The 2015 Interoperability Standards Advisory
The following represents an initial list of what ONC considers the best available standard(s) and implementation specification(s) for many clinical health data interoperability purposes as of December 2014. This list does not yet represent the full breadth and depth necessary to recognize all of the purposes for which stakeholders may seek to interoperate. The standards and implementation specifications listed in future advisories will incrementally include a broader range of clinical health information interoperability purposes.
While the standards and implementation specifications included in an advisory may also be adopted in regulation (already or in the future), required as part of a testing and certification program, or included as procurement conditions, the advisory is non-binding and serves to provide clarity, consistency, and predictability for the public regarding ONC’s assessment of the best available standards and implementation specifications for a given interoperability purpose. It is also plausible, intended, and expected for advisories to be “ahead” of where a regulatory requirement may be, in which case a standard or implementation specification’s reference in an advisory may serve as the basis for industry or government action.
When one standard or implementation specification is listed as the “best available,” it reflects ONC’s initial assessment and prioritization of that standard or implementation specification for a given interoperability purpose. When more than one standard or implementation specification is listed as the best available, it is intended to prompt industry dialogue as to whether one standard or implementation specification is necessary or if the industry and efficiently interoperate more than one.
“Best Available” Characteristics
Standards and implementation specifications in the list were included as the “best available” based on the following characteristics and in consideration of past analyses and factors for assessing standards and implementation specifications 6:
- The standard or implementation specification is adopted for a given purpose by HHS in 45 CFR Part 170 Subpart B (entitled “Standards and Implementation Specifications for Health Information Technology”) or required for compliance by another federal agency for that purpose;
- The standard or implementation specification is used by federal agencies to electronically exchange health information with organizations participating in the eHealth Exchange (and which generally serve as the basis for electronically exchanging with such agencies);
- A “normative” or “draft standard for trial use (DSTU)” (or equivalently labeled) standard or implementation specification is published and in use by a significant number of stakeholders for a given purpose;
- A “normative” or “draft standard for trial use (DSTU)” (or equivalently labeled) standard or implementation specification is published and there is no known alternative or available equivalent to that standard or implementation specification for a given purpose; or
- The next version of a “normative” or “draft standard for trial use (DSTU)” (or equivalently labeled) standard or implementation specification is published and its prior version is included as a best available standard for a given purpose.
Overall, ONC expects some stakeholders to disagree with a standard or implementation specification listed as the “best available” in the 2015 Advisory for a specific purpose, with the omission of a standard or implementation specification, or with the inclusion of “competing” standards or implementation specifications. This disagreement is welcome and supported by the process (discussed in Section VI) through which ample time and opportunity for public comment and dialogue will be provided to improve this advisory for the future. Additionally, if stakeholders have suggestions for other characteristics, Section V includes questions related to the Interoperability Standards Advisory as a whole.
Additional Factors Affecting Best Available Determinations
The characteristics above serve as the primary basis on which a “best available” determination was made for the 2015 Advisory. However, a few additional factors contributed to the overall determination.
- Timelines & Availability – The Interoperability Standards Advisory is meant to reflect the current state of available standards and implementations specifications that stakeholders could adopt, implement, and use within that calendar year for a specific purpose for which interoperability is necessary. As a counter example, next year’s 2016 Advisory would not include a standard or implementation in the process of being developed and expected to be ready during 2016. Instead the 2017 Advisory would be the next available opportunity for that standard or implementation specification to be listed.
- Stability & Adoptability – If a standard or implementation specification is “new” it should not be automatically excluded from consideration as a best available standard or implementation specification. The “stability” of the standard or implementation specification plays an important role in its overall adoptability. In other words, “new” standards and implementation specifications will be open for consideration and inclusion in an Interoperability Standards Advisory so long as a version of the standard or implementation specification is available and not undergoing substantive changes or corrections.
Distinguishing between a Standard and an Implementation Specification
In general, an “implementation specification” is a set of specific constraints, instructions, or requirements that provide additional detail on how to implement a standard to achieve a specific purpose. For instance, many public health reporting purposes use the HL7 2.5.1 standard. But that standard alone is insufficient to achieve interoperability for a specific public health reporting purpose. Thus, for each purpose, an accompanying implementation guide is necessary that includes unique implementation requirements to assure interoperability can be achieved for that purpose (e.g., HL7 2.5.1 standard + immunization reporting implementation guide). In some cases, a “standard” may have “implementation guide” or “implementation specification” in its title. To the degree that there is a clear “parent” standard for an implementation specification, the “parent” standard is listed as the “standard” and all other derivatives are listed as an implementation specification.
The Structure of Sections I through IV
For the purposes of the lists that follow, a specific version of the standard or implementation specification is not listed unless it is necessary to make a distinction. The standards and associated implementation specifications for clinical health information are grouped into four categories:
- Vocabulary/code sets/terminology (i.e., “semantics”).
- Content/structure (i.e., “syntax”).
- Transport (i.e., the method by which information is moved from point A to point B).
- Services (i.e., the infrastructure components deployed and used to accomplish specific information exchange objectives)
A superscript [R] is noted before a standard or implementation specification if it meets the first “best available” characteristic – adopted in regulation by HHS or required by another federal agency. Again, some of the standards and implementation specifications listed may be “ahead” of any regulatory requirement. Additionally, if a “cell” in a table below is blank for a listed “purpose,” the blank was intentional to identify the need for standards for that purpose but for which ONC could not determine a best available standard to indicate without additional input.
An explicit stand-alone category for “security standards” was purposefully omitted because security standards for information exchange using the internet are commonplace and not unique to health care. However, specific security standards are identified with applicable transport standards in order to convey a secure approach for the use of the best available transport standards identified. Stakeholders should consult the information security resources made available by the National Institute of Standards and Technology (NIST), which provides up-to-date references to security standards (such as encryption) among other approaches to secure transmissions over the internet as well as guidance from the HHS Office for Civil Rights.
Section V includes questions related to the Advisory in general as well as specific questions for each individual section in which standards and implementation specifications are listed. In addition, the Advisory is not intended to imply that a standard listed in one section 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 purpose.