E9-31216 III B 3

3. Definition of Certification Criteria

The term certification criteria is described at section 3001(c)(5)(B) of the PHSA to mean ``with respect to standards and implementation specifications for health information technology, criteria to establish that the technology meets such standards and implementation specifications.

We have incorporated this description into our definition of certification criteria described below and expanded it to also address how the term is used in various parts of the HITECH Act.

The definition consequently encompasses more than just certification criteria that establish technology meets ``standards and implementation specifications.

In support of meaningful use, for instance, there are many other capabilities Certified EHR Technology will need to provide under the HITECH Act even though such capabilities do not require a particular standard or implementation specification.

As a result, we believe that it is critical for these capabilities to be tested and certified too.

To do otherwise would potentially make it difficult for eligible professionals and eligible hospitals to know whether the Certified EHR Technology they have adopted and implemented will support their achievement of meaningful use.

For example, if we did not require a certification criterion for medication reconciliation, a proposed meaningful use Stage 1 objective, Certified EHR Technology under this scenario would not provide any assurance to an eligible professional or eligible hospital that the proposed meaningful use Stage 1 requirement could be met.

On the other hand, by adopting a certification criterion for medication reconciliation in this interim final rule, eligible professionals and eligible hospitals can be assured that once they adopt and implement Certified EHR Technology, it includes, at a minimum, the medication reconciliation capabilities required to support their achievement of the proposed meaningful use Stage 1 requirement.

For these reasons we have defined the term certification criteria to encompass both the statutory description and the statutory use of the term.

The definition consequently also includes other certification criteria that are not directly tied to establishing that health information technology has met a standard or implementation specification.

We have therefore defined certification criteria to mean:

criteria:

(1) To establish that health information technology meets applicable standards and implementation specifications adopted by the Secretary; or

(2) that are used to test and certify that health information technology includes required capabilities.