Home > EHR, FDA, IOM > FDA Safety and Innovation Act Workgroup Members to be Named Next Week

FDA Safety and Innovation Act Workgroup Members to be Named Next Week

The Office of the National Coordinator for HIT (ONC) revealed that the roster of the FDA Safety and Innovation Act (FDASIA) Workgroup will be announced late next week.  The workgroup’s first meeting is scheduled for April 9.  This announcement was made during the HIT Standards Committee’s virtual meeting on March 27.

The purpose of the new workgroup will be to advise ONC, FDA, and FCC during the agencies’ development of a report to Congress on an appropriate regulatory framework for HIT, particularly in the area of mobile medical applications.  The FDA Safety and Innovation Act of 2012 mandated this activity due to concern about FDA’s 2011 draft guidance on mobile medical apps, as well as potential jurisdictional overlap between the three regulatory agencies.

Interestingly, Dr. Paul Tang (HIT Policy Committee Chair) will chair the new workgroup even though it was not originally intended by Congress to fall under the ONC HIT Policy Committee.

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Categories: EHR, FDA, IOM

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