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Sonali Gunawardhana Discusses Report Proposing Limits to FDA Regulation of Health IT

eHealth Law & Policy
April 15, 2014

Sonali P. Gunawardhana, of counsel in Wiley Rein’s Food & Drug Law Practice, was quoted in an article published in the April issue of eHealth Law & Policy regarding the proposed strategy and recommendations for a risk-based framework for health information technology (IT) as presented in the FDASIA Health IT Report.

According to the article, the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT, and the Federal Communications Commission published a report on April 3 that proposed the FDA not extend its regulation of health IT.  The report, which was mandated by the FDA Safety and Innovation Act, divided health IT into three software categories—health management, medical devices, and administrative.

“The FDA will take a step back from regulatory oversight of many devices that would meet the statutory definition of a medical device which fall into the health management category,” Ms. Gunawardhana said.  “The FDA has been asked to better clarify which devices it plans to provide oversight of that would fall into the health management category, e.g., clinical decision support (CDS) software.”