{"id":6030,"date":"2021-09-20T10:30:09","date_gmt":"2021-09-20T08:30:09","guid":{"rendered":"https:\/\/www.tauli.cat\/institut\/?p=6030"},"modified":"2025-11-05T11:14:43","modified_gmt":"2025-11-05T10:14:43","slug":"global-trends-in-digital-therapeutics","status":"publish","type":"post","link":"https:\/\/www.tauli.cat\/institut\/actualitat\/vigilancia-tecnologica\/2021\/09\/global-trends-in-digital-therapeutics\/","title":{"rendered":"Global Trends in Digital Therapeutics","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column]<h3 class=\"eut-element eut-align-left eut-title-no-line\" style=\"\"><span>Introduction: Understanding DTx<\/span><\/h3>[vc_column_text]<span style=\"font-weight: 400;\">We have heard and read in many sites that Digital health is becoming more present in the health field. But, this term includes many others like Digital Therapeutics (DTx), that is a subset of Digital Health, the topic about what this article talks about. Here you will find a study on the state of the art of existing solutions, classification, indications, regulatory, challenges and opportunities and more.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">DTx is here to stay, and many institutions like hospitals and pharmaceutical companies are increasing their interest for DTx, where there is a s<\/span><span style=\"font-weight: 400;\">pecial use in chronic and behavioral disorders. <\/span><span style=\"font-weight: 400;\">But, nowadays i<\/span>t is tough to separate unproven or low-value applications from those with proven therapeutic value. <span style=\"font-weight: 400;\">Evidence on safety and efficacy are difficult to obtain what represent big barriers to access the market, but many opportunities are just around the corner.<\/span><\/p>\n<p>But, before entering in the report, it is important to first clarify the differences between some topics that could create confusion, because sometimes they sound very similar and are used interchangeably, let&#8217;s see the differences between Digital health, Digital medicine and Digital Therapeutics. Once understood this easy or difficult differences we could dive in the DTx world that is such an adventure and a land to discover.[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;The differences between Digital Health, Digital medicine and Digital Tx&#8221; tab_id=&#8221;1627284084718-d2827831-b805&#8243;][vc_single_image image=&#8221;6221&#8243; img_size=&#8221;full&#8221; add_caption=&#8221;yes&#8221; alignment=&#8221;center&#8221; onclick=&#8221;zoom&#8221; css_animation=&#8221;none&#8221;][vc_column_text]<span style=\"font-weight: 400;\">Digital therapeutics are not only disruptive to the healthcare system through facilitating remote patient management and personalized treatment, they also have the potential to impact on healthcare cost, regulatory processes, and the way pharmaceutical companies will do businesses and clinical trials. In the following diagram is shown how Digital Tx are prescribed:<\/span>[\/vc_column_text][vc_single_image image=&#8221;6234&#8243; img_size=&#8221;full&#8221; add_caption=&#8221;yes&#8221; alignment=&#8221;center&#8221; onclick=&#8221;zoom&#8221;][vc_column_text][\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Understanding DTx&#8221; tab_id=&#8221;1624264067114-11305369-f975&#8243;][vc_column_text]<strong>DTx subclassification<\/strong><\/p>\n<p>During the search on internet we have found two ways to classificate the existing DTx solutions:<\/p>\n<ul>\n<li><strong>Based on its target product profile<\/strong><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">DTx can be distinguished based on the primary function. Each DTx treatment belongs to one of the following categories:<\/span><\/p>\n<table style=\"border-collapse: collapse; width: 100.016%;\">\n<tbody>\n<tr>\n<td style=\"width: 23.5408%; text-align: center;\"><b>Address a medical condition<\/b><\/td>\n<td style=\"width: 26.5614%; text-align: center;\"><b>Manage or prevent a medical disorder or disease<\/b><\/td>\n<td style=\"width: 23.6987%; text-align: center;\"><b>Optimize medication<\/b><\/td>\n<td style=\"width: 31.4391%; text-align: center;\"><b>Treat a medical disease or disorder<\/b><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 23.5408%; text-align: center;\"><img decoding=\"async\" loading=\"lazy\" class=\"\" src=\"https:\/\/i.pinimg.com\/originals\/ae\/71\/94\/ae71944af758dd36185e7e9e1009dc41.png\" alt=\"Descarga ahora este icono en formato SVG, PSD, PNG, EPS o como fuente para web. Flaticon, la mayor base de datos de i\u2026 | Iconos, Crear iconos, Degradados de colores\" width=\"148\" height=\"148\" \/><\/p>\n<p>Source: <a href=\"https:\/\/www.pinterest.es\/pin\/658088564294423969\/\">link<\/a><\/td>\n<td style=\"width: 26.5614%; text-align: center;\"><img decoding=\"async\" loading=\"lazy\" class=\"\" src=\"https:\/\/icons.iconarchive.com\/icons\/paomedia\/small-n-flat\/512\/house-icon.png\" alt=\"House Icon | Small &amp;amp; Flat Iconset | paomedia\" width=\"154\" height=\"154\" \/><\/p>\n<p>Source: <a href=\"https:\/\/iconarchive.com\/show\/small-n-flat-icons-by-paomedia\/house-icon.html\">link<\/a><\/td>\n<td style=\"width: 23.6987%; text-align: center;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6330\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Rec-300x295.png\" alt=\"\" width=\"152\" height=\"150\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Rec-300x295.png 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Rec.png 384w\" sizes=\"(max-width: 152px) 100vw, 152px\" \/><\/p>\n<p>Source: <a href=\"https:\/\/kit8.net\/icons\/iconstrations\/medical-treatment\/\">link<\/a><\/td>\n<td style=\"width: 31.4391%; text-align: center;\"><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6329 alignnone\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Ra-296x300.png\" alt=\"\" width=\"141\" height=\"144\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Ra-296x300.png 296w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Ra.png 357w\" sizes=\"(max-width: 141px) 100vw, 141px\" \/><\/p>\n<p>Source: <a href=\"https:\/\/kit8.net\/icons\/iconstrations\/medical-treatment\/\">link<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li><strong>Based on how they complement other treatments<\/strong><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Another way to classificate Digital Tx is regarding how they can be used:<\/span><\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 48px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"width: 33.3333%; height: 24px; text-align: center;\"><strong>Standalone<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 24px; text-align: center;\"><strong>Augment<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 24px; text-align: center;\"><strong>Complementary<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 33.3333%; text-align: center;\"><img decoding=\"async\" loading=\"lazy\" class=\"\" src=\"https:\/\/encrypted-tbn0.gstatic.com\/images?q=tbn:ANd9GcTQvH5j6lCOIUny7BGWDGxSCcuviWkWOeS35g&amp;usqp=CAU\" alt=\"smartphone digital consultation medical and health care block style icon 2553209 Vector Art at Vecteezy\" width=\"165\" height=\"165\" \/><\/p>\n<p>Source: <a href=\"https:\/\/www.vecteezy.com\/vector-art\/2553209-smartphone-digital-consultation-medical-and-health-care-block-style-icon\">link<\/a><\/td>\n<td style=\"width: 33.3333%; text-align: center;\"><strong><img decoding=\"async\" loading=\"lazy\" class=\"\" src=\"https:\/\/media.istockphoto.com\/vectors\/business-graph-growth-progress-and-blue-arrow-vector-id450233085?b=1&amp;k=6&amp;m=450233085&amp;s=612x612&amp;w=0&amp;h=sjjbWDsrOA_t0NPP8JgXtV4UHKbTzJm63bOEHLhzSzA=\" alt=\"growth chart - 37 Free Vectors to Download | FreeVectors\" width=\"221\" height=\"150\" \/><\/strong><\/p>\n<p>Source: <a href=\"https:\/\/www.freevectors.net\/free-vectors\/growth-chart\">link<\/a><\/td>\n<td style=\"width: 33.3333%; text-align: center;\"><strong><img decoding=\"async\" loading=\"lazy\" class=\"alignnone\" src=\"https:\/\/image.flaticon.com\/icons\/png\/512\/786\/786771.png\" alt=\"Puzzle - Free gaming icons\" width=\"129\" height=\"129\" \/><\/strong><\/p>\n<p>Source: <a href=\"https:\/\/www.flaticon.com\/free-icon\/puzzle_786771\">link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 33.3333%; height: 24px; text-align: center;\"><span style=\"font-weight: 400;\">Standalone DTx can work individually or even replace pharmacological interventions and they can be used at the same time with other treatments.<\/span><\/td>\n<td style=\"width: 33.3333%; height: 24px; text-align: center;\"><span style=\"font-weight: 400;\">Augment DTx are made to work at the same time with pharmacological interventions to augment existing therapies.<\/span><\/td>\n<td style=\"width: 33.3333%; height: 24px; text-align: center;\"><span style=\"font-weight: 400;\">Complement DTx improving selfmanagement of the condition and related healthcare factors as they work in combination with drugs. Complement with medications, devices, and other therapies to engage patients and improve the overall quality, cohesion, outcomes, and value of how care is delivered.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">DTx is a novel category of therapeutic options. In addition to existing pharmacological, non-pharmacological (surgical, radiation, and physical), and psycho-behavioral therapy, it can cover therapeutic areas that have previously not been well described. However, the current stages of most DTx-based products correspond to the convenient replacement of already existing treatment settings, such as that for cognitive behavioral therapy (CBT) and reminiscence therapy. The conceptual position of DTx in relation to the existing therapeutic options is represented in the following figure. (5)<\/span>[\/vc_column_text][vc_single_image image=&#8221;6235&#8243; img_size=&#8221;medium&#8221; add_caption=&#8221;yes&#8221; alignment=&#8221;center&#8221; css_animation=&#8221;none&#8221;][vc_column_text]<strong>What is and what is not DTx<\/strong><\/p>\n<p>Another interesting way to analyze DTx is trying to understand what is and what is not a DTx solution, evaluating different elements.<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 48px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"width: 9.43201%; height: 24px; text-align: center;\"><\/td>\n<td style=\"width: 49.7201%; text-align: center; height: 24px;\"><strong>YES\u00a0<\/strong><\/td>\n<td style=\"width: 40.8478%; text-align: center; height: 24px;\"><strong>NO<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 9.43201%; text-align: center;\"><b>Functioning<\/b><\/td>\n<td style=\"width: 49.7201%; text-align: center;\"><span style=\"font-weight: 400;\">Relies on algorithms for its mechanism of action as well as the algorithmic information management.<\/span><\/td>\n<td style=\"width: 40.8478%; text-align: center;\"><span style=\"font-weight: 400;\">A tool that not prevents, manages, or treats medical disorders or diseases.\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 9.43201%; text-align: center;\"><b>Indications<\/b><b><br \/>\n<\/b><\/td>\n<td style=\"width: 49.7201%; text-align: center;\"><span style=\"font-weight: 400;\">Focused on one condition. It can be used independently or in combination with other treatment modalities.<\/span><\/td>\n<td style=\"width: 40.8478%; text-align: center;\"><span style=\"font-weight: 400;\">It is focused on various conditions.<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 9.43201%; text-align: center;\"><b>Regulatory<\/b><b><br \/>\n<\/b><\/td>\n<td style=\"width: 49.7201%; text-align: center;\"><span style=\"font-weight: 400;\">It needs to assure that it is safe and proven therapeutic value by evidence.<\/span><\/td>\n<td style=\"width: 40.8478%; text-align: center;\"><span style=\"font-weight: 400;\">Unsubstantiated claims about clinical benefits<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 9.43201%; text-align: center;\"><b>Way to access to the market<\/b><\/td>\n<td style=\"width: 49.7201%; text-align: center;\"><span style=\"font-weight: 400;\">B2B2C<\/span><\/td>\n<td style=\"width: 40.8478%; text-align: center;\"><span style=\"font-weight: 400;\">B2C<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 9.43201%; text-align: center;\"><b>Performance indicators<\/b><\/td>\n<td style=\"width: 49.7201%; text-align: center;\">Efficacy and safety<\/td>\n<td style=\"width: 40.8478%; text-align: center;\"><span style=\"font-weight: 400;\">Number of users, usage, direct turnover<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 9.43201%; text-align: center;\"><b>Reimbursement<\/b><b>\u00a0<\/b><\/td>\n<td style=\"width: 49.7201%; text-align: center;\"><span style=\"font-weight: 400;\">It can be reimbursed by payer<\/span><\/td>\n<td style=\"width: 40.8478%; text-align: center;\"><span style=\"font-weight: 400;\">It can be subscribed by consumers.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][vc_column_text][\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Mechanisms of action for DTx&#8221; tab_id=&#8221;1623246650428-e9132e0d-d467&#8243;][vc_column_text]<strong>Comparing Digital Tx vs. Pharmacotherapy<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">The similarity between pharmacotherapy and DTx is that <strong>they are both medical treatment methods<\/strong>.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">However, <strong>the fundamental difference<\/strong> is that the therapeutic effects of DTx are present in the <strong>absence of an active substance in the systemic circulation<\/strong>. Therefore, all pharmacokinetic (PK)\/pharmacodynamic (PD) parameters related to plasma concentrations cannot be derived and used for response optimization. However, <strong>similar exposure concepts not based on concentrations can be applied<\/strong>. The dosage, frequency, time (total amount of used time and\/or completed percentage out of required sessions), or modules can be all regarded as the exposure of DTx.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The comparisons between pharmacotherapy and DTx from the point of view of clinical pharmacology are summarized in the following table. In this table, there are several fundamental characteristics of DTx that do not apply to conventional pharmacology. However, there is an opportunity to <strong>apply pharmacology concepts by quantitative modeling (pharmacometrics)<\/strong>, <strong>because the input and response variables of DTx are all digitally implemented and quantifiable.<\/strong> (11)<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Exposure-response relationship of digital therapeutics<\/strong><\/p>\n<p><span style=\"font-weight: 400;\"><strong>Exposure-response relationship is a core principle of clinical pharmacology for developing optimal drug therapy<\/strong>. However, there are few dose-response studies related to DTx. In the near future, the use of pharmacometrics for the exploration of dose-response relationships, and real-world big data analysis will spread widely because DTx can generate large data that can be used for pharmacometrics analysis.<\/span>[\/vc_column_text][vc_single_image image=&#8221;6244&#8243; img_size=&#8221;full&#8221; add_caption=&#8221;yes&#8221; alignment=&#8221;center&#8221; onclick=&#8221;zoom&#8221; css_animation=&#8221;none&#8221;][vc_column_text]<strong>Exposure-response relationship of digital therapeutics<\/strong><\/p>\n<p><span style=\"font-weight: 400;\"><strong>Exposure-response relationship is a core principle of clinical pharmacology for developing optimal drug therapy<\/strong>. However, there are few dose-response studies related to DTx. In the near future, the use of pharmacometrics for the exploration of dose-response relationships, and real-world big data analysis will spread widely because DTx can generate large data that can be used for pharmacometrics analysis.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Market landscape&#8221; tab_id=&#8221;1627294248001-ae1f09be-ab97&#8243;][vc_column_text]<strong>Market landscape of DTx<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">The value of the global DTx market is estimated at <strong>USD 1.8 billion in 2018<\/strong>, which is expected <strong>to reach USD 7.1 billion by 2025<\/strong>. A recent report estimates the biggest applications for DTx to be diabetes and weight loss shortly, with other applications likely to be observed in conditions such as chronic obstructive pulmonary disorder (COPD), developmental disorders (with the use of computer games), and post-traumatic stress disorder.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The arrival of DTx is reforming the landscape for new medicines, product reimbursement, and regulatory surveillance. As a result, <strong>new data-sharing processes and payment models will be formed soon to incorporate these products into the broader treatment plans and regulatory structure for drug and device approvals<\/strong>. Recently, there has been a massive investment of USD 12.5 billion in digital health ventures. (7)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When we define the market landscape, it is always useful to analyze the <strong>stakeholders involved<\/strong>. In the following graphic, there are identified the main stakeholders which who the DTx companies will need to interact or offer a value proposal along their development and implementation plan in order to arrive patients:<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6236 aligncenter\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Digital-Tx-scheme-300x170.jpg\" alt=\"\" width=\"418\" height=\"237\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Digital-Tx-scheme-300x170.jpg 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Digital-Tx-scheme-768x436.jpg 768w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Digital-Tx-scheme.jpg 810w\" sizes=\"(max-width: 418px) 100vw, 418px\" \/><\/p>\n<p style=\"text-align: center;\">Source: 2019 DOI: 10.12793\/tcp.2019.27.1.6. Jae-Yong Chung. Digital therapeutics and clinical pharmacology<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Market drivers in Digital Tx<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Appart from the stakeholders in the market landscape, <strong>several elements are origining that Digital Tx will become more present in the upcoming future<\/strong>. This is possible due the following market drivers (9):<\/span>[\/vc_column_text]<div class=\"eut-element eut-image-text\" style=\"\"><div class=\"eut-image\"><img width=\"1280\" height=\"850\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/office-620822_1280.jpg\" class=\"attachment-full size-full\" alt=\"\" decoding=\"async\" loading=\"lazy\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/office-620822_1280.jpg 1280w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/office-620822_1280-300x199.jpg 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/office-620822_1280-1200x797.jpg 1200w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/office-620822_1280-768x510.jpg 768w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/office-620822_1280-1024x680.jpg 1024w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" \/><\/div>  <div class=\"eut-content eut-align-left\"><h6>Growing population of technology users<\/h6>  <p>The increasing internet penetration and growing adoption of smartphones are increasing patient engagement, reducing patient burden, and delivering novel outcomes.<\/p>  <\/div><\/div><div class=\"eut-element eut-image-text\" style=\"\"><div class=\"eut-image\"><img width=\"1920\" height=\"1267\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920.jpg\" class=\"attachment-full size-full\" alt=\"\" decoding=\"async\" loading=\"lazy\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920.jpg 1920w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920-300x198.jpg 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920-1200x792.jpg 1200w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920-768x507.jpg 768w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920-600x396.jpg 600w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/surgery-1807541_1920-1536x1014.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/div>  <div class=\"eut-content eut-align-left\"><h6>Increased emphasis on cost-effective healthcare<\/h6>  <p>The DTx market grew due to industry needs for cost-effectiveness, safety, and increasing emphasis on preventive healthcare.<\/p>  <\/div><\/div><div class=\"eut-element eut-image-text\" style=\"\"><div class=\"eut-image\"><img width=\"640\" height=\"480\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/woman-100343_640.jpg\" class=\"attachment-full size-full\" alt=\"\" decoding=\"async\" loading=\"lazy\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/woman-100343_640.jpg 640w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/woman-100343_640-300x225.jpg 300w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/div>  <div class=\"eut-content eut-align-left\"><h6>Rising aging population<\/h6>  <p>The burden of diseases has moved from tackling infectious diseases to managing long-term conditions such as diabetes, CVD, and cancer.<\/p>  <\/div><\/div><div class=\"eut-element eut-image-text\" style=\"\"><div class=\"eut-image\"><img width=\"640\" height=\"426\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/money-2180330_640.jpg\" class=\"attachment-full size-full\" alt=\"\" decoding=\"async\" loading=\"lazy\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/money-2180330_640.jpg 640w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/money-2180330_640-300x200.jpg 300w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/div>  <div class=\"eut-content eut-align-left\"><h6>Significant investments in DTx<\/h6>  <p>Pharmaceutical companies, medical technology companies, and payers will invest more in DTx as their adoption will see significant growth.<\/p>  <\/div><\/div><div class=\"eut-element eut-image-text\" style=\"\"><div class=\"eut-image\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920.jpg\" class=\"attachment-full size-full\" alt=\"\" decoding=\"async\" loading=\"lazy\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920.jpg 1920w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920-300x200.jpg 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920-1200x800.jpg 1200w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920-768x512.jpg 768w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920-600x400.jpg 600w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/whiteboard-849811_1920-1536x1024.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/div>  <div class=\"eut-content eut-align-left\"><h6>Increased focus on value-based healthcare models<\/h6>  <p>The global health sector is becoming more focused on patient outcomes, and payment for value not volume. <\/p>  <\/div><\/div><div class=\"eut-element eut-image-text\" style=\"\"><div class=\"eut-image\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920.jpg\" class=\"attachment-full size-full\" alt=\"\" decoding=\"async\" loading=\"lazy\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920.jpg 1920w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920-300x200.jpg 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920-1200x800.jpg 1200w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920-768x512.jpg 768w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920-600x400.jpg 600w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/09\/darts-102919_1920-1536x1024.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/div>  <div class=\"eut-content eut-align-left\"><h6>Focus on prevention and precision medicine<\/h6>  <p>DTx brings precision to therapy and the ability to personalize treatment, giving them an important role to play in the transition from the traditional fee-for-service to value-based care.<\/p>  <\/div><\/div>[vc_column_text]<strong>Intellectual Protection Strategies<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">In the rapidly developing, highly competitive digital health industry, you can thing that the use of patents could be the &#8220;option&#8221;, but in this DTx industry there are two relevant elements to strategically protect the solution:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"><strong>Brand protection<\/strong><br \/>\nBrand protection will confer to the project a special, recognziable and differentiator aspect to ease the market access. For that reason a strong brand protection will also offer the opportunity for a great market entry.<br \/>\n<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>Trade secrets to protect technologies<\/strong><br \/>\n<\/span>Trade secrets may protect frequent incremental technological improvements in digital technologies, such as software updates, which may not be regarded as novel or inventive under patent law. Further, as lead time is often a major competitive advantage in the digital health industry, trade secrets can be valuable for pioneering companies to protect their market positions. In addition,\u00a0software, algorithms, and databases underlying digital applications may all be kept secret and fully protected by encryption to prevent reverse engineering by the public after sale.<\/li>\n<\/ul>\n<p><strong>Market access strategies<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Good market access strategy consists of understanding the market access environment, for that reason is important to:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Define standards of safety and efficacy<\/strong> for the healthcare systems and regulatory requirements<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Design clinical trials, with essential efficacy and safety evidence<\/strong> (such as cost-effectiveness)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Collaborate among DTx stakeholders<\/strong>: companies and payers, providers, and pharmaceutical companies<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Identify the unmet needs<\/strong> that a DTx fulfills, and pricing the therapy accordingly<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Analyze the current treatment options<\/strong> and the future competitive landscape<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Some DTx will have the opportunity to be reimbursed through insurance plans in the same way as drugs or medical technologies.<\/span><\/p>\n<p><strong>Reimbursement<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Some DTxs can be reimbursed through insurance depending on the medical benefit they offer, like the case of WellDoc&#8217;s Blue Star and Pear Therapeutics&#8217; reSET. DTx manufactures can give licenses to other interested manufacturers and also there is opportunity of selling data to the same therapeutic field manufacturers for their future development of products.<\/span><\/p>\n<p>There are several reimbursement considerations for DTx to take into account:<\/p>\n<ul>\n<li aria-level=\"1\"><strong>Reimbursement is crucial<\/strong> for DTx to become more adopted in the healthcare system and high in the priorities of payers.<\/li>\n<li aria-level=\"1\">Some DTx will have the <strong>opportunity to be reimbursed through insurance plans<\/strong> in the same way as drugs or medical technologies.<\/li>\n<li aria-level=\"1\"><strong>Current reimbursement models are not suited for all DTx<\/strong>; alternative payment methods, such as an outcome-based payment model, are likely to be more successful and effective for DTx.<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Anyway, there is a widespread uncertainty from healthcare authorities and payers about the value of DTx, due to the nascent state of the market. In many countries, reimbursement is difficult to navigate, often with lengthy processes and unclear requirements. Reimbursement and payment for products are still not widely adopted in clinical practice and this limits DTx <\/span><span style=\"font-weight: 400;\">market access.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/research2guidance.com\/wp-content\/uploads\/2022\/01\/R2G_The-roadmap-to-digital-health-app-reimbursement-in-Europe.png\" \/><\/p>\n<p>Link: https:\/\/research2guidance.com\/where-is-the-money-in-digital-health-the-roadmap-to-digital-health-app-reimbursement-in-europe\/<\/p>\n<p><strong>Platforms to follow the last advances and news<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">The main reference institution in the Digital Tx arena is the Digital Health Alliance: <\/span><a href=\"https:\/\/dtxalliance.org\/join-dta\/\"><span style=\"font-weight: 400;\">https:\/\/dtxalliance.org\/join-dta\/<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><strong>Deals in the Digital Tx arena<\/strong><\/p>\n<p>Some of the examples of real deals that happened between DTx and other companies are represented in the following table:[\/vc_column_text][vc_single_image image=&#8221;6258&#8243; img_size=&#8221;full&#8221; onclick=&#8221;zoom&#8221;][\/vc_tta_section][vc_tta_section title=&#8221;Highlight solutions in medical areas&#8221; tab_id=&#8221;1625210548077-1dd2db72-d009&#8243;][vc_column_text]<span style=\"font-weight: 400;\">The market is evolving through six main therapeutic areas. In the following table is shown the maturity level of the solutions in different therapeutic areas taking into account the different applications of Digital Tx. (12)<\/span>[\/vc_column_text][vc_single_image image=&#8221;6246&#8243; img_size=&#8221;full&#8221; add_caption=&#8221;yes&#8221; onclick=&#8221;zoom&#8221;][vc_column_text]<strong>Solutions landscape in medical areas<\/strong><\/p>\n<p>Several companies found on internet and in the literature have been highlighted. In order to overview the different existing solutions, they have been classified by therapeutic area\/indication:<\/p>\n<p>&nbsp;<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 2200px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"width: 15.8582%; height: 24px; text-align: center;\"><strong>Company<\/strong><\/td>\n<td style=\"width: 62.3016%; height: 24px; text-align: center;\"><strong>Description<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 528px;\">\n<td style=\"width: 15.8582%; height: 10px;\"><img decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-6248 aligncenter\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Welldoc.png\" alt=\"\" width=\"200\" height=\"200\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Welldoc.png 200w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/Welldoc-150x150.png 150w\" sizes=\"(max-width: 200px) 100vw, 200px\" \/><\/td>\n<td style=\"width: 62.3016%; height: 10px;\"><span style=\"font-weight: 400;\"><strong>Metabolism and endocrinology\/Diabetes<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Blue Star was the first digital phone app approved by the FDA to manage diabetes. BlueStar, a DTx developed by WellDoc, provides a 24\/7 platform for delivering real-time education and coaching to guide T2D patients in the self-management of their disease in improving glucose control, by using real-time data and feedback to support healthy behaviors in optimal treatment decisions or pathways.<\/span><\/p>\n<p><a href=\"https:\/\/www.welldoc.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 15.8582%; height: 10px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/theme.zdassets.com\/theme_assets\/1937944\/7a669929bea72cc163e52d4d522321b73cd03d3f.png\" alt=\"Omada Health\" width=\"191\" height=\"45\" \/><\/td>\n<td style=\"width: 62.3016%; height: 10px;\"><span style=\"font-weight: 400;\"><strong>Metabolism and endocrinology\/Diabetes<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">It is a lifestyle modification program for diabetes prevention clinically proven to be more efficacious than lifestyle modifications launched by Omada Health, Canary Health, and Blue Mesa Health. It includes close monitoring of patients in terms of diet, weight, and physical activity and associates them with health coaches, clinicians, or peer groups. This helps to intervene at the time of exacerbations and reduce the frequency of symptoms.<\/span><\/p>\n<p><a href=\"https:\/\/www.omadahealth.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 15.8582%; height: 10px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/mms.businesswire.com\/media\/20201106005270\/en\/754943\/5\/Logo-Pear-Therapeutics-Final.jpg\" alt=\"Pear Therapeutics Announces Publication of Real-World Data Demonstrating Impact of reSET-O\u00ae for Patients with Opioid Use Disorder - Neuro Central\" width=\"173\" height=\"61\" \/><\/td>\n<td style=\"width: 62.3016%; height: 10px;\"><span style=\"font-weight: 400;\"><strong>CNS\/Schizophrenia<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Thrive digital app is used along with antipsychotic medication and targets positive symptoms of schizophrenia.<\/span><\/p>\n<p><a href=\"https:\/\/peartherapeutics.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 120px;\">\n<td style=\"width: 15.8582%; height: 37px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/res.cloudinary.com\/crunchbase-production\/image\/upload\/c_lpad,f_auto,q_auto:eco\/v1488369194\/mq5mbnegksu22gt4pamk.png\" alt=\"Atlantic Therapeutics - Crunchbase Company Profile &amp;amp; Funding\" width=\"184\" height=\"92\" \/><\/td>\n<td style=\"width: 62.3016%; height: 37px;\"><span style=\"font-weight: 400;\"><strong>CNS\/Stress incontinence<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">INNOVO is the first transcutaneous electrical stimulator in women to treat stress urinary incontinence. It offers a safe, clinically effective, and noninvasive choice.<\/span><\/p>\n<p><a href=\"https:\/\/atlantictherapeutics.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 192px;\">\n<td style=\"width: 15.8582%; height: 192px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/mms.businesswire.com\/media\/20200622005733\/en\/689868\/5\/Akili_Logo.jpg\" alt=\"Akili anuncia la aprobaci\u00f3n de la marca CE del tratamiento digital EndeavorRxTM para ni\u00f1os con TDAH \u00bbHablemos de los videojuegos\" width=\"184\" height=\"74\" \/><\/td>\n<td style=\"width: 62.3016%; height: 192px;\"><span style=\"font-weight: 400;\"><strong>Neurology\/ADHD<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Endaavor is an adaptive sensory estimulus software delivered via video games for ADHD, autism, major depressive disorder, multiple sclerosis and inflamatory disesases. First, the U.S. Food and Drug Administration has approved this video game called EndeavorRx as a treatment for children with attention-deficit\/hyperactivity disorder. <\/span><\/p>\n<p><a href=\"https:\/\/www.akiliinteractive.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 264px;\">\n<td style=\"width: 15.8582%; height: 126px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/images.squarespace-cdn.com\/content\/v1\/54740c47e4b0a8f9b2118a04\/1554504566189-526E3VY0IMFEZCFHNG5Q\/ke17ZwdGBToddI8pDm48kOMslC08UqTescu250e2yIBZw-zPPgdn4jUwVcJE1ZvWQUxwkmyExglNqGp0IvTJZUJFbgE-7XRK3dMEBRBhUpyt3ErZkmQF3yBSuY9eNXiplxSKzqrjG_hVPpxliYWKntTrlBrIw0YDLLTlkjJG3dg\/2Morrow-Logo\" alt=\"About \u2014 2Morrow\" width=\"178\" height=\"178\" \/><\/td>\n<td style=\"width: 62.3016%; height: 126px;\"><span style=\"font-weight: 400;\"><strong>Neurology<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">2Morrow is a digital health company focused on delivering wellness and behaviour change programs via smartphone apps for aiding healthcare issues including smoking, vaping, weight, stress\/anxiety, and chronic pain. In Oct 2019, 2Morrow in collaboration with Washington State Department of Health developed and launched its first digital health app for quitting vaping in young and adults.<\/span><\/p>\n<p><a href=\"https:\/\/www.2morrowinc.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td style=\"width: 15.8582%; height: 56px;\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201201005417\/en\/786701\/22\/CT_Lock-up_CMYK_Black.jpg\" alt=\"Click Therapeutics Secures $30M in Growth Capital from K2 HealthVentures to Expand Operations | Business Wire\" \/><\/td>\n<td style=\"width: 62.3016%; height: 56px;\"><span style=\"font-weight: 400;\"><strong>Neurology<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Propietary cognitive and neurobehavioral platform that optimizes user engagement for a variety of indications, including Major depressive disorder (MDD), migraine, insomina and acute coronary syndrome.<\/span><\/p>\n<p><a href=\"https:\/\/www.clicktherapeutics.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 160px;\">\n<td style=\"width: 15.8582%; height: 160px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/www.bighealth.com\/hs-fs\/hubfs\/bighealth-large.png?width=687&amp;name=bighealth-large.png\" alt=\"NHS patient information sheet\" width=\"186\" height=\"41\" \/><\/td>\n<td style=\"width: 62.3016%; height: 160px;\"><span style=\"font-weight: 400;\"><strong>Neurology<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Big Health is an utomated and personalized cognitive behaviroal programs for mental health, including insomnia and anxiety.<\/span><\/p>\n<p><a href=\"https:\/\/www.bighealth.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 184px;\">\n<td style=\"width: 15.8582%; height: 184px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/besafeapp.ca\/sites\/default\/files\/besafe-logo_0.png\" alt=\"Home\" width=\"163\" height=\"59\" \/><\/td>\n<td style=\"width: 62.3016%; height: 184px;\"><span style=\"font-weight: 400;\"><strong>Neurology\/Suicide Prevention App<\/strong><\/span><\/p>\n<p>Besafe is an application for preventing suicide of children or adolescents. As teenagers use smartphones and applications, Besafe app is an effective way to prevent teenagers who are thinking about suicide. The application prevents suicide by transmitting psychology education and offering crisis coping tools, to prevent deliberate self-harm.<\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4748138\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 214px;\">\n<td style=\"width: 15.8582%; height: 214px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/onemindpsyberguide.org\/wp-content\/uploads\/2020\/08\/MoodHacker-1.jpg\" alt=\"MoodHacker Icon\" width=\"175\" height=\"173\" \/><\/td>\n<td style=\"width: 62.3016%; height: 214px;\"><span style=\"font-weight: 400;\"><strong>Neurology<\/strong><\/span><\/p>\n<p>MoodHacker is accessible through a website and mobile application that combines the skills and techniques of positive psychology and cognitive treatment for depression, which is a funding tool for self-management of depression based on Cognitive Behavioral Therapy (CBT). The goal is to motivate employees to work, improve their mood, reduce depressive symptoms, and prevent escalation into clinical depression.<\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4748138\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 184px;\">\n<td style=\"width: 15.8582%; height: 184px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/i.pinimg.com\/originals\/9f\/c4\/02\/9fc4022f18ea2f5585e469bcef59ebaa.jpg\" alt=\"Cognoa for Child Development by Cognoa, Inc. | Child development, Development, Children\" width=\"120\" height=\"120\" \/><\/td>\n<td style=\"width: 62.3016%; height: 184px;\"><span style=\"font-weight: 400;\"><strong>Neurology\/Autism<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">It provides a clinically validated assessment to screen for children&#8217;s risk of developmental delay and autism. It can be used to expedite a diagnosis from clinicians. It also includes personalized activities parents can do with their child, based on their unique strengths and areas for improvement.<\/span><\/p>\n<p><a href=\"https:\/\/cognoa.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 216px;\">\n<td style=\"width: 15.8582%; height: 187px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/d3ueikeqly5swc.cloudfront.net\/mymhealth\/img\/logo\/mymhealth-logo-default.jpg\" alt=\"Digital therapeutics for long-term conditions\" width=\"184\" height=\"45\" \/><\/td>\n<td style=\"width: 62.3016%; height: 187px;\"><span style=\"font-weight: 400;\"><strong>Respiratory\/Asthma<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">The app myCOPD gives patients 24\/7 access to a platform to educate, monitor symptoms, optimize self-management, and improve both their adherence and quality of inhaler administration. The myCOPD self-management plan helps patients understand what medication to take and when.<\/span><\/p>\n<p style=\"text-align: left;\"><a href=\"https:\/\/mymhealth.com\/\">Link<\/a><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 256px;\">\n<td style=\"width: 15.8582%; height: 256px;\"><img decoding=\"async\" src=\"https:\/\/mir-s3-cdn-cf.behance.net\/project_modules\/disp\/f5e7dc86847331.5da618d9c7b69.png\" alt=\"3 AsthmaMD usability studies on Behance\" \/><\/td>\n<td style=\"width: 62.3016%; height: 256px;\"><span style=\"font-weight: 400;\"><strong>Respiratory\/Asthma<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">The free application allows users to easily and quickly log their asthma activity, their medications, causes of their asthma in the form of a diary. Users may share the diary and a color graph chart of their asthma activities with their physicians to be included in their medical records. It combines peak expiratory flow (how fast a person can breathe out air) and symptom data chart. Its main significance is to make it convenient for patients to record their peak flow and data, and take appropriate measures as directed by the doctor. At the same time, researchers can track these data and use it to determine the cause and region of asthma flare formation.<\/span><\/p>\n<p><a href=\"https:\/\/www.asthmamd.org\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 160px;\">\n<td style=\"width: 15.8582%; height: 160px;\"><img decoding=\"async\" src=\"https:\/\/d36w3vgtkvgnsp.cloudfront.net\/69abf25605496554543602f32c38e0b7fe97a3e7.png\" alt=\"Big Health, creators of Sleepio Reviews | Big Health, creators of Sleepio information | Shortlister\" \/><\/td>\n<td style=\"width: 62.3016%; height: 160px;\"><span style=\"font-weight: 400;\"><strong>Sleep\/Insomnia<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">An online therapy program with visual exercises to induce sleep. It claims to replace sleeping pills, being more efficacious and cost-effective.<\/span><\/p>\n<p><a href=\"https:\/\/www.bighealth.com\/sleepio\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 120px;\">\n<td style=\"width: 15.8582%; height: 120px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/mms.businesswire.com\/media\/20201106005270\/en\/754943\/5\/Logo-Pear-Therapeutics-Final.jpg\" alt=\"Pear Therapeutics Announces Publication of Real-World Data Demonstrating Impact of reSET-O\u00ae for Patients with Opioid Use Disorder - Neuro Central\" width=\"167\" height=\"59\" \/><\/td>\n<td style=\"width: 62.3016%; height: 120px;\"><span style=\"font-weight: 400;\"> <strong>Pharmacy\/Curb substance abuse disorder<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">ReSET is used in conjunction with the standard treatment. It claims to improve clinical outcomes by increasing patient&#8217;s adherence to treatment.<\/span><\/p>\n<p><a href=\"https:\/\/peartherapeutics.com\/products\/reset-reset-o\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 408px;\">\n<td style=\"width: 15.8582%; height: 172px;\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201106005270\/en\/754943\/5\/Logo-Pear-Therapeutics-Final.jpg\" alt=\"Pear Therapeutics Announces Publication of Real-World Data Demonstrating Impact of reSET-O\u00ae for Patients with Opioid Use Disorder - Neuro Central\" \/><\/td>\n<td style=\"width: 62.3016%; height: 172px;\"><span style=\"font-weight: 400;\"><strong>Pharma Patient Engagement<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">reSET is a DTx intended to provide Cognitive behavioral therapy (CBT), as an adjunct to a contingency management system to treat Substance Use Disorder (SUD). The app provides CBT through mobile and web-based applications, monitors patient data in real time, and detects behavioral and biological changes in condition regularly.<\/span><\/p>\n<p><a href=\"https:\/\/peartherapeutics.com\/products\/reset-reset-o\/\">Link<\/a><\/td>\n<\/tr>\n<tr style=\"height: 98px;\">\n<td style=\"width: 15.8582%; height: 98px;\"><img decoding=\"async\" src=\"https:\/\/biomaine.org\/wp-content\/uploads\/2018\/07\/Screen-Shot-2018-07-05-at-10.23.15-AM.png\" alt=\"MedRhythms, a Portland-based company that combines sensors, neuroscience and music to help people recover from neurologic injury or disease, exceeds $4M goal in Series A financing round - Bioscience Association of Maine\" \/><\/td>\n<td style=\"width: 62.3016%; height: 98px;\"><span style=\"font-weight: 400;\"><strong>Traumathology &amp; Orthopedics<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Uses neurologic music therapy via a combination of a snesors, music, and AI to measure and improve walking.<\/span><\/p>\n<p><a href=\"https:\/\/www.medrhythms.com\/\">Link<\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 15.8582%;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/www.tuvisionbierzo.com\/wp-content\/uploads\/2021\/02\/logo-wivi-vision.png\" alt=\"Mejora tu rendimiento visual con WiVi - Tu Visi\u00f3n \u00d3ptica Bierzo\" width=\"201\" height=\"109\" \/><\/td>\n<td style=\"width: 62.3016%;\"><strong>Oftalmology<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Cognitive visual function assessment and training of visual dysfunctions providing a personalized plan for each patient and specialist<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Regulatory in Digital Tx solutions&#8221; tab_id=&#8221;1625210995089-ae642bf2-8b41&#8243;][vc_column_text]<strong>Regulatory in DTx<\/strong><\/p>\n<p>The regulatory process works different depending on the countries (information and pictures soruce: 9):<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 280px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"width: 7.1102%; height: 24px;\">Region<\/td>\n<td style=\"width: 49.6816%; height: 24px;\">How does it work there?<\/td>\n<\/tr>\n<tr style=\"height: 256px;\">\n<td style=\"width: 7.1102%; height: 256px;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/b\/b2\/US_flag_large_51_stars.png\/800px-US_flag_large_51_stars.png\" alt=\"Archivo:US flag large 51 stars.png - Wikipedia, la enciclopedia libre\" width=\"106\" height=\"56\" \/><\/td>\n<td style=\"width: 49.6816%; height: 256px;\"><span style=\"font-weight: 400;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6253\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/FDA-300x195.png\" alt=\"\" width=\"409\" height=\"266\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/FDA-300x195.png 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/FDA.png 637w\" sizes=\"(max-width: 409px) 100vw, 409px\" \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\">In its Digital Health Innovation plan, the FDA is piloting a novel risk-based approach to regulating Software as a Medical Device (SaMD) called the Precertification Program,\u00a0 which would enable companies that can demonstrate specific requirements to speed up the approval process. <\/span><span style=\"font-weight: 400;\">This will reduce the time to market.<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 7.1102%;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/ak.picdn.net\/shutterstock\/videos\/15768715\/thumb\/10.jpg\" alt=\"Shutterstock\" width=\"124\" height=\"70\" \/><\/td>\n<td style=\"width: 49.6816%;\"><span style=\"font-weight: 400;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6254\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/EMA-300x185.png\" alt=\"\" width=\"411\" height=\"255\" \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\">The new Medical Devices Regulation 2017\/745 (MDR) replaces the former MDD. The MDR introduces new definitions, classifications, procedural requirement, and rules for medical devices and also intensify and speed up the process of approval. There will be more transparency of information on the benefits for patients, residual risks, and a thorough assessment of the overall risk\/benefit.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Importantly, the new MDR will reclassify some digital technologies from the lowestrisk Class I to Class II+ devices. This reclassification will increase also the standard of evidence required to receive a CE mark, which is a requirement for use and reimbursement in Europe, and will increase post-marketing surveillance expectations from these manufacturers.<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 7.1102%;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/en\/thumb\/a\/ae\/Flag_of_the_United_Kingdom.svg\/1200px-Flag_of_the_United_Kingdom.svg.png\" alt=\"Flag of the United Kingdom - Wikipedia\" width=\"121\" height=\"60\" \/><\/td>\n<td style=\"width: 49.6816%;\"><span style=\"font-weight: 400;\">DTx are not as well-regulated as pharmaceutical products and several challenges are present when it comes to market access and reimbursement, especially for DTx, which are not supported by enough clinical evidence. NICE is still behind compared to the US regulations and FDA guidance and legislation around digital health appraisal and requirements for real-world evidence. Currently NICE, in partnership with NHS, Public Health England, MedCity, and DigitalHealth.London, developed an evidence standards framework for digital health technologies to ensure new technologies are clinically effective and offer economic value.<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 7.1102%;\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter\" src=\"https:\/\/www.curvasenlazadas.com\/wp-content\/uploads\/2011\/03\/japan-flag.jpg\" alt=\"Jap\u00f3n - Curvas Enlazadas\" width=\"119\" height=\"80\" \/><\/td>\n<td style=\"width: 49.6816%;\"><span style=\"font-weight: 400;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6257\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/MHLW-300x185.png\" alt=\"\" width=\"391\" height=\"241\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/MHLW-300x185.png 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/MHLW.png 692w\" sizes=\"(max-width: 391px) 100vw, 391px\" \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\">Japan\u2019s regulatory agency, the Ministry of Health, Labour and Welfare (MHLW) provides marketing authorization and implementing safety standards for medical devices and drugs. In collaboration with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA), an independent agency that is responsible for reviewing drug and medical device applications, assesses new product safety, develops regulations, and monitors postmarket safety.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">DTx are generally reviewed under Marketing Authorization Applications (MAA) and by external advisory experts.<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 7.1102%;\"><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6255 aligncenter\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/China_2-300x177.jpg\" alt=\"\" width=\"124\" height=\"74\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/China_2-300x177.jpg 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/China_2-768x454.jpg 768w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/China_2.jpg 1000w\" sizes=\"(max-width: 124px) 100vw, 124px\" \/><\/td>\n<td style=\"width: 49.6816%;\"><span style=\"font-weight: 400;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6256\" src=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/SAMS-300x184.png\" alt=\"\" width=\"373\" height=\"229\" srcset=\"https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/SAMS-300x184.png 300w, https:\/\/www.tauli.cat\/institut\/wp-content\/uploads\/2021\/06\/SAMS.png 734w\" sizes=\"(max-width: 373px) 100vw, 373px\" \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\">In China, the National Medical Products Administration (NMPA) regulates medical devices, including DTx, within its Department of Medical Device Registration that is responsible for pre-market approvals. The NMPA is a ministry-level organization that is overseen by the State Administration for Market Supervision (SAMS).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Products are also reviewed by Market Authorization Holder (MAH) as they must ensure the quality and meet all applicable requirements, submit self-inspection reports to authorities every year, and maintain their products.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Top challenges and opportunities&#8221; tab_id=&#8221;1627303434861-59e7953b-5831&#8243;][vc_column_text]<strong>TOP 5 Digital Tx Challenges<\/strong><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\"><strong>Clinical evidence for efficacy and safety is still sparse<\/strong><br \/>\nPayers would prefer to offer reimbursement for digital therapy upon achieving better clinical outcomes within a time frame.<\/span><span style=\"font-weight: 400;\"> Now, it is tough to separate unproven or low-value applications from those with proven therapeutic value.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>Cibersecurity<\/strong><br \/>\nThe cibersecurity of patient\u2019s data is a big responsibility for the DTx companies.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>Dose exposure and response<\/strong><br \/>\nThe investigation of dose-response relationships and their application to the designing of optimum therapies is a desirable future direction for DTx. <\/span><span style=\"font-weight: 400;\">Pharmacological concepts need to be applied to the development and optimization of treatment regimens.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>The remote informed consent and who is receiving the treatment<\/strong><br \/>\nIn mobile device based clinical research, the remote informed consent process raises privacy concerns. Hitting the \u201cOK\u201d button by a subject cannot be considered sufficient consent.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>No fast regulatory tracks<\/strong><br \/>\nImplement fastest regulatory tracks for the preparedness of the documentation in order to pass the regulatory approval.\u00a0<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/li>\n<\/ol>\n<p><strong>TOP 5 Digital Tx Opportunities and advantages<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Appart from the challenges that Digital Tx solutions need to overpass, there are also opportunities that due the nature of these solutions can be very present:<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\"><strong>Direct access to patients<\/strong><br \/>\n<\/span><span style=\"font-weight: 400;\">In Practice of Primary Care, DTx offers the physicians an option to provide treatment anywhere and anytime, transcending the physical borders of a clinic or a hospital.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>Personalization of the therapy<\/strong><br \/>\nThe continuous monitoring of patient vitals, can enable primary care physicians to monitor and track response to the prescribed therapies, thereby aiding to provide personalized treatment, for example in conditions such as depression, anxiety, <\/span><span style=\"font-weight: 400;\">chronic diseases such as diabetes, cardiovascular conditions such as hypertension, and pulmonary diseases like Chronic obstructive pulmonary disease (COPD). The life cycle of the DTx can be updated rapidly through regular software updates.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>The VR technology<\/strong><br \/>\nVR in DTx applies simulation to enable people to learn by experiencing real-world situations. For example, through VR, patients go into situations and learn how to think, feel, and act differently.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong> DTx is generally considered safe<\/strong><br \/>\nThe DTx solutions don\u2019t have to produce toxicity or other associated side effects.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Costs optimization<\/strong><br \/>\nMinimizes costs and time associated with attending a hospital or doctor\u2019s clinic and<\/span><span style=\"font-weight: 400;\"> administrative tasks and routine communication, that could be focused on more time spent on treating patients.\u00a0<\/span><\/li>\n<\/ol>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Evaluating Digital Tx solutions&#8221; tab_id=&#8221;1627303994335-4a7c2329-bf29&#8243;][vc_column_text]<strong>Tips to evaluate utility Digital Tx solutions<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">DTx are required to have certain standards to be able to integrate into the healthcare systems. Let\u2019s try to do a Health Technology Assessment and how to differenciate from useful to not useful solutions.<\/span><\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 232px;\">\n<tbody>\n<tr style=\"height: 272px;\">\n<td style=\"width: 29.5322%; height: 82px;\"><strong>Clinical Evidence-Based Therapeutic Benefit<\/strong><\/td>\n<td style=\"width: 70.4678%; height: 82px;\">\n<ul style=\"list-style-type: circle;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">DTx must demonstrate measurable therapeutic benefit through randomized control trials (RCT).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Either replace a drug or augment the therapeutic benefit of a drug.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Help patients make positive and sustainable behavior changes that can be as effective as taking medication or more effective.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Collect real-world evidence of patient outcome and have the potential to speed up clinical trials.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Having therapeutic effect, DTx has to show safety.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">DTx should fill an unmet need in the disease space.<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 176px;\">\n<td style=\"width: 29.5322%; height: 89px;\"><strong>Regulatory Approved and Data-Driven<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><\/td>\n<td style=\"width: 70.4678%; height: 89px;\">\n<ul style=\"list-style-type: circle;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Regulatory approval is considered to be a first step towards integration of DTx into the healthcare systems; however, this does not guarantee reimbursement or prescription.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">DTx collects patient data in a secure and meaningful manner, which will ultimately benefit the patient and lead to a more personalized treatment approach.<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 224px;\">\n<td style=\"width: 29.5322%; height: 61px;\"><strong>Accessibility Prescribed and Reimbursed<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><\/td>\n<td style=\"width: 70.4678%; height: 61px;\">\n<ul style=\"list-style-type: circle;\">\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">In order for DTx to reach patients, physicians have to be able to prescribe the product.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">In order for physicians to prescribe DTx, they have to be covered by payers.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Demonstrating cost-effectiveness of DTx can help with coverage by payers.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\" aria-checked=\"false\"><span style=\"font-weight: 400;\">Physician awareness of the DTx products in their therapy area is critical to patient access.<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Digital Tx and Clinical Trials<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">DTx clinical trials are not as linear as drug development and given the nature of software, they need to be agile as time is the key to be successful clinically and commercially. The FDA has recognized this need for a new regulatory approach to evaluate rapidly and provide clearance for DTx to be used in clinical settings. Some of the key features of Digital Tx in clinical trials are:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>DTx trials allow collection of more clinical data<\/strong>, as data can also be collected passively at home compared to site-clinical trials.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Virtual trials can cost half as much<\/strong> per participant compared to a site-based trial.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>They can speed up recruitment rates<\/strong> by making it more convenient to participate in trials.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>DTx could make clinical trials more patient-focused<\/strong> and also increase the opportunities for patient engagement.<\/span><\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Catalan landscape&#8221; tab_id=&#8221;1625211512164-e38aec80-73d3&#8243;][vc_column_text]The BioRegion has seen <strong>significant growth<\/strong> in companies that fall into this\u00a0<a href=\"https:\/\/www.digital.health\/digital-health-landscape\" target=\"_blank\" rel=\"noopener\">subsector<\/a>\u00a0over the past ten years, as well as the amount invested here, as can be seen in the\u00a0<a href=\"https:\/\/informe.biocat.cat\/\" target=\"_blank\" rel=\"noopener\">2020 BioRegion Report\u00a0<\/a>presented in September. While in 2010 there were only about 20 companies, 10 years later there are over 200: or a tenfold increase in number of companies. <strong>Investment in these companies has tripled in recent years, from \u20ac5.1 million in 2016 to \u20ac18.8 million in 2019, according to the report.<\/strong>[\/vc_column_text][vc_single_image image=&#8221;6632&#8243; img_size=&#8221;full&#8221; onclick=&#8221;zoom&#8221;][vc_column_text]This growth reveals the <strong>subsector\u2019s youth<\/strong>, which is 90% startups and has a joint turnover of \u20ac118 million. So, the average company is young, with <strong>under five years in the business<\/strong>, and no more than 10 employees. One important figure:<strong> 21% of these firms were founded and are led by women<\/strong>.<\/p>\n<p>The Report classifies the <strong>DTx solutions<\/strong> in three typologies: Self-Management, Active Monitoring and Treatment. Doing a Zoom in the Treatment DTx companies there are 7:<\/p>\n<table style=\"border-collapse: collapse; width: 100%;\">\n<tbody>\n<tr>\n<td style=\"width: 20.6985%;\"><img decoding=\"async\" src=\"https:\/\/media-exp3.licdn.com\/dms\/image\/C4E0BAQHaXMAuf_j15Q\/company-logo_200_200\/0\/1622811858640?e=2159024400&amp;v=beta&amp;t=_H0w9nwKwNIYJUBW5cLmgGTiOUXf4mNQdlKEfVbnZCc\" alt=\"Virtual Bodyworks | LinkedIn\" \/><\/td>\n<td style=\"width: 79.3015%;\">Virtual Bodyworks specialises in immersive virtual reality with applications in medical and social rehabilitation.<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 20.6985%;\"><img decoding=\"async\" src=\"https:\/\/vrpharma.io\/wp-content\/uploads\/2019\/04\/logo.png\" alt=\"VRPharma - Mejorando la realidad de sus pacientes\" \/><\/td>\n<td style=\"width: 79.3015%;\">It is a Virtual Reality (VR) solution tailored for hospital usage to enhance patient\u2019s experience during medical procedures. Their mission is to decrease patient\u2019s anxiety levels and pain perception with a user-friendly and innovative system.<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 20.6985%;\"><img decoding=\"async\" src=\"https:\/\/psious.com\/wp-content\/uploads\/2020\/02\/imgcache\/Logo-Azul_lqip.jpg\" alt=\"Logo\" \/><\/td>\n<td style=\"width: 79.3015%;\">The Psious platform has more than 70 virtual environments and scenes specially designed to easily work on dozens of pathologies. The therapist can use the tool for multiple techniques (psychoeducation, gradual exposure, systematic desensitization, relaxation, distraction, acceptance and commitment, mindfulness, EMDR \u2026) to work with their patients.<\/p>\n<p>It supports the professional in their care for all kinds of disorders such as anxiety (phobias, panic, agoraphobia, generalized anxiety, public speaking, exams, etc.), attention management, eating disorders, OCD, ADHD, and pain management, among others.<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 20.6985%;\"><img decoding=\"async\" src=\"https:\/\/www.domusvi.es\/blog\/wp-content\/uploads\/2020\/12\/logo_guttmann_setembre-01.jpg\" alt=\"Plataforma terap\u00e9utica Guttmann. - Blog DomusVi\" \/><\/td>\n<td style=\"width: 79.3015%;\">Neuropsychological evaluation composed by a set of methods and techniques that allow to identify, describe and quantify cognitive, behavioral and emotional alterations. This platform allows us to offer effective and efficient personalized treatments for people who have suffered a neurological disorder. Although their fields of action cover a wide spectrum, they could be considered among the most common: stroke, dementia, Alzheimer, Parkinson, multiple sclerosis, schizophrenia, bipolar disorder, intellectual disability, etc.<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 20.6985%;\"><strong><img decoding=\"async\" src=\"https:\/\/assets.website-files.com\/606eac716b29c4d03866669a\/606eac716b29c4f218666764_Limbix%20logo.png\" alt=\"Limbix: Digital therapeutics for adolescent mental health\" \/><\/strong><\/td>\n<td style=\"width: 79.3015%;\">Limbix is an investigational digital therapeutic solution for adolescent depression. If Limbix Spark is FDA cleared it will be the first prescription digital therapeutic designed to support adolescents with depression. Spark is a multi-week cognitive behavioral therapy based program focused on the completion of value-based activities that spark feelings of pleasure or mastery.<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 20.6985%;\"><strong><img decoding=\"async\" src=\"https:\/\/www.tuvisionbierzo.com\/wp-content\/uploads\/2021\/02\/logo-wivi-vision.png\" alt=\"Mejora tu rendimiento visual con WiVi - Tu Visi\u00f3n \u00d3ptica Bierzo\" \/><\/strong><\/td>\n<td style=\"width: 79.3015%;\">WIVI offers a complete cognitive visual function assessment and training of visual dysfunctions providing a personalized plan for each patient and specialist, with freedom of movement, high accuracy, real time measurement at an affordable price using 3D technologies.\u00a0WIVI is a new immersive and interactive product based on 3D visualization and interaction which allows a comfortable and free way to assess the skills and capabilities of the visual system as well as the design and implementation of treatment by appropriate vision training for improvement and standarization. Various elements where images and 3D models are presented simulating different realistic scenarios with different visual challenges.<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 20.6985%;\"><strong><img decoding=\"async\" src=\"https:\/\/www.uab.cat\/Imatge\/647\/851\/Wear_4.jpg\" alt=\"Wear Technologies\" \/><\/strong><\/td>\n<td style=\"width: 79.3015%;\">WeAR Technologies is a spin-off of the Institute of Research in Artificial Intelligence (IIIA CSIC), specialized in the monitoring of patients with mental and physical health problems.<br \/>\nThe device through the combination of artificial intelligence systems and weareble sensors, monitors the therapies that medical centers apply to patients with chronic or persistent health problems. The system optimizes the work of therapists and allows greater control and personalization of the therapies that apply to each patient.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Appart of these companies showed above, there is <strong>a product from the Parc Taul\u00ed Research and Innovation Institute (I3PT)<\/strong> that is in via to be commercialized in order to reach society, either through exploitation and \/ or distribution licenses, or technology transfer agreements is <strong>EPPICS<\/strong>, from English\u00a0<strong><em>Early prevention of the<\/em>\u00a0<em>Post-Intensive Care Syndrome<\/em><\/strong>, aims to develop an innovative technological tool for the prevention of cognitive and emotional disorders associated with PICS. <strong>EPPICS <\/strong>\u00a0is an innovative digital tool based on our previous proof of concept, which will improve patient recovery and comfort during the ICU stay. EPPICS has various exercises for the <strong>prevention of functional alterations at a cognitive and emotional level, and is integrated into a communicator for those patients who do not have the ability to communicate<\/strong>.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;More information&#8221; tab_id=&#8221;1625212108999-ccd9272d-dd88&#8243;][vc_column_text]<strong>Great quotes<\/strong><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><i><span style=\"font-weight: 400;\">\u201cIf we look at major trends, people are living longer, on average, so there\u2019s a rise in chronic diseases associated with aging. Meanwhile, healthcare workers are in short supply, and physicians and nurses do not have enough time for patients. Yet everyone has powerful computers in their pockets that give them access to technology, education, and information. Put all that together, and it\u2019s the perfect moment for digital solutions to come to the market, change behavior, and enhance health outcomes at scale\u201d. <\/span><\/i>\u2013<a href=\"https:\/\/www.linkedin.com\/in\/bjovicevic\/\">Bozidar Jovicevic, Global head of Digital Therapeutics, Sanofi<\/a><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><i><span style=\"font-weight: 400;\">\u201cDTx are not just a toy in a happy meal to sell more pills\u201d \u2014 Anonymous<\/span><\/i><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><i><span style=\"font-weight: 400;\">\u201cReimbursement, commercial distribution and patient\/provider education are the 3 biggest challenges\u201d\u2013 P. Hames, Big Health<\/span><\/i><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Patient health care journey<\/strong><\/p>\n<p>Also it is interesting to know how Digital Tx can be applied depending on the stage of the patient\u2019s disease. In the following table is shown product examples in different therapeutic areas depending the disease\u2019s stage:[\/vc_column_text][vc_single_image image=&#8221;6247&#8243; img_size=&#8221;full&#8221; add_caption=&#8221;yes&#8221; onclick=&#8221;zoom&#8221;][vc_column_text]<strong>Glossary<\/strong><\/p>\n<ul>\n<li><b>E-patients<\/b><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Patients who are \u201cequipped, enabled, empowered, and engaged in their health and healthcare decisions.\u201d[14] Today, the number of e-patients is on the rise. They are better engaged and want to participate in informed decision-making about their care. They expect informed answers for their medical and health technology-related questions from their physicians.[8] In such an aware world, the need for digital health and related tools becomes inevitable.<\/span><\/li>\n<li><b>Hormesis<\/b><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Is defined as a phenomenon in which a harmful substance gives stimulating and beneficial effects to living organisms when the quantity of the harmful substance is small (Sakai, 2006).<\/span><\/li>\n<li><b>Software as medicine or behavioral medicine in a digital format<\/b><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\">Therapeutics mimicking the product development path of pharmaceutical drugs which indicates online or mobile delivery of skills-based psychotherapy techniques.<\/span><\/li>\n<li aria-level=\"1\"><b>Digital services<br \/>\n<\/b>They modify patient behavior and help in driving a clinical outcome, for example, Omada health&#8217;s digital behavior platform for weight loss.<\/li>\n<li aria-level=\"1\"><b>Adjunctive digital therapeutics<br \/>\n<\/b>This tier complements traditional therapeutics, indirectly improving the clinical outcome, for example, Proteus Digital Health&#8217;s Discover medication.<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\"><b>Digital drug replacement<br \/>\n<\/b>They substitute conventional medicine. This requires stringent criteria in terms of clinical trials and the Food and Drug Administration (FDA) review, for example, reSET application for treating substance abuse disorder.<br \/>\nA host of companies are collaborating with health-care providers to shape up various DT programs in different diseases. Most of these initiatives are currently US based, but emerging trends from countries such as Japan, UK, and India are a positive development.<\/li>\n<\/ul>\n<p><strong>Articles and references<\/strong><\/p>\n<ol>\n<li>https:\/\/www.bostonhealthcare.com\/building-evidence-based-value-propositions-digital-therapeutics\/<\/li>\n<li><span style=\"font-weight: 400;\">2020<\/span> <span style=\"font-weight: 400;\">DOI: 10.4103\/jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane<\/span> <span style=\"font-weight: 400;\">Role of digital therapeutics and the changing future of healthcare<\/span><\/li>\n<li><span style=\"font-weight: 400;\">DTA. Digital therapeutics alliance [homepage on the Internet] 2017. Available from: https:\/\/wwwdtxallianceorg\/ Cited 2020 Jan 09.<\/span><\/li>\n<li>https:\/\/www.healthxl.com\/blog\/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference<\/li>\n<li><span style=\"font-weight: 400;\">2019<\/span> <span style=\"font-weight: 400;\">DOI: 10.12793\/tcp.2019.27.1.6. Jae-Yong Chung. Digital therapeutics and clinical pharmacology<\/span><\/li>\n<li><span style=\"font-weight: 400;\">2020 DOI: 10.4103\/jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane Role of digital therapeutics and the changing future of healthcare.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">2020<\/span> <span style=\"font-weight: 400;\">DOI: 10.4103\/jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane<\/span> <span style=\"font-weight: 400;\">Role of digital therapeutics and the changing future of healthcare.<\/span><\/li>\n<li>2020 DOI: 10.4103\/picr.PICR_89_19. Raj Khirasaria, Vikramjit Singh and Angelika Batta. Exploring digital therapeutics: The next paradigm of modern health-care industry<\/li>\n<li><span style=\"font-weight: 400;\">GlobalData_2019_Digital-therapeutics-and-their-impact-on-health-care<\/span><\/li>\n<li><span style=\"font-weight: 400;\">2020<\/span> <span style=\"font-weight: 400;\">DOI: 10.4103\/jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane<\/span> <span style=\"font-weight: 400;\">Role of digital therapeutics and the changing future of healthcare.<\/span><\/li>\n<li>https:\/\/www.researchgate.net\/figure\/Conceptual-comparison-between-pharmacotherapy-and-digital-therapeutics-from-the-point-of_tbl2_332147628<\/li>\n<li>http:\/\/medicinman.net\/2020\/08\/digital-therapeutics-new-frontiers-in-healthcare\/<\/li>\n<li>https:\/\/www.americanbar.org\/groups\/intellectual_property_law\/publications\/landslide\/2019-20\/november-december\/ip-strategies-red-hot-digital-health-industry\/<\/li>\n<li>2020 DOI: 10.4103\/picr.PICR_89_19. Raj Khirasaria, Vikramjit Singh and Angelika Batta. Exploring digital therapeutics: The next paradigm of modern health-care industry<\/li>\n<li>https:\/\/www.bostonhealthcare.com\/building-evidence-based-value-propositions-digital-therapeutics\/<\/li>\n<\/ol>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row]\n<\/div>","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>DTx is here to stay, and many institutions like hospitals and pharmaceutical companies are increasing their interest for DTx, where there is a special use in chronic and behavioral disorders. But, nowadays it is tough to separate unproven or low-value applications from those with proven therapeutic value. Evidence on safety and efficacy are difficult to obtain what represent big barriers to access the market, but many opportunities are just around the corner. Enjoy the read of this brief Digital Therapeutic report!<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":33,"featured_media":6322,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[182],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/posts\/6030"}],"collection":[{"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/comments?post=6030"}],"version-history":[{"count":114,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/posts\/6030\/revisions"}],"predecessor-version":[{"id":20882,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/posts\/6030\/revisions\/20882"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/media\/6322"}],"wp:attachment":[{"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/media?parent=6030"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/categories?post=6030"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.tauli.cat\/institut\/wp-json\/wp\/v2\/tags?post=6030"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}