FDA, ONC officials reiterate focus of health IT framework

Details and official dates are still mum, and plenty of questions remain, but federal employees gave some detail on the long-awaited new report that creates a risk-based regulatory framework for health IT in a conference call with reporters on Thursday.

Officials with the Office of the National Coordinator for Health IT, the U.S. Food and Drug Administration and the Federal Communications Commission discussed some of the report's fine points during the call.

Jeffrey Shuren (pictured right), director of the FDA's center for devices and radiological health, emphasized that the proposed strategy will focus primarily on health management IT, such as medical management software and most clinical decision support software.

"Efforts to assure the safety of products in this category will be led by ONC, and involves products that are sufficiently low risk, such that even if some of the products may meet the statutory definition of medical device, FDA does not intend to focus on them," Shuren said.

Added Jodi Daniel, director of ONC's office of policy and planning: "These functions are implemented in complex environments, where responsibility is distributed by various actors, such as developers, implementers and users, and safety requires action across all of these entities."

Daniel (pictured left) said that the strategy keeps all of those different "actors" in mind when it comes to regulation.

"Thinking about health IT, and safety in particular, requires consideration of not just the developers, but also how products are used, how they're implemented [and] how they're integrated with other products," she said. "It really is a complex, sociotechnical system. If we want to focus on safety, we have to focus on all of the different players … and activities that occur at different places in that cycle."

Daniel also talked about the report's recommendation to create a health IT safety center, for which $5 million was allocated on ONC's 2015 proposed budget.

"We're looking at this as something that will be a public-private entity with broad stakeholder engagement that will focus on three things," she said, which include:

  • Engagement of all of the different stakeholders involved in development, adoption and use of health IT
  • Education, so that folks can learn from best practices of others--what works, what doesn't, where there might be common challenges, where there may be safety issues that need to be mediated
  • Evidence to try to take all of the data that is out there and pull it together through analytics so we can see trends where there may be health IT safety issues or where there may be best practices to help address some of those safety issues

"We see this as being a trusted convener for all different parties to come together to be able to discuss some of the challenges, as well as some of the successes, that folks are having," Daniel said.

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