The Office of the National Coordinator for Health IT has issued corrections and clarifications to its 2015 edition of certification criteria.
The changes, published in the Federal Register Dec. 11, clean up parenthetical, cross referencing and language errors and omissions in some of the criteria. For instance, ONC corrects an error in the definition of what is in a base EHR, noting that it did not intent to include social, psychological and behavioral data certification criteria in that definition.
The notice also clarifies a few provisions in the certification criteria. For example, the Common Clinical Data Set (CCDS) references four specific C-CDA section templates for the unique implantable device identifier; assessment and plan of treatment; goals; and health concerns. ONC clarifies that "the references to these four specific C-CDA section templates is not meant to be strictly interpreted to mean that a health IT developer must use the C-CDA's syntax for each referenced section." ONC says that for the last three, only the narrative part of the C-CDA section templates are required to satisfy the CCDS.
Additionally, the agency clarifies how the Health IT Module can meet applicable 2015 Edition privacy and security certification criterion "by demonstrating, through system documentation that is sufficiently detailed to enable integration, that the Health IT Module has implemented service interfaces for each applicable privacy and security certification criterion that enable the Health IT Module to access external services necessary to meet the privacy and security certification criterion," known as ''Approach 2." Access includes bi-directional interfaces with external services--defined as outside the scope of the Health IT module being presented for certification--and the Health IT module is not required to be paired with the other services for purposes of certification.
The changes go into effect Jan. 14, 2016. Since the changes are being characterized as merely corrections and clarifications, ONC has taken the position that they are not subject to rulemaking with its notice and public comment requirements.
The 2015 edition of certification criteria was published in the Federal Register on Oct. 16, the same day that the final rule changing the Meaningful Use program for 2015-2017 and outlining Stage 3 of the program was published. The certification rule focuses more on interoperability through the care continuum, not just on the Meaningful Use program, as had prior editions, and moves away from EHR modules to health IT modules.
ONC has also issued certification companion guides to help EHR developers understand and interpret the regulations.
To learn more:
- read the notice (.pdf)