{"id":6232,"date":"2013-03-25T17:12:00","date_gmt":"2013-03-25T17:12:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/fda-promises-final-mobile-app-guidance\/"},"modified":"2019-02-21T01:17:37","modified_gmt":"2019-02-21T01:17:37","slug":"fda-promises-final-mobile-app-guidance","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/","title":{"rendered":"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate"},"content":{"rendered":"

<\/a>In testimony at the March 21, 2013 House Subcommittee on Oversight and Investigations regarding Health Information Technologies: Administration Perspectives on Innovation and Regulation, Christy Foreman,
\nDirector of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health, “promised” that FINAL guidance regarding the regulation of Mobile Medical apps (MMAs) will be released by the end of the current fiscal year; i.e., before October 2013 (read her words here<\/a>).<\/p>\n

There’s been quite a lot of fear mongering regarding the types of health apps that FDA will seek to regulate. PhRMA, for example, agreed with an editorial that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices (see “Mobile Regulatory Fears: PhRMA Raises an Alarm<\/a>“). Foreman specifically excluded such apps in her answers to questions from Rep. Henry Waxman (D-CA):<\/p>\n

\nlisten to \u2018Waxman Asks FDA’s Christy Foreman Which Smartphone Apps It Would Review\u2019 on Audioboo<\/a><\/div>\n

(function() { var po = document.createElement(“script”); po.type = “text\/javascript”; po.async = true; po.src = “http:\/\/d15mj6e6qmt1na.cloudfront.net\/assets\/embed.js”; var s = document.getElementsByTagName(“script”)[0]; s.parentNode.insertBefore(po, s); })();
\n“Just as important as what the policy proposes is what the policy does not <\/b> propose,” said Foreman in her written testimony. “FDA\u2019s proposed mobile medical apps policy would not <\/b>regulate the sale or general consumer use of smartphones or tablets. FDA\u2019s proposed mobile medical apps policy would not <\/b>consider entities that exclusively distribute mobile medical apps, such as the owners and operators of the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers. FDA\u2019s proposed mobile medical apps policy would not <\/b> consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. FDA\u2019s proposed mobile medical apps policy would not <\/b> require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes. FDA\u2019s proposed mobile medical app policy would not <\/b> apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.”<\/p>\n

Near the end of the hearing, Rep. Morgan Griffith (R-VA) asked Foreman if the FDA could regulate these kinds of apps “if it had a change of heart.” Foreman reiterated that the FDA would only regulate apps that were considered medical devices under the FDA Act and only if “strong safety signals” indicated that the FDA was not regulating a device appropriately:<\/p>\n

\nlisten to \u2018FDA’s Christy Foreman on Safety Being a Factor Determining Which Apps Require FDA Regulation\u2019 on Audioboo<\/a><\/div>\n

(function() { var po = document.createElement(“script”); po.type = “text\/javascript”; po.async = true; po.src = “http:\/\/d15mj6e6qmt1na.cloudfront.net\/assets\/embed.js”; var s = document.getElementsByTagName(“script”)[0]; s.parentNode.insertBefore(po, s); })();<\/p>\n

In her written testimony, Foreman said:<\/p>\n

“FDA recognizes the importance of implementing a balanced, transparent approach that fosters the development of health IT solutions and innovative products like mobile medical apps, while ensuring appropriate patient protections. Like traditional medical devices, mobile medical apps may in some cases present significant health risks to patients. FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended. Consistent with this balanced approach, FDA would not regulate the sale or general consumer use of smartphones or tablets.”<\/p>\n

You can see the entire hearing and download the testimony here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

In testimony at the March 21, 2013 House Subcommittee on Oversight and Investigations regarding Health Information Technologies: Administration Perspectives on Innovation and Regulation, Christy Foreman, Director of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health, “promised” that FINAL guidance regarding the regulation of Mobile Medical apps (MMAs) will be released by the […]<\/p>\n","protected":false},"author":2,"featured_media":11113,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[44,193,265,153],"topic":[],"acf":[],"yoast_head":"\nFDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate - 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\/fda-promises-final-mobile-app-guidance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"In testimony at the March 21, 2013 House Subcommittee on Oversight and Investigations regarding Health Information Technologies: Administration Perspectives on Innovation and Regulation, Christy Foreman, Director of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health, “promised” that FINAL guidance regarding the regulation of Mobile Medical apps (MMAs) will be released by the […]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2013-03-25T17:12:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:17:37+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\/03\/FDA_boogeyman_App.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"157\" \/>\n\t<meta property=\"og:image:height\" content=\"200\" \/>\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=\"3 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\/fda-promises-final-mobile-app-guidance\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/\",\"name\":\"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2013-03-25T17:12:00+00:00\",\"dateModified\":\"2019-02-21T01:17:37+00:00\",\"author\":{\"@id\":\"https:\/\/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\/fda-promises-final-mobile-app-guidance\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\",\"url\":\"https:\/\/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\":\"https:\/\/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\":\"https:\/\/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\":\"https:\/\/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":"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate - 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\/fda-promises-final-mobile-app-guidance\/","og_locale":"en_US","og_type":"article","og_title":"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate - Pharma Marketing Network","og_description":"In testimony at the March 21, 2013 House Subcommittee on Oversight and Investigations regarding Health Information Technologies: Administration Perspectives on Innovation and Regulation, Christy Foreman, Director of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health, “promised” that FINAL guidance regarding the regulation of Mobile Medical apps (MMAs) will be released by the […]","og_url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/","og_site_name":"Pharma Marketing Network","article_published_time":"2013-03-25T17:12:00+00:00","article_modified_time":"2019-02-21T01:17:37+00:00","og_image":[{"width":157,"height":200,"url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/03\/FDA_boogeyman_App.jpg","type":"image\/jpeg"}],"author":"Pharma Guy","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Pharma Guy","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/","name":"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate - Pharma Marketing Network","isPartOf":{"@id":"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website"},"datePublished":"2013-03-25T17:12:00+00:00","dateModified":"2019-02-21T01:17:37+00:00","author":{"@id":"https:\/\/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\/fda-promises-final-mobile-app-guidance\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-promises-final-mobile-app-guidance\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/"},{"@type":"ListItem","position":2,"name":"FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate"}]},{"@type":"WebSite","@id":"https:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website","url":"https:\/\/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":"https:\/\/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":"https:\/\/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":"https:\/\/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\/6232"}],"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=6232"}],"version-history":[{"count":1,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6232\/revisions"}],"predecessor-version":[{"id":11114,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6232\/revisions\/11114"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media\/11113"}],"wp:attachment":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media?parent=6232"}],"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=6232"},{"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=6232"},{"taxonomy":"topic","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/topic?post=6232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}