Healthie 21st Century Cures Real World Testing Plan 2025
Last Updated: November 18, 2024
Background
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.
- Real World Testing – What It Means for Health IT Developers – Fact Sheet
- Real World Testing Resource Guide
- Real World Testing Certification Companion Guide
Health IT Developers should also review the following regulatory materials, which establish the core requirements and responsibilities for Real World Testing under the Program.
- 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule, 85 FR 25642 (May 1, 2020) (Century Cures final rule); Section VII.B.5 — “Real World Testing”
General Information
- Plan Report ID Number: Healthie-2025-RWT
- Developer Name: Healthie
- Product Name(s): Healthie
- Version Numbers(s): Cures 1
- Real World Testing Certified Health IT Criteria: 315(b)(1)-(3), (b)(10); (c)(1)-(c)(3); (e)(1); (g)(7), (g)(9), (g)(10); (h)(1)
- Product List (CHPL) ID(s) and Link(s):some text
- 15.04.04.3130.Heal.01.00.1.221207
- https://chpl.healthit.gov/#/listing/11055
Developer Real World Testing Page URL: https://www.gethealthie.com/onc-real-world-testing
Timeline and Milestones for Real World Testing CY 2025
- 1Q-2025: Health IT system is fully enabled for use in real world testing.
- 3Q-2025. Begin making plans to collect data for RWT measures. If necessary, engage clients to ask for their support and participation in real world testing.
- 4Q-2025. During the last quarter of the year, the CY 2025 real world test results will be captured according to our test plan. We also complete work for next year’s Real World Test Plan and submit it by November 1, 2025.
- February 1, 2026. Real World Test Report will be completed and submitted according to ONC and ONC-ACB requirements and expectations.
Standards Updates (SVAP)
Currently, we are using all required ONC Certification Program standard version(s) unless noted differently below. Next year we will be updating our EHR to support the new standard versions according to the HTI-1 rule, including USCDI v3, and based on when we complete these updates, new SVAP version(s) may be captured in our CY 2025 RWT test results, and if so, we will note that in our CY 2025 RWT test report.
Standard (and version) | All standards versions including USCDI v1 are those specified in ONC Certification Program criteria. |
Method used for standard update | N/A |
Date of ONC-ACB notification | N/A |
USCDI-updated criteria | This plan documents the support of all USCDI v1 data elements. |
Real World Testing Measurements
The measurements for our real world testing plan are described below. Each measurement contains:
- Associated ONC criteria
- Testing Methodology used
- Description of the measurement/metric
- Justification for the measurement/metric
- Expected outcomes in testing for the measurement/metric
- Number of client sites to use in testing (if applicable)
- Care settings which are targeted with the measurement/metric
In each measurement evaluation, we elaborate specifically on our justification for choosing this measure and the expected outcomes. All measurements were chosen to best evaluate compliance with the certification criteria and interoperability of exchanging electronic health information (EHI) within the certified EHR.
We include expected usage and success rates for our measures. Additionally, if none of our chosen sites have records or results for measure because of no utilization, we will substitute a test with synthetic patient data in an environment that mirrors production use to confirm our functionality does work according to its certification compliance.
Testing Methodologies
For each measurement, a testing methodology is used. For our test plan, we use the following methodologies. Reporting/Logging: This methodology uses the logging or reporting capabilities of the EHR to examine functionality performed in the system. A typical example of this is the measure reporting done for the automated measure calculation required in 315(g)(2), but it can also be aspects of the audit log or customized reports from the EHR. This methodology often provides historical measurement reports which can be accessed at different times of the year and evaluate interoperability of EHR functionality, and it can serve as a benchmark for evaluating real world testing over multiple time intervals.
Care and Practice Settings Targeted
Our EHR is targeted at ambulatory specialties including family practice, internal medicine, women’s health, and behavioral health, and our measures are designed for their workflows and uses.
1. Number of Transition of Care C-CDAs Successfully Sent
Associated Criteria: 315(b)(1), 315(h)(1)
Testing Methodology: Reporting/Logging
Measurement Description
This measure is tracking and counting how many C-CDAs are created and successfully sent from the Health IT Module to a 3rd party via Direct messaging during a transition of care event over the course of a given interval. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
This measure will provide a numeric value to indicate both how often this interoperability feature is being used as well as its compliance to the requirement. An increment to this measure indicates that the EHR can create a C-CDA patient summary record, including ability to record all clinical data elements, and by sending the C-CDA patient summary record, the EHR demonstrates successful interoperability of an exchanged patient record with a 3rd party. Successfully completing this measure also implies users have a general understanding of the functional operations for this Health IT Module and an overall support for the user experience while not completing this measure may indicate lack of understanding or possibly lack of use or need for this functionality. This test will also examine our interface with our 3rd party HISP, EMR Direct. A successful and working integration with our HISP will be evident by the ability to exchange C-CDA messages.
Measurement Expected Outcome
The measurement will produce numeric results over a given interval. We will utilize various reports and audit logs to determine our measure count. Our expectation is there will be high utilization by providers with a high success rate (95%+).
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
2. Number of C-CDAs Received and/or Incorporated
Associated Criteria: 315(b)(2)
Testing Methodology: Reporting/Logging
Measurement Description
This measure is tracking and counting how many C-CDAs are successfully received and/or incorporated upon receipt from a 3rd party via Direct messaging during a transition of care event over the course of a given interval. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
This measure will provide a numeric value to indicate both how often this interoperability feature is being used as well as its compliance to the requirement. An increment to this measure indicates that the EHR can receive a C-CDA patient summary record, and by incorporating the C-CDA patient summary record, the EHR demonstrates successful interoperability of problems, medications, and medication allergies of patient record with a 3rd party. Successfully completing this measure also implies users have a general understanding of the EHR functional operations for this Health IT Module and an overall support for the user experience while not completing this measure may indicate lack of understanding or possibly lack of use or need for this functionality. This measurement shows support for Direct Edge protocol in connecting to a HISP for successful transmission.
Measurement Expected Outcome
The measurement will produce numeric results over a given interval. We will utilize various reports and audit logs to determine our measure count. Our expectation is there will be moderate utilization by providers with a high success rate (95% +).
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
3. Number of NewRx Prescriptions Messages Successfully Sent
Associated Criteria: 315(b)(3)
Testing Methodology: Reporting/Logging
Measurement Description
This measure is tracking and counting how many NewRx electronic prescriptions were created and successfully sent from the Health IT Module to a pharmacy destination over the course of a given interval. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
This measure will provide a numeric value to indicate both how often this interoperability feature is being used as well as its compliance to the requirement. An increment to this measure indicates that the EHR can create a NewRx SCRIPT electronic prescription message and transmit it to a pharmacy, typically via the Surescripts Network. This measurement demonstrates our integration with our 3rd party ePrescribing solution, DoseSpot. A successful and working integration will be evident by the ability to exchange the SCRIPT ePrescribing messages to pharmacy sites over the Surescripts Network.
Measurement Expected Outcome
The measurement will produce numeric results over a given interval. We will utilize various reports and audit logs to determine our measure count. Our expectation is there will be high utilization by providers with a high success rate (95%+).
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
4. Number of EHI Exports Run
Associated Criteria: 315(b)(10)
Testing Methodology: Reporting/Logging
Measurement Description
This measure is tracking and counting how many patients requested and received EHI exports of their health information by the Health IT Module over the course of a given interval. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
Exporting patient EHI is necessary for patients to have a comprehensive view of their health information. This measure will provide a numeric value, include both success and errors, to indicate how often this interoperability feature is being used as well as its compliance to the requirement, namely that the EHR can create an export of patient EHI in a computable format. A successful export indicates compliance with the underlying ONC criteria and that the EHR can create an export of all patient’s EHI. Successfully completing this measure also implies users have a general understanding of the EHR functional operations for this Health IT Module and an overall support for the user experience. Any observed errors may indicate either lack of understanding by the user, configuration setup issues, or product errors, and we will investigate as necessary.
Measurement Expected Outcome
The measurement will produce numeric results of attempted and completed EHI Export of Patient EHI, both success and error, by the Health IT Module over a given interval. We will likely utilize a database report to determine our measure count. We expect this test will be completed with few, if any, technical errors, although we may observe some user-driven errors unrelated to the functionality of the EHR software. We will examine results to evaluate the performance of the Health IT Module. Because this is a relatively new feature, we are not such how often it will be used by our customers. If none of our chosen sites have records of any patient requested EHI Exports, we will substitute a test with synthetic patient data in an environment that mirrors production use.
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
5. Number of Quality Measures Successfully Reported on to CMS
Associated Criteria: 315(c)(1)-(c)(3)
Testing Methodology: Reporting/Logging
Measurement Description
This measure is tracking and counting how many eCQM quality measures were successfully reported on by the Health IT Module to CMS over the course of a given interval. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
This measure will provide a count and list of electronic clinical quality measures (eCQMs) which are calculated and submitted to CMS for a given program, like MIPS. Clinical quality measures are only used for the respective CMS programs and any production measures should utilize submission to CMS. We will utilize various reports to determine our measure count, and if necessary, obtain clinician user reported activities to document this interoperability feature. Because CQM criteria, 315(c) (1)-(c)(3), all work collectively together in the eCQM functionality of the Health IT Module, this measurement is used for all three. Our measure will also test our relied upon software, Dynamic Health IT CQMsolution.
Measurement Expected Outcome
The measurement will count and list eCQMs submitted to CMS for the annual submission. We expect any of our Health IT Module to be able to calculate and submit any of our certified CQMs to CMS as needed by our customers. Our expectation is there will be a low to no utilization by providers for this metric. If none of our chosen sites have records of CQM submission to CMS, we will substitute a test with synthetic patient data in an environment that mirrors production use.
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
6. Number of Patients Who Accessed Health Data in Patient Portal
Associated Criteria: 315(e)(1)
Testing Methodology: Reporting/Logging
Measurement Description
This measure is tracking and counting how many patients are successfully logged into and accessed their patient portal account to either view, download, or transmit their health data over the course of a given interval. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
This measure will provide a numeric value for:
- Number of patients viewing health data (by login)
- Number of patients who download health information (either C-CDA or human readable version or both)
- Number of patients who transmit health information (either via email or secure method)
These measurements will indicate how often this interoperability feature is being used as well as its compliance with the criteria standards. A successful measure increment indicates compliance to the underlying ONC criteria. It will show that patients can log into their patient portal to view, download, or transmit their health data. Successfully completing this measure also implies users have a general understanding of the EHR functional operations for this Health IT Module and an overall support for the user experience while not completing this measure may indicate lack of understanding or possibly lack of use or need for this functionality.
Measurement Expected Outcome
The measurement will produce numeric results over a given interval. We will utilize various reports and audit logs to determine our measure count. Our expectation is there will be low utilization by patients with a high success rate (95%+).
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
7. Number of Applications/3rd Party Systems Using API Capabilities
Associated Criteria: 315(g)(7), (g)(9)-(g)(10)
Testing Methodology: Reporting/Logging
Measurement Description
This measure will determine how many 3rd party systems or applications are integrated and using the EHR’s FHIR API interface. This measure will allow us to verify our certified API is working with 3rd party applications to access USCDI patient data. We will record results for this measure for a minimum of one (1) month, and we will select an appropriate sample of customer accounts for testing to obtain a reasonable determination of use.
Measurement Justification
This measure will determine how many 3rd party systems or applications are integrated and using the EHR’s FHIR API interface. This measure will allow us to verify our certified API is working with 3rd party applications to access USCDI patient data. This measurement also shows support for integrated 3rd party API service provider, Health Samurai Aidbox.
Measurement Expected Outcome
The measurement will provide a count of FHIR applications which have registered with our server for patient access as well as applications actively connecting to our FHIR server. We will utilize our FHIR API form which developers use to request API access as well as additional reports and audit logs to determine the number of API applications enabled for our system. We will also query clinician users to determine the API applications they have approved for use on their system. We expect that our 3rd party API service provider, Health Samurai Aidbox, will be fully integrated and working with our EHR, and successful query of the API resources will prove this. We do not believe many of our clients will be using API capabilities next year, but for those who do, we expect it to work and return appropriate clinical data. Our expectation is there will be low utilization by patients and providers with a high success rate (95%+).
Care Settings
We designed this measure to test all the specialties that we support and target including family practice, internal medicine, women’s health, and behavioral health.
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: Jenna Parker
Authorized Representative Signature:
[SIGNATURE]
DATE: October 25, 2024