The U.S. Food and Drug Administration, working with the Federal Communications Commission and the Office of the National Coordinator for Health IT, is close to completing its mandated report to Congress on a risk-based regulatory framework for health I.T. Officials from the three agencies provided an update on the status of the report at a HIMSS14 panel discussion.
Though the report was due to Congress by January 2014, panelists said that the agencies' goal is now to issue the report by the end of March. Representatives of the FDA, ONC and FCC all emphasized at the panel session that when the report is released it will be in draft form only. The report is mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA).
"The report that will come out is a draft report for public comment," said Jodi Daniel, director of ONC's Office of Policy and Planning. "It's important to reiterate that so folks don't think we're going to be putting something out in March that will sort of change the landscape. It is the beginning of a conversation and we really do welcome input."
According to the agencies involved, the report will make recommendations on an appropriate, risk-based regulatory framework" for health I.T., including mobile medical applications, and will "promote innovation and protect patient safety while avoiding regulatory duplication." Among other technology areas, the report will cover clinical decision support (CDS) software, which wasn't addressed by the FDA's September 2013 final guidance on mobile medical applications.
"The mobile medical apps guidance specifically called out that clinical decision support needs more discussion," said Bakul Patel, FDA senior policy advisor and the primary author of the agency's final guidance on mobile medical apps. "We said that's part of the bigger framework."
Matthew Quinn, the FCC's Director of Healthcare Initiatives added that "the diversity of what we call CDS is parallel with the diversity of what we call health I.T." and "that's why this is complicated."
Daniel described the process as "challenging yet powerful" to date in putting together the report. In September, a federal advisory committee established under section 618 of FDASIA, which included experts drawn from a wide range of fields, produced their own report laying out a comprehensive taxonomy to help policymakers determine the types of health I.T. that should be considered for possible inclusion in the risk-based regulatory framework.
"The charge was to make recommendations to form the development of the report," said Daniel. "So, it wasn't to actually create or propose a framework. It was to give us feedback and recommendations of what we should be thinking about and how we should be thinking about this task."
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