The Interoperability Standards Advisory (ISA) process represents the model by which the Office of the National Coordinator for Health Information Technology (ONC) will coordinate the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the United States healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, and research purposes. ONC encourages all stakeholders to implement and use the standards and implementation specifications identified in the ISA as applicable to the specific interoperability needs they seek to address. Furthermore, ONC encourages further pilot testing and industry experience to be sought with respect to standards and implementation specifications identified as “emerging” in the ISA. For historical background on the ISA please review prior ISA publications.
The ISA is frequently updated to include improvements made based on recommendations received from public comments and subject matter expert feedback. To learn more about major revisions of the ISA, please review recent ISA updates. Registered users may subscribe to change notifications to be alerted by e-mail of all revisions to individual interoperability needs or for ISA-wide changes. Anyone may become a registered user by submitting an account request. Once logged in, look for the blue “change notification” button at the bottom of the interoperability need page, or at the bottom of the home page to be notified of any changes across the ISA. An RSS Feed was also added in 2018, capturing more granular updates made to the ISA.
Starting with the 2017 ISA, the ISA’s focus expanded to more explicitly include public health and health research interoperability. Thus, its scope includes electronic health information created in the context of treatment, and subsequently used to accomplish a purpose for which interoperability is needed (e.g., a referral to another care provider, public health reporting, or research). Added in late 2017, the ISA now also includes interoperability needs related to Administrative functions within healthcare. These additions were made through coordination with CMS, other administrative healthcare interoperability needs continue to be added.
The ISA is not exhaustive but it is expected to be incrementally updated to include a broader range of health IT interoperability needs. When more than one standard or implementation specification is listed it is intended to prompt industry dialogue as to whether one standard or implementation specification is necessary or if the industry can efficiently interoperate more than one. It may also reflect the fact that there is an ongoing transition from the use of one standard towards a new version or even a next-generation approach.
As noted in previous ISA publications, a standard listed in one section is not intended to imply that it would always be used or implemented independent of a standard in another section. To the contrary, it will often be necessary to combine the applicable standards from multiple sections to achieve interoperability for a particular clinical health information interoperability need.
It is also important to note that the ISA is designed to inform standards and implementation specification choices for all types of health IT that support interoperability needs, not solely electronic health record (EHR) systems. Furthermore, the ISA is not intended to imply that health IT systems need to support all of the listed standards and implementation specifications. Rather, in the event that a health IT developer or healthcare provider seeks to address a particular interoperability need, the ISA should serve as the first resource consulted to inform the selection of standards and implementation specifications. Additionally, the ISA is designed to inform the “what” that could be used to address an interoperability need in order to assure industry consistency around standards selection and is not mean to explicitly direct “how” the standards and implementation specifications would be implemented to address an interoperability need (e.g., application programming interface or conversion tools).
The ISA is designed to be a coordinated catalog of standards and implementation specifications that can be used by different stakeholders to consistently address a specific interoperability need. However, a listed interoperability need (and its associated standard(s) and implementation specifications(s)) is not meant to universally apply to all stakeholders. Rather, if a listed interoperability need is relevant to a particular clinical specialty, for example, the ISA is designed to provide a consistent foundation from which these stakeholders can agree on applicable technical requirements. Similarly, in cases where a listed interoperability need is not applicable to a given stakeholder group, the ISA in no way compels such stakeholders to consider that interoperability need.
Please note that the ISA serves as an informational resource for available standards, specifications, profiles, etc that exist to meet the interoperability needs contained within. Stakeholders should ensure and verify that they are adhering to applicable federal, state, and/or local laws or regulations regarding requirements to use a specific standard or specification that may conflict with the information listed in the ISA, as these requirements supersede the ISA.
The Interoperability Standards Advisory is meant to serve at least the following purposes:
- To provide the industry with a single, public list of standards and implementation specifications that can be used to address specific health information interoperability needs in the United States. Currently, the ISA is focused on interoperability for sharing information between entities and not on intra-organizational uses.
- To reflect the results of ongoing dialogue, debate, and consensus among industry stakeholders when more than one standard or implementation specification could be used to address a specific interoperability need, discussion will take place through the ISA public comments process. The web-version of the ISA improves upon existing processes, making comments more transparent, and allowing for threaded discussions to promote further dialogue.
- To document known limitations, preconditions, and dependencies as well as provide suggestions for security best practices in the form of security patterns for referenced standards and implementation specifications when they are used to address a specific clinical health IT interoperability need.
The ISA is designed to provide clarity, consistency, and predictability for the public regarding the standards and implementation specifications that could be used for a given clinical health IT interoperability purpose.
Stakeholders who administer government programs, procurements, and testing or certification programs with clinical health IT interoperability components are encouraged to look first to the ISA in order to more fully inform their goals. In that regard, standards and implementation specifications in the ISA and their associated informative characteristics are also available to help more fully inform policymaking. In this case, a standard or implementation specification’s reference in the ISA may serve as the initial basis for industry or government consideration and action. While the ISA itself is a non-binding document and meant to be advisory in nature, standards and implementation specifications listed in the ISA may be considered for rulemaking or other Federal requirements. However, those decisions would be made on a case-by-case basis by the administering organization.
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