Feds promise to publish FDASIA report on HIT regulation in March

Federal officials speaking at a panel discussion Tuesday at HIMSS14 in Orlando, Fla., said they expect to publish a draft report on a risk-based regulatory framework for health IT that promotes innovation, protects patient safety and avoids regulatory duplication by the end of March.

The report, mandated by the Food and Drug Administration Safety and Innovation Act of 2012, was supposed to be released last month. But according to Jodi Daniel (pictured center), director of the Office of the National Coordinator for Health IT's Office of Policy Planning, the process for developing the report, which she called "very public facing," allowed for as much stakeholder input as possible.

"We don't have a report out yet because we have had such a collaborative process," Daniel said. "I can vouch personally for the level of engagement and collaboration that we've all had in trying to think this through."

Bakul Patel (pictured left), senior policy advisor to the director of the Center for Devices and Radiological Health at FDA, echoed Daniel's comments, saying that the workgroup has taken feedback very seriously.

"We need to get to a point where we can not only really promote adoption [of health IT], but ... while this adoption is happening, we can continue to be safe and we keep the public health in mind. That's what we are driving toward," Patel said.

According to Patel, one of the key pieces of advice the workgroup received was to focus the framework on functionality of health IT, as opposed to the type of tools used.

"It does not matter how you get to the endpoint of providing better outcomes or decisions or support or healthcare," he said. "It's about what [the tools] do at the end of the day. It's not about platforms."

Added Matt Quinn (pictured right), director of healthcare initiatives at FCC: "This is really about the entire life cycle. It's not just about products and getting on the market, it's about implementing them. Because in the real world, it's not just one product that's in a hospital, it's a conglomeration of a bunch of products."

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