DTx Workshop by Kerstin Denecke and Tobias Kowatsch, MIE2024, Gothenburg, Sweden, 23 May 2023

Today, Prof. Dr. Kerstin Denecke and Tobias Kowatsch conducted a DTx workshop at the Medical Informatics Europe (MIE) 2023 in Gothenburg, Sweden.

Non-communicable diseases (NCDs), such as diabetes, hypertension, asthma, cancer or cardiovascular diseases, and common mental disorders (CMDs) including neurodegenerative diseases such as depression, anxiety or dementia lead to substantial health and economic burdens [1-9]. Risk factors related to NCDs and CMDs are smoking, excessive alcohol consumption, malnutrition, physical inactivity, overweight and obesity, and high levels of blood pressure, cholesterol, and glucose [10-12].

Digital therapeutics (DTx) are “evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease.” [13] DTx have the potential to reduce the burden of NCDs and CMDs [2, 14]. Today, however, DTx are often limited in their scope and usefulness (e.g., DIGAs in Germany [15]) as they focus primarily on one social actor – the patient – and do not consider the orchestration of the broader social system (family, friends, or peers of patients) or more complex care cases that require multiple professions (e.g., patients suffering from multiple NCDs/CMDs) [16]. Especially the latter cases of multi-morbidity are getting increasingly important due to the aging population [3, 4, 17, 18]. These demographic trends also require new DTx technologies that are beyond today’s paradigm of web- or smartphone-based DTx, such as scalable voice assistants [19, 20], to increase access to healthcare services esp. in individuals with physical or mental disabilities. Moreover, the design and evaluation of DTx requires a significant amount of expertise in various areas, such as medicine, health and clinical psychology, software engineering, computer science, ethics, and regulation [21]. Moreover, each DTx requires a robust technology stack that supports DTx designers and other stakeholders, such as physicians, caretakers, and patients.

To this end and as a first step, it is of utmost importance to understand better the requirements for a DTx design and trial service that supports the design of DTx and their efficient evaluation via feasibility studies, optimization trials (e.g., micro-randomized trials), efficacy or effectiveness trials (e.g., randomized controlled trials). This workshop has, therefore, the objective of gathering such requirements by applying the World Café methodology and discussing several complex care scenarios. We welcome participants with various backgrounds (e.g., technical, regulatory, medical, ethical) who bring in different perspectives.

1. Rationale Outcome

The following outcomes are expected:

  1. List of requirements for a DTx design and trial service, esp. for complex care scenarios (immediate outcome)
  2. Scientific article on these requirements (mid-term outcome; interested participants who participate in follow-ups will be offered co-authorship)
  3. Community of experts interested in DTx design and trial services (mid-term outcome)
  4. Collaborative design, implementation, and maintenance of a globally scalable DTx design and trial service (long-term outcome)

2. Program

  1. Introductions (5min, all participants)
  2. Motivating the workshop (15min, workshop chairs)
  3. Requirements gathering with World Café methodology (20 min, all participants, moderation by workshop chairs)
  4. Presentation of the findings (10 min, workshop chairs)
  5. Wrap-up and next steps (10min, workshop chairs)


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[2]     Jacobson N, Kowatsch T, Marsch L, editors. Digital Therapeutics for Mental Health and Addiction: The State of the Science and Vision for the Future. 1st ed. Cambridge, MA, USA: Elsevier, Academic Press; 2023.

[3]     Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, et al. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011;10(4):430-9. Epub 2011/03/16. doi: 10.1016/j.arr.2011.03.003. PubMed PMID: 21402176.

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[10]   WHO. Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Geneva: World Health Organization, 2020.

[11]   Kvedar JC, Fogel AL, Elenko E, Zohar D. Digital medicine’s march on chronic disease. Nat Biotechnol. 2016;34(3):239-46. Epub 2016/03/11. doi: 10.1038/nbt.3495. PubMed PMID: 26963544.

[12]   Katz DL, Frates EP, Bonnet JP, Gupta SK, Vartiainen E, Carmona RH. Lifestyle as Medicine: The Case for a True Health Initiative. Am J Health Promot. 2018;32(6):1452-8. Epub 2017/05/20. doi: 10.1177/0890117117705949. PubMed PMID: 28523941.

[13]   DTA. Digital Therapeutics Definition and Core Principles 2019 [9 February 2023]. Available from: https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf.

[14]   Kowatsch T, Fleisch E. Digital Health Interventions. In: Gassmann O, Ferrandina F, editors. Connected Business: Create Value in a Networked Economy. Cham: Springer International Publishing; 2021. p. 71-95.

[15]   FIDMD. The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V: A Guide for Manufacturers, Service Providers and Users. 2020.

[16]   Kowatsch T, Schachner T, Harperink S, Dittler U, Xiao G, Stanger C, et al. Conversational Agents as Mediating Social Actors in Chronic Disease Management Involving Healthcare Professionals, Patients, and Family Members: Intervention Design and Results from a Multi-site, Single-arm Feasibility Study. Journal of medical Internet research. 2021;23(2). doi: 10.2196/25060.

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[19]   Bérubé C, Fleisch E. Voice-based conversational agents for sensing and support: Examples from academia and industry. In: Jacobson N, Kowatsch T, Marsch LA, editors. Digital Therapeutics for Mental Health and Addiction. Cambridge, MA, USA: Elsevier; 2023.

[20]   Bérubé C, Schachner T, Keller R, Fleisch E, v. Wangenheim F, Barata F, et al. Voice-based Conversational Agents for the Prevention and Management of Chronic and Mental Conditions: A Systematic Literature Review. Jounral of Medical Internet Research. 2021;23(3). doi: 10.2196/25933.

[21]   Kowatsch T, Otto L, Harperink S, Cotti A, Schlieter H. A design and evaluation framework for digital health interventions. it – Information Technology. 2019;61(5-6):253-63. doi: 10.1515/itit-2019-0019.

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