Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development
Abstract
Digital therapeutics represent a new treatment modality in which digital systems such as smartphone apps are used as regulatory‐approved, prescribed therapeutic interventions to treat medical conditions. In this article we provide a critical overview of the rationale for investing in such novel modalities, including the unmet medical needs addressed by digital therapeutics and the potential for reducing current costs of medical care. We also discuss emerging pathways to regulatory approval and how innovative business models are enabling further growth in the development of digital therapeutics. We conclude by providing some recent examples of digital therapeutics that have gained regulatory approval and highlight opportunities for the near future.
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The US Preventive Services Task Force and Agency for Healthcare Research and Quality guidelines have recommended routine screening for depression in healthcare settings to address the under-recognition of depression.
“Over the last two decades, the US Preventive Services Task Force and Agency for Healthcare Research and Quality guidelines have recommended routine screening for depression in healthcare settings to address the under-recognition of depression.23”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
VitalSign 6 software facilitates treatment selection, implementation, and revision for patients with depression.
“VitalSign 6 software facilitates treatment selection, implementation, and revision for patients with depression.23”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
The VitalSign 6 software can be augmented by other models of care (eg, mental health navigation and behavioral activation teletherapy) and offers the potential to add-on research and quality improvement projects.
“The software can be augmented by other models of care (eg, mental health navigation and behavioral activation teletherapy) and offers the potential to add-on research and quality improvement projects.23”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
VitalSign 6 is an EHR-integrated web-based iPad app designed for use in clinics that facilitates screening and diagnosis in patients with depression using the PHQ-2.
“VitalSign 6 is an EHR-integrated web-based iPad app designed for use in clinics that facilitates screening and diagnosis in patients with depression using the two-item version of the Patient Health Questionnaire (PHQ-2).”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
Screening efforts in VitalSign 6 are focused on identifying patients with depression, and there are no additional screening assessments for those who screen negative on the PHQ-2; thus, patients with current suicidality who do not have significant depressive symptoms may be missed.
“Screening efforts are focused on identifying patients with depression, and there are no additional screening assessments for those who screen negative on the PHQ-2; thus, patients with current suicidality who do not have significant depressive symptoms may be missed.”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
The remote patient assessment feature of VitalSign 6 allows patients to complete assessment at home using their own electronic devices, potentially facilitating access to important and timely health data for resource-poor clinics that care for underserved and minority populations.
“In addition, the remote patient assessment feature allows patients to complete the assessment at home using their own electronic devices; this potentially facilitates access to important and timely health data for resource-poor clinics that care for underserved and minority populations.”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
Digital health technologies may help address privacy and security issues, as well as structural or emotional barriers (including stigma) associated with personalized approaches to treating depression.
“Digital health technologies may help address privacy and security issues, as well as the structural or emotional barriers (including stigma) associated with personalized approaches to treating depression.”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
VitalSign 6 data are stored securely, and access to the data is closely monitored to ensure confidentiality.
“For VitalSign, 6 data are stored securely, and access to the data is closely monitored to ensure the confidentiality of these records.”
From Digital health technologies and major depressive disorder (2023) · cites this paper as [23]
Cites
Innovation in the pharmaceutical industry: New estimates of R&D costs
DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016) · Journal of Health Economics · doi:10.1016/j.jhealeco.2016.01.012 · Cited by 3,359 · see citing works
Video game training enhances cognitive control in older adults
Anguera, J. A., Boccanfuso, J., Rintoul, J. L., Al-Hashimi, O., Faraji, F., Janowich, J., Kong, E., Larraburo, Y., Rolle, C., Johnston, E., et al. (2013) · Nature · doi:10.1038/nature12486 · Cited by 1,666 · see citing works
Firth, J., Torous, J., Nicholas, J., Carney, R., Pratap, A., Rosenbaum, S., & Sarris, J. (2017) · World Psychiatry · doi:10.1002/wps.20472 · Cited by 1,097 · see citing works
Collins, L. M., Murphy, S. A., & Strecher, V. (2007) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2007.01.022 · Cited by 1,082 · see citing works
Computer Age Statistical Inference
Efron, B., & Hastie, T. (2016) · Cambridge University Press eBooks · doi:10.1017/cbo9781316576533 · Cited by 926 · see citing works
Firth, J., Torous, J., Nicholas, J., Carney, R., Rosenbaum, S., & Sarris, J. (2017) · Journal of Affective Disorders · doi:10.1016/j.jad.2017.04.046 · Cited by 675 · see citing works
Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction
Redfield, M. M., Anstrom, K. J., Levine, J. A., Koepp, G. A., Borlaug, B. A., Chen, H. H., LeWinter, M. M., Joseph, S. M., Shah, S. J., Semigran, M. J., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1510774 · Cited by 547 · see citing works
Adaptive Designs for Clinical Trials
Bhatt, D. L., & Mehta, C. R. (2016) · New England Journal of Medicine · doi:10.1056/nejmra1510061 · Cited by 504 · see citing works
Dual-task testing to predict falls in community-dwelling older adults: a systematic review
Hunter, S. W., & Wittwer, J. E. (2015) · Physiotherapy · doi:10.1016/j.physio.2015.04.011 · Cited by 285 · see citing works
Smartphone Apps for Schizophrenia: A Systematic Review
Firth, J., & Torous, J. (2015) · JMIR mHealth and uHealth · doi:10.2196/mhealth.4930 · Cited by 268 · see citing works
McConnell, M. V., Shcherbina, A., Pavlovic, A., Homburger, J. R., Goldfeder, R. L., Waggot, D., Cho, M. K., Rosenberger, M. E., Haskell, W. L., Myers, J., et al. (2017) · JAMA Cardiology · doi:10.1001/jamacardio.2016.4395 · Cited by 239 · see citing works
Selmaj, K. W., Li, D. K. B., Hartung, H.-P., Hemmer, B., Kappos, L., Freedman, M. S., Stüve, O., Rieckmann, P., Montalbán, X., Ziemssen, T., et al. (2013) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70102-9 · Cited by 234 · see citing works
Digital medicine's march on chronic disease
Kvedar, J. C., Fogel, A. L., Elenko, E., & Zohar, D. (2016) · Nature Biotechnology · doi:10.1038/nbt.3495 · Cited by 218 · see citing works
Coons, S. J., Eremenco, S. L., Lundy, J. J., O’Donohoe, P., O’Gorman, H., & Malizia, W. (2014) · Patient · doi:10.1007/s40271-014-0090-z · Cited by 213 · see citing works
Sepah, S. C., Jiang, L., & Peters, A. L. (2015) · Journal of Medical Internet Research · doi:10.2196/jmir.4052 · Cited by 206 · see citing works
The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit
Chan, Y.-F. Y., Wang, P., Rogers, L., Tignor, N., Zweig, M., Hershman, S. G., Genes, N., Scott, E. R., Krock, E., Badgeley, M., et al. (2017) · Nature Biotechnology · doi:10.1038/nbt.3826 · Cited by 204 · see citing works
Porto, P. R., Oliveira, L., Mari, J. D. J., Volchan, E., Figueira, I. L. D. V., & Ventura, P. R. (2009) · Journal of Neuropsychiatry · doi:10.1176/jnp.2009.21.2.114 · Cited by 193 · see citing works
Elenko, E., Underwood, L., & Zohar, D. (2015) · Nature Biotechnology · doi:10.1038/nbt.3222 · Cited by 191 · see citing works
Krucoff, M. O., Rahimpour, S., Slutzky, M. W., Edgerton, V. R., & Turner, D. A. (2016) · Frontiers in Neuroscience · doi:10.3389/fnins.2016.00584 · Cited by 188 · see citing works
Cognitive behavioral therapy to aid weight loss in obese patients: current perspectives
Castelnuovo, G., Pietrabissa, G., Manzoni, G. M., Cattivelli, R., Rossi, A., Novelli, M., Varallo, G., & Molinari, E. (2017) · Psychology Research and Behavior Management · doi:10.2147/prbm.s113278 · Cited by 187 · see citing works
Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review
Luik, A. I., Kyle, S. D., & Espie, C. A. (2017) · Current Sleep Medicine Reports · doi:10.1007/s40675-017-0065-4 · Cited by 156 · see citing works
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials
Faris, O., & Shuren, J. E. (2017) · New England Journal of Medicine · doi:10.1056/nejmra1512592 · Cited by 152 · see citing works
Using e-technologies in clinical trials
Rosa, C., Campbell, A. N. C., Miele, G. M., Brunner, M., & Winstanley, E. L. (2015) · Contemporary Clinical Trials · doi:10.1016/j.cct.2015.07.007 · Cited by 147 · see citing works
Adaptive Designs: Terminology and Classification
Dragalin, V. (2006) · Drug Information Journal · doi:10.1177/216847900604000408 · Cited by 142 · see citing works
Orri, M., Lipset, C. H., Jacobs, B. P., Costello, A. J., & Cummings, S. R. (2014) · Contemporary Clinical Trials · doi:10.1016/j.cct.2014.04.009 · Cited by 132 · see citing works
Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation
Iacoviello, B. M., Steinerman, J. R., Klein, D. B., Silver, T. L., Berger, A. G., Luo, S. X., & Schork, N. J. (2017) · JMIR mhealth and uhealth · doi:10.2196/mhealth.7226 · Cited by 115 · see citing works
Doerr, M. J., Truong, A., Bot, B. M., WILBANKS, J. T., Suver, C., & Mangravite, L. M. (2017) · JMIR mhealth and uhealth · doi:10.2196/mhealth.6521 · Cited by 66 · see citing works
Personalized Medicine: Four Perspectives of Tailored Medicine
Ruberg, S. J., & Shen, L. (2015) · Statistics in Biopharmaceutical Research · doi:10.1080/19466315.2015.1059354 · Cited by 61 · see citing works
Moscatiello, S., Luzio, R. D., Bugianesi, E., Suppini, A., Hickman, I. J., Domizio, S. D., Grave, R. D., & Marchesini, G. (2010) · Obesity · doi:10.1038/oby.2010.254 · Cited by 57 · see citing works
Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action
Hirsch, I. B., Martinez, J., Dorsey, E. R., Finken, G., Fleming, A., Gropp, C., Home, P., Kaufer, D., & Papapetropoulos, S. (2017) · Clinical Therapeutics · doi:10.1016/j.clinthera.2017.03.018 · Cited by 57 · see citing works
Digital health revolution: perfect storm or perfect opportunity for pharmaceutical R&D?
Hird, N., Ghosh, S., & Kitano, H. (2016) · Drug Discovery Today · doi:10.1016/j.drudis.2016.01.010 · Cited by 54 · see citing works
Byrom, B., Doll, H., Muehlhausen, W., Flood, E. M., Cassedy, C., McDowell, B., Sohn, J., Hogan, K., Belmont, R., Skerritt, B., et al. (2017) · Value in Health · doi:10.1016/j.jval.2017.10.008 · Cited by 52 · see citing works
Clinical trials for predictive medicine
Simon, R. M. (2012) · Statistics in Medicine · doi:10.1002/sim.5401 · Cited by 50 · see citing works
Building a business model in digital medicine
Steinberg, D., Horwitz, G., & Zohar, D. (2015) · Nature Biotechnology · doi:10.1038/nbt.3339 · Cited by 49 · see citing works
Novel Agents for Relapsing Forms of Multiple Sclerosis
Farber, R. S., Harel, A., & LUBLIN, F. D. (2015) · Annual Review of Medicine · doi:10.1146/annurev-med-052814-023415 · Cited by 42 · see citing works
Heslop, K., Newton, J. L., Baker, C., Burns, G., Carrick‐Sen, D., & Soyza, A. D. (2013) · BMC Pulmonary Medicine · doi:10.1186/1471-2466-13-62 · Cited by 36 · see citing works
Piaserico, S., Marinello, E., Dessi, A., Linder, M., Coccarielli, D., & Peserico, A. (2014) · Acta Dermato Venereologica · doi:10.2340/00015555-2428 · Cited by 34 · see citing works
Gschwind, Y. J., Bridenbaugh, S. A., Reinhard, S., Granacher, U., Monsch, A. U., & Kressig, R. W. (2017) · Aging Clinical and Experimental Research · doi:10.1007/s40520-016-0699-y · Cited by 33 · see citing works
Electroanaesthesia – from torpedo fish to TENS
Francis, J., & Dingley, J. (2014) · Anaesthesia · doi:10.1111/anae.12887 · Cited by 30 · see citing works
Valiani, V., Lauzé, M., Martel, D., Pahor, M., Manini, T. M., Anton, S., & Aubertin-Leheudre, M. (2017) · The Journal of nutrition, health and aging · doi:10.1007/s12603-016-0820-0 · Cited by 30 · see citing works
The Internet of Healthy Things
Colman, C., & Cella, G. (2015) · Cited by 25 · see citing works
Impact of Digital Technologies on Novel Endpoint Capture in Clinical Trials
Clay, I. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.866 · Cited by 23 · see citing works
Lendrem, D. W., Senn, S. J., Lendrem, C., & Isaacs, J. D. (2014) · Pharmaceutical Statistics · doi:10.1002/pst.1653 · Cited by 21 · see citing works
Brauhardt, A., de Zwaan, M., Herpertz, S., Zipfel, S., Svaldi, J., Friederich, H., & Hilbert, A. (2014) · Behaviour Research and Therapy · doi:10.1016/j.brat.2014.07.014 · Cited by 18 · see citing works
Garnefski, N., Kraaij, V., Wijers, E., & Hamming, J. F. (2012) · Journal of Clinical Psychology in Medical Settings · doi:10.1007/s10880-012-9336-x · Cited by 17 · see citing works
mHealth advances clinical research, bit by bit
Kvedar, J. C., & Fogel, A. L. (2017) · Nature Biotechnology · doi:10.1038/nbt.3851 · Cited by 16 · see citing works
Shaking Up Biotech/Pharma: Can Cues Be Taken from the Tech Industry?
Wang, C. K. (2017) · SLAS TECHNOLOGY · doi:10.1177/2472630317698682 · Cited by 2 · see citing works
Abstract TMP44: Personalizing Rehabilitation for Stroke Survivors- A Big Data Approach
Kiran, S., Godlove, J. M., Advani, M., & Anantha, V. (2017) · Stroke · doi:10.1161/str.48.suppl_1.tmp44 · Cited by 2 · see citing works
Nadkarni, N. K., Perera, S., Snitz, B. E., López, O. L., & Klunk, B. E. (2017) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2017.06.184 · Cited by 1 · see citing works
Treatment Options: CBT or Medication?
(2013) · PsycEXTRA Dataset · doi:10.1037/e554172009-001 · Cited by 1 · see citing works
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Personalized medicine: motivation, challenges, and progress
Goetz, L. H., & Schork, N. J. (2018) · Fertility and Sterility · doi:10.1016/j.fertnstert.2018.05.006 · Cited by 976 · see citing works
Introducing artificial intelligence training in medical education
Paranjape, K., Schinkel, M., Nannan Panday, R., Car, J., & Nanayakkara, P. (2019) · JMIR Medical Education · doi:10.2196/16048 · Cited by 634 · see citing works
Role of digital therapeutics and the changing future of healthcare
Dang, A., Arora, D., & Rane, P. (2020) · Journal of Family Medicine and Primary Care · doi:10.4103/jfmpc.jfmpc_105_20 · Cited by 252 · see citing works
Liu, J., Barrett, J. S., Leonardi, E. T., Lee, L., Roychoudhury, S., Chen, Y., & Trifillis, P. (2022) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.2134 · Cited by 126 · see citing works
Triberti, S., Durosini, I., & Pravettoni, G. (2020) · Frontiers in Public Health · doi:10.3389/fpubh.2020.00117 · Cited by 89 · see citing works
Jeon, E., Yoon, N., & Sohn, S. Y. (2022) · Technological Forecasting and Social Change · doi:10.1016/j.techfore.2022.122130 · Cited by 86 · see citing works
Digital therapeutics in the clinic
Phan, P., Mitragotri, S., & Zhao, Z. (2023) · Bioengineering & Translational Medicine · doi:10.1002/btm2.10536 · Cited by 90 · see citing works
Cho, C.-H., Lee, T., Lee, J.-B., Seo, J. Y., Jee, H.-J., Son, S., An, H., Kim, L., & Lee, H.-J. (2020) · doi:10.2196/preprints.21283 · Cited by 69 · see citing works
Exploring digital therapeutics: The next paradigm of modern health-care industry
Khirasaria, R., Singh, V., & Batta, A. (2019) · Perspectives in Clinical Research · doi:10.4103/picr.picr_89_19 · Cited by 60 · see citing works
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Palanica, A., Docktor, M., Lieberman, M., & Fossat, Y. (2020) · Digital Biomarkers · doi:10.1159/000506861 · Cited by 62 · see citing works
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Chung, J. (2019) · Translational and Clinical Pharmacology · doi:10.12793/tcp.2019.27.1.6 · Cited by 57 · see citing works
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Colloud, S., Metcalfe, T., Askin, S., Belachew, S. M., Ammann, J. U., Bos, E., Kilchenmann, T., Strijbos, P. J. L. M., Eggenspieler, D., Servais, L., et al. (2023) · npj Digital Medicine · doi:10.1038/s41746-023-00790-2 · Cited by 56 · see citing works
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Martani, A., Geneviève, L. D., Poppe, C. J., Casonato, C., & Wangmo, T. (2020) · BMC Medical Ethics · doi:10.1186/s12910-019-0443-1 · Cited by 52 · see citing works
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Huh, K. Y., Oh, J., Lee, S., & Yu, K. (2022) · Healthcare Informatics Research · doi:10.4258/hir.2022.28.3.188 · Cited by 51 · see citing works
Kim, E. J., & Kim, J. (2023) · International Neurourology Journal · doi:10.5213/inj.2346108.054 · Cited by 50 · see citing works
Prodan, A., Deimel, L., Ahlqvist, J., Birov, S., Thiel, R., Toivanen, M., Kolitsi, Z., & Kalra, D. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.854665 · Cited by 44 · see citing works
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Fei, Z., Ryeznik, Y., Sverdlov, A., Tan, C. W., & Wong, W. K. (2021) · IEEE Transactions on Big Data · doi:10.1109/tbdata.2021.3103458 · Cited by 41 · see citing works
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Yan, K., Balijepalli, C., & Druyts, E. (2021) · Frontiers in Digital Health · doi:10.3389/fdgth.2021.667016 · Cited by 41 · see citing works
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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 · see citing works
Toward 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 40 · see citing works
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Chisholm, O., & Critchley, H. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2022.1082384 · Cited by 38 · see citing works
Biskupiak, Z., Ha, V. V., Rohaj, A., & Bulaj, G. W. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13020403 · Cited by 42 · see citing works
Polasek, T. M., Rayner, C. R., Peck, R., Rowland, A., Kimko, H. H. C., & Rostami‐Hodjegan, A. (2018) · Clinical Pharmacology in Drug Development · doi:10.1002/cpdd.638 · Cited by 37 · see citing works
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Banerjee, R. K., Shah, N. D., & Dicker, A. P. (2021) · JCO Clinical Cancer Informatics · doi:10.1200/cci.21.00023 · Cited by 38 · see citing works
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Exploring 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 35 · see citing works
Ghaemi, S. N., Sverdlov, O., van Dam, J., Campellone, T. R., & Gerwien, R. W. (2021) · JMIR Formative Research · doi:10.2196/29154 · Cited by 36 · see citing works
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Weinstein, M. M., Dunivan, G., Guaderrama, N. M., & Richter, H. E. (2022) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000004725 · Cited by 34 · see citing works
Hong, W. (2023) · JMIR mhealth and uhealth · doi:10.2196/48803 · Cited by 49 · see citing works
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Cho, C., & Lee, H. (2019) · Psychiatry Investigation · doi:10.30773/pi.2019.01.20 · Cited by 34 · see citing works
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Mois, G., & Fortuna, K. L. (2020) · Journal of Gerontological Social Work · doi:10.1080/01634372.2020.1772436 · Cited by 34 · see citing works
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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 · see citing works
Bulaj, G. W., Clark, J. E., Ebrahimi, M., & Bald, E. M. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.612602 · Cited by 29 · see citing works
Rohaj, A., & Bulaj, G. W. (2023) · Healthcare · doi:10.3390/healthcare11101469 · Cited by 27 · see citing works
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Long, H., Li, S., & Chen, Y. (2023) · Chronic Diseases and Translational Medicine · doi:10.1002/cdt3.68 · Cited by 27 · see citing works
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Gussoni, G., Ravot, E., Zecchina, M., Recchia, G., Santoro, E., R., A., & Perrone, F. (2022) · Annals of Research in Oncology · doi:10.48286/aro.2022.39 · Cited by 23 · see citing works
Deml, M. J., Jungo, K. T., Maessen, M., Martani, A., & Ulytė, A. (2022) · Public health reviews · doi:10.3389/phrs.2022.1604434 · Cited by 27 · see citing works
Ribba, B. (2023) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.1094281 · Cited by 24 · see citing works
Sestino, A., & D’Angelo, A. (2024) · Technological Forecasting and Social Change · doi:10.1016/j.techfore.2024.123526 · Cited by 24 · see citing works
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Saunier, L., Panouilleres, M. T. N., Fetita, C. I., & Preda, M. (2022) · international conference on 3D web technology · doi:10.1145/3564533.3564574 · Cited by 23 · see citing works
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 26 · see citing works
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 · see citing works
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Manchanda, N., Aggarwal, A., Setya, S., & Talegaonkar, S. (2022) · Current Alzheimer Research · doi:10.2174/1567205020666230206124155 · Cited by 20 · see citing works
Application of blended care as a mechanism of action in the construction of digital therapeutics
Netto, A. V. (2020) · Einstein (São Paulo) · doi:10.31744/einstein_journal/2020md5640 · Cited by 18 · see citing works
Izmailova, E. S., Maguire, R. P., McCarthy, T. J., Müller, M. L. T. M., Murphy, P., & Stephenson, D. (2023) · Clinical and Translational Science · doi:10.1111/cts.13461 · Cited by 17 · see citing works
Ribba, B., Peck, R., Hutchinson, L. G., Bousnina, I., & Motti, D. (2023) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.2989 · Cited by 18 · see citing works
Jacobs, F., D’Amico, S., Zazzetti, E., Gaudio, M., Benvenuti, C., Saltalamacchia, G., Gerosa, R., Gentile, D., Lasagna, A., Pedrazzoli, P., et al. (2024) · Digital Health · doi:10.1177/20552076241288821 · Cited by 17 · see citing works
Sverdlov, O., Ryeznik, Y. V., & Wong, W. K. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106397 · Cited by 16 · see citing works
Self-citationRao, G. H. R. (2022) · International Journal of Biomedicine · doi:10.21103/article12(1)_ge · Cited by 15 · see citing works
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 · see citing works
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 14 · see citing works
Hwangbo, N.-K., Woo, K. B., & Kim, S. T. (2023) · Healthcare · doi:10.3390/healthcare11101443 · Cited by 14 · see citing works
Tong, W., Zhang, X., Zeng, H., Pan, J., Gong, C., & Zhang, H. (2024) · JMIR Medical Education · doi:10.2196/48594 · Cited by 19 · see citing works
Bulaj, G. W., Forero, M., & Huntsman, D. D. (2025) · Frontiers in Medicine · doi:10.3389/fmed.2025.1610259 · Cited by 15 · see citing works
The evolution of personalized medicine: literature review
Dolgopolov, I. S., & Rykov, M. Y. (2022) · Research and Practical Medicine Journal · doi:10.17709/2410-1893-2022-9-3-9 · Cited by 13 · see citing works
Sestino, A., Bernardo, A., Rizzo, C., & Bresciani, S. (2023) · European Journal of Innovation Management · doi:10.1108/ejim-08-2023-0633 · Cited by 12 · see citing works
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 · see citing works
Kim, S., Eom, J., & Shim, J. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19159556 · Cited by 11 · see citing works
Davaris, M. T., Bunzli, S., Trieu, J., Dowsey, M. M., & Choong, P. (2022) · ANZ Journal of Surgery · doi:10.1111/ans.17931 · Cited by 11 · see citing works
Digital Therapeutic Device for Urinary Incontinence
Weinstein, M. M., Dunivan, G. C., Guaderrama, N. M., & Richter, H. E. (2022) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000005036 · Cited by 11 · see citing works
Nobel, N. (2021) · Journal of Behavioral Decision Making · doi:10.1002/bdm.2301 · Cited by 10 · see citing works
Rafiei, R., Williams, C., Jiang, J., Aungst, T. D., Durrer, M., Tran, D., & Howald, R. (2021) · JMIR mhealth and uhealth · doi:10.2196/25406 · Cited by 11 · see citing works
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 · see citing works
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 · see citing works
Upton, C. R., Nastasi, J. A., & Raiff, B. R. (2022) · JMIR Serious Games · doi:10.2196/30949 · Cited by 8 · see citing works
The evolution of personalized medicine: publications review
Rykov, M. Y. (2022) · Problems of Social Hygiene Public Health and History of Medicine · doi:10.32687/0869-866x-2022-30-6-1211-1219 · Cited by 8 · see citing works
Athanas, A., McCorrison, J., Campistron, J., Bender, N., Price, J., Smalley, S. L., & Schork, N. J. (2020) · JMIR Mental Health · doi:10.2196/19832 · Cited by 8 · see citing works
Woo, J. H., Kim, E. C., & Kim, S. M. (2022) · Expert Review of Medical Devices · doi:10.1080/17434440.2022.2051479 · Cited by 8 · see citing works
Huntsman, J. L., & Bulaj, G. W. (2023) · Frontiers in Public Health · doi:10.3389/fpubh.2022.949518 · Cited by 10 · see citing works
Moseley, I. H., Roy, A., Deluty, A., & Brewer, J. A. (2020) · Current Addiction Reports · doi:10.1007/s40429-020-00319-7 · Cited by 8 · see citing works
Zang, G. Y., Rao, K., Wu, J., He, Y., Tang, Y., & Shi, L. (2025) · Journal of Medical Internet Research · doi:10.2196/73689 · Cited by 7 · see citing works
Li, M. Y., Chen, Y., Chen, X., Yao, H., & You, L. (2025) · Journal of Medical Internet Research · doi:10.2196/70428 · Cited by 9 · see citing works
Romagnoli, 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 · see citing works
McIntosh, A., Sverdlov, O., Yu, L., & Kaufmann, P. (2021) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.2224 · Cited by 7 · see citing works
Self-citationPersonalized medicine: current trends and prospects
Dolgopolov, I. S., & Rykov, M. Y. (2022) · Rossiyskiy Vestnik Perinatologii i Pediatrii (Russian Bulletin of Perinatology and Pediatrics) · doi:10.21508/1027-4065-2022-67-4-14-21 · Cited by 6 · see citing works
Singh, B. B., Hazra, P., Roy, S., Garg, R., Bhat, S., Patki, N., Gharat, C. H., Patel, K., & Tandel, J. (2023) · Cureus · doi:10.7759/cureus.49628 · Cited by 5 · see citing works
Pani, L., & Becker, K. (2021) · Clinical Drug Investigation · doi:10.1007/s40261-021-01041-6 · Cited by 6 · see citing works
Tang, J., Song, T., Kuang, M., & Liu, H. (2025) · Therapeutic Advances in Chronic Disease · doi:10.1177/20406223251334439 · Cited by 5 · see citing works
Jeon, E., & Sohn, S. Y. (2022) · IEEE Journal of Biomedical and Health Informatics · doi:10.1109/jbhi.2022.3200692 · Cited by 5 · see citing works
The 4P telehealth business framework for Iran
Velayati, F., Ayatollahi, H., Hemmat, M., & Dehghan, R. (2022) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-022-02011-4 · Cited by 5 · see citing works
Rajendran, A., Kella, A., & Narayanasamy, D. (2024) · Cureus · doi:10.7759/cureus.66792 · Cited by 5 · see citing works
Understanding digital therapeutics in disease self-management: A systematic literature review
Yang, L., Zhang, M., Jia, L., Yan, Z., & Yin, Q. (2025) · Technology in Society · doi:10.1016/j.techsoc.2025.102831 · Cited by 7 · see citing works
Liu, X., Li, Y., Yan, R., Hämäläinen, T., Li, D., Liu, S., Zhang, C., Xu, Y. J., Luo, X., & Zhang, B. (2022) · Methods · doi:10.1016/j.ymeth.2022.04.016 · Cited by 5 · see citing works
Digital Technology: The Future Is Bright
Smith, B. P., & Sverdlov, A. (2018) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1092 · Cited by 5 · see citing works
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 · see citing works
Bulaj, G. W., Coleman, M., Johansen, B., Kraft, S., Lam, W., Phillips, K., & Rohaj, A. (2024) · Pharmacy · doi:10.3390/pharmacy12040107 · Cited by 4 · see citing works
Use of a motion‐based digital therapeutic in women with fecal incontinence: A pilot study
Weinstein, M. M., Pulliam, S. J., Keyser, L. E., & Richter, H. E. (2021) · Neurourology and Urodynamics · doi:10.1002/nau.24854 · Cited by 4 · see citing works
PERSONALIZED MEDICINE: AN INNOVATION IN HEALTH-CARE SYSTEM
Khamkat, P., Barık, V., Barik, B. B., MOHAPATRA, S., & Kar, R. K. (2022) · Asian Journal of Pharmaceutical and Clinical Research · doi:10.22159/ajpcr.2022.v15i10.45460 · Cited by 4 · see citing works
Metaverse: a new reality in surgery. Review
Козлов, Ю. А. (2024) · Russian Journal of Pediatric Surgery Anesthesia and Intensive Care · doi:10.17816/psaic1774 · Cited by 4 · see citing works
Mapping research on digital innovation in the health sector: a bibliometric approach
Hegerty, S. W., & Weresa, M. A. (2024) · Economics of Innovation and New Technology · doi:10.1080/10438599.2024.2368130 · Cited by 4 · see citing works
Gadd, S., Tak, C. R., & Bulaj, G. W. (2020) · Journal of Affective Disorders Reports · doi:10.1016/j.jadr.2020.100048 · Cited by 4 · see citing works
Palshikar, A., Gharat, C. H., & Patel, K. (2023) · International Journal of Research in Medical Sciences · doi:10.18203/2320-6012.ijrms20231037 · Cited by 5 · see citing works
Digital Business Model Patterns of Big Pharmaceutical Companies - A Cluster Analysis
Tangour, C., Gebauer, M., Fischer, L., & Winkler, H. (2019) · Lecture notes in business information processing · doi:10.1007/978-3-030-30874-2_31 · Cited by 4 · see citing works
Engagement and Outcomes Associated with Contextual Annotation Features of a Digital Health Solution
DUGAS, M. A., Wang, W., Crowley, K., Iyer, A. K., Peeples, M., Shomali, M. E., & Gao, G. G. (2020) · Journal of Diabetes Science and Technology · doi:10.1177/1932296820976409 · Cited by 4 · see citing works
Cho, I., Kim, B.-H., Lee, H., Song, Y., Chang, M. J., Kim, J., & Han, E. (2025) · Journal of Anxiety Disorders · doi:10.1016/j.janxdis.2025.103074 · Cited by 3 · see citing works
- Authors
- Sverdlov, O., van Dam, J., Hannesdottir, K., & Thornton‐Wells, T.
- Affiliations
- Novartis (United States) (US)
- Novartis Institutes for Biomedical Research Cambridge Massachusetts USA
- Corresponding author
- Sverdlov, Oleksandr
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2018-02-23
- Volume
- 104
- Issue
- 1
- Pages
- 72-80
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W2793903251
- Cited by
- 147
- References
- 50
- Citations by year
- 2026: 11 · 2025: 16 · 2024: 19 · 2023: 31 · 2022: 37 · 2021: 11 · 2020: 13 · 2019: 6 · 2018: 3
- FWCI
- 1.12
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Health Professions › Health Information Management › Health, Technology, Consumer Behavior
- Keywords
- digital therapeutics, drug development, mobile application, regulatory approval, unmet medical needs, health care costs, business models, digital health
- MeSH terms
- Smartphone, Drug Development, Clinical Trials as Topic, Health Services Needs and Demand, Humans, Drug Approval, Precision Medicine, Inventions, Mobile Applications
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