{"id":3957,"date":"2026-09-13T07:36:28","date_gmt":"2026-09-13T07:36:28","guid":{"rendered":"https:\/\/itaca.ai\/?page_id=3957"},"modified":"2026-09-19T14:42:57","modified_gmt":"2026-09-19T14:42:57","slug":"artificial-intelligence-in-medicine-united-states","status":"publish","type":"page","link":"https:\/\/itaca.ai\/en\/inteligencia-artificial-en-medicina-estados-unidos\/","title":{"rendered":"Artificial intelligence in medicine in the United States"},"content":{"rendered":"<div class=\"wp-block-group alignfull has-background-background-color has-background is-layout-constrained wp-container-core-group-is-layout-47d814f2 wp-block-group-is-layout-constrained\" style=\"padding-top:5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:5rem;padding-left:var(--wp--preset--spacing--40)\"><div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-7387b849 wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:62%\"><p class=\"wp-block-paragraph\"><strong>US context<\/strong><\/p><h1 class=\"wp-block-heading\">Artificial intelligence in medicine in the United States<\/h1><p class=\"wp-block-paragraph\">In the United States, clinical artificial intelligence operates within a patchwork of federal and state rules. HIPAA is central for covered entities and their business associates, but it does not protect all health data in all contexts.<\/p><div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button\"><a class=\"wp-block-button__link has-foregound-alt-color has-heading-color-background-color has-text-color has-background wp-element-button\" href=\"#marco-estados-unidos\" style=\"border-radius:100px;text-decoration:none\">Understand the United States framework<\/a><\/div><\/div><\/div><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:38%\"><div class=\"wp-block-group has-background is-layout-flow wp-block-group-is-layout-flow\" style=\"border-radius:10px;background-color:#ffefc7;padding:36px\"><p class=\"wp-block-paragraph\"><span style=\"font-size:40px\">\ud83c\uddfa\ud83c\uddf8<\/span><\/p><h2 class=\"wp-block-heading\">United States<\/h2><ul class=\"wp-block-list\"><li>Federal privacy: HIPAA when it applies.<\/li><li>Interoperability: ONC and Cures Act Rules.<\/li><li>Legal environment: federal and state regulations.<\/li><\/ul><\/div><\/div><\/div><\/div><div id=\"marco-estados-unidos\" class=\"wp-block-group alignfull has-background-alt-background-color has-background is-layout-constrained wp-container-core-group-is-layout-a565c507 wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><p class=\"wp-block-paragraph\"><strong>CLINICAL AND DIGITAL FRAMEWORK<\/strong><\/p><h2 class=\"wp-block-heading\">Medical records and artificial intelligence in the United States<\/h2><h3 class=\"wp-block-heading\">HIPAA and its scope<\/h3><p class=\"wp-block-paragraph\">The HIPAA Privacy Rule establishes protections for health information in covered entities. Not every health app or company automatically falls under HIPAA. <a href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/privacy\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">HHS: HIPAA Privacy Rule \u2197<\/a><\/p><h3 class=\"wp-block-heading\">Suppliers and business partners<\/h3><p class=\"wp-block-paragraph\">When a vendor handles protected information for a covered entity, a business associate agreement and specific contractual safeguards may be necessary. <a href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/privacy\/guidance\/business-associates\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">HHS: Business Associates \u2197<\/a><\/p><h3 class=\"wp-block-heading\">Interoperability and access<\/h3><p class=\"wp-block-paragraph\">The ONC rules derived from the Cures Act promote access and exchange of electronic health information and limit information blocking. States can add obligations. <a href=\"https:\/\/healthit.gov\/regulations\/cures-act-final-rule\/\" target=\"_blank\" rel=\"noopener noreferrer\">HealthIT.gov: Cures Act Final Rule \u2197<\/a><\/p><\/div><div class=\"wp-block-group alignfull has-background-background-color has-background is-layout-constrained wp-container-core-group-is-layout-a565c507 wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><h2 class=\"wp-block-heading\">Clinical documentation challenges in the United States<\/h2> <ul class=\"wp-block-list\"><li>Determine if the organization and the vendor are covered entities or business associates.<\/li><li>Coordinate HIPAA with state privacy, consent, licensing, and internal policies.<\/li><li>Evaluate EHR integration, traceability, human review, and model governance.<\/li><\/ul><p class=\"wp-block-paragraph\">These challenges are not solved with more text. They require useful information, defined owners, and a review process that corresponds to actual practice.<\/p><\/div><div id=\"hospitales-estados-unidos\" class=\"wp-block-group alignfull has-background-alt-background-color has-background is-layout-constrained wp-container-core-group-is-layout-29cee9e6 wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><h2 class=\"wp-block-heading\">Reference hospitals and institutions in the United States<\/h2><p class=\"wp-block-paragraph\">These institutions help understand the scale, specialization, and care models of the country. The selection is informative; it is not a ranking nor does it imply affiliation with Itaca.<\/p> <div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-7387b849 wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.mayoclinic.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Mayo Clinic<\/a><\/h3><p class=\"wp-block-paragraph\"><strong>Minnesota and other states.<\/strong> Academic reference system with care, research, and education.<\/p><\/div><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading\"><a href=\"https:\/\/my.clevelandclinic.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Cleveland Clinic<\/a><\/h3><p class=\"wp-block-paragraph\"><strong>Ohio and other states.<\/strong> High-complexity academic system with international reach.<\/p><\/div><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.massgeneralbrigham.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Mass General Brigham \u2197<\/a><\/h3><p class=\"wp-block-paragraph\"><strong>Massachusetts.<\/strong> Integrated academic network of hospitals and clinical services.<\/p><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-background-background-color has-background is-layout-constrained wp-container-core-group-is-layout-a565c507 wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><h2 class=\"wp-block-heading\">HIPAA is the starting point, not the whole framework<\/h2><p class=\"wp-block-paragraph\">The use of AI changes depending on the function of the tool. An assistant that prepares documentation for review raises different issues than software that formulates autonomous clinical recommendations or a product regulated as a device. In addition to HIPAA, state rules, professional policies, consent requirements, interoperability standards, and, depending on the case, FDA oversight may come into play.<\/p><p class=\"wp-block-paragraph\">For clinical documentation, the organization must determine whether it is a covered entity, whether the provider acts as a business associate, and which agreement protects the information. For health data that falls outside of HIPAA, other federal or state obligations may exist. The assessment must classify the specific use before applying a general compliance label.<\/p><p class=\"wp-block-paragraph\">A documentation pilot must measure corrections, omissions, review time, and integration into the EHR. If use shifts toward diagnostic or therapeutic recommendations, regulatory and clinical evaluation must be reopened.<\/p><h2 class=\"wp-block-heading\">What to evaluate before adopting clinical AI<\/h2><p class=\"wp-block-paragraph\">The review must start with the data flow: what information comes in, which provider processes it, where it is stored, whether it is used for training, what contractual agreement applies, and how the clinician's approval is recorded.<\/p> <ul class=\"wp-block-list\"><li>Determine if the organization and the vendor are covered entities or business associates.<\/li><li>Coordinate HIPAA with state privacy, consent, licensing, and internal policies.<\/li><li>Evaluate EHR integration, traceability, human review, and model governance.<\/li><\/ul><\/div><div class=\"wp-block-group alignfull has-background-alt-background-color has-background is-layout-constrained wp-container-core-group-is-layout-a5cbf47a wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-7387b849 wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:48%\"><figure class=\"wp-block-image size-large\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"1672\" height=\"941\" src=\"https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?resize=1672%2C941&#038;ssl=1\" alt=\"Itaca available for healthcare professionals\" class=\"wp-image-3508\" srcset=\"https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?w=1672&amp;ssl=1 1672w, https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?resize=300%2C169&amp;ssl=1 300w, https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?resize=1024%2C576&amp;ssl=1 1024w, https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?resize=768%2C432&amp;ssl=1 768w, https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?resize=1536%2C864&amp;ssl=1 1536w, https:\/\/i0.wp.com\/itaca.ai\/wp-content\/uploads\/2026\/07\/itaca-mobile-ios-android-illustration.webp?resize=18%2C10&amp;ssl=1 18w\" sizes=\"auto, (max-width: 1000px) 100vw, 1000px\" \/><\/figure><\/div><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:52%\"><h2 class=\"wp-block-heading\">Assisted clinical notes, with the professional in charge<\/h2><p class=\"wp-block-paragraph\">Itaca helps professionals and teams prepare clinical documentation, query information using sources, and organize cases. The professional reviews the results and retains control over clinical decisions.<\/p><div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button\"><a class=\"wp-block-button__link has-foregound-alt-color has-heading-color-background-color has-text-color has-background wp-element-button\" href=\"https:\/\/app.itaca.pro\/sign_up?locale=en\" style=\"border-radius:100px;text-decoration:none\">Try Itaca for free<\/a><\/div><\/div><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-background-background-color has-background is-layout-constrained wp-container-core-group-is-layout-a565c507 wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><p class=\"wp-block-paragraph\">To compare this framework, see <a href=\"\/en\/artificial-intelligence-in-medicine-by-country\/\">Medical AI by country<\/a>, <a href=\"\/en\/ai-for-physicians\/\">AI for Doctors<\/a>, <a href=\"\/en\/software-for-clinics\/\">Clinic software<\/a>, <a href=\"\/en\/clinical-notes-ai\/security-and-privacy\/\">security and privacy<\/a>, and the contexts of <a href=\"\/en\/artificial-intelligence-in-medicine-canada\/\">Canada<\/a> and <a href=\"\/en\/artificial-intelligence-in-medicine-mexico\/\">mexico<\/a>.<\/p><h2 class=\"wp-block-heading\">Public sources for further reading<\/h2><ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/privacy\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">HHS: HIPAA for Professionals \u2197<\/a><\/li><li><a href=\"https:\/\/healthit.gov\/policy\/\" target=\"_blank\" rel=\"noopener noreferrer\">ONC: Policy and Interoperability \u2197<\/a><\/li><\/ul><p class=\"wp-block-paragraph\"><em>Informative content prepared on September 12, 2026. Use this page as initial guidance. Before deciding, confirm the current regulations and policies of your organization.<\/em><\/p><\/div><div class=\"wp-block-group alignfull has-background-alt-background-color has-background is-layout-constrained wp-container-core-group-is-layout-a565c507 wp-block-group-is-layout-constrained\" style=\"padding-top:4.5rem;padding-right:var(--wp--preset--spacing--40);padding-bottom:4.5rem;padding-left:var(--wp--preset--spacing--40)\"><h2 class=\"wp-block-heading\">Frequently asked questions about medical AI<\/h2><details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>Does HIPAA cover any app that uses health data?<\/summary><p class=\"wp-block-paragraph\">No. HIPAA applies to covered entities and certain business associates. Other products may be subject to different rules.<\/p><\/details><details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>Is a documentation tool the same as a medical device?<\/summary><p class=\"wp-block-paragraph\">Not necessarily. The classification depends on the function, product claims, and intended use; the specific case must be evaluated.<\/p><\/details><details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>What should a vendor evaluation contain?<\/summary><p class=\"wp-block-paragraph\">The flow of PHI, the BAA when applicable, sub-processors, storage, retention, incidents, use for training, and access controls.<\/p><\/details><details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary>How can Itaca help?<\/summary><p class=\"wp-block-paragraph\">Itaca prepares clinical drafts that the professional can review and correct. The institution retains clinical decision-making and determines how to incorporate the result into its EHR.<\/p><\/details><\/div>","protected":false},"excerpt":{"rendered":"<p>Clinical context, regulation, documentation, and artificial intelligence for doctors and healthcare organizations in the United States.<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"nf_dc_page":"","slim_seo":{"title":"Medical AI in the United States: Regulation and Practice | Itaca","description":"HIPAA, business associates, EHRs, and professional oversight: A guide to evaluating artificial intelligence in medicine in the United States."},"_joinchat":[],"footnotes":""},"class_list":["post-3957","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/pages\/3957","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/comments?post=3957"}],"version-history":[{"count":6,"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/pages\/3957\/revisions"}],"predecessor-version":[{"id":4565,"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/pages\/3957\/revisions\/4565"}],"wp:attachment":[{"href":"https:\/\/itaca.ai\/en\/wp-json\/wp\/v2\/media?parent=3957"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}