{"id":6328,"date":"2012-10-29T14:26:00","date_gmt":"2012-10-29T14:26:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/my-pov-regarding-regulation-of-pharma\/"},"modified":"2019-02-21T01:18:36","modified_gmt":"2019-02-21T01:18:36","slug":"my-pov-regarding-regulation-of-pharma","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-pov-regarding-regulation-of-pharma\/","title":{"rendered":"My POV Regarding Regulation of Pharma Mobile Medical Apps"},"content":{"rendered":"<p>The pharmaceutical industry has to police itself with regard to development of medical apps. There has to be good documentation of the testing of apps to ensure their correctness.<\/p>\n<p>That&#8217;s the summary of my point of view (POV) regarding the pharma HOTSPOT topic: &#8220;Should Pharma reconsider its mobile application approach with FDA guidance looming?&#8221; See the annotated video below:<\/p>\n<p><iframe loading=\"lazy\" allowfullscreen=\"allowfullscreen\" frameborder=\"0\" height=\"315\" src=\"http:\/\/www.youtube.com\/embed\/OeBmg0Gy0X0\" width=\"420\"><\/iframe><br \/>\n<br \/>\nA &#8220;counterpoint&#8221; was offered by Dr. Chetan Vijayvergia, PhD, Director of Medical Strategy, Ignite Health, on Ignite Health&#8217;s Pharma HOTSPOT web site. Dr. Vijayvergia&#8217;s point was &#8220;The apps that are currently being created in the Pharma space don\u2019t have a predicate in the FDA database. Pharma needs to reconsider the mobile approach to actively help the FDA shape industry guidance&#8221; (see <a href=\"http:\/\/pharmahotspot.com\/Topics\/mobile-healthcare-and-fda-guidance\">here<\/a>).<\/p>\n<p>Vijayvergia contends that the current FDA draft guidance for MMAs &#8220;casts a very wide net&#8221; and if pharma app developers are not careful, their apps can get &#8220;dinged as an MMA [mobile medical application]&#8221; and be subject to regulation as a medical device.<\/p>\n<p>The fear that FDA is casting too &#8220;wide a net&#8221; over MMAs was first expressed by PhRMA (see &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2012\/02\/fda-mobile-regulatory-fear-mongering-by.html\">FDA Mobile Regulatory Fear Mongering by PhRMA<\/a>&#8220;). IMHO, the FDA was pretty clear about staying away from most health-related apps aimed at consumers such as diet apps, etc.<\/p>\n<p><b>The Best Defense Against Zealous FDA Regulation is Self-Regulation!<\/b><\/p>\n<p>In addition to offering FDA its POV regarding what is and what is not a MMA subject to medical device regulation, the pharma industry, IMHO, should begin policing itself to develop MMAs that comply with standards such as Happtique&#8217;s App Certification Program; listen to this podcast regarding that: <\/p>\n<p><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"0\" src=\"http:\/\/c.gigcount.com\/wildfire\/IMP\/CXNID=2000002.0NXC\/bT*xJmx*PTEzNTE1MjAwNzk4NDkmcHQ9MTM1MTUyMDA4MzQ1MSZwPTQ1MDk3MiZkPUhvc3RJRCUzYSUyMDc1NSZnPTImbz1lZGIy\/ZDFiZWZiNzA*ZGY3ODgxZDc5MjVhMDM1Zjg4NiZvZj*w.gif\" style=\"height: 0px; visibility: hidden; width: 0px;\" width=\"0\" \/> <\/p>\n<div style=\"font-size: 10px; text-align: center; width: 210px;\">\nListen to <a href=\"http:\/\/www.blogtalkradio.com\/\">internet radio<\/a> with <a href=\"http:\/\/www.blogtalkradio.com\/pharmaguy\">Pharmaguy<\/a> on Blog Talk Radio<\/div>\n<p>\nYou may also enjoy reading these previous posts regarding pharma mobile medical apps:<\/p>\n<ul>\n<li><a href=\"http:\/\/pharma-mkting.com\/blog\/2011\/07\/fda-issues-long-awaited-guidance-for.html\">FDA Issues Long-Awaited Guidance &#8211; for Mobile Medical Apps. Janssen, Look Out!<\/a><\/li>\n<li><a href=\"http:\/\/pharma-mkting.com\/blog\/2011\/12\/be-aware-of-whats-behind-pharma-mobile.html\">Be Aware of What&#8217;s Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story<\/a><\/li>\n<li><a href=\"http:\/\/pharma-mkting.com\/blog\/2012\/02\/problem-with-unregulated-calculator.html\">The Problem with Unregulated &#8220;Calculator&#8221; Apps for Physicians: Buggy Software!<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The pharmaceutical industry has to police itself with regard to development of medical apps. There has to be good documentation of the testing of apps to ensure their correctness. That&#8217;s the summary of my point of view (POV) regarding the pharma HOTSPOT topic: &#8220;Should Pharma reconsider its mobile application approach with FDA guidance looming?&#8221; See [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[284,44,294,331,87],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>My POV Regarding Regulation of Pharma Mobile Medical Apps - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-pov-regarding-regulation-of-pharma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"My POV Regarding Regulation of Pharma Mobile Medical Apps - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"The pharmaceutical industry has to police itself with regard to development of medical apps. There has to be good documentation of the testing of apps to ensure their correctness. That&#8217;s the summary of my point of view (POV) regarding the pharma HOTSPOT topic: &#8220;Should Pharma reconsider its mobile application approach with FDA guidance looming?&#8221; See [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-pov-regarding-regulation-of-pharma\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2012-10-29T14:26:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:18:36+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"744\" \/>\n\t<meta property=\"og:image:height\" content=\"419\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Pharma Guy\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Pharma Guy\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-pov-regarding-regulation-of-pharma\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-pov-regarding-regulation-of-pharma\/\",\"name\":\"My POV Regarding Regulation of Pharma Mobile Medical Apps - 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