The 2015 Edition Test Method provided the structure for evaluating conformance of the Health IT Module to the certification criteria defined in 45 CFR Part 170 Subpart II of the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule as published in the Federal Register on October 16, 2015.
The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule made several changes to the existing 2015 Edition Health IT Certification Criteria. The final rule introduced a small number of new certification criteria, revised several existing certification criteria, and removed several certification criteria (some immediately and others on a time-limited schedule). These changes constitute the “2015 Edition Cures Update." On December 31, 2022, all developers were required to certify to the 2015 Edition Cures Update versions of their certified criteria for their certified health IT products to remain in compliance with the Certification Program. Following this date, criteria were transitioned to the naming convention of “2015 Edition Cures Update” and any time-limited or revised 2015 Edition criteria were removed from the Certification Program.
The archive below includes access to all criteria that existed as part of the 2015 Edition prior to the implementation of the Cures Act Final Rule.
2015 Edition Base EHR Definition
Effective December 31, 2022, the Base EHR Definition was updated to reflect the 2015 Edition Cures Update criteria and discontinued reference to the 2015 Edition certification criteria. The below table provides a reference for the 2015 Edition Base EHR Definition. The current Base EHR definition can be accessed at 2015 Edition Cures Update – Base EHR Definition.
| Base EHR Capabilities | Certification Criteria Prior to the Final Rule Publication Compliance Date (Before December 31, 2022) |
|---|---|
| Includes patient demographic and clinical health information | Demographics § 170.315(a)(5) Implantable device list § 170.315(a)(14) |
| Capacity to provide clinical decision support | Clinical decision support § 170.315(a)(9) |
| Capacity to support physician order entry | Computerized provider order entry § 170.315(a)(1), (2) or (3) |
| Capacity to capture and query information relevant to health care quality | Clinical quality measures – record and export § 170.315(c)(1) |
| Capacity to exchange electronic health information with, and integrate such information from other sources | • Transitions of care § 170.315(b)(1) or § 170.315(b)(1) (Cures Update) • Application access – patient selection § 170.315(g)(7) • Application access – data category request § 170.315(g)(8) or Standardized API for patient and population services § 170.315(g)(10) • Application access – all data request § 170.315(g)(9) or § 170.315(g)(9) (Cures Update) • Direct Project § 170.315(h)(1) or Direct Project, Edge Protocol, and XDR/XDM § 170.315(h)(2) |
| The requirements of the 2015 Edition Cures Update Base EHR Definition can be met using one Certified Health IT Module or a combination of Certified Health IT Modules. | |