The 21st Century Cures Act of 2016 (Cures Act) required ONC to establish the Electronic Health Records (EHR) Reporting Program to provide transparent reporting on certified health IT in the categories of interoperability, usability and user-centered design, security, conformance to certification testing, and more. The Condition and Maintenance of Certification associated with the “EHR Reporting Program” was created within the ONC Health IT Certification Program as part of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. In HTI-1 Final Rule, the “EHR Reporting Program’ is referred to as the “Insights Condition and Maintenance of Certification” (“Insights Condition”).
The goal of the Insights Condition is to provide transparent reporting on certified health IT. The Insights Condition’s reporting will: (1) Address information gaps in the health IT marketplace; (2) Provide insights on the use of specific certified health IT functionalities; and (3) Provide information about use of certified functionalities by end users.
While both the Insights Condition and Real World Testing seek to provide transparency regarding the interoperability of certified health IT, the Insights Condition consists of a standard set of measures and metrics that applicable developers report on; whereas Real World Testing measures are unique, developer-generated measures.
Insights Condition and Maintenance of Certification Enforcement Discretion: In consideration of potential future deregulatory actions under ASTP/ONC authorities and consistent with EO 14192, ASTP/ONC has identified certain regulatory requirements for which the exercise of enforcement discretion may prevent or mitigate the accrual of sunk costs by regulated entities. Read more about the Insights Condition Enforcement Discretion.
Resources
HTI-1 Insights Condition Fact Sheet
Insights Measure Specifications Version 4 Clarifications Fact Sheet
Measurement Specification Sheets
Note: Certified Health IT developers may use either Insights Measure Specifications finalized in HTI-1 (Version 2) or Version 4 specifications for reporting.
| Measurement Specification | Version(s) Available |
| Individual Access | Version 4, Version 2 |
| C-CDA Reconcile | Version 4, Version 2 |
| Supported Apps | Version 2 |
| Use of FHIR | Version 4, Version 2 |
| Use of FHIR Bulk Data | Version 2 |
| Immunization Administrations | Version 4, Version 2 |
| Immunization Query | Version 4, Version 2 |
Applicable Certification Criteria
The Insights Condition and Maintenance of Certification is an annual requirement. The Insights Condition measures and metrics are phased in over three years, and different criteria will become applicable for these measures based on a phased schedule.
Below lists only the applicable criteria for reporting but does not include the specific measures that are required related to those criteria. Please review the above resources to determine the full scope of measure requirements.
- § 170.315(e)(1) View, download, and transmit to 3rd party
- § 170.315(f)(1) Transmission to immunization registries
- § 170.315(g)(10) Standardized API for patient population services
- § 170.315(b)(2) Clinical information reconciliation and incorporation