The below information is directly related to the Certification Process - for updates and information pertaining to Testing, please visit the ATL's Testing Program Updates page.
On May 1, 2020 the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule was officially published in the federal register. The rule introduced many new changes to the ONC’s 2015 Edition Health IT Certification Program, including the removal of the following 2015 Edition criteria:
Additional criteria set to be removed by January 1, 2022 are:
The criterion set to be removed as of December 31, 2022 is:
The criterion set to be removed as of December 31, 2023 is:
Additionally, the 2015 Edition Cures Update introduced the following two new technical certification criteria as well as two new privicay and security criteria:
Additional details on the changes to the above criteria, and their applicable timelines, can be found on the Cures Update Reference Guide.
Conditions and Maintenance of Certification
The Cures Act established a set of requirements for health IT developers that define both the initial and ongoing certification requirements for health IT developers and their certified health IT modules. These are divided into the following seven distinct areas:
Details regarding the these seven Conditions of Certification can be found on the Conditions and Maintenance of Certification tab.
ONC announced an Interim Final Rule (IFR) that extends many of the compliance dates and timeframes previously issued as part of the recent Cures Act final rule in March of 2020. These changes have been proposed in light of the COVID-19 pandemic. A summary of the changes include:
The Interim Final Rule extends the Program compliance dates beyond those identified in the April 21, 2020 enforcement discretion announcement and establishes new future applicability dates for information blocking provisions. The Interim Final Rule also adopts updated standards and makes technical corrections and clarifications to the ONC Cures Act Final Rule.
New Applicability and Compliance Dates/Timeframes & Corresponding Provisions
April 5, 2021 | December 31, 2022 | One Calendar Year Extension |
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Additionally, compliance for the Real World Testing (RWT) requirements was extended on calendar year.
ICSA Labs certification staff conducts regualar surveillance on all certified products to ensure continued conformance to the standards and requirements under which the product was certified. Surveillance activities are tracked and documented as part of the policy guidance issued by the ONC. For more information on surveillance, see the ONC's Program Guidance.
See the current ICSA Labs Surveillance Plan, here
The Cures Act Final Rule officially retired the 2014 Edition ONC Health IT Certification Program as of June 30, 2020. Developers who were certified in the 2014 Edition Program are no longer able to claim certification and are required to remove any references of their 2014 Edition certified products from their website disclosures and/or marketing materials.