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Update on the Status of the FDA’s Regulation of Mobile Apps

Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP Last July, the U.S. Food and Drug Administration (FDA) issued draft guidance on how the agency intended to regulate certain mobile medical applications (apps). My colleague,...
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HHS Issues Request for Information; Asks for Strategies to Increase Patient Engagement

Medical / Healthcare IT : Project HealthDesign Blog (2 months ago)

Robert D. Belfort, Manatt, Phelps & Phillips, LLP, Proje­ct HealthDesign Regulatory and Assurance Advisory Group On March 6, 2013, the U.S. Department of Health and Human Services (HHS) issued a news release announcing its 2013 agen... Read Post

ONC Releases Draft Health IT Action and Surveillance Plan

Medical / Healthcare IT : Project HealthDesign Blog (4 months ago)

Robert D. Belfort, Manatt, Phelps & Phillips, LLP, Proje­ct HealthDesign Regulatory and Assurance Advisory Group Just before the holidays, on December 21, 2012, the Office of the National Coordinator for Health IT (ONC) released its... Read Post

When is a Mobile App a Mobile Medical App?

Medical / Healthcare IT : Project HealthDesign Blog (2 years ago)

FDA Guidance Regulates Mobile Medical Apps, Exempts Mobile Health and Wellness Apps Deven McGraw, Project HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology On July 21, the U.S. Food and Drug Adm... Read Post


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