review. Create an internal review committee to  
    review initial results.  

  • 2026-Q3. Complete RWT test plan according to ONC and ONC-ACB requirements and expectations. 2026  
    RWT Test Report will be prepared for submission before the end of the year.  

  • 2026-Q4. Submit RWT Test Results to ONC-ACB.  

Standards Updates Standard and Version
 

Standard (and version) All standard versions are those specified in USCDI v1.
Date of ONC-ACB notification (SVAP or USCDI) N/A
Date of customer notification (SVAP only) N/A
USCDI-updated criteria N/A

 

Real World Testing Measurement Methodology

 

The measurements for the Smile CDR product RWT Plan contains the following:  

  • Testing Methodology used
  • Associated ONC criteria
  • Justification for the measurement/metric
  • Expected outcomes in testing for the measurement/metric

In each measurement evaluated, the justification for selecting this measure is provided. All measurements were selected to best evaluate compliance with the certification criteria and interoperability of exchanging electronic health information (EHI) with the Smile CDR Product.  


Testing Methodology

For each measurement, we will leverage the logging and FHIR reporting capabilities of Smile CDR to examine functionality performed in the solution. This methodology often provides historical measurement reports which can be accessed for different time intervals and evaluate interoperability functionality, and it may serve as a benchmark for evaluating real world testing over multiple time intervals.  

 

Measurements

Measurement 2026-CDR-01

Associated Certification Criterion: 170.315 (g)(7) Application Access - Patient Selection  

Measurement: Count the number of API queries for a patient search made in a real world setting  

Description: Using the Smile CDR FHIR API, the product is able to demonstrate meeting the requirement (g)(7)(i) respond to requests for a single patient’s data according to the standard adopted in § 170.215(a)(1) and implementation specification adopted in §170.215(a)(2) 

Justification: Demonstrating the ability Smile CDR API module to respond to (i)(A) requests 

Expected Outcomes: Demonstrate the compliance of the standard by confirming that Smile CDR can process queries as expected and with less than 1% errors.  

Measurement 2026-CDR-02

Associated Certification Criterion: 170.315 (g)(10) Standardized API of Patient and Population Services  

Measurement: Count the number of API queries for the category of clinical data set made in a real world setting.  

Description: During the testing period, a report will be generated which tracks and logs the FHIR API queries made for specific data category requests in the real world.

Justification: Demonstrate the capability of Smile CDR to process FHIR API queries with a patient as a subject and fetch that patient-specific data by category.

Expected Outcomes: Demonstrate the compliance of the standard by confirming that Smile CDR can process queries as expected and with less than 1% errors.  

Measurement 2026-CDR-03

Associated Certification Criterion: 170.315 (b)(10) Electronic Health Information Export

Measurement: Count the number of API queries for EHI exports made in a real world setting. 

Description: During the testing period, a report will be generated which tracks and logs the FHIR API queries  made for exporting Electronic Health Information requests in the real world.  

Justification: Demonstrate the capability of Smile CDR to export Electronic Health Information.  

Expected Outcomes: Demonstrate the compliance of the standard by confirming that Smile CDR can process queries as expected and with less than 1% errors.