Archive for May, 2013

FDASIA Workgroup Releases Initial Request for Comments

On May 30, the Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup—the newly formed advisory body jointly administered by the Food and Drug Administration, Office of the National Coordinator for HIT, and Federal Communications Commission—published a Request for Comments (RFC) on potential considerations for the development of recommendations on an appropriate, risk-based regulatory framework for HIT and mobile medical applications.

The FDASIA Workgroup is soliciting initial input on the following broad questions:

1. Taxonomy

a. What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?

2. Risk and Innovation

a. What are the risks to patient safety posed by health IT and what is the likelihood of these risks?
b. What factors or approaches could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety?

3. Regulation

a. Are there current areas of regulatory overlap among FDA, ONC, and/or FCC and if so, what are they? Please be specific if possible.
b. If there are areas of regulatory overlap, what, if any, actions should the agencies take to minimize this overlap? How can further duplication be avoided?

The ACR IT and Informatics Committee is currently reviewing the RFC. If any members of the American College of Radiology are interested in submitting feedback for potential inclusion in the ACR’s future comments, please contact me at or 202-223-1670 ext. 4546.

Categories: EHR, FDA, IOM, research

FDASIA Workgroup Gets Started

May 16, 2013 1 comment

Over the past couple of weeks, the newly formed Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup, administered by the Food and Drug Administration, Office of the National Coordinator for HIT (ONC), and Federal Communications Commission, held its first series of virtual meetings and established subgroups.  The three subgroups will address taxonomy, risk assessment, and regulatory levers.

The plan is for a series of draft FDASIA Workgroup recommendations to be presented to the ONC HIT Policy Committee on August 7, with final recommendations presented on September 4.  The three agencies intend to publish draft strategies/recommendations for public comment between September 2013 and January 2014.  The goal is to release a final report by the end of January 2014.

Categories: EHR, FDA, research