Healthcare groups are urging the Office of the National Coordinator for Health Information Technology to update its interoperability standards advisory to include information beyond its traditional focus on clinical care.
The ISA is a collection of agency-recognized interoperability standards and implementation specifications. It isn't binding and is meant to be used as a reference of available standards. The ONC encourages healthcare stakeholders to use it, particularly to help pilot emerging standards and specifications.
The ONC plans to release its 2020 edition of the ISA in December, after reviewing feedback from provider and technology groups. Public comment on the most recent version of the ISA closed Monday.
Healthcare groups requested the ONC more clearly specify the voluntary nature of the ISA, so as not to confuse those participating in other agency programs, such as the Trusted Exchange Framework and Common Agreement.
In comments to the ONC, stakeholders also highlighted the growing need to incorporate patient data beyond clinical care.
The EHR Association requested the ONC revamp its stated purpose of promoting "clinical health IT interoperability needs" and, as part of that mission, replace all references to "EHR" with a more comprehensive "HIT." In a separate comment, Kaiser Permanente advocated for adding standards to connect administrative transactions as a way to "enhance the ISA's value."
Kaiser Permanente also suggested the ONC look into linking EHR systems with patient-facing apps, including consumer devices and FDA-regulated remote monitoring tools.
"The complexity, abundance and variety of use cases for mobile devices and (patient-generated health data) argues for strict adherence to a limited set of national standards to avoid overloading certified health IT with conflicting demands for software development and deployment," Kaiser wrote.
Kaiser's request dovetailed with the Pew Charitable Trusts' request that the ONC add standards related to social determinants of health.
While researchers and developers are still studying how to best capture and use information on a patient's social and environmental factors including housing and employment status, Pew encouraged the ONC to begin identifying data elements and associated standards to ensure greater consistency across technologies.
"Addressing this challenge with SDOH now prior to widespread capture and development can help prevent interoperability hurdles that exist with other information due to a lack of uniformity," Pew wrote in a comment to the ONC.
Provider and technology groups also called on the ONC to revamp how it quantifies ISA adoption. Currently, the ONC uses a five-point scale to indicate the agency's "best guess" at a standard's average adoption level across the U.S. ranging from low adoption to high or widespread adoption.
But that system needs to be clearer, according to comments on the ISA. That could include more clearly indicating what factors and sources were considered for each rating, or by retiring the five-point scale and replacing it with quantitative data, such as assessing what types of users—EHR vendors or patient-facing apps, for example—have deployed each standard.
"The adoption level choices and judgments for individual ISA and standards entries can be too subjective," said Health Level Seven, a not-for-profit standards organization, adding that identifying the percent of users using a particular standard could prove helpful to understand adoption. HL7 oversees FHIR, a framework for moving health data that's included in the ISA.
In a letter to the ONC, Epic Systems Corp. argued the agency needs to assess what types of software companies are using different standards.
"The adoption level would be a more reliable metric if it were informed by quantitative data about the rate of implementation," Epic wrote. "Because reviewers have little understanding of how adoption level is assessed, it is unclear how a health IT developer would use the informative characteristic when designing their system."
