{"id":6221,"date":"2013-04-08T16:57:00","date_gmt":"2013-04-08T16:57:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/more-mobile-health-app-guidance-fro\/"},"modified":"2019-02-21T01:17:33","modified_gmt":"2019-02-21T01:17:33","slug":"more-mobile-health-app-guidance-fro","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/","title":{"rendered":"More Mobile Health App Guidance from FDA for Pharma to Worry About"},"content":{"rendered":"<p>The more I dig into FDA regulation of mobile health\/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA&#8217;s crosshairs.<\/p>\n<p>At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA &#8220;will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices&#8221; (see &#8220;<a href=\"http:\/\/www.news.pharma-mkting.com\/pmn112-article02.htm\">Mobile Regulatory Fears: PhRMA Raises an Alarm<\/a>&#8220;). <\/p>\n<p>Then I interviewed Bradley Merrill Thompson, Member of the Firm at Epstein Becker &amp; Green and General Counsel to the mHealth Regulatory Coalition. We discussed the prospects for FDA&#8217;s final guidance on regulation of mobile medical apps (MMAs) and other regulatory issues that the mobile health community and FDA will need to face after publication of the &#8220;final&#8221; guidelines. In his closing remarks, however, Thompson revealed that there is ANOTHER FDA mobile guidance that the drug industry should be concerned about: new guidelines regarding FDA&#8217;s regulation of clinical decision support (CDS) software.<\/p>\n<div class=\"ab-player\" data-boourl=\"http:\/\/audioboo.fm\/boos\/1315956-fda-s-upcoming-cds-guidance\/embed\">\n<a href=\"http:\/\/audioboo.fm\/boos\/1315956-fda-s-upcoming-cds-guidance\">listen to \u2018FDA&#8217;s Upcoming CDS Guidance\u2019 on Audioboo<\/a><\/div>\n<p>(function() { var po = document.createElement(&#8220;script&#8221;); po.type = &#8220;text\/javascript&#8221;; po.async = true; po.src = &#8220;http:\/\/d15mj6e6qmt1na.cloudfront.net\/assets\/embed.js&#8221;; var s = document.getElementsByTagName(&#8220;script&#8221;)[0]; s.parentNode.insertBefore(po, s); })();<br \/>\nYou can listen to the full interview&nbsp;<a href=\"http:\/\/www.talk.pharma-mkting.com\/show194.htm\">here<\/a>. FDA has been regulating many different types of CDS for the last 20 years, but &#8212; surprise, surprise &#8212; it has never published a guidance document regarding its CDS regulatory program.<\/p>\n<p>What is CDS? Here&#8217;s FDA&#8217;s definition:<\/p>\n<ul>\n<li>Uses an individual\u2019s information from various sources (electronically or manually entered)&nbsp;<\/li>\n<li>Converts this information into new information that is intended to support a clinical decision&nbsp;<\/li>\n<li>Could be a mobile application, web-based service or desk top application<\/li>\n<\/ul>\n<div>\nConverting data could include the use of algorithms or formulas such as the Janssen&#8217;s PASI calculator and other pharma apps (see &#8220;<a href=\"http:\/\/www.news.pharma-mkting.com\/pmn1019-article04.htm\">Checking Under the Hood of Pharma Mobile Apps<\/a>&#8221; and &#8220;<a href=\"http:\/\/www.news.pharma-mkting.com\/pmn112-article03.htm\">Some Unregulated Physician Smartphone Apps May Be Buggy<\/a>&#8220;).<\/p>\n<p>These days, CDS software is increasingly being run by mobile apps. Hence, the importance of determining which apps are likely to be regulated as CDS devices.<\/p><\/div>\n<div>\n<\/div>\n<div>\nWhat are examples of CDS? Some examples that FDA lists as examples of CDS include mobile apps that remind users to take their medication:<\/div>\n<ul>\n<li>calculates creatinine clearance or BMI<\/li>\n<li>gives reminders for tests, consults or medications<\/li>\n<li>checks for drug-drug interaction<\/li>\n<li>checks for allergies<br \/>\ndirects where to biopsy&nbsp;<\/li>\n<li>suggests cancer treatment based on proprietary algorithm, not widely accepted<\/li>\n<li>provides radiation treatment recommendation from combines multiple physiological inputs<\/li>\n<li>interprets complex information to an untrained user<\/li>\n<\/ul>\n<p>FDA says its regulation of CDS apps depends on the clinical impact of medical decisions made on the basis of such apps (see this <a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/NewsEvents\/WorkshopsConferences\/UCM271894.pdf\">FDA PPT<\/a> and figure below).<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/4.bp.blogspot.com\/-pWzNndptB_c\/UWL1yTousEI\/AAAAAAAAF0A\/XCxlVo382fA\/s1600\/CDS-Impact.png\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"225\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/04\/CDS-Impact.png\" width=\"400\" \/><\/a><\/div>\n<p><\/p>\n<div style=\"text-align: center;\">\n(click on image for an enlarged view)<\/div>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The more I dig into FDA regulation of mobile health\/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA&#8217;s crosshairs. At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA &#8220;will soon require [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11138,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[284,44,145,294,331,265],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>More Mobile Health App Guidance from FDA for Pharma to Worry About - 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\/more-mobile-health-app-guidance-fro\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"More Mobile Health App Guidance from FDA for Pharma to Worry About - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"The more I dig into FDA regulation of mobile health\/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA&#8217;s crosshairs. At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA &#8220;will soon require [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2013-04-08T16:57:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:17:33+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/04\/CDS-Impact.png\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"227\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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\/more-mobile-health-app-guidance-fro\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/\",\"name\":\"More Mobile Health App Guidance from FDA for Pharma to Worry About - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2013-04-08T16:57:00+00:00\",\"dateModified\":\"2019-02-21T01:17:33+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\/blog\/more-mobile-health-app-guidance-fro\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/#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\":\"More Mobile Health App Guidance from FDA for Pharma to Worry About\"}]},{\"@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":"More Mobile Health App Guidance from FDA for Pharma to Worry About - 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\/blog\/more-mobile-health-app-guidance-fro\/","og_locale":"en_US","og_type":"article","og_title":"More Mobile Health App Guidance from FDA for Pharma to Worry About - Pharma Marketing Network","og_description":"The more I dig into FDA regulation of mobile health\/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA&#8217;s crosshairs. At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA &#8220;will soon require [&hellip;]","og_url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/","og_site_name":"Pharma Marketing Network","article_published_time":"2013-04-08T16:57:00+00:00","article_modified_time":"2019-02-21T01:17:33+00:00","og_image":[{"width":400,"height":227,"url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/04\/CDS-Impact.png","type":"image\/png"}],"author":"Pharma Guy","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Pharma Guy","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/","name":"More Mobile Health App Guidance from FDA for Pharma to Worry About - Pharma Marketing Network","isPartOf":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website"},"datePublished":"2013-04-08T16:57:00+00:00","dateModified":"2019-02-21T01:17:33+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\/blog\/more-mobile-health-app-guidance-fro\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/more-mobile-health-app-guidance-fro\/#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":"More Mobile Health App Guidance from FDA for Pharma to Worry About"}]},{"@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\/6221"}],"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=6221"}],"version-history":[{"count":1,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6221\/revisions"}],"predecessor-version":[{"id":11139,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6221\/revisions\/11139"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media\/11138"}],"wp:attachment":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media?parent=6221"}],"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=6221"},{"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=6221"},{"taxonomy":"topic","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/topic?post=6221"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}