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The regulatory status of health apps that employ gamification

O. Freyer, K.J. Wrona, Q. de Snoeck, M. Hofmann, T. Melvin, A. Stratton-Powell, P. Wicks, A.C. Parks, S. Gilbert, Scientific Reports 14 (2024).

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Freyer, Oscar; Wrona, Kamil JosephFH Bielefeld ; de Snoeck, Quentin; Hofmann, Moritz; Melvin, Tom; Stratton-Powell, Ashley; Wicks, Paul; Parks, Acacia C.; Gilbert, Stephen
Abstract
Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet, it remains unclear whether gamified approaches help to deliver effective, safe, and clinically beneficial products to users. This study examines the compliance of 69 gamified mHealth apps with the EU Medical Device Regulation and assesses the specific risks arising from the gamified nature of these apps. Of the identified apps, 32 (46.4%) were considered non-medical devices; seven (10.1%) were already cleared/approved by the regulatory authorities, and 31 (44.9%) apps were assessed as likely non-compliant or potentially non-compliant with regulatory requirements. These applications and one approved application were assessed as on the market without the required regulatory approvals. According to our analysis, a higher proportion of these apps would be classified as medical devices in the US. The level of risk posed by gamification remains ambiguous. While most apps showed only a weak link between the degree of gamification and potential risks, this link was stronger for those apps with a high degree of gamification or an immersive game experience.
Erscheinungsjahr
Zeitschriftentitel
Scientific Reports
Band
14
Zeitschriftennummer
1
Artikelnummer
21016
eISSN
FH-PUB-ID

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Freyer, Oscar ; Wrona, Kamil Joseph ; de Snoeck, Quentin ; Hofmann, Moritz ; Melvin, Tom ; Stratton-Powell, Ashley ; Wicks, Paul ; Parks, Acacia C. ; u. a.: The regulatory status of health apps that employ gamification. In: Scientific Reports Bd. 14, Springer Science and Business Media LLC (2024), Nr. 1
Freyer O, Wrona KJ, de Snoeck Q, et al. The regulatory status of health apps that employ gamification. Scientific Reports. 2024;14(1). doi:10.1038/s41598-024-71808-2
Freyer, O., Wrona, K. J., de Snoeck, Q., Hofmann, M., Melvin, T., Stratton-Powell, A., … Gilbert, S. (2024). The regulatory status of health apps that employ gamification. Scientific Reports, 14(1). https://doi.org/10.1038/s41598-024-71808-2
@article{Freyer_Wrona_de Snoeck_Hofmann_Melvin_Stratton-Powell_Wicks_Parks_Gilbert_2024, title={The regulatory status of health apps that employ gamification}, volume={14}, DOI={10.1038/s41598-024-71808-2}, number={121016}, journal={Scientific Reports}, publisher={Springer Science and Business Media LLC}, author={Freyer, Oscar and Wrona, Kamil Joseph and de Snoeck, Quentin and Hofmann, Moritz and Melvin, Tom and Stratton-Powell, Ashley and Wicks, Paul and Parks, Acacia C. and Gilbert, Stephen}, year={2024} }
Freyer, Oscar, Kamil Joseph Wrona, Quentin de Snoeck, Moritz Hofmann, Tom Melvin, Ashley Stratton-Powell, Paul Wicks, Acacia C. Parks, and Stephen Gilbert. “The Regulatory Status of Health Apps That Employ Gamification.” Scientific Reports 14, no. 1 (2024). https://doi.org/10.1038/s41598-024-71808-2.
O. Freyer et al., “The regulatory status of health apps that employ gamification,” Scientific Reports, vol. 14, no. 1, 2024.
Freyer, Oscar, et al. “The Regulatory Status of Health Apps That Employ Gamification.” Scientific Reports, vol. 14, no. 1, 21016, Springer Science and Business Media LLC, 2024, doi:10.1038/s41598-024-71808-2.
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