EHR Interoperability Issues Hindering Health Data Registries
March 25, 2015 in News
At a Senate Committee on Health, Education, Labor and Pensions hearing on Tuesday, stakeholders said the lack of interoperability among electronic health record systems is preventing data registries from realizing their full potential, Health Data Management reports.
During the hearing — titled “Continuing America’s Leadership: Advancing Research and Development for Patients” — experts said that registries could expedite the medical device approval process (Slabodkin, Health Data Management, 3/25).
Senate HELP Committee Chair Lamar Alexander (R-Tenn.) said, “FDA has struggled to regulate the most cutting-edge medical products,” adding, “The disparity is threatening America’s position as a leader in biomedical innovation” (Allen et al., “Morning eHealth,” Politico, 3/25)
Michael Mussallem — chair and CEO of Edwards Lifesciences who was testifying on behalf of the Advanced Medical Technology Association — said his firm leveraged a registry to get FDA approval for a new use of one of its products.
Allan Coukell, senior director of health programs at The Pew Charitable Trusts, cited a clinical trial in Sweden that mined data from a cardiovascular disease registry. He said, “The TASTE trial enrolled more than 7,000 patients, and — in unprecedented fashion — allowed investigators to keep track of every patient throughout the course of the research at a total cost of $50 per patient, or only $300,000 for the entire trial.” According to Coukell, conducting such a study in the U.S. would “cost hundreds of millions of dollars, if not more.”
Interoperability Key to Realizing Full Potential of Registries
Several barriers are limiting the ability of registries to help bolster medical innovation, according to experts at the hearing.
Coukell said, “Despite the dramatic uptake of electronic health information sources, these systems cannot easily transmit data among one another,” adding, “Instead, registries must develop the ability to extract information from the EHR systems at each facility, or require manual entry from providers.”
According to Coukell, “[I]f we were better at pulling that from the electronic health record — or at least some of the data — it would reduce the costs of operating the registries.”
Mussallem said registries are “very powerful tools that can really work” if they “can be automatically populated so you don’t make this another big administrative burden for hospitals” (Health Data Management, 3/25).