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

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 methodo...

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Autores principales: Denecke, Kerstin, May, Richard, Gabarron, Elia, Lopez-Campos, Guillermo H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10608744/
https://www.ncbi.nlm.nih.gov/pubmed/37888134
http://dx.doi.org/10.3390/jpm13101523
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author Denecke, Kerstin
May, Richard
Gabarron, Elia
Lopez-Campos, Guillermo H.
author_facet Denecke, Kerstin
May, Richard
Gabarron, Elia
Lopez-Campos, Guillermo H.
author_sort Denecke, Kerstin
collection PubMed
description 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.
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spelling pubmed-106087442023-10-28 Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas Denecke, Kerstin May, Richard Gabarron, Elia Lopez-Campos, Guillermo H. J Pers Med Article 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. MDPI 2023-10-23 /pmc/articles/PMC10608744/ /pubmed/37888134 http://dx.doi.org/10.3390/jpm13101523 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Denecke, Kerstin
May, Richard
Gabarron, Elia
Lopez-Campos, Guillermo H.
Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas
title Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas
title_full Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas
title_fullStr Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas
title_full_unstemmed Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas
title_short Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas
title_sort assessing the potential risks of digital therapeutics (dtx): the dtx risk assessment canvas
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10608744/
https://www.ncbi.nlm.nih.gov/pubmed/37888134
http://dx.doi.org/10.3390/jpm13101523
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