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3rd Quarterly Lecture IN PERSON - Mobile Health Apps & Other Health Software—What Does FDA Regulate?
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Mobile Health Apps and Other Health Software—What Does FDA Regulate? What Does It Not?

When: Thursday, September 19, 2019
8:30 am central time
Where: Katten Muchin Rosenman LLP AND Illinois Health and Hospital Association
525 W. Monroe Street Chicago; 700 S. Second St, Springfield
Chicago and Springfield, Illinois 
United States
Contact: Kimberly LaBounty
(630) 433-4516

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Mobile Health Apps and Other Health Software—What Does FDA Regulate?  What Does It Not?

DESCRIPTION: Mobile health apps and other health software play an important role in U.S. healthcare.  Healthcare professionals and medical institutions routinely use such technology in healthcare delivery.  Patients and other individuals increasingly use such products to manage their own medical conditions and wellness. 

This session will focus on the following questions, using hypotheticals to discuss key answers and bringing together the perspectives of law firm, industry and provider representatives:

• Under FDA law and policy, what types of mobile health apps and other health software does FDA actively regulate as a medical device?  What types does it not?

• What is the difference between an unregulated health “wellness” product claim and an FDA-regulated “medical device” claim?

• What FDA requirements apply to such products when regulated?

• Are healthcare professionals and medical institutions subject to FDA regulation if they create or modify such products?

 • What other legal issues arise from development and use of such products?

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