{"id":5464,"date":"2013-04-17T00:00:00","date_gmt":"2013-04-17T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2013\/04\/17\/pmn1204-article01\/"},"modified":"2019-02-18T20:21:24","modified_gmt":"2019-02-18T20:21:24","slug":"pmn1204-article01","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/","title":{"rendered":"Mobile Medical App Guidance &amp; Beyond!"},"content":{"rendered":"<p>Mobile Medical App Guidance &amp; Beyond!        Keeping Up with Technology, Enforcement Headaches, and Still More FDA Guidance<br \/><img loading=\"lazy\" decoding=\"async\" alt=\"DaVinci Android\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/davinciAndroid.png\" width=\"288\" height=\"240\" align=\"right\" hspace=\"8\"\/>In July, 2011, FDA&#8217;s Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research, which is responsible for regulating medical devices, issued DRAFT guidance for mobile medical applications. The mobile industry as well as the medical device and drug industries have commented on the draft guidance and are anxiously awaiting the final guidance. The nearly 2-year delay may have been part of the reason for the recent House Subcommittee on Oversight and Investigations hearing regarding &#8220;Health Information Technologies: Administration Perspectives on Innovation and Regulation.&#8221;<\/p>\n<p>Many experts and industry representatives testified at these hearings, including Bradley Merrill Thompson, Member of the Firm at Epstein Becker &amp; Green and General Counsel to the mHealth Regulatory Coalition. Thompson was also interviewed by <i>Pharma Marketing News<\/i>.<\/p>\n<p>This article is a review of Thompson&#8217;s testimony and interview. It covers the prospects for FDA&#8217;s final guidance on regulation of MMAs and other regulatory issues that the mobile health community and FDA will likely face after publication of the &#8220;final&#8221; guidelines.  <\/p>\n<p>Topics include:<\/p>\n<ul>\n<li>Draft MMA Guidance<\/li>\n<li>FDA Addresses Fears of Over Regulation<\/li>\n<li>The FDA Director Man Who Cried &#8220;Soon!&#8221;<\/li>\n<li>Keeping Up with Technology<\/li>\n<li>Taxing Innovation<\/li>\n<li>Don&#8217;t Pee on Your Smartphone &#8211; Keep FDA<\/li>\n<li>Apr\u00e8s La Guidance, Le D\u00e9luge<\/li>\n<li>The Cheerios Lesson<\/li>\n<li>Patient Groups Not Being Heard<\/li>\n<li>Small Enterprises, Big Problems<\/li>\n<li>Enforcement Issues<\/li>\n<li>Other Mobile Guidance of Concern to Pharma<\/li>\n<\/ul>\n<p>Download the full text PDF file here:<br \/><a style=\"color: #993300;\" track=\"on\" shape=\"rect\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1204-article01.pdf\" linktype=\"link\">http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1204-article01.pdf<\/a>    <\/p>\n<p>PMN1204-01<br \/>Issue: Vol. 12, No. 4.1: 17 April 2013<\/p>\n<p\/><b>Find other articles in related Topic Areas:<\/b> <\/p>\n<ul>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNpatedReprints.htm\">Patient Education<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNphysMktingReprints.htm\">Physician Marketing &amp; Promotion<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNeMktingReprints.htm\">eMarketing and ePromotion<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This article is a review of an interview of Bradley Merrill Thompson, Member of the Firm at Epstein Becker &#038; Green and General Counsel to the mHealth Regulatory Coalition. It covers the prospects for FDA&#8217;s final guidance on regulation of MMAs and other regulatory issues that the mobile health community and FDA will likely face after publication of the &#8216;final&#8217; guidelines.<\/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":[62,6],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Mobile Medical App Guidance &amp; Beyond! - 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\/articles\/pmn1204-article01\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mobile Medical App Guidance &amp; Beyond! - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"This article is a review of an interview of Bradley Merrill Thompson, Member of the Firm at Epstein Becker &amp; Green and General Counsel to the mHealth Regulatory Coalition. It covers the prospects for FDA&#039;s final guidance on regulation of MMAs and other regulatory issues that the mobile health community and FDA will likely face after publication of the &#039;final&#039; guidelines.\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2013-04-17T00:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-18T20:21:24+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=\"1 minute\" \/>\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\/articles\/pmn1204-article01\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/\",\"name\":\"Mobile Medical App Guidance &amp; Beyond! - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2013-04-17T00:00:00+00:00\",\"dateModified\":\"2019-02-18T20:21:24+00:00\",\"author\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\"},\"breadcrumb\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Mobile Medical App Guidance &amp; Beyond!\"}]},{\"@type\":\"WebSite\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\",\"name\":\"Pharma Marketing Network\",\"description\":\"Pharma Marketing Network\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\",\"name\":\"Pharma Guy\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/image\/\",\"url\":\"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g\",\"contentUrl\":\"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g\",\"caption\":\"Pharma Guy\"},\"description\":\"Pharmaguy\u2122 is a \u201cconstructive critic\u201d of pharma marketing and publishes commentary on the Pharma Marketing Blog and on Scoop.it.\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/author\/ehs-pharmaguy\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Mobile Medical App Guidance &amp; Beyond! - Pharma Marketing Network","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/","og_locale":"en_US","og_type":"article","og_title":"Mobile Medical App Guidance &amp; Beyond! - Pharma Marketing Network","og_description":"This article is a review of an interview of Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green and General Counsel to the mHealth Regulatory Coalition. It covers the prospects for FDA's final guidance on regulation of MMAs and other regulatory issues that the mobile health community and FDA will likely face after publication of the 'final' guidelines.","og_url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/","og_site_name":"Pharma Marketing Network","article_published_time":"2013-04-17T00:00:00+00:00","article_modified_time":"2019-02-18T20:21:24+00:00","og_image":[{"width":744,"height":419,"url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg","type":"image\/jpeg"}],"author":"Pharma Guy","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Pharma Guy","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/","name":"Mobile Medical App Guidance &amp; Beyond! - Pharma Marketing Network","isPartOf":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website"},"datePublished":"2013-04-17T00:00:00+00:00","dateModified":"2019-02-18T20:21:24+00:00","author":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1"},"breadcrumb":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1204-article01\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/"},{"@type":"ListItem","position":2,"name":"Mobile Medical App Guidance &amp; Beyond!"}]},{"@type":"WebSite","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/","name":"Pharma Marketing Network","description":"Pharma Marketing Network","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1","name":"Pharma Guy","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/image\/","url":"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g","contentUrl":"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g","caption":"Pharma Guy"},"description":"Pharmaguy\u2122 is a \u201cconstructive critic\u201d of pharma marketing and publishes commentary on the Pharma Marketing Blog and on Scoop.it.","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/author\/ehs-pharmaguy\/"}]}},"_links":{"self":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/5464"}],"collection":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/comments?post=5464"}],"version-history":[{"count":1,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/5464\/revisions"}],"predecessor-version":[{"id":5516,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/5464\/revisions\/5516"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media\/13101"}],"wp:attachment":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media?parent=5464"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/categories?post=5464"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/tags?post=5464"},{"taxonomy":"topic","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/topic?post=5464"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}