[This story was corrected on 6.21.10 to clarify that ONC's plan to pick organizations to certify and test health IT systems under its temporary certification program for health IT is not limited to non-profit organizations. We regret the error. -- Ed.]
The Office of the National Coordinator will launch its health IT certification program on Thursday when it makes available applications for organizations that want to apply to become testers and certifiers of electronic health records.
ONC released its final rule last week for its "temporary" certification program, which lays out steps organizations must take to be authorized by ONC to test and certify EHRs.
The temporary program is designed to enable health IT vendors to have the products and services certified in time for providers to meet looming 2011 deadlines for qualifying for first stage meaningful use requirements.
The publication of the rule June 24 in the Federal Register will trigger the launch of the program. On July 1, ONC will begin to accept and process applications from organizations that want to become an ONC-Authorized Testing and Certification Body, according to senior ONC officials.
ONC expects the authorized organizations to begin testing and certifying EHRs "in late summer," and "by fall, certified EHR products will be on the market," said Carol Bean, ONC division director of certification and testing. ONC will list the selected authorized organizations on its Web site.
The regulation "is absolutely pivotal to our long-term goals of creating an environment in which providers can, with confidence, acquire electronic health records, and electronic health records can realize their full benefits for the American people," said Dr. David Blumenthal, the national health IT coordinator, in a briefing with reporters also June 18.
Certification provides assurances to healthcare providers who purchase an EHR system or EHR modules that the product or service will work as expected and will also include the functions and features to help them improve the quality of care of their patients and to meet the meaningful use criteria to qualify for payment incentives, he said.
According to the final rule, testing determines the degree to which an EHR can meet specific and measurable requirements. Certification is the assessment by an organization once it has analyzed the quantitative results of testing that the EHR has met all of the certification criteria.
The authorized testing and certifying organizations will report to ONC on the products that they have certified and supply information, including version, model and vendor, as well as each certification requirement to which that product has been certified, and a unique identification number, Bean said.
ONC will keep a Certified Health IT Product List (CHPL), pronounced "˜chapel' of all certified EHR products and to what criteria they have been certified in order to manage and monitor what is available in the market. With the master list, ONC will also be able to provide the unique identification numbers for the combination of certified products or modules that together satisfy all of the certification criteria, she said.
"This is an important piece so organizations that already have some technology or choose to go a route that enables them to customize or pick and choose will be able to do," Bean said. They will have a way to test and report that they satisfy all the criteria that will make them technologically capable to achieve meaningful use.
In March, ONC published a notice of proposed rulemaking in which it detailed a two-stage process for a temporary program that would bridge to a more comprehensive permanent certification program. According to the final rule, the temporary program will end Dec. 31, 2011, when ONC anticipates that the permanent program will start up.
The National Institute of Standards and Technology is assisting ONC in establishing the certification programs as called for under the HITECH Act.
