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ehr onc final certification - Department of Health Care Services

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We estimate that this <strong>final</strong> rule could have effects on Complete EHR and EHR<br />

Module developers, some <strong>of</strong> which may be small entities. However, we believe that we<br />

have established the minimum amount <strong>of</strong> requirements necessary to accomplish our<br />

policy goals and that no appropriate regulatory alternatives could be developed to lessen<br />

the compliance burden associated with this <strong>final</strong> rule. In order for a Complete EHR or<br />

EHR Module to provide the capabilities an eligible pr<strong>of</strong>essional or eligible hospital will<br />

be required to use under the Medicare and Medicaid EHR Incentive Programs <strong>final</strong> rule,<br />

it will need to comply with the applicable <strong>certification</strong> criteria adopted by the Secretary.<br />

Moreover, we note that this <strong>final</strong> rule does not impose the costs cited in the regulatory<br />

impact analysis as compliance costs, but rather as investments which Complete EHR and<br />

EHR Module developers voluntarily take on and expect to recover with an appropriate<br />

rate <strong>of</strong> return. Accordingly, we do not believe that the <strong>final</strong> rule will create a significant<br />

impact on a substantial number <strong>of</strong> small entities. The Secretary certifies that this <strong>final</strong><br />

rule will not have a significant impact on a substantial number <strong>of</strong> small entities.<br />

E. Executive Order 13132--Federalism<br />

Executive Order 13132 establishes certain requirements that an agency must meet<br />

when it promulgates a proposed rule (and subsequent <strong>final</strong> rule) that imposes substantial<br />

direct requirement costs on State and local governments, preempts State law, or otherwise<br />

has federalism implications.<br />

Nothing in this <strong>final</strong> rule imposes substantial direct compliance costs on State and<br />

local governments, preempts State law or otherwise has federalism implications. We are<br />

not aware <strong>of</strong> any State laws or regulations that are contradicted or impeded by any <strong>of</strong> the<br />

standards, implementation specifications, or <strong>certification</strong> criteria that have been adopted.<br />

Page 204 <strong>of</strong> 228

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