FAQ: Options for (g)(10) API and Real World Testing requirement

FAQ: Options for (g)(10) API and Real World Testing requirements

What are the costs for Drummond’s Advisory Services?

Costs vary based on customer needs and requirements. Our offerings are designed to provide different pricing based on how much and what types of assistance a software developer may need. For example, we have 170.315(g)(10) offerings for customers who are in early, middle and late stages of development of 170.315(g)(10) functionality. We can assist with each of the phases in the RWT process – plan development, plan execution and results reporting. If you would like to review and discuss your need areas and assess cost options, please contact us at advisoryservices@drummondgroup.com.

Are Drummond Advisory Services applicable to an EMR who is just starting the certification process?

Yes, Advisory Services team has the expertise and experience to help you understand and prepare for your first certification and can tailor our services to your areas of need.

Please provide the difference between a FAILURE and a WARNING for certification purposes.

When using the ONC-approved test tools, a FAILURE results in a failure of the test. WARNINGS are permissible and should be reviewed for best practices.

If you fail a portion of a certification, do you have to retake the entire test or just the failed portion?

Typically, a developer would only need to retest a failed portion of its test unless the changes made would impact other certified functionality. It will be at the discretion of the test lab to determine what will be required to be retested.

What is the SVAP process?

Detailed information about the Standards Version Advancement Process (SVAP) can be located on the www.HealthIT.gov website here: https://www.healthit.gov/isa/standards-version-advancement-process

Drummond Advisory Services also can provide expertise to help you better understand this process. Email advisoryservices@drummondgroup.com to discuss further.

Regarding USCDI, what version is required for compliance, version 1 or 2?

Currently, USCDI version 1 is the approved version. Under SVAP, ONC may decide to approve USCDI v2 in 2022, but no announcements have been made to date. In the meantime, we advise clients to use USCDI v1.

How soon may I submit my 2022 RWT results report and how does this relate to the 2023 test plan deadlines?

Test plans (for 2023) are due to Drummond’s ONC Authorized Certification Body (ACB) by Nov. 1, 2022. They will be reviewed by the ACB and posted to the CHPL website by Dec. 15, 2022.

Note: Test results (for 2022 plans) are separate from 2023 test plans, although your testing and results experience may drive changes to your 2023 plan. Test results reports for 2022 plans are due to the ACB no later than Feb. 1, 2023. These may be submitted as early as Dec. 1, 2022 (when the Drummond customer portal opens for submission of 2022 reports). Early submission of 2022 RWT results reports is expected to enable earlier review and feedback, if any, from the ACB.

Is there a certain number of  “customers” who are used to perform the RWT plan, whether we are performing this activity ourselves or using Drummond Advisory Services?

ONC did not specify a minimum or maximum number of customers. The answer to how many customers should be included in the data collected will vary by developer based on the number of care settings, number of users, etc. Drummond Advisory Services can provide more detailed answers to questions like these as part of our RWT engagements.

For RWT, what is the overall process Drummond will be using to engage customers or will the developer engage customers in testing and issuing the final results report?

Customer engagement is the responsibility of the developer. The Advisory Services team can provide planning and input on considerations in the customer engagement process and help you organize and execute other steps in the RWT process. For a detailed description of how Drummond Advisory Services can assist your RWT efforts, please contact advisoryservices@drummondgroup.com.

How is the RWT plan going to change year by year?

Developers should expect to be required to make changes to their RWT plans each year. This could be necessary for several reasons, including changes to criteria requirements, new versions of standards, or changes in ONC’s requirements for RWT. For example, all certified health IT updated to newer versions of standards (voluntary or mandatory) prior to Aug. 31 of the year in which the updates were made must be included in the following year’s test plan.

If there are no changes in the application for list of certification criteria, do we still need to submit the revised RWT plan this year?

RWT plans must be submitted every year, regardless of whether the certified health IT product adds or removes any criteria to its listing. It also may be advisable to make changes based on “lessons learned” from year to year. Note: All certified health IT software updated to newer versions of standards (voluntary or mandatory) prior to Aug. 31 of the year in which the updates were made must be included in the following year’s test plan.

Can the same test plan be submitted again in this case?

Theoretically, yes, you can submit the same test plan updated to the current calendar year. However, it is unlikely no additional changes will be required given the requirements to include any criteria updated to newer versions of standards and any criteria updated to 21st Century Cures update revisions. Other variables that may require changes to your test plan include changes to the types of care settings where the certified health IT is deployed or the number of users. The Advisory Services team will be focused this year on helping customers assess what changes may be needed in 2023 plans and how to address them.

Regarding 170.315(g)(10), please expand on what is meant with this statement made in the webinar: “Deadline for ACB acceptance is the end of November.” Does this mean we need to complete our live certification session by Nov. 30?

A scheduled test session prior to Nov 30, 2022, is highly recommended to allow for the possibility that retesting could be required (i.e., due to any “failure”). The final deadline to conduct (g)(10) testing with Drummond’s ATL is Dec. 16, 2022. We anticipate the test dates will be filled quickly, so we advise scheduling your test session soon to secure your preferred date for testing. The Advisory Services team’s (g)(10) Workbench Review also can provide you with pretesting support and guidance to help you prepare for your ATL test session.

What happens if we do not certify to all the (g)(10) criteria by the deadline?

ONC has not provided specific outcomes at this time. Depending on which criteria are not updated for a given certified health IT product, we anticipate the action taken could vary from specific criteria removed from a certified health IT product’s listing or enforcement action up to and including decertification.

Can you share where to find the test plan for (g)(10) in the Drummond portal?

Please login to Drummond’s customer portal and search for the term “Proctor” in the search bar near in the upper right corner.

What is the deadline to update to FHIRv4?

For products currently certified to (g)(8) API-Data Category Requests, developers must certify and deploy technology to the new (g)(0) Standardized API for Patient and Population Services criterion no later than Dec. 31, 2022.

What if your EHR will be decommissioning its third-party API prior to the need for updating to (g)(10), i.e., changing to use a vendor provided solution?

Any requests to remove certified functionality should be done well before Dec. 31, 2022, to avoid compliance issues. If you remove any certified functionality from your certified health IT product, your CHPL listing must be updated to reflect the changes. In this scenario, all API criteria would be removed from that product’s CHPL listing. Removing the API criteria means the certification will no longer meet the ONC base EHR definition: https://www.healthit.gov/topic/certification-ehrs/2015-edition-test-method/2015-edition-cures-update-base-electronic-health-record-definition

If you would like your product to remain certified to the API criteria, you would need to retest using your new API solution designed to meet the g10 criterion.

Please confirm if SDOH is required for (g)(10) certification.

SDOH is not a requirement under USCDI v1. Currently, USCDI v1 is the only standard acceptable for certification to (g)(10). Under SVAP, ONC may decide to approve USCDI v2 in 2022, but no announcements have been made to date. In the meantime, we advise clients to use USCDI v1.

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