The growing debate over how and whether the FDA should regulate health IT will be one of the big stories of the year, Jeff Smith, assistant director of advocacy for College of Healthcare Information Management Executives (CHIME), said in a podcast at healthsystemCIO.com.
"There are factions that want the FDA to have more defined and even tighter control over health IT, and then there are others who would rather have a self-regulatory regime. And as to which side is going to ultimately win out, it's not at all clear," he said.
"I do think that right now a lot of CIOs can at least rest easy for the time being in the sense that I don't think they're going to be in danger of coming under any kind of new regulatory regime," Smith said. "This is something that the vendor community is acutely interested in, but as with most things health IT, what affects the vendors will ultimately affect the providers. So it's a conversation that will be developing over the course of the year for sure."
The Food and Drug Administration, the Office of the National Coordinator for Health IT, and the Federal Communications Commission are due to unveil a report in February to address a proposed risk-based strategy for health IT that promotes innovation, protects patient safety and avoids regulatory duplication. That framework will be open to public comment.
New National Coordinator of Health IT Karen DeSalvo is coming in at a pivotal point as several programs--among them the health information exchange and Beacon communities--are set to expire.
"A lot of what's been driving activity at ONC is starting to come to a close, and yet they still have a tremendous amount of work to do in the standards arena," said Smith, adding that he hopes DeSalvo brings renewed focus as well as vitality to the scene.
With the delay of Meaningful Use Stage 3, Smith said he's hopeful health IT leaders will spend the extra time trying to understand outcome measures that just wouldn't be possible without technology.
"We still have a hard time convincing federal officials that the degree of folks struggling with Stage 2 is as high as we say it is. They're a very data-driven group of people, and unfortunately, with Meaningful Use it's one of those situations where you just might not know until it's too late," he said, according to healthsystemCIO.com.
After a "bridge year" for Meaningful Use, 2014 could be painful for providers, FierceEMR's Marla Durben Hirsch wrote recently.
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