ISO/TR 12310, “Health informatics – Principles and guidelines for the measurement of conformance in the implementation of terminological systems,” has just been released. This new Technical Report is a milestone in the efforts to provide EHR (Electronic Health Record) users with consistent data from system to system. Stakeholders now have guidance on how to determine what a terminology system is and how to judge if it has been implemented in a correct and consistent manner. This in turn promotes interoperability, an essential component of an effective EHR system. The principles of this technical report can be extrapolated wherever a move to conformance standardization is of benefit.
The ISO/TR 12310 is based on current work occurring in Canada as well as that of the IHTSDO (International Health Terminology Standards Development Organization) and HL7’s Vocabulary Committee. It is not only intended for a commercial audience but also for government stakeholders. It is expected to facilitate the development of policies and practices from a local level to the international arena.
The 34-page report is especially broad in it’s approach. It starts with the usual scope clause but instead of a referenced documents section, clause 2 covers the report’s objectives. Clause 3 returns to the usual format of a definitions section. Then the publication moves into the heart of the matter.
Clause 4, “Purposes for conformance,” discusses the benefits of using a conformity scheme. And clause 5 covers the four steps of the conformance process itself. Additionally, you’ll learn what the various levels of required compliance are so that there’s no confusion over a recommendation vs. a requirement and so on.
Next the report covers how to review existing material prior to instituting the new conformance system itself. This is referred to as “artefact” considerations, in this case codes that are already in use. Clause 7 focuses in on the user experience that will be impacted by the conformance system itself: data capture, exchange and analysis. It takes a look at both coded and non-coded information for a complete picture of the situation and proposed new outcome.
Clause 8 covers sharing and persisting conformance expectations. This is a discussion of how to present specific conformance requirements for use by developers and by assessment schemes. It helps you understand why some requirements are actually included as XML or CSV statements rather than as documentation “representations.”
The ISO/TR 12310 then addresses the need of those who are compliant to this type of specification to have a way to assert conformity. It discusses various levels of conformity, assumptions, variations and so on. Clauses 10 and 11 show you how to evaluate and verify these types of conformance statements. A review of other considerations like comparing conformance statements and IP issues that can arise finish up the report. A two-item bibliography is included.
This new Technical Report is a great overview of conformance documents and how to create and use them. It will be of great value to the Health Informatics industry, but has something to offer others considering developing or implementing such schemes.
Of course, to get your copy of ISO/TR 12310, you’ll need to purchase a copy from an authorized distributor like Document Center Inc. Why? This is copyright information that comes with specific rights and responsibilities. You can purchase your copies in paper format or for pdf download with confidence from the Document Center Store at www.document-center.com. Want to go directly to this technical report? Here’s the link for ordering ISO/TR 12310.
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