REAL WORLD TESTING PLAN TEMPLATE
REAL WORLD TESTING PLAN TEMPLATE
BACKGROUND & INSTRUCTIONS
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 170.405). 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 in developing 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 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 the 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. While the use of this template is voluntary, health IT developers
may find it useful in preparing their Real World Testing plans. 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 expects 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. While every effort
has been made to ensure the accuracy of restatements of 45 CFR Part 170, this template is not a
legal document. The official program requirements are contained in the relevant laws and
regulations. 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 – Coming Soon
• 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) (ONC Cures Act Final
Rule)
o Section VII.B.5 — “Real World Testing”
9/10/2021