[{"data":1,"prerenderedAt":407},["ShallowReactive",2],{"slug-the-current-state-of-fda-approved-ai-based-medical-devices":3},{"post":4,"relatedPosts":179,"relatedBooks":318},{"id":5,"date":6,"date_gmt":7,"guid":8,"modified":10,"modified_gmt":11,"slug":12,"status":13,"type":14,"link":15,"title":16,"content":18,"excerpt":21,"author":23,"featured_media":24,"comment_status":25,"ping_status":25,"sticky":26,"template":27,"format":28,"meta":29,"categories":30,"tags":32,"project_category":42,"contact_email_category":44,"yst_prominent_words":45,"class_list":55,"better_featured_image":73,"acf":106,"yoast_meta":123,"_links":126},51165,"2026-03-25T10:09:43","2026-03-25T09:09:43",{"rendered":9},"https:\u002F\u002Fmedicalfuturist.com\u002F?post_id=51165&_wpnonce=66b92b2f0d&status=auto-draft&type=post","2026-03-27T06:17:13","2026-03-27T05:17:13","the-current-state-of-fda-approved-ai-based-medical-devices","publish","post","https:\u002F\u002Fmedicalfuturist.com\u002Fthe-current-state-of-fda-approved-ai-based-medical-devices",{"rendered":17},"The Current State Of Over 1450 FDA-Approved, AI-Based Medical Devices",{"rendered":19,"protected":20},"\n\u003Cp>The rise of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Ftop-ai-algorithms-healthcare\" target=\"_blank\">has reshaped the industry\u003C\u002Fa>. And due to the recent march of \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fchatgpt-in-healthcare-what-the-science-says\" target=\"_blank\">ChatGPT\u003C\u002Fa>, and \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fmedpalm-new-ai-medical-chatbots-will-soon-be-better-than-waiting-for-a-doctor\" target=\"_blank\">similar tools\u003C\u002Fa>, various AI algorithms \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fhere-is-how-you-get-friendly-with-a-i-before-it-gets-to-the-office\" target=\"_blank\">have entered the lives\u003C\u002Fa> of the \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fhow-can-you-use-ai-in-your-healthcare-right-now\u002F\" target=\"_blank\">general population\u003C\u002Fa> as well. These technologies \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fthe-chatgpt-revolution-heres-our-new-book-on-generative-ai-in-healthcare\" target=\"_blank\">will undoubtedly change\u003C\u002Fa> the way \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fwhy-it-is-important-to-understand-multimodal-large-language-models-in-healthcare\u002F\" target=\"_blank\">medicine is practiced\u003C\u002Fa>. Given that healthcare is an industry where decisions can literally be a matter of life and death, the importance of effective regulation can’t be overstated. Now this is one hell of a challenge even for the most seasoned professionals.\u003C\u002Fp>\n\n\n\n\u003Cp>AI and ML present novel regulatory challenges. Unlike traditional medical devices, these technologies are \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Flocked-and-adaptive-algorithms-in-healthcare-differences-importance-and-regulatory-hurdles\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">capable of evolving and learning over time\u003C\u002Fa>. This means that they could perform differently in the real world than they did during their pre-market testing. While this could mean improved patient outcomes, it also could introduce new risks that need to be managed. Which is no easy task with a constantly changing algorithm. \u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-1-768x432.png\" alt=\"\" class=\"wp-image-51171\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-1-768x432.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-1-370x208.png 370w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-1-1536x864.png 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-1.png 1600w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\n\n\n\u003Cp>Historically, the FDA has been a global pioneer in regulating novel technologies in healthcare. From pharmaceuticals to medical devices, the FDA was traditionally setting standards, no wonder, all eyes seem to be on the American regulatory body these days. \u003C\u002Fp>\n\n\n\n\u003Cp>Traditionally, \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fsoftware-medical-device-samd\u002Fartificial-intelligence-and-machine-learning-aiml-enabled-medical-devices\" target=\"_blank\">FDA updates its AI-enabled database\u003C\u002Fa> once a year, always in the fall months, so it was time to take a look at what we can learn from the latest available statistics. \u003C\u002Fp>\n\n\n\n\u003Cp>Now the FDA database has a total of 1451 devices (up from 1250 last year). As of March, 2026, no device has been authorized that uses generative AI or is powered by large language models.\u003C\u002Fp>\n\n\n\n\u003Cp>\u003Cstrong>From zero to hero\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>A few years ago, the regulatory landscape for AI and ML technologies was almost non-existent. Medical device approvals didn’t explicitly indicate if a technology was AI-based. This made it difficult for healthcare professionals, patients, and other stakeholders to understand the extent to which AI was being integrated into healthcare solutions. Inventors and developers are also seriously hindered as they see no clear path to market approval of new technologies. It’s crucial to distinguish these AI-based technologies because they carry unique considerations and implications for users and patients.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-full\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"1436\" height=\"1080\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-2.png\" alt=\"AI-based medical devices\" class=\"wp-image-51173\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-2.png 1436w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-2-768x578.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-2-1536x1155.png 1536w\" sizes=\"auto, (max-width: 1436px) 100vw, 1436px\" \u002F>\u003Cfigcaption class=\"wp-element-caption\">For the full-size version, right-click on the image and open in a new tab\u003C\u002Ffigcaption>\u003C\u002Ffigure>\n\n\n\n\u003Cp>The FDA has been approving AI-based devices for years but didn’t initially distinguish them as a unique category. A few years back, we at The Medical Futurist Institute took it upon ourselves to sift through all these approvals and \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.nature.com\u002Farticles\u002Fs41746-020-00324-0\" target=\"_blank\">identify the ones that were AI-based\u003C\u002Fa>. From our work, we created an open-access database, which we shared with the FDA so they could build on our groundwork. To our gratification, a year later, the \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fsoftware-medical-device-samd\u002Fartificial-intelligence-and-machine-learning-aiml-enabled-medical-devices\" target=\"_blank\">FDA published its own database\u003C\u002Fa> and cited us as a source.\u003C\u002Fp>\n\n\n\n\u003Cp>\u003Cstrong>The exponential growth we witness now\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"845\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F07\u002F20260324_FDA-Approved-AI-Based-Medical-Devices-small-768x845.jpg\" alt=\"\" class=\"wp-image-60507\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F07\u002F20260324_FDA-Approved-AI-Based-Medical-Devices-small-768x845.jpg 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F07\u002F20260324_FDA-Approved-AI-Based-Medical-Devices-small-1396x1536.jpg 1396w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\n\n\n\u003Cp>To date, the most recent database shows a total of 1250 approvals. Look how sharply this number has been rising:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>1995: 2\u003C\u002Fli>\n\n\n\n\u003Cli>1997: 1\u003C\u002Fli>\n\n\n\n\u003Cli>1998: 2\u003C\u002Fli>\n\n\n\n\u003Cli>2001: 2\u003C\u002Fli>\n\n\n\n\u003Cli>2002: 1\u003C\u002Fli>\n\n\n\n\u003Cli>2004: 1\u003C\u002Fli>\n\n\n\n\u003Cli>2005: 1\u003C\u002Fli>\n\n\n\n\u003Cli>2006: 1\u003C\u002Fli>\n\n\n\n\u003Cli>2008: 5\u003C\u002Fli>\n\n\n\n\u003Cli>2010: 3\u003C\u002Fli>\n\n\n\n\u003Cli>2011: 3\u003C\u002Fli>\n\n\n\n\u003Cli>2012: 5\u003C\u002Fli>\n\n\n\n\u003Cli>2013: 4\u003C\u002Fli>\n\n\n\n\u003Cli>2014: 6\u003C\u002Fli>\n\n\n\n\u003Cli>2015: 6\u003C\u002Fli>\n\n\n\n\u003Cli>2016: 18\u003C\u002Fli>\n\n\n\n\u003Cli>2017: 27\u003C\u002Fli>\n\n\n\n\u003Cli>2018: 65\u003C\u002Fli>\n\n\n\n\u003Cli>2019: 80\u003C\u002Fli>\n\n\n\n\u003Cli>2020: 114\u003C\u002Fli>\n\n\n\n\u003Cli>2021: 130\u003C\u002Fli>\n\n\n\n\u003Cli>2022: 163\u003C\u002Fli>\n\n\n\n\u003Cli>2023: 226\u003C\u002Fli>\n\n\n\n\u003Cli>2024: 236\u003C\u002Fli>\n\n\n\n\u003Cli>2025: 350  \u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>\u003Cstrong>Which specialties are most affected?\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>According to our latest data analysis, \u003Ca href=\"https:\u002F\u002Faicentral.acrdsi.org\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">radiology stands out\u003C\u002Fa> as the most AI-invested medical specialty, boasting a whopping 1104 approved devices. A distant second is \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Ffuture-of-cardiology\" target=\"_blank\" rel=\"noreferrer noopener\">cardiology\u003C\u002Fa> or cardiovascular (as a category), with 141 devices.\u003C\u002Fp>\n\n\n\n\u003Cp>Beyond that, other specialties (neurology, hematology, gastroenterology-urology and ophthalmology among others) see a handful of devices. What propelled imaging to such heights? Well, deep learning found a \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fthe-future-of-radiology-and-ai\" target=\"_blank\">fertile ground in radiology\u003C\u002Fa>, which is largely data-driven. \u003C\u002Fp>\n\n\n\n\u003Cp>Here is the full list:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Radiology 1104\u003C\u002Fli>\n\n\n\n\u003Cli>Cardiovascular 141\u003C\u002Fli>\n\n\n\n\u003Cli>Neurology 67\u003C\u002Fli>\n\n\n\n\u003Cli>Anesthesiology 27\u003C\u002Fli>\n\n\n\n\u003Cli>Gastroenterology-Urology 26\u003C\u002Fli>\n\n\n\n\u003Cli>Hematology 21\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>\u003Cstrong>The FDA submission types\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>The FDA recognises three distinct submission types: the 510(k), pre-market approval, and the De Novo pathway. By a long shot, \u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>the 510(k) is the most popular with 1396 (+201 since last year) approvals so far,\u003C\u002Fli>\n\n\n\n\u003Cli>leaving De Novo 37 (+1)\u003C\u002Fli>\n\n\n\n\u003Cli>and pre-market 18 (+2) far behind. \u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>No wonder 510(k) is so popular, simply put, it’s the easiest route, as it is the pathway used for devices that are substantially equivalent to another legally marketed device. No new clinical trials are needed, although companies need to prove that their device is as safe and as effective as the already approved one. \u003C\u002Fp>\n\n\n\n\u003Cp>Meanwhile, pre-market approval is the most stringent type of device marketing application process. It is for high-risk devices, and it requires the manufacturer to provide clinical evidence demonstrating the safety and effectiveness of the device. This often involves clinical trials, which in turn makes it expensive. \u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-768x432.png\" alt=\"\" class=\"wp-image-51169\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-768x432.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-370x208.png 370w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage-1536x864.png 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F06\u002Fimage.png 1600w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\n\n\n\u003Cp>The De Novo pathway is a regulatory pathway for low- to moderate-risk devices that are novel and for which there are no legally marketed predicate devices. It is suitable for Class I or II (lower-risk classifications) medical devices.\u003C\u002Fp>\n\n\n\n\u003Cp>We will continue to monitor this field, given that the FDA’s approach can set a valuable precedent for regulatory bodies in other countries. So, buckle up and stay tuned – there will be a lot to learn in the coming few years.\u003C\u002Fp>\n",false,{"rendered":22,"protected":20},"\u003Cp>Given that healthcare is an industry where decisions can literally be a matter of life and death, the importance of effective regulation can’t be overstated. Now this is one hell of a challenge even for the most seasoned professionals.\u003C\u002Fp>\n",6,30807,"closed",true,"","standard",{"_acf_changed":20,"footnotes":27},[31],504,[33,34,35,36,37,38,39,40,41],313,7671,7673,7827,134,144,207,236,275,[43],950,[],[46,47,48,49,50,51,52,53,54],4505,5067,1621,1683,1723,1833,2017,3841,4295,[56,14,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"post-51165","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-artificial-intelligence","tag-medicine","tag-ai-in-healthcare","tag-ai-in-medicine","tag-ai-based-medical-devices","tag-ai","tag-artificial-intelligence","tag-digital-health","tag-fda-2","tag-healthcare","project_category-medical-professionals",{"id":24,"alt_text":74,"caption":27,"description":27,"media_type":75,"media_details":76,"post":104,"source_url":105},"algorithm, deep learning, tmf","image",{"width":77,"height":78,"file":79,"sizes":80,"image_meta":102},1920,1080,"2020\u002F10\u002F214_tmf-01-1.png",{"medium":81,"large":87,"thumbnail":92,"medium_large":96,"1536x1536":97},{"file":82,"width":83,"height":84,"mime-type":85,"source_url":86},"214_tmf-01-1-370x208.png","370","208","image\u002Fpng","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2020\u002F10\u002F214_tmf-01-1-370x208.png",{"file":88,"width":89,"height":90,"mime-type":85,"source_url":91},"214_tmf-01-1-768x432.png","768","432","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2020\u002F10\u002F214_tmf-01-1-768x432.png",{"file":93,"width":94,"height":94,"mime-type":85,"source_url":95},"214_tmf-01-1-150x150.png","150","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2020\u002F10\u002F214_tmf-01-1-150x150.png",{"file":88,"width":89,"height":90,"mime-type":85,"source_url":91},{"file":98,"width":99,"height":100,"mime-type":85,"source_url":101},"214_tmf-01-1-1536x864.png","1536","864","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2020\u002F10\u002F214_tmf-01-1-1536x864.png",{"aperture":103,"credit":27,"camera":27,"caption":27,"created_timestamp":103,"copyright":27,"focal_length":103,"iso":103,"shutter_speed":103,"title":27,"orientation":103},"0",14484,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2020\u002F10\u002F214_tmf-01-1.png",{"cta_type":107,"cta_color":27,"related_books":108,"related_posts_footer":112,"related_posts":20,"subtitle":27,"key_takeaways":116},"subscribe",[109,110,111],52203,24759,24761,[113,114,115],27125,53971,53645,[117,119,121],{"title":118},"\u003Cp>The FDA, a global leader in healthcare regulation, is adapting its framework to include AI-based medical devices, with 1400 approvals and clearances to date, indicating an acknowledgment of AI’s expanding role in healthcare.\u003C\u002Fp>\n",{"title":120},"\u003Cp>The rise of AI in healthcare is revolutionizing medical practice, presenting unique regulatory challenges given AI’s evolving nature, which necessitates effective oversight to manage potential risks.\u003C\u002Fp>\n",{"title":122},"\u003Cp>Radiology leads in AI device approvals reflecting deep learning’s applicability in image-based diagnostics, while the 510(k) submission pathway is predominant due to its streamlined process for devices similar to existing ones.\u003C\u002Fp>\n",{"yoast_wpseo_title":124,"yoast_wpseo_metadesc":125,"yoast_wpseo_canonical":15},"The Current State Of FDA-Approved AI-Enabled Medical Devices","Decisions in healthcare can be a matter of life and death, the importance of effective regulation can't be overstated. One hell of a challenge with AI.",{"self":127,"collection":133,"about":136,"author":139,"replies":142,"version-history":145,"predecessor-version":149,"wp:featuredmedia":153,"wp:attachment":156,"wp:term":159,"curies":175},[128],{"href":129,"targetHints":130},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F51165",{"allow":131},[132],"GET",[134],{"href":135},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts",[137],{"href":138},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Ftypes\u002Fpost",[140],{"embeddable":26,"href":141},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fusers\u002F6",[143],{"embeddable":26,"href":144},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcomments?post=51165",[146],{"count":147,"href":148},31,"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F51165\u002Frevisions",[150],{"id":151,"href":152},60529,"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F51165\u002Frevisions\u002F60529",[154],{"embeddable":26,"href":155},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fmedia\u002F30807",[157],{"href":158},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fmedia?parent=51165",[160,163,166,169,172],{"taxonomy":161,"embeddable":26,"href":162},"category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcategories?post=51165",{"taxonomy":164,"embeddable":26,"href":165},"post_tag","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Ftags?post=51165",{"taxonomy":167,"embeddable":26,"href":168},"project_category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fproject_category?post=51165",{"taxonomy":170,"embeddable":26,"href":171},"contact_email_category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcontact_email_category?post=51165",{"taxonomy":173,"embeddable":26,"href":174},"yst_prominent_words","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fyst_prominent_words?post=51165",[176],{"name":177,"href":178,"templated":26},"wp","https:\u002F\u002Fapi.w.org\u002F{rel}",[180],{"id":115,"date":181,"date_gmt":182,"guid":183,"modified":185,"modified_gmt":186,"slug":187,"status":13,"type":14,"link":188,"title":189,"content":191,"excerpt":193,"author":23,"featured_media":195,"comment_status":25,"ping_status":25,"sticky":26,"template":27,"format":28,"meta":196,"categories":197,"tags":201,"project_category":205,"contact_email_category":207,"yst_prominent_words":208,"class_list":212,"better_featured_image":221,"acf":261,"yoast_meta":274,"_links":276},"2025-06-02T10:00:39","2025-06-02T08:00:39",{"rendered":184},"https:\u002F\u002Fmedicalfuturist.com\u002F?post_id=53645&_wpnonce=e4cc01339a&status=auto-draft&type=post","2025-06-02T10:00:40","2025-06-02T08:00:40","are-you-too-old-to-use-digital-health","https:\u002F\u002Fmedicalfuturist.com\u002Fare-you-too-old-to-use-digital-health",{"rendered":190},"Golden Years, Digital Gears: Digital Health For Aging Populations",{"rendered":192,"protected":20},"\n\u003Cp>\u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fhow-to-make-life-worth-living-over-90\u002F\" target=\"_blank\">The elderly\u003C\u002Fa> are \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fsenior-health-2021\u002F\" target=\"_blank\">not the archetypal target group\u003C\u002Fa> of various digital health developments. We have \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fthe-greatest-technological-developments-for-the-elderly\u002F\" target=\"_blank\">already discussed\u003C\u002Fa> the topic \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Ftop-18-technologies-for-the-aging-populations\u002F\" target=\"_blank\">multiple times\u003C\u002Fa>, however, nothing captures the main setbacks as accurately as this brilliant, and in my opinion, underrated sketch from Saturday Night Live. It’s a timeless piece, all tiny details – the characters, the device design, the voiceovers – nuggets of gold.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\">\u003Cdiv class=\"wp-block-embed__wrapper\">\n\u003Ciframe loading=\"lazy\" title=\"Amazon Echo - SNL\" width=\"640\" height=\"360\" src=\"https:\u002F\u002Fwww.youtube.com\u002Fembed\u002FYvT_gqs5ETk?start=5&feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen>\u003C\u002Fiframe>\n\u003C\u002Fdiv>\u003C\u002Ffigure>\n\n\n\n\u003Cp>Although features like continuous aFib screening (or blood pressure monitoring, alerts about changes in respiratory patterns, in gait, reminders on medication or drinking enough, and so on, and so on) \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fbeyond-the-hype-the-top-5-digital-health-devices-making-a-real-difference-in-my-life\" target=\"_blank\" rel=\"noreferrer noopener\">would do more favor\u003C\u002Fa> for the seventy-somethings than for the twenty-somethings, we just seem to acknowledge the status quo. \u003C\u002Fp>\n\n\n\n\u003Cp>So we have a handful of well-known factors hindering digital health adoption in the elderly generation: \u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Most devices specifically target younger customers – as opposed to just simply not specifically focusing on the elderly\u003C\u002Fli>\n\n\n\n\u003Cli>This results in usability issues, which range from not seeing the screen to not understanding the aim of the device\u002Ftechnology\u002Fsolution\u003C\u002Fli>\n\n\n\n\u003Cli>Often, our elderly relatives might not even consider that they could (let alone should) use such technologies\u003C\u002Fli>\n\n\n\n\u003Cli>And of course, there are hard barriers: these devices are often not cheap and the elderly are more likely to have a tight budget.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>Still, there is a growing body of evidence showing that we don’t need to wait until today’s youngsters grow into their golden years to make technology work for seniors. If we could just make older people want these devices, it would profoundly alter the situation.\u003C\u002Fp>\n\n\n\n\u003Cp>When trying to determine \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fdigital-technology-make-an-impact-on-primary-care\" target=\"_blank\" rel=\"noreferrer noopener\">who will\u002Fcan use a digital health solution\u003C\u002Fa>, we won’t be able to set a universally valid age limit. Let’s take a look at Peter and Klara, the parents of my friend. They are well in their 70s and they both received an emergency wearable from the local municipality. The little device can be worn with a neck strap, on the wrist as a watch, or clipped to the belt and has an SOS button connected to a 24\u002F7 dispatcher service, it is waterproof and has a fall detection feature. Quite what you want for your elderly parents living on their own. While Klara is a happy user of the gadget and makes sure hers is always worn and properly charged, Peter’s device lives on his nightstand. “It’s impossible to always remember to wear it “ – he grumbles when asked. \u003C\u002Fp>\n\n\n\n\u003Cp>Both perceived usefulness and perceived ease of use are significantly linked to attitudes toward the use of digital health technologies – \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.jmir.org\u002F2023\u002F1\u002Fe41915\" target=\"_blank\">this study found\u003C\u002Fa>. In other words: if you believe that you can use a device and trust in its usefulness, you’ll have a much higher chance of actually feeling comfortable using said device and finding it useful. And the positive attitude is linked to tech literacy: the more informed you are, the higher the chances you will be optimistic about the technology.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>Let’s find good selling points, like prolonged independence\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>We can’t just say to our parents\u002Fgrandparents: \u003Cem>you need to want to use this smartwatch\u003C\u002Fem> and expect anything to happen – other than giving them a laugh. Or make them want to use generative AI by pointing out that they should do it.\u003C\u002Fp>\n\n\n\n\u003Cp>So we need to find selling points, and one of the best is prolonged independence. Grandma might not want to use digital health, but she surely wants to live in her own place independently as long as possible. And she may want to use devices that make it possible. \u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"439\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002FDALL·E-elderly-DHT-768x439.png\" alt=\"elderly health tech\" class=\"wp-image-53685\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002FDALL·E-elderly-DHT-768x439.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002FDALL·E-elderly-DHT-1536x878.png 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002FDALL·E-elderly-DHT.png 1613w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\n\n\n\u003Cp>“An overwhelming majority of respondents (93%) said aging in place is an important goal of theirs. Aging in place is considered the ability to live in one’s home and community safely, independently, and comfortably, regardless of age, income or ability level” – this \u003Ca href=\"https:\u002F\u002Fwww.managedhealthcareexecutive.com\u002Fview\u002Fmore-older-adults-plan-to-use-digital-health-technologies-as-they-age-in-place-\" target=\"_blank\" rel=\"noreferrer noopener\">U.S. News & World Report survey\u003C\u002Fa> found.\u003C\u002Fp>\n\n\n\n\u003Cp>This survey shows that aging is the primary reason for using assistive or health-related technologies. And the primary reason for not using them is that people feel they don’t need them \u003Cem>yet\u003C\u002Fem>. Only 16% of non-users cited financial reasons. \u003C\u002Fp>\n\n\n\n\u003Cp>The things that matter most are that it’s easy to use (75%), easy to set up (50%), accessible using a mobile app (38%), and wireless (37%). An overwhelming majority (88%) said that assistive or health-related technologies have improved their quality of life, and they provide a sense of independence for more than half of the respondents.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>The invisible population\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>As the above-linked study discussed, a positive attitude is key and people with higher levels of digital health literacy have more positive attitudes. So what do we know about the digital health literacy of the elderly? \u003C\u002Fp>\n\n\n\n\u003Cp>Well, not much. \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fpmc\u002Farticles\u002FPMC9389004\u002F\" target=\"_blank\">This scoping review\u003C\u002Fa> targeted these specific questions. They started their work with a whopping 1,924 articles to analyse the current state of digital health literacy of the elderly. After applying the inclusion and exclusion criteria, only 47 articles were selected for the review. Of the vast amount of literature only a small subset focused specifically on older adults as per the defined criteria of the review.\u003C\u002Fp>\n\n\n\n\u003Cp>Not only are the elderly not in our eyesight \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fcardiosignal.com\u002Fblog\u002Fage-should-not-limit-the-use-of-digital-health\" target=\"_blank\">when we design these technologies\u003C\u002Fa>, but they are also almost invisible when we analyse the field. \u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F09\u002F107_How-to-make-life-worth-living-over-75-or-100_-768x432.png\" alt=\"tmf_life worth over elderly care, seniors, digital health\" class=\"wp-image-24847\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F09\u002F107_How-to-make-life-worth-living-over-75-or-100_-768x432.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F09\u002F107_How-to-make-life-worth-living-over-75-or-100_-370x208.png 370w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F09\u002F107_How-to-make-life-worth-living-over-75-or-100_-1536x864.png 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F09\u002F107_How-to-make-life-worth-living-over-75-or-100_-2048x1152.png 2048w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F09\u002F107_How-to-make-life-worth-living-over-75-or-100_.png 1920w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\n\n\n\u003Cp>Here, \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Flink.springer.com\u002Fchapter\u002F10.1007\u002F978-3-030-51406-8_13\" target=\"_blank\">the authors identified four types of drivers\u003C\u002Fa> of old-age digital health exclusion, namely structural, environmental, socio-technical and individual, which intersect with each other to increase the vulnerability of older people to exclusion from health services. We discussed the individual drive in detail above, that is the attitude one has towards the technology. \u003C\u002Fp>\n\n\n\n\u003Cp>Structural, environmental and socio-technical drivers are primarily only modifiable by organizational and high-level actors (e.g. policymakers, policymakers and market players). We don’t need to take old-age exclusion for granted, though. \u003C\u002Fp>\n\n\n\n\u003Cp>As policies and market evolution influence social norms and values, which can either facilitate or hinder older adults’ access to digital health services, structural divides can be addressed with the right policymaking attitude. Environmental drivers – like technological infrastructure – are evolving, and although they are not typically developed with the elderly in mind, the general improvement in infrastructure benefits all age groups. \u003C\u002Fp>\n\n\n\n\u003Cp>Socio-technical limits arise from product design, which is basically determined by a business perspective. Tech companies are after profit and rarely after philanthropic laurels, so we need to find the business rationale behind senior tech – like savings in healthcare spending.\u003C\u002Fp>\n",{"rendered":194,"protected":20},"\u003Cp>With finding good selling points (like independence), we can make our elderly motivated to use health tech. These wearables are most beneficial for seniors. \u003C\u002Fp>\n",53653,{"_acf_changed":20,"footnotes":27},[198,199,200],7079,521,499,[37,39,202,203,204],7887,453,1305,[43,206],952,[],[209,210,211],1571,1617,1681,[213,14,57,58,59,60,61,214,215,216,67,69,217,218,219,72,220],"post-53645","category-tmf","category-future-medicine","category-healthcare-design","tag-senior-health","tag-wearables-2","tag-health-tech","project_category-policy-makers",{"id":195,"alt_text":27,"caption":27,"description":27,"media_type":75,"media_details":222,"post":115,"source_url":260},{"width":223,"height":224,"file":225,"filesize":226,"sizes":227,"image_meta":258},6667,3750,"2023\u002F11\u002Ftmf_article_391.png",755449,{"medium":228,"large":234,"thumbnail":240,"medium_large":245,"1536x1536":246,"2048x2048":252},{"file":229,"width":230,"height":231,"mime-type":85,"filesize":232,"source_url":233},"tmf_article_391-370x208.png",370,208,35354,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002Ftmf_article_391-370x208.png",{"file":235,"width":236,"height":237,"mime-type":85,"filesize":238,"source_url":239},"tmf_article_391-768x432.png",768,432,85189,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002Ftmf_article_391-768x432.png",{"file":241,"width":242,"height":242,"mime-type":85,"filesize":243,"source_url":244},"tmf_article_391-150x150.png",150,17338,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002Ftmf_article_391-150x150.png",{"file":235,"width":236,"height":237,"mime-type":85,"filesize":238,"source_url":239},{"file":247,"width":248,"height":249,"mime-type":85,"filesize":250,"source_url":251},"tmf_article_391-1536x864.png",1536,864,197419,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002Ftmf_article_391-1536x864.png",{"file":253,"width":254,"height":255,"mime-type":85,"filesize":256,"source_url":257},"tmf_article_391-2048x1152.png",2048,1152,279055,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002Ftmf_article_391-2048x1152.png",{"aperture":103,"credit":27,"camera":27,"caption":27,"created_timestamp":103,"copyright":27,"focal_length":103,"iso":103,"shutter_speed":103,"title":27,"orientation":103,"keywords":259},[],"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F11\u002Ftmf_article_391.png",{"cta_type":107,"cta_color":27,"related_books":262,"related_posts_footer":263,"related_posts":20,"subtitle":27,"key_takeaways":267},[111,109,110],[264,265,266],52933,53187,20749,[268,270,272],{"title":269},"\u003Cp>\u003Cspan style=\"font-weight: 400;\">Despite the perception that digital health technologies are not aimed at older adults, they have the potential to significantly benefit this demographic with features like health monitoring and reminders for medication or hydration.\u003C\u002Fspan>\u003C\u002Fp>\n",{"title":271},"\u003Cp>Older adults’ willingness to use digital health technologies is closely tied to their attitude – their beliefs in the technology’s usefulness and their own ability to use it.\u003C\u002Fp>\n",{"title":273},"\u003Cp>If they want to use such technologies – for example, to live autonomously for as long as possible-, their attitudes will significantly improve. In simple terms, it means we need to find good selling points to make our elderly relatives interested in owning such devices.\u003C\u002Fp>\n",{"yoast_wpseo_title":190,"yoast_wpseo_metadesc":275,"yoast_wpseo_canonical":188},"With finding good selling points (like independence), we can make our elderly motivated to use health tech. 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