Real World Testing: Deadlines and Compliance
The latest Condition of Certification to maintain your 2015 Edition EHR Certification is approaching fast. Recently, we wrote a blog with a focus on the new Real World Testing requirements and received an overwhelming response. Based on the queries we received, it is evident that there are some common concerns where almost everyone needs extra assistance. In this blog, I want to address those questions and approaches available to you to meet the Real World Testing requirements.
To quickly recap, the EHRs will need to have an APPROVED Real World Test-plan (RWT) in place by December 15th, 2021. Please note with caution that December 15th is the ONC deadline for the ACBs. The real deadline for your EHR would be the deadline that your ACB has established for accepting the RWTs. Depending upon your ACB, these deadlines may have already come into effect as of October 1st, 2021. Some ACBs are allowing applications till November 15th, 2021, which is a full month earlier than the ONC deadline.
Does Real World Testing Apply to your EHR?
This is the first question that needs to be answered before we go any further. So let’s address this.
All 2015 Edition Certified EHRs are required to submit a Real World Test-plan (RWT) to their ACBs by the established deadline covering the applicable criteria. Not sure if it applies to you this year? A quick test is to look at your CHPL listing. If any of the RWT applicable criteria have a checkmark next to them, and those criteria were certified prior to August 31st, 2021, then you must include those criteria in your RWT plan.
Real World Testing for Patient APIs: It Gets Real
Among all the RWT applicable criteria, the Patient APIs are mired with the most concern and confusion. Many EHRs share the concern that their Patient API functionality has not been fully embraced by the EHR users. For the RWT, EHRs must describe in the test plan and then demonstrate during the testing how all of the applicable API-certified criteria perform in a production environment using real users*, and real patient (de-identified) data. This applies to the EHR or third-party applications that the EHR integrates with. *The Postman API Tool with synthetic data will not be acceptable.
The specific Application Programming Interfaces (API) Criteria for the Real World Testing are:
§ 170.315(g)(7) Application access—Patient Selection
§ 170.315(g)(8) Application access—Data Category Request [(g)(10) in lieu of (g)(8)]
§ 170.315(g)(9) Application access—All Data Request
§ 170.315(g)(10) Standardized API for Patient and Population Service
a. What EHRs Need to Demonstrate for API RWT
Specifically, the EHR will need to demonstrate the EHR’s interoperability and conformance with the certified API technology (authentication, data search, and acquisition) in the RWT plan. This needs to include a real third-party patient-facing application running on a device (smartphone, iPad, etc.) outside of your environment and controlled by a patient or their authorized representative. The RWT plan and testing must cover all such use case scenarios as applicable to your setting type.
We have received multiple inquiries focusing on what to do to satisfy the API criteria (g-8 or g-10, and g-9) for the Real World Test-plan and the subsequent testing. Having gone through the RWT process ourselves, we at Darena understand your dilemma. We have two options that allow you to accomplish what is needed for RWT plans and testing for the Application Programming Interfaces (APIs) prior to the deadline:
Do it yourself with guidance from us: Develop an API RWT plan that will detail how you will test the process using a production-ready, patient-facing application and submit it in time to meet the deadline posted by your ACB.
Integrate and be relieved of the API RWT responsibility: Integrate with our Certified API product. This option would remove the need to include the API criteria from your RWT plan and testing. Darena would be responsible for those criteria as a part of our RWT plan and testing.
Regardless of the RWT compliance path you chose in the face of looming deadlines, the experienced Darena team is here to help. We can assist you in developing a patient app with your existing certified criteria, or by signing up for certified BlueButtonPRO Integration you can have the RWT plan and its testing covered for you.
b. Benefits of Integrating with the FHIR-based Certified BlueButtonPRO
The Conditions of Certifications have related dependencies. By incorporating the 2015 Edition Cures Act Certified BlueButtonPRO Module into your EHR, you can address all the current and future Cures Act Updates required to retain and maintain the 2015 Edition Certification Status of your EHR. The Real World Testing for the API is managed by Darena Solutions, removing it from the developers’ task list.
To summarize the benefits of utilizing the Certified BlueButtonPRO module:
You don’t need to worry about RWT as that would be handled by BlueButtonPRO
Future proof your EHR for certification as it is already certified to the (g)(10) FHIR-based standard
Patient-API price locked for 3 years
Additional revenue opportunities (Ask us about it)
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