ONC Releases Proposed Rule for Standards, Certification Criteria for 2014 and Beyond

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By Genevieve Douglas  

The Office of the National Coordinator for Health Information Technology Feb. 24 released a proposed rule detailing standards, implementation specifications, and certification criteria needed to achieve “meaningful use” of electronic health records beginning in 2014.

ONC's proposed rule complements the recently released Centers for Medicare & Medicaid Services' proposed rule for Stage 2 of the Medicare and Medicaid EHR incentive programs—which provide incentive payments to eligible health care providers as they adopt certified EHR technology (36 HCDR, 2/24/12).

The proposed rule includes revised EHR certification criteria for ONC's permanent certification program that would increase regulatory clarity and transparency, reduce regulatory burden, and add flexibility for the health information technology community, the agency said.

Additionally, the revised EHR criteria would enhance care coordination, patient and family engagement, interoperability, and the security, safety, and efficacy of EHR technology, according to ONC.

The proposed rule will appear in the March 7 Federal Register. Comments are due 60 days after publication.

New Certification Criteria

Specifically, ONC's proposed rule would revise the definition of “certified EHR technology” to describe a “Base EHR” (EHR technology that includes fundamental capabilities all providers would need), in addition to EHR technology necessary to meet the meaningful use objectives for any given stage of meaningful use.

A Base EHR would include such fundamental capabilities as the ability to provide clinical decision support, to support physician order entry; the capacity to exchange health information with other sources; and the capacity to protect the confidentiality, integrity, and availability of health information stored and exchanged, ONC said.

The proposed rule also modifies the certification processes ONC-Authorized Certification Bodies (ONC-ACBs) would need to follow for certifying EHR modules. The modified certification processes would provide clear implementation direction and compliance with proposed new certification criteria, and also reduce regulatory burden by eliminating the certification requirement that every EHR module be certified to the privacy and security certification criteria, according to the rule.


ONC wants public comment on whether it should require EHR technology developers to disclose the full cost of a certified complete EHR or certified EHR module.


Furthermore, the proposed rule revises the process for permitting the use of newer versions of “minimum standard” EHR code sets. This new approach would reduce regulatory complexity and burden by providing the industry with the flexibility to quickly utilize newer versions of adopted minimum standard code sets, ONC said.

Request for Public Input

ONC requested that the public comment specifically on proposed certification criteria that are intended to improve patient safety, such as through patient-centered technology and clinical quality measurement.

Additionally, ONC would like feedback on ways to improve data portability, including comment on a proposal to improve data portability for providers.

ONC is also seeking comment on the concept of “price transparency” in regard to the cost of a certified complete EHR or certified EHR module.

Feedback is also requested from the public on whether it should require EHR technology developers to disclose the full cost of a certified complete EHR or certified EHR module.

For More Information

The proposed rule is at http://op.bna.com/hl.nsf/r?Open=lroi-8rst65.


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