ATLANTA -- In a surprise announcement at the Healthcare Information and Management Systems Society conference here today, national coordinator of health IT Dr. David Blumenthal and his staff unveiled the administration's proposal for how electronic health record systems will be certified under the health IT incentive plan.
The notice of proposed rulemaking details a two-stage process that would enable health IT vendors initially to receive temporary certification for their products in time for providers to meet looming 2011 deadlines for qualifying for first stage meaningful use requirements.
To meet that time frame, certified electronic health records must be "available before fall 2010," according to the proposed rule.
Under the proposal, the ONC would authorize multiple organizations to test and certify electronic health records (EHRs) and EHR modules prior to first round of meaningful use deadlines.
"The temporary program is critical as it assures the availability of certified EHR technology prior to the date on which health care providers may begin demonstrating meaningful use," said Blumenthal, who appeared at an ONC Town Hall at the HIMSS conference to introduce the plan.
The temporary initial program would serve as a bridge to a second, permanent level of certification, which would establish detailed guidelines to support an ongoing program of testing and certification of health IT, Blumenthal wrote in a blog posting describing the plan.
The permanent certification program would separate responsibilities for performing testing and certification, introduce accreditation requirements and establish requirements for certification bodies authorized by the ONC for the surveillance of certified EHR technology.
The temporary program would end once the permanent certification program is put in place and ONC has approved at least one certification body.
The National Institute of Standards and Technology will assist ONC in establishing the certification programs as called for under the HITECH Act.
A defined program for certification will ensure providers that electronic health record systems they purchase are capable of meeting the standards, functionality, security and other approved technical requirements that would enable physicians and hospitals to become meaningful users of health IT under the plan.
Those standards and requirements are defined in the Interim Final Rule that ONC published in January.
"Certification isn't just about meaningful use," Blumenthal said. "At its core, it is about providing assurances to patients and providers that EHR technology can deliver the benefits of improved quality of care and protect personal health information."
While the two certification programs are described in the proposed rule, ONC said it anticipates issuing separate final rules for each of the programs.
HHS will accept public comment period for the temporary certification program for 30 days after publication in the Federal Register and for the permanent certification program, 60 days after publication in the Federal Register.
Under the temporary certification program, an organization or group of organizations could apply to ONC to be temporary certifiers of either complete EHRs or HER modules, but not both.
ONC will act for the time being as an accreditor of organizations but not in the permanent certification process.
According to the rule, applicants would provide ONC with documentation that they can perform quality assurance and testing under International Organization for Standardization, as well as provide a copy of their quality manual, management structure, and policies and approach to confidentiality.
Applicants would also have to take a proficiency exam to assess their ability to "competently" test EHRs and modules.
Temporary certifiers would perform both testing and certification of EHRs.
However, in the permanent certification program, testing and certification will be done by different organizations. According to the proposed rule, testing produces "objective, unanalyzed" data, while certification results in an "assessment of the test results."
For a vendor to pass the testing requirements for an e-prescribing EHR module, for instance, the software needs to be able to transmit an electronic prescription using mock patient data, according to the required standards.
Then, the module would be evaluated for certification, which requires that the vendor agree to a number of provisions, including, for example, displaying the module's version and revision number so potential purchasers may compare when it was last updated or certified.
