E9-31216 I


 * I. Background *

The Health Information Technology for Economic and Clinical Health Act (HITECH Act), Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111–5), was enacted on February 17, 2009.

The HITECH Act amended the Public Health Service Act (PHSA) and created ‘‘Title XXX—Health Information Technology and Quality’’ to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT) and the electronic exchange of health information.

Section 3004(b)(1) of the PHSA requires the Secretary of the Department of Health and Human Services (the Secretary) to adopt an initial set of standards, implementation specifications, and certification criteria by December 31, 2009 to enhance the interoperability, functionality, utility, and security of health information technology.

It also permits the Secretary to adopt this initial set through an interim final rule.

The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health Record (EHR) technology (Certified EHR Technology) will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.

Throughout this interim final rule, we routinely refer to eligible professionals and eligible hospitals.

This is done because we have closely aligned the initial set of standards, implementation specifications, and certification criteria adopted by this rule to focus on the capabilities that Certified EHR Technology must be able to provide in order to support the achievement of the proposed criteria for meaningful use Stage 1 by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.

This initial focus is not meant to limit or preclude health care providers who do not meet the definitions of eligible professional or eligible hospital from obtaining or adopting Certified EHR Technology.

To the contrary, Certified EHR Technology will possess the capabilities that can assist any health care provider to improve the quality, safety and efficiency of the care they deliver.

We note that ordinarily we publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule.

The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved.

As mentioned above, however, section 3004(b)(1) explicitly authorizes the Secretary to issue this rule on an interim final basis.

Moreover, section 3004(b)(1) requires the Secretary to adopt an initial set of standards, implementation specifications, and certification criteria by December 31,2009.

We have therefore decided to proceed directly with this interim final rule.

Nevertheless, we are providing the public with a 60-day period following publication of this document to submit comments on the interim final rule.

The following discussion provides the background information relevant to the Secretary’s adoption of an initial set of standards, implementation specifications, and certification criteria.