One of the most important functions that the Office of National Coordinator for Health IT (ONC) performs is administering the ONC Health IT Certification Program (the Program). A critical aspect of the Program is to ensure that certified health IT meets established requirements in order to give confidence to users that the health IT performs in conformance with those requirements. Testing in controlled test environments has been a cornerstone of the Program’s processes, however, it is also important to gauge the performance of systems in the field, just as drug development evaluates both efficacy in the laboratory and effectiveness in the real world.
To that end the 21st Century Cures Act required ONC to include real world testing as a condition of certification in the Program, which ONC implemented as part of the Cures Act Final Rule. The Program’s real world testing processes require certified health IT developers to demonstrate the interoperability and functionality of their products in real world settings. December 15, 2021 was the deadline for certified health IT developers to submit their first real world testing plans which will measure performance in 2022. ONC is pleased to note that 100% of the certified health IT developers subject to this requirement submitted their real world testing plans!
ONC worked closely with the ONC-Authorized Certification Bodies (ONC-ACBs) and the developer community throughout 2021, and we thank our industry partners for their commitment to achieving the goals of real world performance at the point of care, where it counts the most. While the Program hit its first real world testing milestone and is off to a great start, the work has only just begun! By March 15, 2023, the results of these testing plans covering performance in 2022 will be posted on the CHPL, which will provide the market with the first comprehensive view of real world performance of certified health IT.
Health IT is dynamic and ever-evolving, so real world testing will be an ongoing annual process in order to keep pace. By December 15th of each year, certified health IT developers will need to submit updated plans for testing over the coming calendar year, with results made available to the public by March 15 of the next year.
We encourage everyone to visit the CHPL to view the 2022 real world testing plan submissions and look forward to posting the results early next year. Please go to HealthIT.gov for more information about the program, including recorded public webinars and presentations, and to stay on top of latest developments.
This article was originally published on the Health IT Buzz and is syndicated here with permission.