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The launch of the permanent program for certification of electronic health records will be delayed in the USA

07/11/2011

WASHINGTON – The launch of the permanent program for certification of electronic health records will be delayed until mid-2012, in order to coincide with the anticipated final rule for Stage 2 of meaningful use and standards and certification criteria.

ONC officials also cited the need more time to assemble and approve testing labs and authorized certifying bodies, according to a Nov. 2 announcement by National Coordinator Farzad Mostashari, MD, in a preview area of the Federal Register. ONC will officially publish the notice Nov. 3.

Previously, ONC intended to sunset its temporary program at the end of the year and open the permanent and more comprehensive program on or around Jan. 1. ONC has authorized six temporary testing and certifying bodies to approve EHRs and/or EHR modules, which perform only selected functions. They have certified 1,200 EHRs or modules to date.

The certification program assures that EHRs can perform the functions needed by providers to meet meaningful use requirements.

[See also: ONC issues final rule for permanent certification program.]

“We believe that the sunset of the temporary certification program should be tied to the effective date of the final rule that we intend to issue in summer 2012,” ONC said in the notice.

The final rule is expected to require new and revised standards, specifications for establishing the standards and certification criteria to qualify for the Medicare and Medicaid EHR incentive program.

Aligning the expiration of the temporary certification program with the effective date of the final rule will offer “certainty to healthcare providers, EHR technology developers, and other stakeholders, while also ensuring a sufficient number of accredited testing laboratories and ONC-ACBs [ONC-Authorized Certification Bodies] exist to meet market demand,” ONC said, adding that it will publish another notice if it anticipates more changes to the temporary program.

ONC pushed the plan back after it consulted with the American National Standards Institute (ANSI), which ONC selected as its approved accreditor (ONC-AA) earlier this year, and the National Institute of Standards and Technology (NIST), which administers the National Voluntary Laboratory Accreditation Program (NVLAP). ANSI and NIST said they needed more time to complete the approval of testing labs and certification organizations and ONC to review the applications of the certifiers.

[See also: ANSI approved for permanent EHR certification program.]

ONC published in January a final rule describing the permanent health IT testing and certification program details. Organizations must first be accredited in order to test and/or certify health IT. Certification organizations, or ONC-ACBs, will conduct surveillance of EHRs after they receive certification.

They may also perform "gap certification" of new functions and features when ONC requires new or revised certification criteria. NIST is developing a laboratory accreditation program for organizations to be accredited to test health IT.

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