ehr onc final certification - Department of Health Care Services

commenters reasoned that because a Complete EHR or EHR Module must be tested and
certified to be in compliance with 42 CFR 493.1291(c)(1) through (7) that certification
should replace any requirement for the laboratory to confirm that the information has
been properly transmitted and meets the CLIA requirements. These commenters also
asserted that a laboratory should be relieved of any further regulatory responsibility under
42 CFR 493.1291(c)(1) through (7) for the display of the required report information to
the physician or subsequent viewers of the information if the Certified EHR Technology
has been implemented by an eligible professional or eligible hospital. One commenter
reiterated the point by stating that because Certified EHR Technology would be required
to display the required CLIA report elements, laboratories should not be unfairly held
accountable for any elements that may be removed or altered by other parties from the
test report before received by the physician.
Response. While we can understand the concern expressed by these commenters,
we reiterate that the scope of our authority under this final rule only applies to
capabilities that Certified EHR Technology must include. As a result, we cannot provide
the regulatory relief that these commenters seek.
Comments on 170.302(g)(4)
Comments. A couple of commenters questioned whether we intended for the
“updates” to be manual updates of electronic records. If that were true, some
commenters were concerned that would create workflow problems and reduce the
availability of results. Other commenters suggested that either the user be able to create
an additional record, rather than be permitted to change the “official” record or that an
adequate audit trail be preserved of the existing data and any updates, since an update
Page 71 of 228