[{"data":1,"prerenderedAt":167},["ShallowReactive",2],{"slug-5-digital-health-areas-to-be-impacted-by-the-fda-layoffs":3},{"post":4,"relatedPosts":165,"relatedBooks":166},{"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":37,"project_category":38,"contact_email_category":39,"yst_prominent_words":40,"class_list":46,"better_featured_image":59,"acf":102,"yoast_meta":110,"_links":112},58581,"2025-03-14T10:00:00","2025-03-14T09:00:00",{"rendered":9},"https:\u002F\u002Fmedicalfuturist.com\u002F?post_id=58581&_wpnonce=83e38d9357&status=auto-draft&type=post","2025-03-13T15:59:15","2025-03-13T14:59:15","5-digital-health-areas-to-be-impacted-by-the-fda-layoffs","publish","post","https:\u002F\u002Fmedicalfuturist.com\u002F5-digital-health-areas-to-be-impacted-by-the-fda-layoffs",{"rendered":17},"5 Digital Health Areas To Be Impacted By The FDA Layoffs",{"rendered":19,"protected":20},"\n\u003Cp>In the early days of Facebook, the company’s progress was guided by the \u003Ca href=\"https:\u002F\u002Fhbr.org\u002F2019\u002F01\u002Fthe-era-of-move-fast-and-break-things-is-over\" target=\"_blank\" rel=\"noreferrer noopener\">“move fast and break things” principle\u003C\u002Fa>. To a certain extent, this was the motto across the tech industry to put products on the market. This principle emphasized the benefit of speed and experimentation, \u003Ca href=\"https:\u002F\u002Fwww.masterclass.com\u002Farticles\u002Fmove-fast-and-break-things\" target=\"_blank\" rel=\"noreferrer noopener\">often with mistakes and disruption\u003C\u002Fa> in relation to regulations and traditional practices, over a slow and cautious pace.\u003C\u002Fp>\n\n\n\n\u003Cp>With tech moguls now working closely with the second Trump administration, this concept has been \u003Ca href=\"https:\u002F\u002Fwww.theguardian.com\u002Fcommentisfree\u002F2025\u002Ffeb\u002F09\u002Fwhile-trump-is-moving-fast-and-breaking-things-americans-wanting-to-escape-should-come-to-australia\" target=\"_blank\" rel=\"noreferrer noopener\">adopted at a governmental level\u003C\u002Fa> in the US. As a result, things are indeed moving fast, and breaking, with \u003Ca href=\"https:\u002F\u002Fwww.statnews.com\u002F2025\u002F02\u002F19\u002Ffda-layoffs-could-shift-regulatory-burden-health-systems-ai-prognosis\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">thousands of jobs\u003C\u002Fa> across key agencies have been eliminated. This includes sensitive sectors such as healthcare where the Food and Drug Administration (FDA), the world’s leading regulatory agency, \u003Ca href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\" rel=\"noreferrer noopener\">experienced widespread layoffs and scrambling rehires\u003C\u002Fa>. \u003C\u002Fp>\n\n\n\n\u003Cp>As this happened in a matter of weeks of the new administration taking office, it leads to concerns over the FDA’s future; especially in new and rapidly evolving areas such as digital health and healthcare artificial intelligence (AI) which were markedly affected by the layoffs. \u003C\u002Fp>\n\n\n\n\u003Cp>As such disruptions \u003Ca href=\"https:\u002F\u002Fwww.theguardian.com\u002Fcommentisfree\u002F2025\u002Ffeb\u002F09\u002Fwhile-trump-is-moving-fast-and-breaking-things-americans-wanting-to-escape-should-come-to-australia\">might still be \u003C\u002Fa>\u003Ca href=\"https:\u002F\u002Fwww.theguardian.com\u002Fcommentisfree\u002F2025\u002Ffeb\u002F09\u002Fwhile-trump-is-moving-fast-and-breaking-things-americans-wanting-to-escape-should-come-to-australia\" target=\"_blank\" rel=\"noreferrer noopener\">o\u003C\u002Fa>\u003Ca href=\"https:\u002F\u002Fwww.theguardian.com\u002Fcommentisfree\u002F2025\u002Ffeb\u002F09\u002Fwhile-trump-is-moving-fast-and-breaking-things-americans-wanting-to-escape-should-come-to-australia\">n the table\u003C\u002Fa> over the coming years of this new administration, it is worth considering the emerging digital health sectors that could be the most impacted. Moreover, will another agency take up the FDA’s role as the world’s leading regulatory body in the medical and healthcare space? We consider these aspects in this article.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>What’s behind the FDA layoffs?\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>In February 2025, as part of \u003Ca href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\" rel=\"noreferrer noopener\">a cost-cutting approach\u003C\u002Fa> initiated by the White House and the Department of Government Efficiency, which is led by billionaire Elon Musk, \u003Ca href=\"https:\u002F\u002Fwww.reuters.com\u002Fworld\u002Fus\u002Fus-fda-asks-fired-scientists-return-including-some-reviewing-musks-neuralink-2025-02-22\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">a thousand employees\u003C\u002Fa> were fired from the FDA. As with other agencies affected by this “move fast, break things” approach, the FDA terminations targeted those \u003Ca href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\" rel=\"noreferrer noopener\">in their probationary period\u003C\u002Fa>, which is usually the first two years of federal employment.\u003C\u002Fp>\n\n\n\n\u003Cp>However, this impacted \u003Ca href=\"https:\u002F\u002Fwww.statnews.com\u002F2025\u002F02\u002F19\u002Ffda-layoffs-could-shift-regulatory-burden-health-systems-ai-prognosis\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">new and rapidly evolving\u003C\u002Fa>, but important, areas like digital health and healthcare AI, where the agency was building up its capacity for regulation as these areas quickly advanced in the past few years. For example, the job cuts \u003Ca href=\"https:\u002F\u002Fwww.mobihealthnews.com\u002Fnews\u002Ffda-neuralink-reviewers-fired-musk-s-doge-cuts-jobs\" target=\"_blank\" rel=\"noreferrer noopener\">affected 20 employees\u003C\u002Fa> from the FDA’s Office of Neurological and Physical Medicine devices. This \u003Ca href=\"https:\u002F\u002Fwww.mobihealthnews.com\u002Fnews\u002Ffda-neuralink-reviewers-fired-musk-s-doge-cuts-jobs\" target=\"_blank\" rel=\"noreferrer noopener\">included individuals\u003C\u002Fa> reviewing Elon Musk’s Neuralink, which was under pressure for alleged animal deaths during testing of its neurotech device.\u003C\u002Fp>\n\n\n\n\u003Cp>“These people are indispensable,” \u003Ca href=\"https:\u002F\u002Fwww.nbcnews.com\u002Fhealth\u002Fhealth-news\u002Ffda-rehires-staff-medical-devices-division-mass-layoffs-rcna193501\" target=\"_blank\" rel=\"noreferrer noopener\">a former FDA employee\u003C\u002Fa> said. “Many of these roles require so much training and specialization and are so important for keeping people alive.” Indeed, the fired employees included physicians and cybersecurity experts responsible for the approval and safety monitoring of products ranging from X-ray machines to surgical implants.\u003C\u002Fp>\n\n\n\u003Cdiv class=\"wp-block-image\">\n\u003Cfigure class=\"aligncenter size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"511\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ffda-office-768x511.jpg\" alt=\"\" class=\"wp-image-58583\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ffda-office-768x511.jpg 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ffda-office.jpg 1521w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003Cfigcaption class=\"wp-element-caption\">Source: https:\u002F\u002Fapnews.com\u002F\u003C\u002Ffigcaption>\u003C\u002Ffigure>\n\u003C\u002Fdiv>\n\n\n\u003Cp>These layoffs were met with \u003Ca href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\" rel=\"noreferrer noopener\">significant pushback\u003C\u002Fa> from medical device industry lobbyists who fund the FDA with millions of dollars annually to hire extra scientists to review products. In fact, \u003Ca href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\" rel=\"noreferrer noopener\">about $3.3 billion\u003C\u002Fa> or approximately half of the FDA’s budget originates from fees paid by drugmakers, device and tobacco companies. As such, the Musk-led cuts won’t be as significant to their aim at reducing the federal budget.\u003C\u002Fp>\n\n\n\n\u003Cp>The lobbyists \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\">cautioned that\u003C\u002Fa> the job cuts would lead to slower product approvals and a scarcity of new treatment options for patients. Following their call for reversal, the FDA did move to reinstate \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.fiercebiotech.com\u002Fmedtech\u002Ffda-works-reverse-layoffs-rehire-lost-staff-reports\" target=\"_blank\">a reported 300 people\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>Digital health fields that might get impacted by the FDA lay-offs\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>Despite the rehires, this leaves a vacuum in key areas of FDA’s regulatory oversight – due to the US President’s executive order to \u003Ca href=\"https:\u002F\u002Fwww.biopharmadive.com\u002Fnews\u002Ffda-layoffs-trump-doge-hhs-cuts-impact\u002F740499\u002F\">limit the rate\u003C\u002Fa> of future hiring – and a sense of uncertainty amidst the broader medical community. With the new administration only recently taking office, there remains the possibility of a future reduction in the FDA workforce. \u003C\u002Fp>\n\n\n\n\u003Cp>The immediate effects of the reduction of the FDA’s work will mean that the agency will take longer to review applications, which will cascade into reduced efficiency and overall oversight. With fewer hires, the agency’s expertise and expansion in emerging healthcare fields will further diminish. We consider some that are more likely to be impacted below.\u003C\u002Fp>\n\n\n\u003Cdiv class=\"wp-block-image\">\n\u003Cfigure class=\"aligncenter size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F11\u002Ftop-technologies-768x432.png\" alt=\"Top medical technologies\" class=\"wp-image-25448\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F11\u002Ftop-technologies-768x432.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F11\u002Ftop-technologies-370x208.png 370w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F11\u002Ftop-technologies-1536x864.png 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F11\u002Ftop-technologies-2048x1152.png 2048w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F11\u002Ftop-technologies.png 1920w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\u003C\u002Fdiv>\n\n\n\u003Ch3 class=\"wp-block-heading\">\u003Cstrong>1. Digital health devices \u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\n\u003Cp>The majority of the layoffs impacted the FDA’s Center for Devices and Radiological Health (CDRH), with a reported \u003Ca href=\"https:\u002F\u002Fwww.raps.org\u002Fnews-and-articles\u002Fnews-articles\u002F2025\u002F2\u002Fexperts-fda-layoffs-will-slow-device-reviews,-impa\" target=\"_blank\" rel=\"noreferrer noopener\">200 device staff positions\u003C\u002Fa> made redundant. As such, this could affect the review and regulation of \u003Ca href=\"https:\u002F\u002Fwww.nytimes.com\u002F2025\u002F02\u002F21\u002Fhealth\u002Ffda-trump-layoffs-device-and-food-safety.html\" target=\"_blank\" rel=\"noreferrer noopener\">digital health devices\u003C\u002Fa> such as brain implants, new surgical staplers and insulin-delivery systems. The turnover rate of assessing their safety and subsequent approval is likely to be reduced and new digital health devices will take longer to be available in the US market.\u003C\u002Fp>\n\n\n\n\u003Ch3 class=\"wp-block-heading\">\u003Cstrong>2. Healthcare AI\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\n\u003Cp>FDA employees specializing in healthcare AI were hit particularly hard by the terminations. It is estimated that \u003Ca href=\"https:\u002F\u002Fwww.medtechdive.com\u002Fnews\u002Ffda-cdrh-cuts-device-industry-impact\u002F740528\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">half of that division\u003C\u002Fa> was laid off. The approval of such new technologies is among the most challenging and complicated; and a reduced workforce overseeing them will face additional challenges in keeping up with the breakneck speed of AI development. It is crucial to ensure the reliability of such tools when AI software such as \u003Ca href=\"https:\u002F\u002Fwww.nytimes.com\u002F2025\u002F02\u002F21\u002Fhealth\u002Ffda-trump-layoffs-device-and-food-safety.html\" target=\"_blank\" rel=\"noreferrer noopener\">MRI scan analysers and cancer detection tools\u003C\u002Fa> are actively being reviewed.\u003C\u002Fp>\n\n\n\n\u003Ch3 class=\"wp-block-heading\">\u003Cstrong>3. Digital therapeutics\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\n\u003Cp>\u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Ften-ways-technology-changing-healthcare\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">Digital therapeutics\u003C\u002Fa> (DTx) are an emerging digital health approach which involves the delivery of clinically-backed solutions via software (usually smartphone apps). They can aid in reducing readmission rates and managing chronic conditions more effectively. As a larger number of software are developed and backed by research, the FDA might not have the capacity to regulate this expanding landscape.\u003C\u002Fp>\n\n\n\u003Cdiv class=\"wp-block-image\">\n\u003Cfigure class=\"aligncenter size-large\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"1350\" src=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F08\u002FTMF_Drugs-Vs-DTx-768x1350.png\" alt=\"TMF Drugs Vs Digital Therapeutics\" class=\"wp-image-51983\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F08\u002FTMF_Drugs-Vs-DTx-768x1350.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F08\u002FTMF_Drugs-Vs-DTx-874x1536.png 874w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F08\u002FTMF_Drugs-Vs-DTx-1165x2048.png 1165w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2023\u002F08\u002FTMF_Drugs-Vs-DTx.png 1920w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \u002F>\u003C\u002Ffigure>\n\u003C\u002Fdiv>\n\n\n\u003Ch3 class=\"wp-block-heading\">\u003Cstrong>4. Software as a Medical Device (SaMD)\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\n\u003Cp>Software as a Medical Device (SaMD) is \u003Ca href=\"https:\u002F\u002Fwww.imdrf.org\u002Fsites\u002Fdefault\u002Ffiles\u002Fdocs\u002Fimdrf\u002Ffinal\u002Ftechnical\u002Fimdrf-tech-131209-samd-key-definitions-140901.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">defined by the International Medical Device Regulators Forum (IMDRF)\u003C\u002Fa> as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. Examples \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fsoftware-medical-device-samd\u002Fwhat-are-examples-software-medical-device\" target=\"_blank\" rel=\"noreferrer noopener\">range from\u003C\u002Fa> smartphone apps that allow radiological images to be read for diagnostic purposes, to bespoke software that interfaces with medical devices such as a glucose monitor to assess the readings. \u003C\u002Fp>\n\n\n\n\u003Cp>With the increasing reliance on companion or even standalone software in the digital health age, the use of SaMD \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fdigital-health-center-excellence\u002Fsoftware-medical-device-samd\" target=\"_blank\" rel=\"noreferrer noopener\">continues to increase\u003C\u002Fa>. Regulators are expected to assess this increasing volume of software in a timely manner, but restructuring at the FDA might not facilitate this task. This can result in a slower pace of innovation in commercially-available SaMD which might otherwise assist patients and physicians.\u003C\u002Fp>\n\n\n\n\u003Ch3 class=\"wp-block-heading\">\u003Cstrong>5. 3D printing\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\n\u003Cp>The FDA’s CDRH \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002F3d-printing-medical-devices\u002Ffdas-role-3d-printing\" target=\"_blank\">also evaluates 3D-printed medical devices\u003C\u002Fa> to determine safety and effectiveness. 3D printing \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002F3d-printing-in-medicine-and-healthcare\" target=\"_blank\">has been a promising\u003C\u002Fa> approach in healthcare for decades but their rate of market availability has been stifled by regulatory hurdles. With the CDRH’s reduced capacity, this digital health area is likely to slow down further, preventing widespread access to products such as \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Ffuture-3d-printing-drugs-pharmacies-closer-think\u002F\" target=\"_blank\">3D printed drugs\u003C\u002Fa> to facilitate medication adherence and \u003Ca rel=\"noreferrer noopener\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002F3d-printing-in-medicine-and-healthcare\" target=\"_blank\">3D printed biomaterials\u003C\u002Fa> to replace failing organs.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-embed aligncenter 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=\"The Ultimate List of What We Can 3D Print in Healthcare - The Medical Futurist\" width=\"640\" height=\"360\" src=\"https:\u002F\u002Fwww.youtube.com\u002Fembed\u002F9XYLRaVqzNY?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\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>Will another agency take over the FDA’s lead?\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>The recent layoffs at the FDA do not (hopefully) presage the demise of the agency. Its importance is widely recognized, as reflected by lobbyists who aided towards the rehiring of some employees. \u003C\u002Fp>\n\n\n\n\u003Cp>“The disarray caused by the wholesale termination of a wide swath of device centre staff was counterproductive and appears to have caused a variety of unintended and negative results,” \u003Ca href=\"https:\u002F\u002Fapnews.com\u002Farticle\u002Ffda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702\" target=\"_blank\" rel=\"noreferrer noopener\">said Steve Silverman\u003C\u002Fa>, a former FDA device official who now runs a consulting firm. “It’s encouraging to see a shift in the opposite direction that recognizes the critical expertise of these staffers.”\u003C\u002Fp>\n\n\n\n\u003Cp>However, this state of affairs adds a sense of uncertainty to what has been, so far, considered the world’s leading and most forward-looking regulatory agency in medicine and healthcare. The prevailing notion of potential future layoffs could further make current FDA employees \u003Ca href=\"https:\u002F\u002Fwww.raps.org\u002Fnews-and-articles\u002Fnews-articles\u002F2025\u002F2\u002Fexperts-fda-layoffs-will-slow-device-reviews,-impa\" target=\"_blank\" rel=\"noreferrer noopener\">more risk-averse\u003C\u002Fa> and more cautious about making controversial approval decisions.\u003C\u002Fp>\n\n\n\n\u003Cp>As a result, other agencies might take over the FDA’s role in pushing innovations further. The European Union’s \u003Ca href=\"https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fabout-us\" target=\"_blank\" rel=\"noreferrer noopener\">European Medicines Agency\u003C\u002Fa> (EMA), established in 1995, could be an option with its decades of experience and collaboration across member states. However, there \u003Ca href=\"https:\u002F\u002Fwww.euractiv.com\u002Fsection\u002Fhealth-consumers\u002Fnews\u002Fstudy-highlights-eus-fragmented-access-to-new-medicine\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">remains a fragmentation\u003C\u002Fa> in individual states regarding access to new therapies. \u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-embed aligncenter 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=\"EMA Working for every patient in Europe - (multi-language)\" width=\"640\" height=\"360\" src=\"https:\u002F\u002Fwww.youtube.com\u002Fembed\u002FkuCuWSLslGI?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>Such fragmentation might persist, with other agencies such as China’s \u003Ca href=\"https:\u002F\u002Fenglish.nmpa.gov.cn\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">National Medical Products Administration\u003C\u002Fa> (NMPA) and the more recent \u003Ca href=\"https:\u002F\u002Fwww.nepad.org\u002Fmicrosite\u002Fafrican-medicines-agency-ama\" target=\"_blank\" rel=\"noreferrer noopener\">African Medicines Agency\u003C\u002Fa> (AMA) leading innovation in specific digital health fields, rather than the sector as a whole. This further reflects the uncertainties brought upon by the recent “move fast and break things” principle brought to key agencies like the FDA. As a consequence, it is worth contemplating a future where other agencies take up the mantle of leaders in digital health innovation.\u003C\u002Fp>\n\n\n\n\u003Cp>\u003Cem>Written by Dr. Bertalan Meskó & Dr. Pranavsingh Dhunnoo\u003C\u002Fem>\u003C\u002Fp>\n",false,{"rendered":22,"protected":20},"\u003Cp>In the early days of Facebook, the company’s progress was guided by the “move fast and break things” principle. To a certain extent, this was […]\u003C\u002Fp>\n",16,58589,"closed",true,"","standard",{"_acf_changed":20,"footnotes":27},[31,32,33,34,35,36],7079,504,521,490,800,799,[],[],[],[41,42,43,44,45],1571,1617,1681,4859,5067,[47,14,48,49,50,51,52,53,54,55,56,57,58],"post-58581","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tmf","category-artificial-intelligence","category-future-medicine","category-future-of-pharma","category-healthcare-policy","category-security-privacy",{"id":24,"alt_text":27,"caption":27,"description":27,"media_type":60,"media_details":61,"post":5,"source_url":101},"image",{"width":62,"height":63,"file":64,"filesize":65,"sizes":66,"image_meta":98},2316,1302,"2025\u002F03\u002Ftmf-fda-layoffs.jpg",398001,{"medium":67,"large":74,"thumbnail":80,"medium_large":85,"1536x1536":86,"2048x2048":92},{"file":68,"width":69,"height":70,"mime-type":71,"filesize":72,"source_url":73},"tmf-fda-layoffs-370x208.jpg",370,208,"image\u002Fjpeg",12317,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ftmf-fda-layoffs-370x208.jpg",{"file":75,"width":76,"height":77,"mime-type":71,"filesize":78,"source_url":79},"tmf-fda-layoffs-768x432.jpg",768,432,33802,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ftmf-fda-layoffs-768x432.jpg",{"file":81,"width":82,"height":82,"mime-type":71,"filesize":83,"source_url":84},"tmf-fda-layoffs-150x150.jpg",150,4712,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ftmf-fda-layoffs-150x150.jpg",{"file":75,"width":76,"height":77,"mime-type":71,"filesize":78,"source_url":79},{"file":87,"width":88,"height":89,"mime-type":71,"filesize":90,"source_url":91},"tmf-fda-layoffs-1536x864.jpg",1536,864,107937,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ftmf-fda-layoffs-1536x864.jpg",{"file":93,"width":94,"height":95,"mime-type":71,"filesize":96,"source_url":97},"tmf-fda-layoffs-2048x1151.jpg",2048,1151,190107,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ftmf-fda-layoffs-2048x1151.jpg",{"aperture":99,"credit":27,"camera":27,"caption":27,"created_timestamp":99,"copyright":27,"focal_length":99,"iso":99,"shutter_speed":99,"title":27,"orientation":99,"keywords":100},"0",[],"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2025\u002F03\u002Ftmf-fda-layoffs.jpg",{"subtitle":27,"key_takeaways":103,"cta_type":27,"cta_color":27,"related_books":20,"related_posts_footer":20,"related_posts":20},[104,106,108],{"title":105},"\u003Cp>Recently, the US Food and Drug Administration (FDA) experienced widespread layoffs in key departments overseeing the safety of digital health technologies.\u003C\u002Fp>\n",{"title":107},"\u003Cp>We consider 5 digital health areas that could be the most impacted by such restructuring.\u003C\u002Fp>\n",{"title":109},"\u003Cp>The events also raise an air of uncertainty about the FDA’s leading role in regulating the medical space and encouraging innovation; raising the question of whether other agencies could take up its role.\u003C\u002Fp>\n",{"yoast_wpseo_title":111,"yoast_wpseo_metadesc":27,"yoast_wpseo_canonical":15},"5 Digital Health Areas To Be Impacted By The FDA Layoffs - The Medical Futurist",{"self":113,"collection":119,"about":122,"author":125,"replies":128,"version-history":131,"predecessor-version":135,"wp:featuredmedia":139,"wp:attachment":142,"wp:term":145,"curies":161},[114],{"href":115,"targetHints":116},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F58581",{"allow":117},[118],"GET",[120],{"href":121},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts",[123],{"href":124},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Ftypes\u002Fpost",[126],{"embeddable":26,"href":127},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fusers\u002F16",[129],{"embeddable":26,"href":130},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcomments?post=58581",[132],{"count":133,"href":134},3,"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F58581\u002Frevisions",[136],{"id":137,"href":138},58595,"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F58581\u002Frevisions\u002F58595",[140],{"embeddable":26,"href":141},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fmedia\u002F58589",[143],{"href":144},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fmedia?parent=58581",[146,149,152,155,158],{"taxonomy":147,"embeddable":26,"href":148},"category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcategories?post=58581",{"taxonomy":150,"embeddable":26,"href":151},"post_tag","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Ftags?post=58581",{"taxonomy":153,"embeddable":26,"href":154},"project_category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fproject_category?post=58581",{"taxonomy":156,"embeddable":26,"href":157},"contact_email_category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcontact_email_category?post=58581",{"taxonomy":159,"embeddable":26,"href":160},"yst_prominent_words","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fyst_prominent_words?post=58581",[162],{"name":163,"href":164,"templated":26},"wp","https:\u002F\u002Fapi.w.org\u002F{rel}",[],[],1786367708440]