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Characteristics and challenges of the clinical pipeline of digital therapeutics
Open accessAbstract
In this Comment, we characterize the current pipeline of digital therapeutics and offer a clinical perspective into the advantages, challenges, and barriers to implementation of this treatment modality for patient care, which we hope will inform future regulatory policy, prescribing decisions, and scope of real-world evidence collection.
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“Although mobile apps targeting treatment adherence have been understudied, several recent examples have shown promise: AiCure uses a HIPAA-compliant and scalable AI platform to monitor treatment adherence 86,87 ; Mango Health and Health Prize are incentive-based apps to improve access and adherence to prescribed treatments 88,89 ; Medisafe is an app that provides reminders and alerts for users to”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [86]
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Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence.
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Algorithms on regulatory lockdown in medicine
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Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Coravos, A., Doerr, M., Goldsack, J., Manta, C., Shervey, M., Woods, B., & Wood, W. A. (2020) · npj Digital Medicine · doi:10.1038/s41746-020-0237-3 · Cited by 82 · cited 1×
“…of cybersecurity and data rights are preconditions for the mass adoption of DTx. Similar to prior work regarding connected sensors in medicine 16 , as DTx transfer information over the internet, risks of unauthorized access and manipulation of these products and underlying data could…”
Background
Cited by
Sorted by citations
Marwaha, J. S., Landman, A. B., Brat, G. A., Dunn, T., & Gordon, W. J. (2022) · npj Digital Medicine · doi:10.1038/s41746-022-00557-1 · Cited by 241
“We recommend identifying the resources necessary to address five issues: (1) training, (2) IT integration, (3) information security, (4) human capital investment, and (5) adapting existing real-world workflows and EHR workflows to incorporate the new tool.”
MethodModern views of machine learning for precision psychiatry
Chen, Z. S., Kulkarni, P., Galatzer‐Levy, I. R., Bigio, B., Nasca, C., & Zhang, Y. (2022) · Patterns · doi:10.1016/j.patter.2022.100602 · Cited by 247
“Examples that are in development or have received FDA (Food and Drug Administration) approval include treatments for substance use disorder (SUD), ADHD, schizophrenia, ASD, MDD, PTSD, and generalized anxiety disorder (GAD) [250].”
BackgroundDigital therapeutics from bench to bedside
Wang, C., Lee, C., & Shin, H. (2023) · npj Digital Medicine · doi:10.1038/s41746-023-00777-z · Cited by 196
Data Integration Challenges for Machine Learning in Precision Medicine
Martínez-García, M., & Hernández-Lemus, E. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2021.784455 · Cited by 185
“…toward the definition of clinical pipelines in digital therapeutics (loosely defined as evidence based therapeutics basedon software applications to prevent, manage or treat a disease or medical condition) (264), often related with data obtained from wearables and other subject-based sources.”
BackgroundIntroduction of digital therapeutics
Hong, J. S., Wasden, C. L., & Han, D. H. (2021) · Computer Methods and Programs in Biomedicine · doi:10.1016/j.cmpb.2021.106319 · Cited by 163
Integration of personalized drug delivery systems into digital health
Raijada, D. K., Wac, K., Greisen, E., Rantanen, J., & Genina, N. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.113857 · Cited by 142
“The terms and conditions must respect all relevant international and national regulations [169].”
BackgroundWearable devices for continuous monitoring of biosignals: Challenges and opportunities
Stuart, T., Hanna, J., & Gutruf, P. (2022) · APL Bioengineering · doi:10.1063/5.0086935 · Cited by 121
van Kessel, R., Srivastava, D., Kyriopoulos, I., Monti, G., Novillo-Ortiz, D., Milman, R., Zhang-Czabanowski, W. W., Nasi, G., Stern, A. D., Wharton, G., et al. (2023) · JMIR mhealth and uhealth · doi:10.2196/49003 · Cited by 110
“The adoption of digital health solutions within health systems is subject to various factors, including pricing and reimbursement [8,9,11-13].”
BackgroundForbes, A., Keleher, M. R., Venditto, M., & DiBiasi, F. (2023) · Journal of Medical Internet Research · doi:10.2196/43727 · Cited by 102
“These tools offer increased access to treatment (including asynchronous access outside the clinic) [34-36], can reduce stigma concerns [35], and have the potential to be cost-effective [34,37,38].”
Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review
van Kessel, R., Román-Urrestarazu, A., Anderson, M., Kyriopoulos, I., Field, S., Monti, G., Reed, S. D., Pavlova, M., Wharton, G., & Mossialos, E. A. (2023) · Journal of Medical Internet Research · doi:10.2196/48000 · Cited by 109
“There are also factors that influence uptake at the patient level, including digital infrastructure and literacy [2,15-18], and at the health professional level, including lack of training, uncertainties surrounding accountability, and shifts in professional workflow [13,19].”
BackgroundMaqbool, B., & Herold, S. (2023) · Journal of Systems and Software · doi:10.1016/j.jss.2023.111881 · Cited by 133
Digital approaches to enhancing community engagement in clinical trials
Tan, R. K. J., Wu, D., Day, S., Zhao, Y., Larson, H. J., Sylvia, S., Tang, W., & Tucker, J. D. (2022) · npj Digital Medicine · doi:10.1038/s41746-022-00581-1 · Cited by 93
“Speci fi cally, existing regulatory frameworks such as those that govern the use of digital platforms, medical devices or therapeutic approaches may not be favorable for novel approaches in digital health, therefore posing barriers to innovation and adoption 82 .”
BackgroundJeon, E., Yoon, N., & Sohn, S. Y. (2022) · Technological Forecasting and Social Change · doi:10.1016/j.techfore.2022.122130 · Cited by 95
Fürstenau, D., Gersch, M., & Schreiter, S. (2023) · Business & Information Systems Engineering · doi:10.1007/s12599-023-00804-z · Cited by 83
“Companies have partnered with large pharmaceutical companies or attracted significant venture financing: Pear Therapeutics, a company developing a Digital Therapeutic for substance and opioid use disorder, has raised $139 million and Akili Interactive, a company developing a Digital Therapeutic for Attention Deficit H…”
BackgroundInfluentialEccleston, C., Fisher, E., Liikkanen, S., Sarapohja, T., Stenfors, C., Jääskeläinen, S. K., Rice, A. S. C., Mattila, L., Blom, T., & Bratty, J. R. (2022) · Pain · doi:10.1097/j.pain.0000000000002617 · Cited by 64
“The inclusion criteria were (1) adults $18 years of age; (2) reported low back pain for at least 3 months, with average pain intensity of $4/10 over the past week on a 0 to 10 numeric rating scale, Oswestry Disability Index (ODI) of $26%, and medium (34-41) or high (42-68) TampaScale of Kinesiophobia (TSK) score; (3)…”
BackgroundPatient-Centric Product Development: A Summary of Select Regulatory CMC and Device Considerations
Algorri, M., Cauchon, N. S., Christian, T. R., O'Connell, C., & Vaidya, P. (2023) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2023.01.029 · Cited by 52
Clinical Evaluation of Digital Therapeutics: Present and Future
Huh, K. Y., Oh, J., Lee, S., & Yu, K. (2022) · Healthcare Informatics Research · doi:10.4258/hir.2022.28.3.188 · Cited by 51
“The Digital Therapeutic Alliance defines digital therapeutics (DTx) as “evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or diseases” [1,2].”
BackgroundMethodThe role of telehealth startups in healthcare service delivery: A systematic review
Chakraborty, I., Edirippulige, S., & Ilavarasan, P. V. (2023) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2023.105048 · Cited by 47
Eis, S., Solà-Morales, O., Duarte‐Díaz, A., Vidal‐Alaball, J., Perestelo‐Pérez, L., Robles, N., & Carrión, C. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19042186 · Cited by 43
Digital health technologies and major depressive disorder
McIntyre, R. S., Greenleaf, W., Bulaj, G., Taylor, S. T., Mitsi, G., Saliu, D., Czysz, A., Silvesti, G., Garcia, M., & Jain, R. (2023) · CNS Spectrums · doi:10.1017/s1092852923002225 · Cited by 38
“124 CT-152 is a PDT developed by Otsuka Pharmaceutical and Click Therapeutics with the aim to be classified by the US FDA as a SaMD.”
MethodToward Data-Driven Digital Therapeutics Analytics: Literature Review and Research Directions
Lee, U., Jung, G., Ma, E.-Y., Kim, J. S., Kim, H., Alikhanov, J., Noh, Y., & Kim, H. (2023) · IEEE/CAA Journal of Automatica Sinica · doi:10.1109/jas.2023.123015 · Cited by 42
“The coverage of therapeutics includes obesity, prediabetes, hypertension, hyperlipidemia, smokingrelated diseases, chronic pain, chronic obstructive pulmonary disease and asthma, diabetes, alcoholism, coronary artery disease, and serious mental illnesses [17], [18].”
Biskupiak, Z., Ha, V. V., Rohaj, A., & Bulaj, G. W. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13020403 · Cited by 45
“Digital therapies for the treatment of diabetes type 2 were pioneered with the development of DTx BlueStar ® [5,315,316], and showed efficacy in reducing HbA1c [317,318].”
BackgroundMethodInfluentialKim, M., Patrick, K., Nebeker, C., Godino, J., Stein, S., Klasnja, P., Perski, O., Viglione, C., Coleman, A., & Hekler, E. B. (2024) · Journal of Medical Internet Research · doi:10.2196/49208 · Cited by 44
“The aspiration is that DTx can improve a patient’s health outcomes, reduce the burden on health care professionals, and increase access to and usability of interventions [1,5], by providing safe, effective, and equitable support for individual and population health [6].”
Choi, E., Yoon, E.-H., & Park, M.-H. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.986687 · Cited by 37
“Although DTx usually get approval from the regulatory institutions (30), game-based DTx for mental health problems in children and adolescents are an emerging research field where only one game-based DTx (i.”
BackgroundInfluentialExploring the potential of digital therapeutics: An assessment of progress and promise
Armeni, P., Polat, I., Rossi, L. M. D., Diaferia, L., Meregalli, S., & Gatti, A. M. (2024) · Digital Health · doi:10.1177/20552076241277441 · Cited by 42
Digital Therapeutics for Obesity and Eating-Related Problems
Kim, M., & Choi, H. J. (2021) · Endocrinology and Metabolism · doi:10.3803/enm.2021.107 · Cited by 33
“Moreover, adequate RCT with active placebo, evidence-based psychological theory (i.e., CBT), and intervention temporal strategies are other important issues to be considered in developing DTx.”
BackgroundInfluentialOpen challenges in developing digital therapeutics in the United States
Miao, B. Y., Arneson, D. V., Wang, M., & Butte, A. J. (2022) · PLOS Digital Health · doi:10.1371/journal.pdig.0000008 · Cited by 34
“Because DTx are typically administered through consumer devices, such as smartphones or tablets, they also have the potential to bridge significant care gaps created by shortages of specialized health providers and geographic barriers in accessing physical healthcare systems [2], but could also face other obstacles, s…”
BackgroundSelf-citationThe Rise of Prescription Digital Therapeutics in Behavioral Health
Brezing, C., & Brixner, D. I. (2022) · Advances in Therapy · doi:10.1007/s12325-022-02320-0 · Cited by 32
“Nine PDTs are currently authorized by the FDA to treat the behavioral dimensions of conditions such as substance use disorders, attentiondeficit disorder, chronic insomnia, irritable bowel syndrome, and post-traumatic stress disorder [11].”
BackgroundMiao, B. Y., Sushil, M., Xu, A., Wang, M., Arneson, D. V., Berkley, E., Subash, M., Vashisht, R., Rudrapatna, V. A., & Butte, A. J. (2024) · The Lancet Digital Health · doi:10.1016/s2589-7500(23)00244-3 · Cited by 34
Self-citationChallenges With the Use of Digital Sham: Systematic Review and Recommendations
Bos, E., Preller, K. H., Kaur, G., Malhotra, P., Kharawala, S., & Motti, D. (2023) · Journal of Medical Internet Research · doi:10.2196/44764 · Cited by 29
“For DTx that do not fall under the United States Food and Drug Administration enforcement discretion, standard regulatory requirements for class I, II, and III devices apply [8,9].”
InfluentialLee, J., Kim, J., & Ory, M. G. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1471269 · Cited by 29
“Digital health technology is a novel approach to care for mental health conditions whose feasibility and efficacy have been tested in various clinical settings (Jacobson et al., 2019; Naslund et al., 2017; Patel and Butte, 2020).”
BackgroundBulaj, G. W., Clark, J. E., Ebrahimi, M., & Bald, E. M. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.612602 · Cited by 31
“The adjunct digital therapy, reSET ® , has been approved in combination with buprenorphine for opioid use disorder (Patel and Butte, 2020).”
BackgroundMethodResultInfluentialRohaj, A., & Bulaj, G. W. (2023) · Healthcare · doi:10.3390/healthcare11101469 · Cited by 27
Sestino, A., & D’Angelo, A. (2024) · Technological Forecasting and Social Change · doi:10.1016/j.techfore.2024.123526 · Cited by 24
Digital Therapeutics: Virtual Coaching Powered by Artificial Intelligence on Real-World Data
den Akker, H. O., Cabrita, M., & Pnevmatikakis, A. (2021) · Frontiers in Computer Science · doi:10.3389/fcomp.2021.750428 · Cited by 24
Lee, Y. K., Yoon, E.-J., Kim, T. H., Kim, J.-I., & Kim, J.-H. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14238467 · Cited by 29
“Digital therapeutics (DTx) represent a distinct category of regulated, evidence-based software interventions designed to treat, manage, or prevent medical conditions [18,19].”
Miller‐Rosales, C., Morden, N. E., Brunette, M. F., Busch, S. H., Torous, J. B., & Meara, E. R. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.23741 · Cited by 24
Co-Creation in the Development of Digital Therapeutics: A Narrative Review
Mimoso, I., Figueiredo, T., Midão, L., Carrilho, J., Henriques, D. V., Alves, S., Duarte, N. S. C., Bessa, M. J., Facal-Mayo, D., Felpete, A., et al. (2024) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph21121589 · Cited by 20
Kowatsch, T., & Fleisch, E. (2021) · Springer eBooks · doi:10.1007/978-3-030-76897-3_4 · Cited by 23
Giravi, H. Y., Biskupiak, Z., Tyler, L. S., & Bulaj, G. W. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2022.884047 · Cited by 22
“Digital therapeutics (DTx), also known as mobile medical applications, are software-based interventions intended to treat specific medical conditions (16–18).”
BackgroundDigital Therapeutics: Emerging New Therapy for Nonalcoholic Fatty Liver Disease
Zhou, R., Gu, Y., Zhang, B., Kong, T., Zhang, W., Li, J., & Shi, J. (2023) · Clinical and Translational Gastroenterology · doi:10.14309/ctg.0000000000000575 · Cited by 21
Conceptualizing socially-assistive robots as a digital therapeutic tool in healthcare
Stanojević, Č., Bennett, C. C., Šabanović, S., Collins, S., Henkel, K. B., Henkel, Z., & Piatt, J. A. (2023) · Frontiers in Digital Health · doi:10.3389/fdgth.2023.1208350 · Cited by 20
“When fitting all three requirements, a DTx tool can theoretically be an ideal tool to empower both patients and healthcare providers by informing the course of treatment through data-driven interventions, while collecting data in real-time and reducing the number of patient office visits needed (8, 9).”
MethodCumulative Burden of Digital Health Technologies for Patients With Multimorbidity
Phi, N. T. T., Montori, V. M., Kunneman, M., Ravaud, P., & Tran, V.-T. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.7288 · Cited by 19
Digital Intervention for the Management of Alzheimer’s Disease
Manchanda, N., Aggarwal, A., Setya, S., & Talegaonkar, S. (2022) · Current Alzheimer Research · doi:10.2174/1567205020666230206124155 · Cited by 20
Salisbury, J. P. (2021) · JMIR Biomedical Engineering · doi:10.2196/26942 · Cited by 17
“Regarding data rights and governance, manufacturers may employ end user license agreements, terms of service, and privacy policies to establish and convey company and user data rights for monitoring, evaluation, and distribution of collected data [73].”
BackgroundDû, K. L., Septans, A.-L., Maloisel, F., Vanquaethem, H., Schmitt, A., Legoff, M., Clavert, A., Zinger, M., Bourgeois, H. P., Dupuis, O., et al. (2023) · Journal of Medical Internet Research · doi:10.2196/38619 · Cited by 17
“Digital therapeutics have recently emerged, and immersion in virtual reality (VR) environments has demonstrated efficacy in preventing pain and anxiety in phase 2 trials [21-27].”
Ribba, B., Peck, R., Hutchinson, L. G., Bousnina, I., & Motti, D. (2023) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.2989 · Cited by 18
Zion, S. R., Taub, C. J., Heathcote, L. C., Ramiller, A., Tinianov, S., McKinley, M., Eich, G., Penedo, F. J., Ganz, P. A., Antoni, M. H., et al. (2023) · JCO Oncology Practice · doi:10.1200/op.23.00210 · Cited by 16
Shin, H. J., Cho, I. T., Choi, W., Kim, H. R., Kang, M.-B., & Yang, W. (2024) · Journal of Yeungnam Medical Science · doi:10.12701/jyms.2024.01004 · Cited by 15
“plex medical issues [4].”
Therapies go digital. What drives physicians’ acceptance?
Carrera, A., Lettieri, E., Lietti, G., Martignoni, S., Sgarbossa, C., & Cafazzo, J. A. (2024) · PLoS ONE · doi:10.1371/journal.pone.0303302 · Cited by 17
Catania, J., Beaver, S., Kamath, R. S., Worthington, E., Lu, M., Gandhi, H., Waters, H. C., & Malone, D. C. (2024) · JMIR Mental Health · doi:10.2196/57401 · Cited by 16
“…digital mental health (MH) therapeutics, a category of digital MH technologies (DMHTs), have received US Food and Drug Administration (FDA) approval to prevent, manage, or treat a medical disorder or disease based on evidence from superiority trials and compliance with technical guidelines [1,2].”
BackgroundExamining Diversity in Digital Therapeutics Clinical Trials: Descriptive Analysis
Adu-Brimpong, J., Pugh, J., Darko, D. A., & Shieh, L. (2023) · Journal of Medical Internet Research · doi:10.2196/37447 · Cited by 13
“These clinical trials investigate the usability, accessibility, sustainability, and overall benefit among different populations [1,3].”
Bulaj, G. W., Forero, M., & Huntsman, D. D. (2025) · Frontiers in Medicine · doi:10.3389/fmed.2025.1610259 · Cited by 18
Sun, T. H., Yeom, J. W., Choi, K., Kim, J. L., Lee, H., Kim, H. J., & Cho, C. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1169030 · Cited by 14
“DTx is a therapeutic intervention based on scientific evidence and powered by high-quality software programs for preventing, managing and treating medical disorders and diseases (25).”
BackgroundMoravcová, K., Sovová, M., Ožana, J., Karbanová, M., Klásek, J., Kolasińska, A. B., & Sovová, E. (2024) · Nutrients · doi:10.3390/nu16101510 · Cited by 17
“Therefore, the primary challenge in designing DTx lies in ensuring the engaging nature of the therapeutic product and its suitability for diverse groups of patients, including older adults who may be less comfortable with using new technologies [17].”
BackgroundTapia, J. L., Puertas, F. J., & Duñabeitia, J. A. (2023) · Journal of Integrative Neuroscience · doi:10.31083/j.jin2202034 · Cited by 12
Lee, J., Oh, Y., Kim, M., Cho, B., & Shin, J. (2023) · JMIR mhealth and uhealth · doi:10.2196/40834 · Cited by 11
“The US Food and Drug Administration approved several digital health apps, such as those for the management of diabetes (BlueStar) or the treatment of substance use disorder (reSET) [19].”
Gómez-Lumbreras, A., Hurwitz, J. T., Liang, X., Schippers, S., Phillip, K., Bhattacharjee, S., Waters, H. C., & Malone, D. C. (2024) · Journal of Managed Care & Specialty Pharmacy · doi:10.18553/jmcp.2024.30.4.313 · Cited by 12
A comprehensive survey of the clinical trial Landscape on digital therapeutics
Yao, H., Liao, Z., Zhang, X., Zhang, X., Li, M., You, L., & Liu, Y. (2024) · Heliyon · doi:10.1016/j.heliyon.2024.e36115 · Cited by 11
“The focus remains largely centered on the psychiatric field and chronic disease management [10,11].”
BackgroundMarier-Tétrault, E., Bebawi, E., Béchard, S., Brouillard, P., Zuchinali, P., Rémillard, É., Carrier, Z., Jean-Charles, L., Nguyen, J., Lehoux, P., et al. (2024) · JMIR Formative Research · doi:10.2196/53444 · Cited by 17
Digital therapeutics in pain medicine
Lee, H. (2021) · The Korean journal of pain · doi:10.3344/kjp.2021.34.3.247 · Cited by 11
Pana, B. C., Ciufu, N., Ciufu, C., Furtunescu, F., Turcu-Ştiolică, A., & Mazilu, L. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1171699 · Cited by 11
“Consequently, we have witnessed a major rise in the development of digital technologies in the last few years and an increase in healthcare delivery through online settings (3).”
BackgroundTracing Digital Therapeutics Research Across Medical Specialties: Evidence from ClinicalTrials.gov
Masanneck, L., & Stern, A. D. (2024) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.3260 · Cited by 10
“7 Against this backdrop, early real-world studies have shown the potential for DTx to offer large, scalable benefits.”
BackgroundStamatis, C. A., Heusser, A. C., Simon, T. J., Alailima, T., & Kollins, S. H. (2024) · Translational Psychiatry · doi:10.1038/s41398-024-03045-0 · Cited by 11
Kim, S.-Y., Moon, J. Y., Shin, J., Sim, J. Y., Kim, M., & Jang, J. (2022) · Yonsei Medical Journal · doi:10.3349/ymj.2022.63.s56 · Cited by 10
Digital Therapeutics in China: Comprehensive Review
Jiang, N., Yu, X., Yang, Y., Li, G., He, C., Wang, M. P., Tham, Y. C., Wong, T. Y., & Rao, K. (2025) · Journal of Medical Internet Research · doi:10.2196/70955 · Cited by 9
“Unlike traditional pharmaceuticals, DTx leverage digital tools like mobile apps, wearables, and virtual reality to enhance health outcomes [4].”
Zhou, J., Jiang, W., Wang, J., & Dou, J. (2025) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2025.05.028 · Cited by 9
Jeong, W., Oh, G.-S., Oh, S. H., & Whangbo, T. K. (2023) · Journal of Web Engineering · doi:10.13052/jwe1540-9589.2181 · Cited by 9
“Still, they failed to actively research because they did not meet the strict standards of medical device regulatory policies [51].”
BackgroundHamamoto, R., Koyama, T., Takahashi, S., Yasuda, T., Kobayashi, K., Akagi, Y., Kouno, N., Sudo, K., Hirata, M., Sunami, K., et al. (2026) · Journal of Hematology & Oncology · doi:10.1186/s13045-026-01781-y · Cited by 8
“…and maintenance, a quality management approach aligned with the 10 GMLP guiding principles is recommended [205–207], and for adaptive systems, lifecycle change governance (e.g., FDA’s Prede-termined Change Control Plan) can help operationalize safe updates while preserving accountability [208–210].”
Can Digital Therapeutics Open a New Era of Sleep Medicine?
Park, K., Lee, S., & Lee, E. M. (2021) · Chronobiology in Medicine · doi:10.33069/cim.2021.0028 · Cited by 8
“In the US, DTx have been granted approval or cleared by the FDA following submission of superiority trial data via either the de novo or 510(k) pathways, which are traditional regulatory process for medical devices [45].”
BackgroundMethodHuntsman, J. L., & Bulaj, G. W. (2023) · Frontiers in Public Health · doi:10.3389/fpubh.2022.949518 · Cited by 10
Mental Health Problems During COVID-19 and Attitudes Toward Digital Therapeutics
Kwon, M., Jung, Y., Lee, D., & Ahn, J. (2023) · Psychiatry Investigation · doi:10.30773/pi.2022.0150 · Cited by 7
Zang, G. Y., Spira, A. P., Keqin, R. A. O., 吴, 菁., He, Y., Yi, T. A. N. G., & Leiyu, S. H. I. (2025) · Journal of Medical Internet Research · doi:10.2196/73689 · Cited by 10
“The lack of harmonized regulatory standards results in inconsistent prescribing criteria across jurisdictions, which complicates clinical integration and limits the scalability of DTx solutions [62,63].”
Ono, M., & Iwasaki, K. (2022) · Therapeutic Innovation & Regulatory Science · doi:10.1007/s43441-022-00442-9 · Cited by 7
“How therapeutic applications are evaluated (against conventional therapeutics) through clinical studies has not yet been investigated [6].”
BackgroundBae, C., Kim, B.-S., Cho, K., Kim, J., Kim, I.-H., & Kim, J.-H. (2022) · JMIR Formative Research · doi:10.2196/41427 · Cited by 7
“It is a new concept of health care service that is rapidly emerging as a form of new treatment for the prevention, management, and treatment of chronic disease and behavioral modification [13-15].”
BackgroundRomagnoli, A., Zovi, A., Sabbatucci, M., Ferrara, F., & Vitiello, A. (2023) · Journal of Interprofessional Education & Practice · doi:10.1016/j.xjep.2023.100656 · Cited by 7
Ge, Y., Yao, D., Ung, C. O. L., Xue, Y., Li, M., Lin, J., Hu, H., & Lai, Y. (2023) · Journal of Medical Internet Research · doi:10.2196/43812 · Cited by 11
“However, these responsibilities no longer align with market development trends, and the companies can assume more social and corporate responsibilities [45].”
Pfitzer, E., Giger, O.-F., Kausch, C., & Kowatsch, T. (2025) · BMC Health Services Research · doi:10.1186/s12913-025-12748-z · Cited by 6
Chengyu, Z., Xueyan, H., & Feng, Y. (2024) · Digital Health · doi:10.1177/20552076241297064 · Cited by 11
Bélisle‐Pipon, J., & David, P. (2023) · Pharmaceutical Medicine · doi:10.1007/s40290-022-00459-3 · Cited by 6
“Gaps such as lack of specialised healthcare providers and geographic barriers to accessing physical health care systems, or even intolerance or inability to use or access other conventional therapies [36].”
BackgroundTang, J., Song, T., Kuang, M., & Liu, H. (2025) · Therapeutic Advances in Chronic Disease · doi:10.1177/20406223251334439 · Cited by 5
“58 Second, adherence is also a challenge, as patient engagement with digital tools often wanes over time.”
Jeon, E., & Sohn, S. Y. (2022) · IEEE Journal of Biomedical and Health Informatics · doi:10.1109/jbhi.2022.3200692 · Cited by 6
“…companies and their target diseases was retrieved from three sources [31]: the website of the Digital Therapeutics Alliance (DTA) [33], a representative association on digital healthcare [34]; Crunchbase, a database of innovative companies and start-ups [35]; and previous studies [3], [4], [36].”
MethodDigital healthcare: the new frontier of holistic and efficient care
Cha, D. (2023) · Clinical and Experimental Emergency Medicine · doi:10.15441/ceem.23.054 · Cited by 5
“The increasing use of smartphones, wearables, and other connected devices has resulted in a new modality of treatment—digital therapeutics [4,5].”
BackgroundKim, M., Patrick, K., Nebeker, C., Godino, J., Stein, S., Klasnja, P., Perski, O., Viglione, C., Coleman, A., & Hekler, E. B. (2022) · doi:10.31219/osf.io/8t5xy · Cited by 5
Romagnoli, A., Valentino, F., Zovi, A., Caprodossi, A., Vitiello, A., & Ferrara, F. (2023) · Journal of Pharmaceutical Innovation · doi:10.1007/s12247-023-09767-w · Cited by 4
“Additionally, the inconsistent reimbursement policies surrounding DTx present a significant challenge [60]; • Explicability : the lack of comprehension regarding the underlying processes and methods used to develop DTx algorithms often prevents patients and users from understanding and trusting the…”
Bulaj, G. W., Coleman, M., Johansen, B., Kraft, S., Lam, W., Phillips, K., & Rohaj, A. (2024) · Pharmacy · doi:10.3390/pharmacy12040107 · Cited by 4
“…stress disorder (PTSD), diabetes, insomnia, migraine, substance use disorder, heart failure, depression, anxiety, rheumatoid arthritis, cancer, chronic obstructive pulmonary disease (COPD), irritable bowel syndrome (IBS), neurodegenerative and cardiovascular diseases (CVDs), etc. [27,31–36].”
BackgroundDevelopment of a Digital Healthcare Management System for Lower-Extremity Amputees: A Pilot Study
Kim, J. H., Kim, Y. R., Han, M. H., Lee, J., Kim, J. S., Kang, Y. C., Yoon, S. J., Chang, Y., Lee, G., & Cho, N. S. (2022) · Healthcare · doi:10.3390/healthcare11010106 · Cited by 4
Editorial: Computing and artificial intelligence in digital therapeutics
Hu, P., Hu, L., Wang, F., & Mei, J. (2024) · Frontiers in Medicine · doi:10.3389/fmed.2023.1330686 · Cited by 4
Applying the Ethical Data Practices Framework to Digital Therapeutics
Kane, O., & Ferryman, K. (2023) · The American Journal of Bioethics · doi:10.1080/15265161.2023.2256280 · Cited by 3
“…incorporate clinically validated meth-ods such as behavioral therapies into video games, online modules, and smart products (e.g., wearables) to provide supplemental behavioral coaching, self-tracking, and health education to improve symptom management and health outcomes (Patel and Butte 2020).”
BackgroundPatient perceptions of digital and therapist-led CBT for insomnia: A qualitative study
Gumport, N. B., Tully, I. A., Tutek, J., Dietch, J. R., Zulman, D. M., Rosas, L. G., Simpson, N. S., & Manber, R. (2024) · Behavioral Sleep Medicine · doi:10.1080/15402002.2024.2386611 · Cited by 3
“Telehealth can potentially improve patient reach in remote areas (N. A. Patel & Butte, 2020), eliminates travel time (Harvey & Gumport, 2015), and is acceptable to providers (Connolly et al., 2022; McClellan et al., 2020; Molfenter et al., 2021).”
A Holistic Digital Health Framework to Support Health Prevention Strategies in the First 1000 Days
Gabrielli, S., Mayora, O., & Forti, S. (2024) · JMIR Pediatrics and Parenting · doi:10.2196/55235 · Cited by 3
“Both BITs and DTx are DH solutions that can improve health outcomes, reduce burdens on health care professionals, and increase access to and usability of interventions [25,26].”
Compagnone, A. M., & Cole, R. I. (2024) · Elsevier eBooks · doi:10.1016/b978-0-443-23901-4.00013-1 · Cited by 2
Digital Therapeutics: Scientific, Technological, and Regulatory Challenges
Recchia, G., & Gussoni, G. (2023) · Springer eBooks · doi:10.1007/978-3-031-32614-1_4 · Cited by 3
Song, Y., Jeong, I. C., Ryu, S., Lee, S., Koh, J., Jeong, S., Park, S., Kim, M., Lee, W., Rye, O., et al. (2024) · Kidney Research and Clinical Practice · doi:10.23876/j.krcp.23.273 · Cited by 3
“Since the U.S. Food and Drug Administration approved ‘reSET’ for the management of substance use disorder in 2017, a variety of digital therapeutics have emerged and are now widely used in the clinical field [2].”
Kim, S., & Eom, J. (2025) · Digital Health · doi:10.1177/20552076251408866 · Cited by 2
“Hypotheses 1 – 3 relate to digital literacy; hypotheses 4 – 6 address online information trust; hypothesis 7 examines the role of privacy concern; and hypotheses 8a – 8b test the effects of perceived usefulness and ease of use. variables and for validating complex theoretical models such as the…”
Sonobe, T., Ogawa, I., Seki, T., Watanabe, K., Kaneko, Y., Yokota, T., Mawatari, T., Harada, S., Kadowaki, Y., Takenaka, Y., et al. (2026) · JMIR Aging · doi:10.2196/86174 · Cited by 2
“Digital therapeutics (DTx), defined by the Digital Therapeutics Alliance as “evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease” [10], is an area of mobile health that is receiving particular attention [11].”
Desiderata for a New Generation of EHRs for Inclusive Healthcare
Román-Villarán, E., Ammenwerth, E., Wijayaratne, J., & Parra-Calderón, C. L. (2022) · Yearbook of Medical Informatics · doi:10.1055/s-0042-1742507 · Cited by 2
“Digital Therapeutics Alliance has declared digital therapeutics as “evi-dence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease” [48].”
BackgroundJin, W. H., Montoya, C., Rich, B. J., Seldon, C. S., Noy, M. A., Kwon, D., Spieler, B. O., Mahal, B. A. V., Abramowitz, M. C., Yechieli, R. L., et al. (2024) · JMIR Cancer · doi:10.2196/51061 · Cited by 2
“Failures arise when subclinical usage occurs [32].”
Sonobe, T., & Matsumoto, Y. (2025) · JMIR Research Protocols · doi:10.2196/70163 · Cited by 2
“Digital therapeutics (DTx) are an area of mHealth that is receiving particular attention [10].”
Towards a model for understanding failures in health data protection: a mixed-methods study
Pool, J., Akhlaghpour, S., Hassandoust, F., Fatehi, F., & Burton‐Jones, A. (2025) · Behaviour and Information Technology · doi:10.1080/0144929x.2025.2551568 · Cited by 3
“Similarly, emerging trends such as the European Health Data Space (Vayena 2021), Edge Computing and Privacy-Preserving Federated Learning, Virtual Bots (Parmar et al. 2022), and Digital Therapeutics (Patel and Butte 2020), need thorough exploration due to their potential implications in health data protection.”
Metadata
- Authors
- Patel, N. A., & Butte, A. J.
- Affiliations
- University of California, San Francisco (US)
- Corresponding author
- Patel, Nisarg A.
- Venue
- npj Digital Medicine
- Published
- 2020-12-11
- Volume
- 3
- Issue
- 1
- Pages
- 159-159
- ISSN
- 2398-6352 (ISSN-L)
- PMC
- PMC7733514
- OpenAlex
- W3110865436
- Cited by
- 143
- References
- 16
- Citations by year
- 2026: 18 · 2025: 20 · 2024: 27 · 2023: 40 · 2022: 26 · 2021: 11
- FWCI
- 17.40
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- npj Digital Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- eScholarship (California Digital Library) (submittedVersion)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- digital therapeutics, regulatory policy, prescribing decisions, real-world evidence, implementation barriers, digital health products
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