E9-31216 III B 2

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2. Definition of Implementation Specification

The term implementation specification is defined at 45 CFR 160.103 of the HIPAA Rules as ``specific requirements or instructions for implementing a standard.

We believe that this definition conveys accurately the meaning of the term as used in the HITECH Act, which seeks consistency between these implementation specifications and those adopted under HIPAA.

Moreover, the concept it applies complements the definition of standard adopted in this interim final rule.

Additionally, this definition is straightforward, easy to understand, and is otherwise consistent with our goals.

We have therefore adopted the HIPAA regulatory definition of implementation specification without modification.