FDASIA Workgroup Recommends FDA Expedite Guidance on HIT Software and Mobile Medical Apps
September 20, 2013 02:31 PM
Earlier this month, a wide ranging group of stakeholders involved in healthcare, patient safety, the U.S. government, and the mobile industry known as FDASIA released its final Committee Report to the Health IT Policy Committee (HITPC), which is an important Federal Advisory Committee within the U.S. Department of Health & Human Services (HHS) under the Office of the National Coordinator for Health IT (ONC). The HITPC delivered the FDASIA report to three federal agencies including the Food and Drug Administration (FDA), ONC, and the Federal Communications Commission (FCC).
The FDASIA workgroup was charged to provide expert input to the FDA, ONC, and FCC, to help inform the development of a report by those three agencies on “an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.”
In this report, the FDASIA group makes the following statement: “FDA should expedite guidance on HIT software, mobile medical apps and related matters.” The report goes further to explain that the FDASIA workgroup has “described current regulatory frameworks, potential new approaches, and deficiencies, ambiguities and duplication in current frameworks” in addition to having “described what we believe will be helpful to promote innovation in both the short and long term and maintain patient safety.”
The report goes on to state that, “The agencies should address the deficiencies, ambiguities and duplication the FDASIA group has identified.” Taken in part or in whole, these recommendations are clear: The FDA should move forward and expeditiously release the final Mobile Medical Applications (MMA) Guidance Document.
Jodi G. Daniel, J.D., Director of the Office of Policy and Planning at ONC, Bakul Patel Patel, Senior Policy Advisor at the FDA’s Center for Devices and Radiological Health, and Matthew Quinn, Director of Healthcare Initiatives at Federal Communications Commission (FCC) issued a combined statement to thank the FDASIA group for their recommendations and included the “next steps” that the agencies will take.
Over the next few months the FDA, ONC, and FCC will review the HIT Policy Committee’s recommendations and public comments submitted through a docket opened for FDASIA on regulations.gov. Referencing the public comments, ONC, FDA, and FCC will work closely together to develop a report - by the January 2014 statutory deadline - that proposes an overarching health IT regulatory strategy and provides recommendations on ways to appropriately promote innovation, protect patient safety, and avoid regulatory duplication.
The three agencies stated that they “recognize the complex nature of health IT and its importance to our nation’s health.” Therefore, they intend to provide an opportunity for public comment and additional stakeholder input on the draft report following its publication in January 2014.