{"id":22701,"date":"2022-12-12T09:26:04","date_gmt":"2022-12-12T14:26:04","guid":{"rendered":"https:\/\/healthit-gov.go-vip.net\/buzz-blog\/?p=22701"},"modified":"2026-01-17T21:36:07","modified_gmt":"2026-01-17T21:36:07","slug":"guiding-developers-through-foundational-federal-laws-applicable-to-mobile-health-technology","status":"publish","type":"post","link":"https:\/\/healthit.gov\/blog\/health-data\/guiding-developers-through-foundational-federal-laws-applicable-to-mobile-health-technology\/","title":{"rendered":"Guiding Developers through Foundational Federal Laws Applicable to Mobile Health Technology"},"content":{"rendered":"\n<p>As you design, market, and distribute a mobile health (mHealth) app that your customers will use to collect, share, use, or maintain individuals\u2019 health information, it is likely you have questions about what U.S. federal laws apply. You may also wonder which federal agencies oversee various aspects of mHealth \u2014 including how this varies by how individuals, their health plan, or health care providers will use the app. &nbsp;Depending on who is expected to use an app and how they will get and use the app (e.g., direct-to-consumer (patient) app or a health care provider-directed app), this can vary.<\/p>\n\n\n\n<p>To help you find answers, the Federal Trade Commission (FTC) released an update to the online, interactive <a href=\"https:\/\/www.ftc.gov\/business-guidance\/resources\/mobile-health-apps-interactive-tool\">Mobile Health Apps Tool<\/a>. The updated tool was produced collaboratively, with contributions from ONC and our HHS colleagues at the Food and Drug Administration (FDA) and the Office for Civil Rights (OCR).<\/p>\n\n\n\n<p>The interactive tool is structured simply, using a list of questions to help you assess which of the below federal laws may apply based on what an app will do or how it will be used, how users will get it, and who will use it. This tool helps you figure out whether, in addition to the FTC Act, you need to learn more about the following federal laws and how they may apply:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules<\/li>\n\n\n\n<li>Federal Food, Drug, and Cosmetic Act (FD&amp;C Act)<\/li>\n\n\n\n<li>21<sup>st<\/sup> Century Cures Act\u2019s Health IT and Information Blocking Provisions, ONC\u2019s Cures Act Final Rule (including the ONC Health IT Certification Program)<\/li>\n\n\n\n<li>Federal Trade Commission Act (FTC Act) &amp; FTC\u2019s Health Breach Notification Rule<\/li>\n\n\n\n<li>Children\u2019s Online Privacy Protection Act (COPPA)<\/li>\n<\/ul>\n\n\n\n<p>Whether you are a developer new to mHealth, focusing on different users than you have with prior mHealth products, or are building innovative features into an existing app focused on the same kind(s) of users, the Mobile Health Apps Tool can serve as a sort of \u201ctrail guide\u201d to these federal laws centered on information governance and federally required protections for information related to an individual\u2019s health, as well as the safety and effectiveness of medical devices \u2014 which some mobile health apps might be. (However, please note there are federal as well as state laws that could apply to you or your technology that are not within the scope of this tool.)<\/p>\n\n\n\n<p>We recognize the important role health technology developers have in helping enable and establish trust in the adoption and use of mobile technology. Building information privacy and security protections into mobile technology from the start makes privacy and security the default setting embedded in the overall design and development of the technology and business practices (sometimes referred to as privacy or security by design). This provides some assurance to users that the information is secure and will be used and disclosed only as expected or approved.<\/p>\n\n\n\n<p>For example, if a developer chooses to have a health IT product, such as an app, certified through the ONC Health IT Certification Program, that health IT would need to meet specific certification criteria for <a href=\"https:\/\/www.federalregister.gov\/d\/2020-07419\/p-817\">privacy and security<\/a> technical capabilities and make publicly available statements (\u201cattestations\u201d) that ensure transparency about <a href=\"https:\/\/www.federalregister.gov\/d\/2020-07419\/p-725\">certain privacy and security features<\/a> of the certified technology.<\/p>\n\n\n\n<p>Beyond the scope of the Mobile Health Apps Tool, developers may want to consider privacy and security practices beyond solely complying with applicable federal laws. For example, ONC supports developers <a href=\"https:\/\/healthit.gov\/model-privacy-notice-mpn\/\">providing transparency<\/a> into what happens to a patient\u2019s digital health data when they use the developer\u2019s application, including conveying information about privacy and security to users in a way that\u2019s easy for them (patients) \u2013 not just the developer\u2019s or users\u2019 legal counsel \u2014 to understand.<\/p>\n\n\n\n<p>Wherever you are in your mHealth innovation journey, be sure to check out the <a href=\"https:\/\/www.ftc.gov\/business-guidance\/resources\/mobile-health-apps-interactive-tool\">Mobile Health Apps Tool<\/a> to help identify and understand your obligations, so that by proactively meeting or exceeding those obligations, you can earn and keep customers\u2019 trust in your mobile technology.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As you design, market, and distribute a mobile health (mHealth) app that your customers will [&hellip;]<\/p>\n","protected":false},"author":619,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_selected_menu":"","_show_breadcrumbs":"true","_blog_show_featured_image":false,"footnotes":""},"categories":[18,22],"archived-category":[],"featured":[],"topics":[459,444],"class_list":["post-22701","post","type-post","status-publish","format-standard","hentry","category-electronic-health-and-medical-records","category-health-data","topics-certification-testing","topics-guidance-best-practices"],"acf":{"blog_authors":[{"blog_author_profiles":"193015"},{"blog_author_profiles":"198721"}],"hp_news_hide":false},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.3 (Yoast SEO v24.8.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Guiding Developers through Foundational Federal Laws Applicable to Mobile Health Technology - ONC Blog<\/title>\n<meta name=\"description\" content=\"Discover federal laws and guidance for mobile health app developers with the FTC&#039;s Mobile Health Apps Tool. Ensure compliance and user trust in mHealth innovation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/healthit.gov\/blog\/health-data\/guiding-developers-through-foundational-federal-laws-applicable-to-mobile-health-technology\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Guiding Developers through Foundational Federal Laws Applicable to Mobile Health Technology\" \/>\n<meta property=\"og:description\" content=\"Discover federal laws and guidance for mobile health app developers with the FTC&#039;s Mobile Health Apps Tool. 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