Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas

Author:

Denecke Kerstin1ORCID,May Richard2ORCID,Gabarron Elia34,Lopez-Campos Guillermo H.5

Affiliation:

1. Department Engineering and Computer Science, Institute Patient-Centered Digital Health, Bern University of Applied Sciences, 3012 Bern, Switzerland

2. Department of Automation and Computer Science, Harz University of Applied Sciences, 38855 Wernigerode, Germany

3. Norwegian Centre for E-Health Research, University Hospital of North Norway, 9019 Tromsø, Norway

4. Department of Education, ICT and Learning, Østfold University College, 1757 Halden, Norway

5. Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University Belfast, Belfast BT9 7BL, UK

Abstract

Motivation: Digital therapeutics (DTX), i.e., health interventions that are provided through digital means, are increasingly available for use; in some countries, physicians can even prescribe selected DTX following a reimbursement by health insurances. This results in an increasing need for methodologies to consider and monitor DTX’s negative consequences, their risks to patient safety, and possible adverse events. However, it is completely unknown which aspects should be subject to surveillance given the missing experiences with the tools and their negative impacts. Objective: Our aim is to develop a tool—the DTX Risk Assessment Canvas—that enables researchers, developers, and practitioners to reflect on the negative consequences of DTX in a participatory process. Method: Taking the well-established business model canvas as a starting point, we identified relevant aspects to be considered in a risk assessment of a DTX. The aspects or building blocks of the canvas were constructed in a two-way process: first, we defined the aspects relevant for discussing and reflecting on how a DTX might bring negative consequences and risks for its users by considering ISO/TS 82304-2, the scientific literature, and by reviewing existing DTX and their listed adverse effects. The resulting aspects were grouped into thematic blocks and the canvas was created. Second, six experts in health informatics and mental health provided feedback and tested the understandability of the initial canvas by individually applying it to a DTX of their choice. Based on their feedback, the canvas was modified. Results: The DTX Risk Assessment Canvas is organized into 15 thematic blocks which are in turn grouped into three thematic groups considering the DTX itself, the users of the DTX, and the effects of the DTX. For each thematic block, questions have been formulated to guide the user of the canvas in reflecting on the single aspects. Conclusions: The DTX Risk Assessment Canvas is a tool to reflect the negative consequences and risks of a DTX by discussing different thematic blocks that together constitute a comprehensive interpretation of a DTX regarding possible risks. Applied during the DTX design and development phase, it can help in implementing countermeasures for mitigation or means for their monitoring.

Publisher

MDPI AG

Subject

Medicine (miscellaneous)

Reference33 articles.

1. Denecke, K.B., Elizabeth, M., and Andre, W.K. (2022). Studies in Health Technology and Informatics, IOS Press.

2. (2021). Technical Specification: Part 2: Health Software—Health and Wellness Apps—Quality and Reliability (Standard No. ISO/TS 82304-2). Available online: https://www.iso.org/standard/78182.html.

3. Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance;Crisafulli;Front. Drug Saf. Regul.,2022

4. Web-based intervention programs for depression: A scoping review and evaluation;Renton;J. Med. Internet Res.,2014

5. Anatomy of a Woebot® (WB001): Agent guided CBT for women with postpartum depression;Darcy;Expert Rev. Med. Devices,2022

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