On March 21 in the third of three hearings held by subcommittees of the House Energy and Commerce Committee, Farzad Mostashari, National Coordinator for Health Information Technology reassured a congressional panel that health IT interoperability will take some dramatic leaps forward within the next two years.
Michael Burgess, MD, (R-Texas) vice-chairman of the House Subcommittee on Oversight and Investigation, questioned the sluggishness of interoperability.
“We do hear about this a lot,” Burgess said. “Even anecdotally, hospital systems in the same city, that have the same operating system aren’t talking to each other.”
“You’re the head, why don’t you fix that?” Burgess asked Mostshari. “Why don’t you just make that happen?”
“We are using every lever at our disposal to increase the sharing of information,” Mostashari answered. The Office of the National Coordinator is trying to get the industry to help with standards. “We don’t want to be the ones to say, 'we’ll choose the standards.’ We want to really work with industry to get consensus and to accelerate this,” he said.
“The 2014 certification criteria are a big step forward, and I believe that hospitals and doctors around the country will see a palpable difference once those certification criteria are in place,” Mostashari added.
The March 21 hearing focused on discussing the development and innovation in healthcare technologies, particularly “apps,” and how federal regulations may impact this growing industry. Joining Mostashari as witness was Christy Foreman, director of the Office of Device Evaluation within the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA).
Over the course of three days, the GOP-led subcommittees questioned the FDA regarding potential taxes on healthcare apps. Foreman joined others who testified on previous days in reassuring Congress that very few apps will need FDA approval; only apps that are used for medical diagnostics.
On March 4, the House Subcommittee on Oversight and Investigation sent a letter to the FDA regarding the rapid growth of health apps in the market, and the still undetermined landscape of FDA regulation in this area. In 2011, the FDA issued draft guidance on healthcare app regulation. Over the course of the three hearings, a continual cry went up from witnesses urging FDA to publish final guidance soon.