Certification as a catalyst to accelerate HIT adoption

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The Certification Commission for Health Information Technology (CCHIT) is well on its way to meeting the aggressive timeframe of certifying the first EHR products this year. The group held a town meeting during the Medical Records Institute annual conference Towards the Electronic Patient Record (TEPR 2006), held this week in Baltimore.

The mission of CCHIT is to accelerate the adoption of robust, interoperable healthcare information technology throughout the United States by creating an efficient, credible, sustainable mechanism for the certification of healthcare IT products. CCHIT was founded in 2004 with support from three industry associations in healthcare information management and technology -- the American Health Information Management Association (AHIMA), the Healthcare Information and Management Systems Society (HIMSS), and The National Alliance for Health Information Technology (Alliance). In September 2005, CCHIT was awarded a contract by the U.S. Department of Health and Human Services to develop, create prototypes for, and evaluate the certification criteria and inspection process for electronic health records (EHRs) and the infrastructure components through which they interoperate.

After extensive planning, via pilot testing and open comment periods, among other steps, the Commission settled on a $28,000 fee for the first year of certification, followed by a much lower annual maintenance fee. Mark Leavitt, MD, PhD, chair of the Commission, said the group wanted to be sure the fee didn’t eliminate small vendors. However, he said a sliding scale proposal was rejected by all the vendors, large and small. That would have required that they disclose their revenues, something most want to avoid. Besides, that fee is minimal compared to the cost of staying relevant in the marketplace. “Realistically, if you can’t invest $28,000 in certification, are you investing enough to keep your product up-to-date?” Leavitt said. The Commission thought that amount was low enough that all the vendors could handle it.

The fees were the main criticism that arose during the town meeting. Leavitt reminded the attendees that certification of EHRs is voluntary. However, several vendors and audience members said that they would lose market share if they weren’t certified.

Leavitt said CCHIT would continue to seek the right balance in the coming years for who pays what for certification. He said the group, which holds a federal contract to certify healthcare IT products and the networks that connect them, was in talks with employers about pitching in to pay for tests. Leavitt said he did not know whether certification fees in subsequent years would go up, down or stay the same. Once certified, a vendor can market its product as “2006 certified” for three years.

The fees must not be too prohibitive – at least two dozen vendors have applied for certification of ambulatory EHR products. The inspection process is now under way. CCHIT plans to announce which products are certified by mid-July.

Leavitt said there will be an open application period four times a year. Prior to this first round, the Commission put out a call for jurors and got at least 175 applications. The group recruited and trained 50 jurors who signed confidentiality and conflict of interest agreements. They conducted a pilot test of a web conferencing setup for the inspection. Vendors provide a functional demonstration and the jurors conduct a security inspection with about 250 steps. A proctor runs the session and the jurors vote independently. One hundred percent compliance is required. If the product does not pass each step, the vendor can request another inspection and three new jurors.

Leavitt said there was some fear that a lack of jurors could be a weak link in the process. They were pleasantly surprised with the response. “People are interested in seeing this process be successful.”

The Commission also focused on “developing something everyone could trust,” he said. Providers wanted a rigorous certification process while vendors wanted a simple process. “Hopefully, the result is fair and balanced.”

The certification contract set an aggressive schedule, which was challenging but good for the industry, Leavitt said. “There’s so much inertia. The rising ride of faster adoption will lift all boats. The HIT market is smaller than it could be so if this is done right, it helps everyone at the table.”