{"id":15250,"date":"2015-02-13T14:47:07","date_gmt":"2015-02-13T19:47:07","guid":{"rendered":"http:\/\/blog.carecloud.com\/?p=15250"},"modified":"2025-10-21T14:23:00","modified_gmt":"2025-10-21T14:23:00","slug":"will-fda-monitor-mobile-medical-app-3-things-know-2","status":"publish","type":"post","link":"https:\/\/carecloud.com\/continuum\/will-fda-monitor-mobile-medical-app-3-things-know-2\/","title":{"rendered":"Will the FDA Monitor Your Mobile Medical App? 3 Things to Know &#8230;"},"content":{"rendered":"<p>Not all mobile health apps are created equal, the FDA recently stated, and the agency will only regulate apps that work like medical devices.<\/p>\n<p>Three take-home messages from the 44-page FDA Guidance on Mobile Medical Applications include:<\/p>\n<p><!--more--><\/p>\n<p><strong>#1. FDA will limit regulation<\/strong>. Certain apps that work in concert with wearable devices to track arrhythmias, monitor glucose levels or provide heart information to an iPhone are specific examples of <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DigitalHealth\/MobileMedicalApplications\/ucm368784.htm\"><strong>apps the FDA already regulates<\/strong><\/a> as \u2018medical devices.\u2019<\/p>\n<p>The FDA now calls these \u2018mobile medical apps.\u2019 Noting that any malfunction could jeopardize patient safety, the agency will regulate this subset of apps.<\/p>\n<p><strong>#2. Most mobile health apps are low-risk.<\/strong> The agency considers the majority of mobile health apps as just \u201cmobile apps.\u201d Because they\u2019re not medical devices, the FDA will not regulate them \u2014 according to the long awaited <a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM263366.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\"><strong>FDA Guidance on Mobile Medical Applications<\/strong><\/a> released February 9, 2015. (The agency left itself some room in these recommendations for exceptions.)<\/p>\n<p><strong>#3. Most mobile software companies applaud the FDA\u2019s move.<\/strong> That includes us. We believe this will mean a big win for more innovation in the mobile health app marketplace, potentially helping mobile health technology continue its <a href=\"https:\/\/www.carecloud.com\/continuum\/blog\/5-tech-trends-moving-mobile-health-2015\/\"><strong>impressive growth throughout 2015<\/strong><\/a>.<\/p>\n<p>\u201cFDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software,\u201d attorney and FDA regulation specialist Brad Thompson told <a href=\"http:\/\/venturebeat.com\/2015\/02\/06\/fda-makes-official-its-hands-off-approach-to-regulating-health-apps-and-medical-software\/\"><strong>VentureBeat<\/strong><\/a>. \u201cIt\u2019s exciting because it means that innovation in this space can truly flourish.\u201d<\/p>\n<p>Want to see an app that can help you manage your patients and your practice?<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Not all mobile health apps are created equal, the FDA recently stated, and the agency will only regulate apps that work like medical devices. Three take-home messages from the 44-page FDA Guidance on Mobile Medical Applications include:<\/p>\n","protected":false},"author":1,"featured_media":43237,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4],"tags":[184,210,211,212,23],"class_list":["post-15250","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-growth","category-revenue","tag-companion","tag-fda","tag-fda-regulation","tag-mobile-apps","tag-mobile-medical-apps"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Will the FDA Monitor Your Favorite Mobile Medical App?<\/title>\n<meta name=\"description\" content=\"The FDA will limit oversight of mobile medical apps to those that act like medical devices. 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