{"id":6133,"date":"2013-09-25T20:03:00","date_gmt":"2013-09-25T20:03:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/dozens-of-currently-available\/"},"modified":"2019-02-21T01:17:09","modified_gmt":"2019-02-21T01:17:09","slug":"dozens-of-currently-available","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/","title":{"rendered":"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor"},"content":{"rendered":"<p>Perhaps 27% of the 229 dermatology-related mobile applications (apps) that are available today may be subject to FDA regulation despite the agency\u2019s &#8220;enforcement discretion&#8221; safe harbor, which exempts most mobile apps that &#8220;pose minimal risk to consumers.&#8221;<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/2.bp.blogspot.com\/-RzUrGJWVl-M\/UkMwapDHiAI\/AAAAAAAAGPA\/v__UnZazHkA\/s1600\/FDA-EnforcementDiscretion.png\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"206\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/09\/FDA-EnforcementDiscretion.png\" width=\"400\" \/><\/a><\/div>\n<p>A study by Ann Chang Brewer, M.D., of the University of Arizona, Phoenix, and colleagues, published today in JAMA Dermatology ((JAMA Dermatol. Published online September 25, 2013. doi:10.1001\/jamadermatol.2013.5517), identified 229 dermatology-related apps in several categories, including: general dermatology reference (61), self-surveillance\/diagnosis aids (41), disease guides (39), educational aids (20) and sunscreen\/UV (ultraviolet light) recommendations (19). Of the 229 apps, more than half were free. <\/p>\n<p>The following table from that study gives the percentages:<\/p>\n<p><a name='more'><\/a><\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/1.bp.blogspot.com\/-sSbd_OHs1RE\/UkMwqLUMCaI\/AAAAAAAAGPI\/ny3T77zE6dA\/s1600\/DermApp-Table.jpg\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"193\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/09\/DermApp-Table.jpg\" width=\"400\" \/><\/a><\/div>\n<p>\nAccording to FDA\u2019s Final Guidance on Mobile Medical Applications (<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?t=88997\">here<\/a>), &#8220;FDA intends to exercise enforcement discretion&#8221; for mobile apps that:<\/p>\n<ul>\n<li>Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;<\/li>\n<li>Provide patients with simple tools to organize and track their health information;<\/li>\n<li>Provide easy access to information related to patients\u2019 health conditions or treatments;<\/li>\n<li>Help patients document, show, or communicate potential medical conditions to health care providers;<\/li>\n<li>Automate simple tasks for health care providers; or<\/li>\n<li>Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.<\/li>\n<\/ul>\n<p>\nI believe at least three categories of dermatology apps fall outside FDA&#8217;s \u201cenforcement discretion\u201d safe harbor:<\/p>\n<ol>\n<li>Self-surveillance\/diagnosis (18%)<\/li>\n<li>Calculator (5%)<\/li>\n<li>Teledermatology (4%)<\/li>\n<\/ol>\n<p>\n\u201cSelf-surveillance\/diagnosis apps varied in capabilities,\u201d note the authors, \u201cwith some allowing patients to document lesions, upload and receive dermatologist or algorithm-based feedback about the malignancy potential of lesions, follow diagnosis algorithms, log personal treatment regimens, and\/or record symptoms to allergen exposures.\u201d<\/p>\n<p>\u201cApplications included in the calculator category provided quick calculations for medication dosing, laser fluence levels, or dermatology- related indexes, such as the  Psoriasis Area Severity Index\u201d (e.g., see \u201c<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>\u201d).<\/p>\n<p>The authors warn patients and clinicians to maintain a healthy sense of skepticism about the apps. They note studies regarding the safety and accuracy of such apps are limited and misdiagnoses from the apps could harm patients by potentially delaying treatment for conditions such as melanoma.<\/p>\n<p>Considering the potential for harm, IMHO, the dermatology apps highlighted here should be elevated to the apex of the FDA\u2019s mobile app regulatory scope triangle depicted above.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Perhaps 27% of the 229 dermatology-related mobile applications (apps) that are available today may be subject to FDA regulation despite the agency\u2019s &#8220;enforcement discretion&#8221; safe harbor, which exempts most mobile apps that &#8220;pose minimal risk to consumers.&#8221; A study by Ann Chang Brewer, M.D., of the University of Arizona, Phoenix, and colleagues, published today in [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11324,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[314,44,294,265],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor - 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\/dozens-of-currently-available\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Perhaps 27% of the 229 dermatology-related mobile applications (apps) that are available today may be subject to FDA regulation despite the agency\u2019s &#8220;enforcement discretion&#8221; safe harbor, which exempts most mobile apps that &#8220;pose minimal risk to consumers.&#8221; A study by Ann Chang Brewer, M.D., of the University of Arizona, Phoenix, and colleagues, published today in [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2013-09-25T20:03:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:17:09+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\/09\/DermApp-Table.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"194\" \/>\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\/dozens-of-currently-available\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/\",\"name\":\"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2013-09-25T20:03:00+00:00\",\"dateModified\":\"2019-02-21T01:17:09+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\/dozens-of-currently-available\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/#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\":\"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor\"}]},{\"@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":"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor - 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\/dozens-of-currently-available\/","og_locale":"en_US","og_type":"article","og_title":"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor - Pharma Marketing Network","og_description":"Perhaps 27% of the 229 dermatology-related mobile applications (apps) that are available today may be subject to FDA regulation despite the agency\u2019s &#8220;enforcement discretion&#8221; safe harbor, which exempts most mobile apps that &#8220;pose minimal risk to consumers.&#8221; A study by Ann Chang Brewer, M.D., of the University of Arizona, Phoenix, and colleagues, published today in [&hellip;]","og_url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/","og_site_name":"Pharma Marketing Network","article_published_time":"2013-09-25T20:03:00+00:00","article_modified_time":"2019-02-21T01:17:09+00:00","og_image":[{"width":400,"height":194,"url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2013\/09\/DermApp-Table.jpg","type":"image\/jpeg"}],"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\/dozens-of-currently-available\/","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/","name":"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor - Pharma Marketing Network","isPartOf":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website"},"datePublished":"2013-09-25T20:03:00+00:00","dateModified":"2019-02-21T01:17:09+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\/dozens-of-currently-available\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dozens-of-currently-available\/#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":"Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA\u2019s \u201cEnforcement Discretion\u201d Safe Harbor"}]},{"@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\/6133"}],"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=6133"}],"version-history":[{"count":1,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6133\/revisions"}],"predecessor-version":[{"id":11325,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6133\/revisions\/11325"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media\/11324"}],"wp:attachment":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media?parent=6133"}],"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=6133"},{"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=6133"},{"taxonomy":"topic","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/topic?post=6133"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}