Diana Manos, Senior Editor

The Certification Commission for Health Information Technology is expected to release more details on its “modular” certification on Sept. 24, and it is also tentatively planning training sessions in Chicago on Sept. 29 and Oct. 1, to orient vendors and developers to new programs, including updated application processes, certification criteria and test scripts.

The modular approach to certification would tell providers that a healthcare IT product is capable of performing to provide meaningful use, a requirement under the federal stimulus law under which providers could receive bonus payments beginning in 2011.

The certification would be provided in advance of the definition of meaningful use, which is expected out by the end of the year.

Federal officials have said providers would have to make “a business decision” as to whether to go forward in faith with the modular certification ahead of the final rulemaking.

The Certification Commission for Health Information Technology held a “town call” Web conference Thursday to gather input from the vendor and developer communities on the commission’s planned new paths to certification for electronic health record technologies.

CCHIT Chairman Mark Leavitt, MD, said the goal is to achieve more rapid, widespread adoption and meaningful use under the American Recovery and Reinvestment Act of 2009 (ARRA).

“We are concerned that providers could not achieve meaningful EHR use in 2011 if they wait until spring 2010 - the expected date of (the Department of Health and Human Services’)’ final approval of requirements - to begin adopting this technology,” said Leavitt, “CCHIT has analyzed the recommendations of the federal HIT advisory committees and is preparing to offer new paths to certification beginning this October.”

Besides updating and enhancing its certification program for comprehensive EHRs in ambulatory, inpatient and emergency department settings, the commission plans to launch a more limited, modular inspection program for EHR technology, focusing solely on compliance with ARRA-required standards.

In an Aug. 14 meeting, the federal government’s Health IT Policy Committee adopted additional recommendations on meaningful use and proposed expansion of EHR certification to include 10 to 12 certification panels in addition to the existing Certification Commission for Health Information Technology. Physicians, activists, vendors and others warned the committee at a meeting that it was moving too fast.

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Researchers at the University of Pennsylvania School of Medicine have discovered that electronic medical records can be used to test drug efficacy.

Richard Tannen, MD, a professor of medicine at the university, was the lead researcher in the study to find out if patient data, as captured by EMR databases, could be used to obtain vital information as effectively as randomized clinical trials when evaluating drug therapies.

“Our findings show that if you do studies using EMR databases and you conduct analyses using new biostatistical methods we developed, we get results that are valid,” Tannen said. “That’s the real message of our paper - this can work.”

Tannen said his group recognized that large EMR databases could potentially give researchers the ability to study groups reflective of the total population, not just those who participate in clinical trials, and circumvent studies too costly or unethical for clinical trials.

“Our study cautiously, yet strongly, suggests that enormous amounts of information within electronic medical records can be used to expand evidence of how we should or shouldn’t manage healthcare,” he said.

Some critics have argued that these databases contain observational information, which does not offer the same level of control as random trials. To address this criticism, Tannen’s group had to determine a way to use EMR databases for insights on therapy efficacy and then prove the results they found were valid.

Tannen’s team selected six previously performed random trials with 17 measured outcomes and compared them to study data from an electronic database - the UK general practice research database (GPRD), which included the medical records of roughly 8 million patients. Treatment efficacy was determined by the prevalence of cardiovascular outcomes, such as stroke, heart attack and death.

Researchers used standard biostatistical methods to adjust for differences in the treated and untreated groups in the analysis of the database information and found there were no differences in the database outcomes compared to random clinical trials in nine out of 17 outcomes.

In the other eight outcomes, Tannen’s group used an additional new biostatistical approach that controlled for differences between the treated and untreated groups prior to the time the study began. By using the new method instead of the standard approach, the researchers showed there were no differences between the outcomes in the EMR database study compared to the random clinical trials.

Tannen said the ability to use EMR databases from the United States to measure the efficacy of therapies will take more than 10 years of national data, and the results of this study should serve as a catalyst for more researchers to explore the accuracy of the information that can be obtained using EMR database studies.

“An appropriately configured EMR database could offer an invaluable tool, but we need to get to work now on how to configure it properly,” Tannen said. “If we don’t worry about this issue right now and promote a higher investment in the area of EMR research, we’ll lose … an enormous health opportunity.”

Source from HealthcareITNews