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Media Coverage

Fish’s Keith Barritt Quoted in BNA's Health IT Law & Industry “FDA Proposes Approach for Regulating Certain Mobile Health Care Applications”

July 19, 2011

Media Coverage

Fish’s Keith Barritt Quoted in BNA's Health IT Law & Industry “FDA Proposes Approach for Regulating Certain Mobile Health Care Applications”

July 19, 2011

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Keith Barritt (DC) was quoted in BNA’s Health IT Law & Industry.

 

Attorney Keith Barritt, with Fish & Richardson PC in Washington, told BNA that among mobile apps not covered by the proposed FDA guidance are electronic versions of textbooks and teachings aids, diet tracking software, exercise software, and personal health records.

 

Barritt also said FDA was not seeking in the proposed guidance to oversee entities that merely distribute mobile medical apps.

 

FDA cautioned that the proposed guidance was not intended to cover all mobile health products for which it could exercise oversight authority and that for some products it would issue similar guidance in the future.

 

Welcomed Guidance.

The mobile health care industry has urged FDA to provide clarity on how it will regulate mobile health care products.

 

‘‘The FDA draft guidance document is a very welcome step in the evolving regulation of mobile apps, as currently there is much uncertainty and confusion in the marketplace as to when FDA jurisdiction kicks in,’’ Barritt said.

 

Reproduced with permission from Health IT Law & Industry, Vol. 3, No. 30 (July 19, 2011).  Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com/

To read the entire article, click here.

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