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Statement of Need: The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria for electronic health record (EHR) technology. In a notice of proposed rulemaking, the Secretary would propose new and revised standards, implementation specifications, and certification criteria that would establish the technical capabilities that certified EHR technology would need to include in order to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

Summary of the Legal Basis: Under the authority provided by section 3004 of the Public Health Service Act (PHSA), the Secretary would propose to adopt revisions to the initial set of standards, implementation specifications, and certification criteria and propose new standards, implementation specifications and certification criteria.

Alternatives: No alternatives are available because eligible professionals, eligible hospitals, and critical access hospitals under the CMS Medicare and Medicaid EHR Incentive Programs are required to demonstrate meaningful use of certified EHR technology. This rule ensures that the certification requirements necessary to support the achievement of meaningful use Stage 2 keep pace with the changes to the requirements in the CMS Medicare and Medicaid EHR Incentive Programs.

Anticipated Costs and Benefits: EHR technology developers seeking certification are expected to incur costs related to EHR technology redesign, reprogramming, and new capability development. Benefits include greater standardization and increased EHR technology interoperability and functionality.

Risks: Absent a rulemaking, it is unlikely that currently certified EHR technology would include the requisite capacities to support an eligible professional's, eligible hospital's, or critical access hospital's achievement of meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.