After holding hearings in May about the problems associated with the EHR certification program, the Health IT Policy Committee recommended at its June 10 meeting that the Office of the National Coordinator hold a “kaizen” workshop to streamline the program and that ONC consider limiting the scope of certification requirements.
Paul Tang, M.D., vice president and chief innovation and technology officer at the Palo Alto Medical Foundation and vice chair of the committee, first summarized some of the challenges identified by providers, vendors, certification bodies and others. Providers noted that EHR products may meet certification criteria, but the way the functions are implemented may disrupt their workflow, he said. Vendors complained that certification criteria for meaningful use objectives, reports that measure these objectives, and the clinical quality measures are not aligned with each other and are not necessarily aligned with clinical practice.
The committee adopted vendors’ recommendation that a “kaizen” continuous improvement process be used to support a review of the certification program to reduce complexity. The kaizen would cover the end-to-end certification process, all the way from translation of meaningful use objective to certification criteria to development of testing scripts to development and quality assurance of testing tools to conduct of test to auditing.
Karen DeSalvo, M.D., national coordinator for health IT, said that certification “is an area we believe there is an opportunity for improvement, and we are open and willing to make that happen. She said the general notion of a culture of continuous improvement for the certification process is a high priority for ONC. “Where we can make iterative improvements now, we will, while we work on broader improvements.”
The committee’s discussion became more contentious when it came to the second recommendation: that the scope of the certification program be considerably curtailed.
The initial proposal was to minimize the burden on providers and vendors by limiting the scope of certification to interoperability, clinical quality measures, and privacy and security.
As committee member and software entrepreneur Paul Egerman said, during the May hearing it was clear that people are very unhappy with the current process, which he called “broken.”
But several committee members asked what was potentially being sacrificed by limiting certification to three areas only. Christine Bechtel, an advisor with the National Partnership for Women & Families, asked how would any future meaningful use objective develop around issues such as patient-generated health data or clinical decision support if they were not tied to certification criteria. “Would vendors create functionality but not based on any standard?” she asked.
Tang responded that the meaningful use program is migrating toward using clinical quality measures, and providers need certain functionality from their systems to meet those measures. But that it might rely less on certification of EHR features and more on how health IT can help deliver better outcomes. That was the original vision, he noted.
New committee member Chris Lehmann, M.D., professor of pediatrics and biomedical informatics at Vanderbilt University, said that as a representative for vulnerable populations, he had “fundamental concerns about weakening certification processes.” Like Bechtell, he said the committee would have to look closely at what functionality would fall by the wayside.
Eventually, the committee approved the recommendation to create a Kaizen process to streamline and rationalize the certification process. It also approved a somewhat watered-down version of the scope limitation recommendation, which suggests limiting the scope but not necessarily to just the three outlined in the original proposal.
The meeting also began a discussion of April’s JASON report called “A Robust Health Data Infrastructure.” DeSalvo said discussion about the report will help develop a roadmap on refining interoperability goals and strategy. A work group has been established to evaluate the JASON report, which called on ONC to define an overarching software architecture for the health data infrastructure within the next 12 months. It said EHR vendors should be required to develop and publish APIs that support the architecture of the health data infrastructure.
