2024 BlueButtonPRO Real World Test Plan

For Criteria §170.315 (g)(7), §170.315 (g)(10), and §170.315 (b)(10)

General Information

Plan Report ID Number: RWT Plan_BlueButtonPRO_Darena_Solutions_11-30-2023

Developer Name: Darena Solutions LLC

Product Name(s): BlueButtonPRO

Version Number(s): 2

Certified Health IT: 15.04.04.1322.Blue.02.00.0.200807

Product List (CHPL) ID(s): 15.04.04.1322.Blue.02.00.0.200807

Developer Real World Testing Page URL: https://www.darenasolutions.com/bluebuttonpro-real-world-test-plan-2024

Justification for Real World Testing approach

Currently, the Certified Health IT module, BlueButtonPRO is sold as a stand-alone module to EHRs to provide a solution for their §170.315 (g)(7), §170.315 (g)(10), and §170.315 (b)(10) criteria for the 2015 Edition Certification. The API criteria were tested individually during the ONC certification process. However, in the real world, these certified API modules provide one seamless approach to accomplish the patient/authorized representative’s request for PHI documentation from providers using a 2015 Edition Certified EHR. We will test the §170.315 (b)(10) criteria separately. This will cover both single and bulk data requests for all criteria. To that end, the Real World Test plan will be designed to demonstrate how these combined modules perform in the production environment. This certified product is deployed with many EHRs covering multiple specialties within the ambulatory marketplace. We will design our Real World Test plan to reinforce the capabilities that we encounter in these ambulatory use cases. The BlueButtonPRO application does allow providers to fully satisfy their reporting requirements for the Promoting Interoperability category of MIPS.

  
STANDARDS UPDATES (INCLUDING STANDARDS VERSION ADVANCEMENT PROCESS (SVAP) AND UNITED STATES CORE DATA FOR INTEROPERABILITY (USCDI)) 

    Standard (and version)
    Standards as specified by the USCDI v1

    Updated certification criteria and associated product
    N/A

    Health IT Module CHPL ID
    N/A

    Method used for standard update
    N/A

    Date of ONC-ACB notification
    N/A

    Date of customer notification (SVAP only)
    N/A

    Conformance measure
    N/A

    USCDI-updated certification criteria (and USCDI version)
    N/A

Measures Used in Overall Approach

DESCRIPTION OF MEASUREMENT/METRIC

Describe the measure(s) used to support the overall approach to Real World Testing.

The Measure/Metrics and the Descriptions listed below will apply to the simultaneous and seamless use of the functionality of certified measures §170.315 (g)(7) and §170.315 (g)(10). We will test the §170.315 (b)(10) criteria independently. The RWT will be witnessed via a Zoom session with the participants using a production environment and real patient data. Upon completion, we will observe the successful conformance of the certified technology to be able to Authenticate a patient/authorized representative and for them to request portions of the PHI using an application of their choice outside of the EHR’s domain.

  
    Measurement/Metric
    Description

    MEASURE 1: The patient/authorized representative will have the ability to access (after authentication) partial summary PHI by way of an API call from a 3rd-party application running on a patient-owned device to the API of the EHR.                                   
    This same patient/authorized representative will be enabled to present their authenticated credentials to use a 3rd-party application running on a patient-owned device to access partial encounter summary data of their choice, for a given date range. We will demonstrate a single and bulk data request. They will have the ability to view and or transmit their information as they see fit from the application on their device. This will meet § 170.315 (g)(7 & 10).

ASSOCIATED CERTIFICATION CRITERIA

    Measurement/Metric
    Associated Certification Criteria
  Relied Upon Software

    MEASURE 1
    §170.315 (g)(7) and §170.315 (g)(10)
  N/A

    MEASURE 2
    §170.315 (b)(10)
  N/A

JUSTIFICATION FOR SELECTED MEASUREMENT/METRIC

    Measurement/Metric
    Justification

    MEASURE 1: The patient/authorized representative will have the ability to access (after authentication) partial summary PHI by way of an API call from a 3rd-party application running on a patient-owned device to the API of the EHR.                                   
    The certified EHR technology must provide the patient with the ability to obtain portions of their medical information via a request from an application of their own, outside of the domain of an EHR, for a given date range. This single and bulk data request must be supported. This functionality will supplement the capabilities that are achieved with a patient portal.

    MEASURE 2: Export USCDIv1 clinical data for a population of patients for use in a different
health information technology product or a third party system.  This export can be
used for many purposes, including data portability when a physician practice
switches to a new EHR platform.                                   
    We chose to concentrate on the aspects of this criterion that would:
1) Demonstrate and EHR's ability to export batches of patient data in a straightforward fashion
2) Facilitate interoperability by providing the exported data in the form of valid C-CDA files that conform to the HL7 standards as described in the HL7
Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm). Additionally, Includes a publicly accessible hyperlink of the export’s format.

CARE SETTING(S)

    Care Setting
    Justification

    This plan will test within ambulatory settings with EHRs the have solo providers and up to 150 providers. The plan will include testing within practices of different specialties to confirm that the type of specialty does not play a role in the data collection.
    The BlueButtonPRO is positioned to be used by providers using EHRs in multiple points of service and multiple specialties. This test plan will demonstrate that the overall functionality is the same regardless of the facility or specialty. We will get feedback from Internal Medicine, Cardiology, Behavioral Health, and Dermatology. Additionally, we will document that the EHR performs the same in different facilities. The overall process will be the same in all specialties. However, we will confirm that the EHR accommodates the specific workflow of each specialty. 
Real patient data will be deidentified and the testing will be using a production environment.  
The ability to complete all measures successfully with these practices will be documented through observation of the completed tasks. Deviations from the designed process, if any, will be noted and addressed.

EXPECTED OUTCOMES

    Measurement/Metric
    Expected Outcomes

     Measure 1: 
§170.315 (g)(7) and §170.315 (g)(10)
    The Real World Testing will demonstrate that the clinician has the functionality within their EHR to receive a request with sufficient information to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data. 
The EHR will demonstrate the functionality to respond to specific date range requests for patient data (single and bulk) containing partial data categories specified in the USCDI v1 Data Set. This one-time return of such data (according to the specified standards, where applicable) will allow the patient/authorized representative to view and transmit the date as needed on their application on their selected device. The requests will respond to requests for patient data associated with a specific date as well as requests for patient data within a specified date range. A 0% error rate is expected.

     Measure 2: 
 §170.315 (b)(10)
     • Date and time ranges can be configurable via the UI 

• Targeted Practices can be configurable via the UI

• Patients exported can be configurable via the UI

• Logging in as a Vendor Admin will allow access to the export functionality

• Logging in as a non-Vendor Admin will not allow access to the export functionality

• Use the Edge Test Tool to check validity of output file

• Data was available for the entered date and time range 

• The export summary contained data only within that date and time range

• Export summary was created and completed successfully

• Saving to a preferred location is allowed

• Visually confirming the export after save is performed and successful

• Prepare RWT results report with 95% plus success rate

SCHEDULE OF KEY MILESTONES






  

    Key Milestone
    Care Setting
    Date/Timeframe

    Prepare the BlueButtonPRO application for use in collect data upon requests by patients/authorized representatives
    Ambulatory Setting
Multiple Specialties 
    December 2023

    Identify the user practices the will participate in the test plan
    Ambulatory Setting
Multiple Specialties 
    December 2023 & January 2024

    Confirm that the Real World Test Plan participants are able to log into their accounts and are ready to demonstrate the request and response for patient PHI
    Ambulatory Setting
Multiple Specialties

    January 2024

    Follow-up with the Real World Test Plan participants on a regular basis (minimum, once a quarter) to obtain feedback on their progress and or if there are any issues to address
    Ambulatory Setting
Multiple Specialties

    Quarterly 2024

    End the Real World Test to coincide with the end of the 2024 Calendar Year
    Ambulatory Setting
Multiple Specialties

    December 2024

    Real World Test analysis and generation of the report
    Ambulatory Setting
Multiple Specialties

    January 2025

    Submit Real World Test Report to ACB before established deadline
    Ambulatory Setting
Multiple Specialties

    January 2025

Attestation

The Real World Testing plan must include the following attestation signed by the health IT developer authorized representative.

This Real World Testing plan includes all required elements, including measures that address all certification criteria and care settings. All information in this plan is current and comprehensively addresses the health IT developer’s Real World Testing requirements.

Authorized Representative Name: Wayne Singer

Authorized Representative Email: wayne@darenasolutions.com

Authorized Representative Phone: 832-736-2552

Authorized Representative Signature: /Wayne Singer/

Date: 11/30/2023

Interested in Utilizing BlueButtonPRO’s Real World Test Plan?

Get In Touch

Measurement/Metric	Justification
MEASURE 1: The patient/authorized representative will have the ability to access (after authentication) partial summary PHI by way of an API call from a 3rd-party application running on a patient-owned device to the API of the EHR.	The certified EHR technology must provide the patient with the ability to obtain portions of their medical information via a request from an application of their own, outside of the domain of an EHR, for a given date range. This single and bulk data request must be supported. This functionality will supplement the capabilities that are achieved with a patient portal.
MEASURE 2: Export USCDIv1 clinical data for a population of patients for use in a different health information technology product or a third party system. This export can be used for many purposes, including data portability when a physician practice switches to a new EHR platform.	We chose to concentrate on the aspects of this criterion that would: 1) Demonstrate and EHR's ability to export batches of patient data in a straightforward fashion 2) Facilitate interoperability by providing the exported data in the form of valid C-CDA files that conform to the HL7 standards as described in the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm). Additionally, Includes a publicly accessible hyperlink of the export’s format.

Measurement/Metric	Expected Outcomes
Measure 1: §170.315 (g)(7) and §170.315 (g)(10)	The Real World Testing will demonstrate that the clinician has the functionality within their EHR to receive a request with sufficient information to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data. The EHR will demonstrate the functionality to respond to specific date range requests for patient data (single and bulk) containing partial data categories specified in the USCDI v1 Data Set. This one-time return of such data (according to the specified standards, where applicable) will allow the patient/authorized representative to view and transmit the date as needed on their application on their selected device. The requests will respond to requests for patient data associated with a specific date as well as requests for patient data within a specified date range. A 0% error rate is expected.
Measure 2: §170.315 (b)(10)	• Date and time ranges can be configurable via the UI • Targeted Practices can be configurable via the UI • Patients exported can be configurable via the UI • Logging in as a Vendor Admin will allow access to the export functionality • Logging in as a non-Vendor Admin will not allow access to the export functionality • Use the Edge Test Tool to check validity of output file • Data was available for the entered date and time range • The export summary contained data only within that date and time range • Export summary was created and completed successfully • Saving to a preferred location is allowed • Visually confirming the export after save is performed and successful • Prepare RWT results report with 95% plus success rate